What is nabumetone?

Nabumetone is a nonsteroidal anti-inflammatory drug (NSAID). Nabumetone works by reducing hormones that cause inflammation and pain in the body.

Nabumetone is used to relieve the symptoms of rheumatoid arthritis or osteoarthritis.

Nabumetone may also be used for purposes not listed in this medication guide.

Nabumetone side effects

Get emergency medical help if you have signs of an allergic reaction (hives, sneezing, runny or stuffy nose, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Nabumetone may cause serious side effects. Stop using nabumetone and call your doctor at once if you have:

• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• the first sign of any skin rash, no matter how mild;
• signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems–nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems–little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
• low red blood cells (anemia)–pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of nabumetone may include:

• stomach pain, indigestion, nausea;
• diarrhea, constipation, gas;
• swelling in your hands and feet;
• headache, dizziness;
• itching, skin rash; or
• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA

Warnings

Nabumetone can increase your risk of fatal heart attack or stroke. Do not use nabumetone just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Nabumetone may also cause stomach or intestinal bleeding, which can be fatal.

Before taking this medicine

Nabumetone can increase your risk of fatal heart attack or stroke, even if you don’t have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Nabumetone may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using nabumetone, especially in older adults.

You should not use nabumetone if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Tell your doctor if you have ever had:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a heart attack, stroke, or blood clot;
• stomach ulcers or bleeding;
• asthma;
• liver or kidney disease; or
• fluid retention.

If you are pregnant, you should not take nabumetone unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

You should not breastfeed while using this medicine.

Nabumetone is not approved for use by anyone younger than 18 years old.

How should I take nabumetone?

Follow all directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Use the lowest dose that is effective in treating your condition.

You may take nabumetone with or without food.

If you use nabumetone long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Nabumetone dosing information

Usual Adult Dose for Osteoarthritis:

Initial dose: 1000 mg orally once a day
Maintenance dose: 1500 to 2000 mg orally per day in 1 or 2 divided doses
Maximum dose: 2000 mg/day

Comments:
-Patients weighing less than 50 kg may be less likely to require dosages beyond 1000 mg.
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient’s treatment goals.

Use: For the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.

Usual Adult Dose for Rheumatoid Arthritis:

Initial dose: 1000 mg orally once a day
Maintenance dose: 1500 to 2000 mg orally per day in 1 or 2 divided doses
Maximum dose: 2000 mg/day

Comments:
-Patients weighing less than 50 kg may be less likely to require dosages beyond 1000 mg.
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient’s treatment goals.

Use: For the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking nabumetone?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to nabumetone (such as aspirin, ibuprofen, ketoprofen, or naproxen).

NAC is used to help prevent or lessen liver damage caused by taking large quantities of acetaminophen (Tylenol).

There are other brands and forms of acetylcysteine available, and some can be purchased over the counter. Not all forms of NAC are effective as an acetaminophen antidote. Do not attempt to treat an acetaminophen overdose without medical advice.

NAC may also be used for purposes not listed in this medication guide.

NAC side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

NAC may cause serious side effects. Call your doctor at once if you have:

• severe or ongoing vomiting;
• coughing up blood or vomit that looks like coffee grounds; or
• signs that the medicine may not be working–upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of NAC may include:

• nausea, vomiting, upset stomach;
• rash; or
• fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA

Warnings

In an emergency, you may not be able to tell caregivers about your health conditions. Make sure any doctor caring for you afterward knows you received NAC.

Before taking this medicine

You should not use NAC if you are allergic to it.

If possible before you receive NAC, tell your caregivers if you have ever had:

• a stomach ulcer;
• stomach bleeding or bleeding in your esophagus (esophageal varices);
• high blood pressure, or if you are on a low-salt diet;
• congestive heart failure; or
• kidney disease.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

In an emergency, you may not be able to tell caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you received this medicine.

How should I take NAC?

Use exactly as directed on the label, or as prescribed by your doctor.

Do not take NAC at home if you don’t understand all instructions.

If you are in an emergency medical setting: Before you take NAC, your caregivers will perform a blood test to measure the level of acetaminophen in your body. This test is most effective when performed within 4 to 8 hours after an acetaminophen overdose. If you cannot remember when you last took acetaminophen or how much you took, you will most likely be given the first dose of acetylcysteine right away.

Your doctor will determine how long to treat you with NAC. Do not stop taking NAC until your doctor tells you to.

If you vomit within 1 hour after taking NAC, you may need to take another dose.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking NAC?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

What is nadolol?

Nadolol is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins).

Nadolol is used to treat angina (chest pain) or hypertension (high blood pressure).

Nadolol may also be used for other purposes not listed in this medication guide.

Nadolol side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Nadolol may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• slow heartbeats;
• shortness of breath (even with mild exertion), swelling, rapid weight gain; or
• bronchospasm (wheezing, chest tightness, trouble breathing).

Common side effects of nadolol may include:

• numbness or cold feeling in your hands or feet;
• dizziness;
• feeling tired;
• upset stomach, vomiting, diarrhea, constipation;
• vision problems; or
• mood changes, confusion, memory problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

You should not use nadolol if you have asthma, a serious heart condition, severe heart failure, or if your heart cannot pump blood properly.

Before taking this medicine

You should not use nadolol if you are allergic to it, or if you have:

• asthma;
• a serious heart condition such as “AV block” (2nd or 3rd degree) or severe heart failure; or
• if your heart cannot pump blood properly.

To make sure nadolol is safe for you, tell your doctor if you have:

• coronary artery disease (clogged arteries);
• congestive heart failure;
• a thyroid disorder;
• kidney disease;
• diabetes (taking nadolol can make it harder for you to tell when you have low blood sugar); or
• a history of allergies.

It is not known whether nadolol will harm an unborn baby. Nadolol may cause heart or lung problems in a newborn if the mother takes the medicine during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using nadolol.

Nadolol can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking nadolol.

How should I take nadolol?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use nadolol in larger or smaller amounts or for longer than recommended.

Nadolol is usually taken once per day. Follow your doctor’s dosing instructions very carefully.

Do not skip doses or stop using nadolol suddenly. Stopping suddenly may make your condition worse. Follow your doctor’s instructions about tapering your dose.

Your blood pressure will need to be checked often.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using nadolol.

If you need surgery, tell the surgeon ahead of time that you are using nadolol.

If you are being treated for high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Nadolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Nadolol dosing information

Usual Adult Dose for Angina Pectoris:

Initial dose: 40 mg orally once a day; may be increased by 40 to 80 mg every 3 to 7 days until optimum response is obtained or pronounced heart rate reduction occurs
Maintenance dose: 40 to 80 mg orally once a day; up to 240 mg once a day may be required
Maximum dose: 240 mg/day

Usual Adult Dose for Hypertension:

Initial dose: 40 mg orally once a day; may be increased in 40 to 80 mg increments until optimum blood pressure reduction is achieved
Maintenance dose: 40 to 80 mg orally once a day; up to 320 mg once a day may be required

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 8 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include slow heart rate, extreme dizziness, or fainting.

What should I avoid while taking nadolol?

nadolol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of nadolol.

What is naloxone?

Naloxone is an FDA approved medicine used to quickly reverse an opioid overdose. Naloxone is a opioid antagonist that works by attaching to opioid receptors and therefore reverses and blocks the effects of other opioids.

Naloxone should be used as soon as possible to treat a known or suspected opioid overdose emergency if there are signs of slowed breathing, severe sleepiness or the person is not able to respond (loss of consciousness). Once naloxone has been given the patient must receive emergency medical care straight away, even if they wake up.

Naloxone is not a controlled substance, according to the US Drug Enforcement Administration (DEA).

Naloxone is available as a nasal spray (Narcan 4mg, Rezenopy 10 mg, Kloxxado 8mg) or an injection (Zimhi 5 mg/0.5 mL).

Narcan nasal spray became approved by the FDA on March 29, 2023 as is an over-the-counter (OTC) medicine that is available without a prescription. Other naloxone products are still prescription medicines, but in many states, these products are available from a pharmacist without a prescription from your doctor, under state Naloxone Access Laws or alternate arrangements.

Opioids are sometimes called a narcotic. Examples of opioids are buprenorphine, codeine, fentanyl, oxycodone (Oxycontin), heroin, hydrocodone (Vicodin, Lortab), hydromorphone, meperidine, morphine, methadone, oxymorphone, and tramadol.

What is Naloxone used for?

Naloxone is used to treat a known or suspected opioid overdose emergency in children or adults. Signs of an opioid overdose may include:

• slowed breathing, or no breathing;
• very small or pinpoint pupils in the eyes;
• slow heartbeats; or
• extreme drowsiness, especially if you cannot wake the person from sleep.

Even if you are not sure an opioid overdose has occurred, if the person is not breathing or is unresponsive, give the naloxone right away and then seek emergency medical care.

Naloxone has different uses when used in multi-ingredient medications including buprenorphine with naloxone (Suboxone, Zubsolv, Bunavail) which is used to treat opioid addiction, and naloxone with oxycodone (Targiniq ER) which is used for pain.

Warnings

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows that you have received this medicine.
A person caring for you can give the naloxone if you stop breathing or don’t wake up. Make sure any person caring for you knows where you keep this medicine and how to use it.

Your caregiver must get emergency help after giving you this medicine. You may need another injection every 2 to 3 minutes until emergency help arrives.

Drinking alcohol can increase certain side effects of naloxone.

Naloxone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

If you are using any narcotic pain medication, the pain-relieving effects of the narcotic will be reversed while you are also receiving this medicine.

Before taking this medicine

You should not be treated with this medicine if you are allergic to naloxone or any inactive ingredients in the injection or nasal spray.

If possible, before you receive naloxone, tell your doctor if:

• you have heart problems; or
• you are pregnant or breastfeeding.

Using naloxone while you are pregnant may cause opioid withdrawal effects in your unborn baby. However, having an opioid overdose can be fatal to both mother and baby. It is much more important to treat an overdose in the mother. You must get emergency medical help after using this medicine. Be sure all emergency medical caregivers know that you are pregnant.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

In an emergency, you may not be able to tell caregivers if you are pregnant or breastfeeding. Make sure any doctor caring for your pregnancy or your baby knows you received this medicine.

How is naloxone given?

Use naloxone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

If you are a caregiver or family member, read all instructions when you first get this medicine so you will know how to use it in an emergency. Ask your doctor or pharmacist if you have any questions.

Naloxone injection instructions

• Each naloxone injection contains only one dose of medicine and cannot be reused.
• Place the patient on their back and when you are ready to inject, pull off cap to expose needle.
• Do not put your finger on top of the device. For a child under the age of 1 years old, pinch the thigh muscle while administering the dose.
• Hold naloxone injection by finger grips only and slowly insert the needle into the thigh.
• After needle is in thigh you should push the plunger all the way down until it clicks and then hold for 2 seconds.
• Right after the injection, using one hand with fingers behind the needle, slide the safety guard over the needle. You should not use two hands to activate the safety guard. Put the used syringe into the blue case and close the case.

Naloxone nasal spray instructions

• Each naloxone nasal spray contains only one dose of medicine and cannot be reused.
• Lay the person on their back. Support their neck with your hand and allow the head to tilt back before giving the nasal spray.
• Remove the nasal spray from the box. Peel back the tab to open the nasal spray blister.
• Hold the nasal spray with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle. Do not apply any pressure until you are ready to give the dose.
• Gently insert the tip of the nozzle into one nostril until your fingers on either side of the nozzle are against the bottom of the person’s nose.
• Press the plunger firmly to give the dose of nasal spray, then after giving the dose, remove the nasal spray from the nostril.

After giving a dose of naloxone

• You need to get emergency medical help as soon as you have been given the injection or nasal spray.
• Tell the healthcare provider that you have given a dose of this medicine.
• Turn the patient on their side to place them in the recovery position after giving them the naloxone.
• If symptoms continue or return after using this medicine, an additional dose may be needed.
• If you are giving additional doses, use a new nasal spray or new injection every 2 to 3 minutes and continue to watch the person closely until emergency help has arrived closely.
• You may need to perform CPR (cardiopulmonary resuscitation) on the person while you are waiting for emergency help to arrive.
• Using naloxone does not take the place of emergency medical care.

Dosing information

Usual Adult Dose for Opioid Overdose

Initial dose:

• 0.4 mg to 2 mg IV; alternatively, may give IM or subcutaneously
• If the desired response is not obtained, doses should be repeated at 2 to 3 minute intervals
• If no response is observed with a total dose of 10 mg, the diagnosis of opioid-induced or partial opioid-induced toxicity should be questioned

Auto-injector:

• Administer 0.4 mg (1 actuation) IM or subcutaneously into the anterolateral aspect of the thigh (through clothing if necessary)
• If the desired response is not achieved, a second dose may be administered after 2 or 3 minutes; additional doses may be administered every 2 to 3 minutes until emergency medical assistance arrives

Nasal Spray:

• Administer 1 spray intranasally into 1 nostril
• If the desired response is not achieved after 2 or 3 minutes, give a second dose intranasally into alternate nostril; additional doses may be administered every 2 to 3 minutes in alternating nostrils until emergency medical assistance arrives

Comments:

• IV route is recommended in emergency situations since it has the most rapid onset of action.
• The duration of action of some opioids exceed that of this drug, therefore, repeat doses may be needed; the need for repeat doses will depend on the amount, type, and route of administration of the opioid being antagonized.

Usual Adult Dose for Reversal of Opioid Sedation

Initial dose:

• 0.1 to 0.2 mg IV at 2 to 3 minute intervals to the desired degree of reversal
• Supplemental doses administered IM have been shown to produce a longer-lasting effect

Intravenous Infusion:

• A concentration of 0.004 mg/mL may be administered by IV infusion; titrate in accordance with patient’s response

Comments:

• For the partial reversal of opioid depression following the use of opioids during surgery, smaller doses of naloxone are usually sufficient; larger than necessary doses may result in significant reversal of analgesia and increases in blood pressure.

Usual Pediatric Dose for Opioid Overdose

Neonates:

• Initial dose: 0.01 mg/kg IV, IM, or subcutaneously; repeat dose every 2 to 3 minutes as needed

Children:

• Initial dose: 0.01 mg/kg IV; if the desired response is not obtained, may give 0.1 mg/kg IV
• If the IV route is not available may give IM or subcutaneously in divided doses.
• Administer 0.4 mg (1 actuation) IM or subcutaneously into the anterolateral aspect of the thigh (through clothing if necessary); if the desired response is not achieved, a second dose may be administered after 2 or 3 minutes; additional doses may be administered every 2 to 3 minutes until emergency medical assistance arrives
• Under 1 year of age: Thigh muscle should be pinched while administering injection

Comments:

• Neonatal opioid withdrawal syndrome may be life-threatening and should be treated according to protocols developed by neonatology experts.
• To avoid precipitating opioid withdrawal symptoms, consider use of a naloxone product that can be dosed according to weight and titrated to effect.
• The duration of action of some opioids will exceed that of this drug, therefore, repeat doses may be needed; the need for repeat doses will depend on the amount, type, and route of administration of the opioid being antagonized.
• Patients should remain under continued surveillance; if a patients responds and relapses back into respiratory depression, additional doses should be given.
• Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

Usual Pediatric Dose for Reversal of Opioid Sedation

Neonates:

• Initial dose: 0.01 mg/kg IV, IM or subcutaneously at 2 to 3 minute intervals to the desired degree of reversal

Children:

• 0.005 mg to 0.01 mg IV at 2 to 3 minute intervals to the desired degree of reversal

Intravenous Infusion:

• A concentration of 0.004 mg/mL may be administered by IV infusion; titrate in accordance with patient’s response

Comments:

• For the partial reversal of opioid depression following the use of opioids during surgery, smaller doses of naloxone are usually sufficient; larger than necessary doses may result in significant reversal of analgesia and increases in blood pressure.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using naloxone?

Avoid leaving a person alone after giving him or her a naloxone dose. An overdose can impair a person’s thinking or reactions.

Naloxone side effects

Get emergency medical help if you have signs of an allergic reaction to naloxone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Because naloxone reverses opioid effects, the administration may cause sudden withdrawal symptoms such as:

• nausea, vomiting, diarrhea, stomach pain;
• fever, sweating, body aches, weakness;
• tremors or shivering, fast heart rate, pounding heartbeats, increased blood pressure;
• goose bumps, shivering;
• runny nose, yawning; or
• feeling nervous, restless, or irritable.

Sudden withdrawal symptoms in a baby younger than 4 weeks old may be life-threatening if not treated the right way. Symptoms include crying, stiffness, overactive reflexes, and seizures. Call your doctor or get emergency medical help if you are unsure how to properly give this medicine to a baby.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect naloxone?

Other drugs may interact with naloxone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Ingredients

Kloxxado nasal spray
Active ingredient: naloxone hydrochloride
Inactive ingredients: dehydrated alcohol (20% (w/w)), edetate disodium dihydrate, propylene glycol, purified water, and sodium hydroxide and hydrochloric acid to adjust pH. The pH range is from 4.0 to 5.5.

Narcan nasal spray
Active ingredient: naloxone hydrochloride
nactive ingredients: benzalkonium chloride (preservative), disodium ethylenediaminetetraacetate (stabilizer), sodium chloride, hydrochloric acid to adjust pH and sterile water.

Narcan is not made with natural rubber latex.

Rezenopy nasal spray
Active ingredient: naloxone hydrochloride
Inactive ingredients: glycerin, trisodium citrate dihydrate, hydrochloric acid, and sodium hydroxide to adjust pH, and purified water.

Rezenopy nasal spray is not made with natural rubber latex.

Zimhi injection
Active ingredient: naloxone hydrochloride
Inactive ingredients: sodium chloride, hydrochloric acid to adjust pH, and water for injection.
Zimhi is not made with natural rubber latex.

Storage

Kloxxado

• Store at room temperature 68ºF to 77ºF (20°C to 25°C).
• Do not freeze. Do not expose to temperatures below 41°F (5°C) or above 104°F (40°C).
• Keep Kloxxado nasal spray in its box until ready to use. Protect from light.

Narcan

• Store below 77°F (25°C) with excursions permitted up to 104°F (40°C).
• Do not freeze Narcan or expose it to excessive heat above 104°F (40°C).
• Keep Narcan in its box until ready to use. Protect from light.
• Replace Narcan before the expiration date on the box.
• Keep this medicine and all medicines out of the reach of children.

Rezenopy

• Store Rezenopy nasal spray either in the refrigerator or at room temperature between 2°C to 25°C (36°F to 77°F).
• Do not freeze. Do not expose to excessive heat above 40°C (104°F). Keep it in its box until ready to use. Protect from light.
• Replace the nasal spray before the expiration date on the box.
• Keep out of the reach of children.

Zimhi

• Store between 68°F to 77°F (20°C to 25°C). Do not expose to extreme cold or heat. For example, do not store in your vehicle’s glove box and do not store in the refrigerator or freezer.
• Store the Zimhi syringe in its closed plastic case to protect from light.
• Check Your Stored Zimhi Often – The solution should be clear when viewed through the window on the device. If the solution is discolored (yellowish or brown color), cloudy or contains particles, replace Zimhi with a new one.

What is naltrexone?

Naltrexone is a prescription medication used to treat alcohol use disorder (AUD) and opioid use disorder (OUD) to reduce cravings and help control physiological dependence. Naltrexone works by blocking the effects of alcohol and opioid medications, preventing the euphoria and intoxication (the “buzz”) these substances cause, and it also helps reduce the urge or cravings to use alcohol or opioids. 

For alcohol use disorder, naltrexone helps people lessen their drinking behaviors and avoid relapses, and over time, cravings for alcohol will decrease. For opioid use disorder, naltrexone prevents euphoria and reduces physiological dependence on opioids such as heroin, morphine, and codeine to help people avoid relapses and remain opioid-free.

Low dose naltrexone (LDN) is used for conditions such as fibromyalgia, Crohn’s disease, multiple sclerosis, and complex regional pain syndrome, as it may work as an anti-inflammatory agent in the central nervous system. Use of low dose naltrexone is an off-label use and is not FDA-approved for these conditions.

Naltrexone is available as an intramuscular injection (Vivitrol) and as oral tablets. The branded tablets (Revia, Depade) have been discontinued, but generic versions are available.

Naltrexone is an opioid antagonist. Its mechanism of action (MOA) is blocking the mu opioid receptor. This medicine also modifies how the hypothalamus, pituitary gland, and adrenal gland (hypothalamic-pituitary-adrenal axis, HPA axis) interact to suppress the amount of alcohol consumed.

What is naltrexone used for?

Naltrexone to is a prescription medication that is FDA-approved: 

• to treat alcohol dependence
• for the blockade of the effects of exogenously administered opioids. To prevent relapse to opioid dependence after opioid detoxification.

You should stop drinking alcohol or using opioids before starting this medicine. To avoid precipitated opioid withdrawal, it is recommended you should have an opioid-free interval of a minimum of 7 to 10 days if previously dependent on short-acting opioids. Patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as two weeks.

Low dose naltrexone (LDN) use is not FDA approved.

This medicine should not be used in children and adolescents under 18 years.

Naltrexone side effects

Common naltrexone side effects

Common side effects of naltrexone may include nausea, vomiting, loss of appetite, joint pain, muscle cramps, headache, dizziness, drowsiness, sleep problems (insomnia), tooth pain or cold symptoms such as stuffy nose, sneezing, sore throat, feeling, anxious or nervous.

Serious naltrexone side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Using opioid medicine while you are receiving this medicine could stimulate opioid withdrawal symptoms. Common withdrawal symptoms are craving for opioids, sweating, yawning, fever, stomach pain, vomiting, diarrhea, watery eyes, runny or stuffy nose, tingling, goose bumps, body aches, shaking, muscle twitching, trouble sleeping, feeling anxious, depressed, fearful, restless or uneasy.

Naltrexone may cause other serious side effects. Call your doctor at once if you have:

• weak or shallow breathing;
• cough that does not go away;
• new or worsening cough, wheezing, trouble breathing;
• severe nausea, vomiting, or diarrhea;
• severe pain, swelling, blistering, skin changes, a dark scab, or a hard lump where the medicine was injected;
• liver problems – stomach pain (upper right side), dark urine, tiredness, vomiting, loss of appetite, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• symptoms of depression – unusual mood or behavior changes, loss of interest in things you once enjoyed, crying, new sleep problems, thoughts about hurting yourself.

You may feel nauseated the first time you receive an injection of this medicine. You may also have a headache, tiredness, joint and muscle pain, loss of appetite, and vomiting.

Tell your healthcare provider if you have any side effect that bothers you, or that does not go away.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA.

Before taking this medicine

You should not be treated with  this medicine if you are allergic to it, or if:

• you are currently addicted to opioids;
• you are having withdrawal symptoms from opioid addiction;
• you are using any opioid pain medicine (including fentanyl, Vicodin, OxyContin, and many others);
• you have failed the naloxone challenge test or have a positive urine screen for opioids or
• you have used any opioid medicine such as methadone, buprenorphine, tramadol, and other opioids within 7 to 14 days.

Also, tell your doctor if you have or have ever had:

• bleeding problems such as hemophilia; or
• liver or kidney disease.
• have alcohol dependence and use opioids.

Pregnancy 

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. This medication should only be used during pregnancy if the potential benefits justify the potential risk to the fetus.

Breastfeeding

Tell your doctor if you are breastfeeding. It is not known if this medicine passes into your milk when it is administered by IM injection, and it is not known if it can harm your baby. Naltrexone from tablets passes into breast milk. Talk to your healthcare provider about whether you will breastfeed or take this medication. You should not do both.

Important information

This medicine can cause serious side effects, including:

Risk of opioid overdose.

You can accidentally overdose in two ways.

• Naltrexone blocks the effects of opioid drugs. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of this medication. This can lead to serious injury, coma, or death.
• After you receive a dose of the extended-release injection form of this medication, its blocking effect slowly decreases and completely goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:
  • after you have gone through detoxification
  • when your next injection is due
  • if you miss a dose of this medication
  • after you stop treatment with this medicine

It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.

You or someone close to you should call 911 or get emergency medical help right away if you:

• have trouble breathing
• become very drowsy with slowed breathing
• have slow, shallow breathing (little chest movement with breathing)
• feel faint, very dizzy, confused, or have unusual symptoms

Talk to your healthcare provider about naloxone, a medicine that is available to patients for the emergency treatment of an opioid overdose.

Call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered.

Severe reactions at the site of the naltrexone injection (injection site reactions).

Some people have had severe injection site reactions, including tissue death (necrosis), while receiving injections. Some of these injection site reactions have required surgery. This medication must be injected by a healthcare provider. Call your healthcare provider right away if you notice any of the following at any of your injection sites:

• intense pain
• the area feels hard
• large area of swelling
• lumps
• blisters
• an open wound
• a dark scab

Tell your healthcare provider about any reaction at an injection site that concerns you, gets worse over time, or does not get better by two weeks after the injection.

Sudden opioid withdrawal

Anyone who receives naltrexone must not use any type of opioid (must be opioid-free), including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, buprenorphine or methadone, for at least 7 to 14 days before starting this medication. Using opioids in the 7 to 14 days before you start receiving treatment may cause you to suddenly have symptoms of opioid withdrawal when you receive treatment. Sudden opioid withdrawal can be severe, and you may need to go to the hospital.

You must be opioid-free before receiving naltrexone unless your healthcare provider decides that you don’t need to go through detox first. Instead, your doctor may decide to give this medication in a medical facility that can treat you for sudden opioid withdrawal.

Liver damage or hepatitis.

This medicine can cause liver damage or hepatitis.

Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with this medication:

• stomach area pain lasting more than a few days
• dark urine
• yellowing of the whites of your eyes
• tiredness

Your healthcare provider may need to stop treating you with this medication if you get signs or symptoms of a serious liver problem.

You must inform every doctor who treats you that you are taking Naltrexone. Non-opiate based anesthetics should be used if you require an anesthetic in an emergency situation. If you have to use opiate-containing anesthetics, you may need higher doses than usual. You may also be more sensitive to the side-effects (breathing difficulties and circulatory problems).

How should I use this medicine?

Using opioids in the 7 to 14 days before you start receiving naltrexone may cause you to suddenly have symptoms of opioid withdrawal. To avoid this, you should not use short-acting opioids for a minimum of 7-10 days before starting treatment with this medicine.

How to take naltrexone tablets

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• Take this medication once a day by mouth as your doctor tells you to.
• The amount of time you should take this medication will be decided by your doctor. In certain cases, a longer period of treatment may be beneficial.

How you will receive a naltrexone injection

• Your injection will be given by a healthcare provider every 4 weeks or once a month.
• Get your injection regularly to get the most benefit. Inform your doctor when you received the last injection.
• Do not attempt to inject yourself with this medication. Serious reactions, some that may require hospitalization, might happen.
• This medicine is given as an injection into a muscle in your buttocks using a special needle that comes with it.
• You may notice pain, redness, itching, bruising, swelling, or a hard lump where the medicine was injected. Call your doctor if you have this type of reaction, especially if it gets worse or does not clear up within 2 weeks.
• After this medication is injected, it lasts for a month, and it cannot be removed from the body.

General dosing information

Naltrexone is only part of a complete treatment program that may also include additional forms of counseling and/or monitoring. Follow your doctor’s instructions very carefully.

After taking this medicine, your body will be more sensitive to opioids. If you use an opioid medicine in the future, you will need to use less than before the naltrexone treatment. Using the same amount of opioids you used before could lead to overdose or death.

Whenever you need medical treatment, be sure to tell the treating healthcare provider that you are receiving this medication and mention when you got your last dose. This is important because naltrexone can also block the effects of opioid-containing medicines that might be prescribed for you for pain, cough or colds, or diarrhea.

Carry written information with you at all times to alert healthcare providers that you are taking this medication so that they can treat you properly in an emergency. Ask your healthcare provider how you can get a wallet card to carry with you.

Naltrexone Dosing information

Naltrexone dose tablets:

• Alcohol dependence: The recommended dose is 1 tablet (50 mg) once a day.
• Opioid use disorder: Start with half a tablet (25 mg), and if no withdrawal signs occur, increase the dose to 1 tablet (50 mg) a day from then on.

Naltrexone dose intramuscular injection:

• Alcohol dependence and opioid use disorder: The recommended dose is naltrexone 380 mg delivered intramuscularly (IM) as a gluteal injection every 4 weeks or once a month, alternating buttocks for each subsequent.

Comments:

• There is no data specifically addressing switching from buprenorphine or methadone to naltrexone; however, some patients have reported severe manifestations of precipitated
• Patients switching from buprenorphine or methadone may be vulnerable to precipitated withdrawal for up to 2 weeks.
• Be prepared to manage withdrawal symptomatically with non-opioid medications.
• This drug is of value only as a part of a comprehensive management plan that includes measures to ensure the patient takes this medication.

For more detailed dosing information, click on the link below.

What happens if I miss a dose?

If you forget to take your tablet, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you miss your appointment for your naltrexone injection, schedule another appointment as soon as possible.

What happens if I overdose?

If you take more naltrexone tablets than you should, tell your Doctor or Pharmacist or contact your nearest hospital emergency department immediately.

What should I avoid while using this medicine?

Do not drive a car, operate machinery, or do other dangerous activities until you know how this medication affects you. This medicine may make you feel dizzy and sleepy.

What is Namenda?

Namenda (memantine) reduces the actions of chemicals in the brain that may contribute to the symptoms of Alzheimer’s disease.

Namenda is used to treat moderate to severe dementia of the Alzheimer’s type.

Namenda’s mechanism of action is to help balance a brain chemical called glutamate. In Alzheimer’s, there can be too much glutamate activity, which can harm brain cells. By controlling glutamate, Namenda may help protect brain cells from damage and improve memory and thinking skills in some people with Alzheimer’s. Namenda is not a cure for Alzheimer’s.

Because Namenda works differently from other Alzheimer’s medications it may be prescribed along with other Alzheimer’s drugs for better results. Namenda belongs to the drug class called NMDA (N-methyl-D-aspartate) inhibitors.

Namenda gained FDA approval on October 16, 2003. A Namenda generic is available under the name memantine.

Namenda side effects

The most common Namenda side effects are:

• dizziness
• headache
• confusion
• constipation.

Serious side effects and warnings

Your body gets rid of Namenda through your urine. Some health conditions, such as a urinary tract infection, kidney disease, medications, or diet can make your urine less acidic (raise its pH). If this happens, your body might not remove Namenda as well as it should. This could cause more Namenda to stay in your blood than usual.

Namenda can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything requiring you to be alert.

Namenda may cause an allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Namenda: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Before taking this medicine

Do not take Namenda if you are allergic to memantine, Namenda, or any of the inactive ingredients in the tablets (see the ingredient list below).

Before taking Namenda, tell your doctor about all your medical conditions including if you have:

• have or have had seizures or epilepsy
• have liver disease
• have kidney disease
• have problems passing urine
• have a bladder or kidney infection
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Namenda will harm an unborn baby.

Breastfeeding

It is not known if Namenda passes into breast milk or if it could harm a nursing baby. Talk to your doctor about the best way to feed your baby if you take Namenda.

How do I take Namenda?

Take Namenda exactly as it was prescribed for you. Follow all directions on your prescription label and do not take this medicine in larger or smaller amounts or for longer than recommended.

• Namenda is usually taken once or twice daily (see Namenda dosage below).
• Namenda can be taken with or without food.
• Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

To make swallowing easier, you may open the extended-release capsule and sprinkle the medicine into a spoonful of applesauce. Swallow right away without chewing. Do not save the mixture for later use.

Use Namenda regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

• Your doctor will need to check your progress while you are using Namenda.

Namenda dosing information

Usual Adult Dose of Namenda for Alzheimer’s Disease:

IMMEDIATE-RELEASE:
Initial dose: Namenda 5 mg orally once a day, then titrated upwards by 5 mg per week
Maintenance dose: Namenda 5 mg once a day up to Namenda 10 mg twice a day
Maximum dose: 20 mg per day

EXTENDED-RELEASE:
Initial dose: Namenda XR 7 mg orally once a day, then titrated upwards by 7 mg per week
Maintenance dose: Namenda XR 7 mg once a day up to Namenda XR 28 mg once a day
Maximum dose: 28 mg orally once a day

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up for the missed dose.

If you miss doses or forget to take your medicine for several days, call your doctor before starting the medicine again.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Namenda can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything requiring you to be alert.

What other drugs will affect Namenda?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• amantadine
• ketamine
• zonisamide
• cough medicine that contains dextromethorphan (Delsym, Robitussin Maximum Strength, Vicks 44, and others)
• medicines to make the urine alkaline – urine sodium bicarbonate, potassium citrate (K-Lyte, Urocit-K), sodium citrate and citric acid (Bicitra, Oracit), or sodium citrate and potassium (Citrolith, Polycitra) (can reduce the clearance of Namenda by about 80%)
• medicine to treat glaucoma or increased pressure inside the eyes – acetazolamide, methazolamide.

This list is not complete. Other drugs may interact with memantine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Namenda ingredients

Active ingredient: memantine hydrochloride 5 mg or 10 mg

Inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate

Inactive ingredients of tablet film coating: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).

Available as Namenda 5 mg tablets and Namenda 10 mg tablets.

Storage

Store Namenda at room temperature between 59°F to 77°F (15°C to 30°C) away from moisture and heat.

Who makes Namenda?

Merz Pharmaceuticals GmbH makes Namenda which is distributed by Allergan USA, Inc.

What is Naprosyn?

Naprosyn is a nonsteroidal anti-inflammatory drug (NSAID). Naproxen works by reducing hormones that cause inflammation and pain in the body.

Naprosyn is used to treat pain or inflammation caused by conditions such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

Naprosyn delayed-release tablets are slower-acting forms of naproxen that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms of naproxen will not work fast enough to treat acute pain.

Warnings

You should not use Naprosyn if you have a history of allergic reaction to aspirin or other NSAID (nonsteroidal anti-inflammatory drug).

Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use Naprosyn just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Before taking this medicine

Naprosyn may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Naprosyn, especially in older adults.

You should not use Naprosyn if you are allergic to naproxen, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor before giving naproxen to a child younger than 12 years old.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a history of heart attack, stroke, or blood clot;
• a history of stomach ulcers or bleeding;
• asthma;
• liver or kidney disease;
• fluid retention: or
• if you take aspirin to prevent heart attack or stroke.

If you are pregnant, you should not take Naprosyn unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

It may not be safe to breastfeed while using Naprosyn. Ask your doctor about any risk.

Naprosyn is not approved for use by anyone younger than 2 years old. Do not give this medicine to a child without medical advice.

How should I take Naprosyn?

Use Naprosyn exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you change brands, strengths, or forms of naproxen, your dosage needs may change. Ask your pharmacist if you have any questions about the kind of naproxen you are using.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Naproxen doses are based on weight in children, and any changes may affect your child’s dose.

If you use Naprosyn long-term, you may need frequent medical tests.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Naprosyn.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

What happens if I miss a dose?

Since Naprosyn is sometimes used only when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

What to avoid

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin or other NSAIDs unless your doctor tells you to.

Ask your doctor before taking any other medication for pain, arthritis, fever, or swelling. Many medicines available over the counter contain aspirin, salicylates, or other medicines similar to naproxen (such as ibuprofen or ketoprofen). Taking certain products together can cause you to get too much of this type of medication.

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb naproxen.

Naprosyn side effects

Get emergency medical help if you have signs of an allergic reaction to Naprosyn (runny or stuffy nose, wheezing or trouble breathing, hives, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using Naprosyn and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using Naprosyn and call your doctor at once if you have:

• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• the first sign of any skin rash, no matter how mild;
• signs of stomach bleeding – blood in the stools or dark, tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems – nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems – little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
• low red blood cells (anemia) – fatigue, pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• severe skin reaction – fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Naprosyn side effects may include:

• indigestion, heartburn, stomach pain, nausea;
• headache, dizziness, drowsiness;
• bruising, itching, rash;
• swelling; or
• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect Naprosyn?

Ask your doctor before using Naprosyn if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use Naprosyn if you are also using any of the following drugs:

• cholestyramine;
• cyclosporine;
• digoxin;
• lithium;
• methotrexate;
• pemetrexed;
• phenytoin or similar seizure medications;
• probenecid;
• warfarin (Coumadin, Jantoven) or similar blood thinners;
• a diuretic or “water pill”;
• heart or blood pressure medication; or
• insulin or oral diabetes medicine.

What is naproxen?

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps. It can also be used to treat acute pain caused by other conditions not listed in this medication guide.

The delayed-release or extended-release tablets are slower-acting forms of naproxen that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms will not work fast enough to treat acute pain.

Naproxen is also available in combination with other medications under the following brand names: Aleve PM, Aleve-D Sinus and Cold, Treximet, and Vimovo

Naproxen side effects

Common naproxen side effects

Common naproxen side effects may include indigestion, heartburn, stomach pain, nausea, headache, dizziness, drowsiness, bruising, itching, rash, swelling or ringing in your ears.

Serious naproxen side effects

Get emergency medical help if you have signs of an allergic reaction to naproxen (runny or stuffy nose, wheezing or trouble breathing, hives, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using naproxen and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using naproxen and call your doctor at once if you have:

• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• the first sign of any skin rash, no matter how mild;
• signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems – nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems – little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
• low red blood cells (anemia) – pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• severe skin reaction – fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

You should not use naproxen if you have a history of allergic reaction to aspirin or other NSAID (nonsteroidal anti-inflammatory drug).

Naproxen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have swelling of the face or throat, chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance. Stop taking naproxen and notify your physician if you notice stomach pain, tiredness or weakness, yellow skin or eyes, nausea, vomiting, bloody or black and sticky bowel movements, skin rash, unexplained weight loss or weight gain, or swelling of the hands and feet.

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

Before taking this medicine

Naproxen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not use naproxen if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor before giving naproxen to a child younger than 12 years old.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
• a history of heart attack, stroke, or blood clot;
• a history of stomach ulcers or bleeding;
• asthma;
• liver or kidney disease;
• fluid retention: or
• if you take aspirin to prevent heart attack or stroke.

If you are pregnant, you should not take naproxen unless your doctor tells you to. Taking a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

It may not be safe to breastfeed while using naproxen. Ask your doctor about any risk.

Naproxen is not approved for use by anyone younger than 2 years old. Do not give this medicine to a child without medical advice.

How should I take naproxen?

Use naproxen exactly as directed on the label, or as prescribed by your doctor. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If you change brands, strengths, or forms of this medicine, your dosage needs may change. Ask your pharmacist if you have any questions about the kind of naproxen you are using.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Doses are based on weight in children, and any changes may affect your child’s dose.

If you use this medicine long-term, you may need frequent medical tests.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using naproxen.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

What happens if I miss a dose?

Since naproxen is sometimes used only when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin or other NSAIDs unless your doctor tells you to.

Ask your doctor before taking any other medication for pain, arthritis, fever, or swelling. Many medicines available over the counter contain aspirin, salicylates, or other medicines similar to naproxen (such as ibuprofen or ketoprofen). Taking certain products together can cause you to get too much of this type of medication.

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb naproxen.

What other drugs will affect naproxen?

Ask your doctor before using naproxen if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you are also using any of the following drugs:

• cholestyramine;
• cyclosporine;
• digoxin;
• lithium;
• methotrexate;
• pemetrexed;
• phenytoin or similar seizure medications;
• probenecid;
• warfarin (Coumadin, Jantoven) or similar blood thinners;
• a diuretic or “water pill”;
• heart or blood pressure medication; or
• insulin or oral diabetes medicine.

What is naratriptan?

Naratriptan is a headache medicine that narrows blood vessels around the brain. Naratriptan also reduces substances in the body that can trigger headache pain, sensitivity to light and sound, and other migraine symptoms.

Naratriptan is used to treat migraine headaches. Naratriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Naratriptan should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use naratriptan only if your condition has been confirmed by a doctor as migraine headaches.

Naratriptan may also be used for purposes not listed in this medication guide.

Naratriptan side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Naratriptan may cause serious side effects. Stop using naratriptan and call your doctor at once if you have:

• fast or pounding heartbeats;
• numbness or tingling and a pale or blue-colored appearance in your fingers or toes;
• pain or heavy feeling in your legs, hip pain, burning pain in your feet;
• sudden and severe stomach pain, bloody diarrhea, constipation, fever, weight loss;
• dangerously high blood pressure–severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats, seizure;
• heart attack symptoms–chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• high levels of serotonin in the body–agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; or
• signs of a stroke–sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects of naratriptan may include:

• dizziness, drowsiness;
• feeling weak or tired;
• numbness or tingling;
• flushing (warmth, redness, or tingly feeling);
• nausea; or
• pain or tightness in your jaw, neck, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA

Warnings

You should not use naratriptan if you have uncontrolled high blood pressure, heart problems, certain heart rhythm disorders, severe liver or kidney disease, a history of heart attack or stroke, or circulation problems that cause a lack of blood supply within the body.

Do not take naratriptan within 24 hours before or after using another migraine headache medicine.

Before taking this medicine

You should not use this medicine if you are allergic to naratriptan, or if you have:

• severe or uncontrolled high blood pressure;
• past or present heart problems;
• history of coronary artery disease, heart attack, or stroke, including “mini-stroke”;
• Wolff-Parkinson-White syndrome or other heart rhythm disorder;
• a blood vessel disorder or circulation problems that cause a lack of blood supply within the body;
• severe liver or kidney disease; or
• a headache that seems different from your usual migraine headaches.

To make sure naratriptan is safe for you, tell your doctor if you have:

• liver or kidney disease;
• high blood pressure, a heart rhythm disorder; or
• coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether naratriptan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to anyone younger than 18.

How should I use naratriptan?

Your doctor may want to give your first dose of naratriptan in a hospital or clinic setting to quickly treat any serious side effects that occur.

Follow all directions on your prescription label. Never use more than your recommended dose. Overuse of migraine headache medicine can make headaches worse. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

Take naratriptan as soon as you notice migraine symptoms.

Take 1 tablet whole with a full glass of water.

After taking a tablet: If your headache does not go away completely, or if it goes away and comes back, call your doctor before taking a second tablet.

Do not take the second tablet until at least 4 hours have passed since you took the first tablet. Do not take more than 5 milligrams (mg) of naratriptan in 24 hours.

If your symptoms have not improved after taking 2 tablets in 24 hours, contact your doctor before taking any more tablets.

Tell your doctor if you have more than four headaches in one month (30 days).

Naratriptan can raise blood pressure to dangerous levels. Your blood pressure may need to be checked often while you are using this medicine. If you use naratriptan long-term, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Store at room temperature away from moisture, heat, and light.

Naratriptan dosing information

Usual Adult Dose for Migraine:

Use only after a clear diagnosis of migraine has been established

Initial dose: 1 mg or 2.5 mg orally, once
-Provided there has been some response to first dose, a second dose may be administered at least 4 hours later if migraine returns or symptoms recur.
Maximum dose: 5 mg in a 24-hour period

Comments:
-This drug should not be used to treat basilar or hemiplegic migraines because these patients are at a greater risk of stroke.
-The safety of treating an average of 4 or more migraine attacks in a 30-day period has not been established.

Use: For the acute treatment of migraine with or without aura.

What happens if I miss a dose?

Since naratriptan is used as needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using naratriptan.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include tiredness, neck stiffness, loss of coordination, or feeling light-headed.

What should I avoid while using naratriptan?

Do not take naratriptan within 24 hours before or after using another migraine headache medicine, including:

• medicines like naratriptan–almotriptan, eletriptan, frovatriptan, rizatriptan, sumatriptan, zolmitriptan, and others; or
• ergot medicine–dihydroergotamine, ergotamine, ergonovine, methylergonovine.

naratriptan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect naratriptan?

Taking naratriptan while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called “serotonin syndrome,” which can be fatal. Tell your doctor if you also use:

• medicine to treat depression;
• medicine to treat a psychiatric disorder;
• a narcotic (opioid) medication; or
• medicine to prevent nausea and vomiting.

What is Narcan?

Narcan (naloxone) nasal spray is an over-the-counter medicine used to treat an opioid overdose emergency, Narcan works by rapidly reversing the opioid’s effects. Naran should be given as soon as possible when an opioid overdose is suspected, and then the patient should also receive emergency medical care immediately, even if they wake up.

Narcan nasal spray became FDA-approved on March 29, 2023, as an over-the-counter (OTC) medicine without the need for a prescription, however, it is unknown when the OTC Narcan nasal spray product will be available. Until the OTC nasal spray becomes available, the nasal spray with the prescription label will still be available from a pharmacist without a prescription from your doctor under state Naloxone Access Laws or alternate arrangements.

Narcan nasal spray can be used for adults and children for known or suspected opioid overdose if there are signs of slowed breathing, severe sleepiness, or the person is not able to respond (loss of consciousness).

Narcan works to block the opioid effect as it is an opioid antagonist as it competes for the opiate receptors in the brain and other areas of the body to help reverse the dangerous effects of the opioid so that the patient’s breathing improves and they become more awake, and their blood pressure normalizes.

Examples of opioids are codeine, oxycodone (Oxycontin), heroin morphine, hydrocodone (Vicodin, Lortab), fentanyl, methadone, oxymorphone, meperidine, tramadol, buprenorphine, and hydromorphone.

Narcan was originally available as an njection, which has since been discontinued. The Narcan nasal spray is available as an over-the-counter medicine, so a prescription is NOT needed. 

Important information

Narcan is used to reverse the effects of opioid medicines temporarily, it will have no effect in people who are not taking opioid medicines. Always carry a nasal spray with you in case of an opioid overdose emergency.

Use Narcan as soon as possible if you or your caregiver think there are signs or symptoms of an opioid emergency, even if you are not sure because an opioid emergency can cause severe injury or death. Signs and symptoms of an opioid emergency may include:

• unusual sleepiness and you are not able to wake the person up with a loud voice or by rubbing firmly on the middle of their chest (sternum)
• breathing problems including slow or shallow breathing in a person who is difficult to wake up or who looks like they are not breathing
• the pupil (black circle in the center of the colored part of the eye) is very small, sometimes called “pinpoint pupils,” in someone difficult to awaken.

You should know where the nasal spray is stored and how to give the nasal spray before an opioid emergency happens. This is important if you have family members, caregivers, or other people who are at risk of opioid overdose and may need to have Narcan administered in an opioid emergency.

After giving the first dose of this medicine, you need to get emergency medical help right away, even if the person wakes up. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help

The signs and symptoms of an opioid emergency can return after this medicine is given. If this happens, give another dose after 2 to 3 minutes using a new nasal spray device and watch the person closely until emergency help is received.

Before taking this medicine

You should not be treated with Narcan if you are allergic to naloxone or any of the ingredients in this nasal spray. See below for a full list of Narcan ingredients.

If possible before you receive Narcan, tell your doctor if:

• you have heart problems; or
• you are pregnant or breastfeeding.

If you use opioid medicine during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Using Narcan while you are pregnant may also cause opioid withdrawal effects in your unborn baby. However, having an opioid overdose can be fatal to both mother and baby. It is much more important to treat an overdose in the mother. You must get emergency medical help after using this medicine. Be sure all emergency medical caregivers know that you are pregnant.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

In an emergency, you may not be able to tell caregivers if you are pregnant or breastfeeding. Make sure any doctor caring for your pregnancy or your baby knows you received Narcan.

How should I use Narcan?

Use this medicine exactly as prescribed by your healthcare provider.

• Each nasal spray device contains only one dose of medicine and cannot be reused.
• Narcan is available in 2 mg and 4 mg strength. Your healthcare provider will prescribe the strength that is right for you.
• Remove the nasal spray device from the box. Peel back the tab with the circle to open the nasal spray.
• Do not prime Narcan nasal spray.
• Lay the person on their back with their neck supported with your hand and allow the head to tilt back before giving the nasal spray.
• Hold the nasal spray with your thumb on the bottom of the red plunger and your first and middle fingers on either side of the nozzle.
• Gently insert the tip of the nozzle into one nostril until your fingers on either side of the nozzle are against the bottom of the person’s nose.
• Press the red plunger firmly to administer the dose of Narcan.
• Remove the Narcan from the nostril after giving the dose.
• You must get emergency help immediately after giving this medicine.
• After giving this medicine, stay with the person and watch for continued signs of overdose. You may need to give another dose every 2 to 3 minutes until emergency help arrives. If another dose is needed, give Narcan in the other nostril from a new Narcan nasal spray.
• Do not assume that an overdose episode has ended if symptoms improve. You may need to perform CPR (cardiopulmonary resuscitation) on the person while you are waiting for emergency help to arrive.

Dosing information

Usual Adult and Pediatric Dose for Opioid Overdose:

Administer 1 spray intranasally into 1 nostril

If desired response is not achieved after 2 or 3 minutes, give a second dose from a new nasal spray device, intranasally into alternate nostrils; additional doses may be administered every 2 to 3 minutes in alternating nostrils until emergency medical assistance arrives.

Comments:

• IV route is recommended in emergency situations since it has the most rapid onset of action.
• The duration of action of some opioids exceed that of this drug, therefore, repeat doses may be needed; the need for repeat doses will depend on the amount, type, and route of administration of the opioid being antagonized.
• Patients should remain under continued surveillance; if a patients responds and relapses back into respiratory depression, additional doses should be given.
• Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

What should I avoid while taking Narcan?

Avoid leaving a person alone after giving him or her a dose of this medicine. An overdose of naloxone can impair a person’s thinking or reactions.

Narcan side effects

Get emergency medical help if you have signs of an allergic reaction to Narcan: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Because Narcan reverses opioid effects, its use may cause sudden withdrawal symptoms such as:

• nausea, vomiting, diarrhea, stomach pain;
• fever, sweating, body aches, weakness;
• tremors or shivering, fast heart rate, pounding heartbeats, increased blood pressure;
• goose bumps, shivering;
• runny nose, yawning; or
• feeling nervous, restless, or irritable.

What is Nayzilam?

Nayzilam nasal spray contains midazolam, a benzodiazepine (ben-zoe-dye-AZE-eh-peen).

Nayzilam nasal spray is a prescription medicine used short term to treat seizure clusters (also called “acute repetitive seizures”) in adults and children at least 12 years old.

Nayzilam is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or giving away this medicine may harm others and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription drugs, or street drugs.

It is not known if Nayzilam is safe and effective in children under 12 years of age.

Warnings

You should not use Nayzilam nasal spray if you have narrow-angle glaucoma.

MISUSE OF NAYZILAM CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Nayzilam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, if you are hard to wake up, or if you stop breathing.

Do not stop using Nayzilam nasal spray without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use. Some withdrawal symptoms may last up to 12 months or longer.

Get medical help right away if you stop using Nayzilam and have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, or thoughts about suicide.

Some people have thoughts about suicide while using Nayzilam. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Before taking this medicine

You should not use Nayzilam if you are allergic to midazolam, or if you have:

• narrow-angle glaucoma.

To make sure Nayzilam is safe for you, tell your doctor if you have ever had:

• glaucoma;
• depression, or a mood disorder;
• suicidal thoughts or actions;
• drug or alcohol addiction;
• asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;
• congestive heart failure; or
• liver or kidney disease.

Some people have thoughts about suicide while using Nayzilam. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Tell your doctor if you are pregnant or plan to become pregnant. If you use Nayzilam during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I use Nayzilam?

Use Nayzilam nasal spray exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Nayzilam in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Do not take by mouth. This medicine is for use only in the nose.

Be sure you know how to recognize what is and is not a seizure cluster and when it is best to use this medicine. Ask your doctor or pharmacist if you have questions.

Nayzilam nasal spray is usually given as a single spray into one nostril. If you still have seizures 10 minutes after using 1 spray, use a second spray in the opposite nostril.

Get emergency medical help if you have still have seizures after using this medicine.

You should not use a second spray if you have very slow breathing after using the first spray.

Do not use more than 2 sprays of Nayzilam to treat a seizure cluster. Do not use this medicine to treat more than 1 seizure cluster every 3 days, or more than 5 seizure clusters in one month (30 days).

Do not stop using Nayzilam nasal spray without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use.

Store at room temperature away from moisture and heat, in a place where no one can use it improperly. Keep the spray bottle in the blister pack until you are ready to use the medicine.

Dosing information

Usual Adult Dose for Epilepsy:

Nasal:
-Initial dose: 5 mg (1 spray) intranasally in 1 nostril ONCE
-Subsequent dose: 5 mg (1 spray) intranasally in the opposite nostril after 10 minutes if the patient has not responded to the initial dose
-Maximum dose: 10 mg/day.

Usual Adult Dose for Seizures:

Nasal:
-Initial dose: 5 mg (1 spray) intranasally in 1 nostril ONCE
-Subsequent dose: 5 mg (1 spray) intranasally in the opposite nostril after 10 minutes if the patient has not responded to the initial dose.

Usual Pediatric Dose for Epilepsy:

Nasal:
12 years and older:
-Initial dose: 5 mg (1 spray) intranasally in 1 nostril ONCE
-Subsequent dose: 5 mg (1 spray) intranasally in the opposite nostril after 10 minutes if the patient has not responded to the initial dose
-Maximum dose: 10 mg/day.

Usual Pediatric Dose for Seizures:

Nasal:
12 years and older:
-Initial dose: 5 mg (1 spray) intranasally in 1 nostril ONCE
-Subsequent dose: 5 mg (1 spray) intranasally in the opposite nostril after 10 minutes if the patient has not responded to the initial dose
-Maximum dose: 10 mg/day

Comments:
-This drug should not be used to treat more than 1 episode every 3 days, and no more than 5 episodes/month.
-The subsequent dose should not be administered if the patient has difficulty breathing OR if the patient has sedation that is not typically observed during a seizure cluster episode.

Use: Acute treatment of intermittent, stereotypic episodes of frequent seizure activity (e.g., acute repetitive seizures, seizure clusters) that are distinct from a patient’s usual seizure pattern.

What happens if I miss a dose?

Since Nayzilam nasal spray is used when needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using this medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of midazolam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

Overdose symptoms may include drowsiness, confusion, muscle weakness, loss of coordination, or coma.

What should I avoid while using Nayzilam?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Nayzilam side effects

Get emergency medical help if you have signs of an allergic reaction to Nayzilam: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Nayzilam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• weak or shallow breathing;
• confusion, paranoia, thoughts about suicide or hurting yourself;
• a seizure; or
• blurred vision, eye pain or redness, seeing halos around lights.

Common Nayzilam side effects may include:

• drowsiness;
• headache;
• runny nose, discomfort in your nose; or
• throat irritation.

What is nebivolol?

Nebivolol is a beta-blocker that is used to treat hypertension (high blood pressure). Lowering blood pressure may lower your risk of a stroke or heart attack.

Nebivolol may also be used for purposes not listed in this medication guide.

Nebivolol side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Nebivolol may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• rapid weight gain;
• shortness of breath;
• slow or uneven heartbeats; or
• numbness or cold feeling in your hands and feet.

Common side effects of nebivolol may include:

• dizziness;
• swelling in your legs;
• slow heartbeats;
• tiredness; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Do not skip doses or stop taking nebivolol without first talking to your doctor.

Before taking this medicine

You should not take nebivolol if you are allergic to it, or if you have:

• a serious heart condition such as heart failure, “AV block” (2nd or 3rd degree), or sick sinus syndrome (unless you have a pacemaker);
• very slow heartbeats;
• severe liver disease; or
• if your heart cannot pump blood properly.

Tell your doctor if you have ever had:

• asthma, bronchitis, emphysema;
• a heart attack;
• problems with circulation (especially in your feet and legs);
• diabetes (taking nebivolol can make it harder for you to tell when you have low blood sugar);
• a thyroid disorder;
• liver or kidney disease;
• allergies; or
• pheochromocytoma (tumor of the adrenal gland).

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether nebivolol will harm an unborn baby. However, having high blood pressure during pregnancy may cause complications such as diabetes or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating hypertension may outweigh any risks to the baby.

You should not breastfeed while using nebivolol.

How should I take nebivolol?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take nebivolol with or without food.

Your blood pressure will need to be checked often.

If you need surgery, tell the surgeon ahead of time that you are using nebivolol.

You should not skip doses or stop using nebivolol suddenly. Stopping suddenly may make your condition worse or cause serious heart problems, including heart attack. Follow your doctor’s instructions about tapering your dose.

Keep using nebivolol as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture and heat.

Nebivolol dosing information

Usual Adult Dose for Hypertension:

Initial dose: 5 mg orally once a day
Dose adjustment: Titrate dose at 2-week intervals up to 40 mg once a day as needed.
Maximum dose: 40 mg per day

Comments:
-Titrating doses more frequently than every 2 weeks is unlikely to be beneficial.
-The dose should be individualized to patient requirements.

Use: For the management of hypertension, alone or with another antihypertensive agent.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line

Overdose symptoms may include slow heart rate, dizziness, vomiting, trouble breathing, or feeling like you might pass out.

What should I avoid while taking nebivolol?

Avoid driving or hazardous activity until you know how nebivolol will affect you. Your reactions could be impaired.

What is neffy?

neffy (epinephrine nasal spray) is used to treat severe allergic reactions, including anaphylaxis, in adults and children 4 years of age and older who weigh 33 lbs (15 kg) or more. 

• Each neffy nasal spray for severe allergic reactions contains 1 dose of epinephrine.
• There are 2 strengths:
  • 1 mg/0.1 mL of epinephrine per spray for children 33-66 lbs (15-30 kg) 
  •  2 mg/0.1 mL of epinephrine per spray for patients 66 lbs (30 kg) or greater.
• Administer right away.
• Can be self-administered or a caregiver can give it.

How does neffy work?

neffy’s mechanism of action for anaphylaxis is the same as epinephrine injections. It activates both alpha and beta receptors, which results in the following effects:

• relaxes smooth muscle in the airways to help with breathing
• narrows blood vessels and redirects blood flow to vital organs, such as the heart
• maintains adequate blood pressure and increases heart rate
• relaxes smooth muscles of the stomach and intestine to relieve digestive symptoms.

neffy FDA approval

neffy gained FDA approval on August 9, 2024, and is the first needle-free treatment for severe allergic reactions.

neffy cost

Eligible patients with commercial insurance pay as little as $25 with a neffy Copay card.

If you are uninsured or insured but without any government or commercial drug coverage for neffy and need help paying for it, you may be able to receive it at no cost through the neffy Connect Support Program.

neffy side effects

The most common side effects of neffy are:

• throat irritation
• tingling nose
• headache
• nasal discomfort
• feeling over excitement, nervousness, or anxiety
• tingling sensation
• fatigue
• shakiness
• runny nose
• itchy nose
• sneezing
• stomach pain
• pain in the gums of teeth
• numbness in the mouth
• nasal congestion
• dizziness
• nausea
• vomiting.

Serious side effects and warnings

Always carry neffy with you because you may not know when anaphylaxis may happen. You should carry 2 neffy devices with you because you may need a second neffy nasal spray if symptoms continue or come back.

Talk to your healthcare provider about additional neffy nasal sprays to keep at work, school, or other locations. Tell your family members, caregivers, and others where you keep your neffy nasal spray and how to use it before you need it. You may be unable to speak in an allergic emergency. When you have an allergic emergency (anaphylaxis)

• Use neffy right away.
• Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy. Before you receive neffy, your healthcare provider should talk to you about when to get emergency help.

neffy may aggravate angina or affect the heartbeat in people with heart disease.

neffy contains a sulfite but this should not stop people allergic to sulfites from using it. Talk to your healthcare provider about this.

If you have certain medical conditions or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use neffy. Talk to your healthcare provider about all your medical conditions.

• You should still use neffy to treat anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicine you take.

It is not known if neffy is safe and effective in children who weigh less than 33 pounds (15 kilograms).

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of neffy. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Before using neffy

People with certain nasal conditions, such as nasal polyps or a history of nasal surgery, should talk to their healthcare provider before using neffy because these conditions may affect the absorption of neffy.

Before using neffy, tell your healthcare provider about all your medical conditions, especially if you:

• have nasal problems including nasal polyps, a history of injury such as a broken nose, or any past nasal surgery
• have heart problems
• have kidney problems
• have low potassium levels in your blood
• have Parkinson’s disease
• have thyroid problems
• have high blood pressure
• have diabetes
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if neffy will harm your unborn baby.

Breastfeeding

It is not known if neffy passes into your breast milk.

How should I use neffy?

Read the neffy Instructions for Use for detailed information about how to use the neffy nasal spray. Use neffy exactly as your healthcare provider tells you to use it. Talk to your healthcare provider or pharmacist if you have questions about the use of neffy.

• neffy is for use in the nose only. Do not spray in the eyes or mouth.
• Each neffy nasal spray has 1 dose of medicine and cannot be reused. Do not test or prime (pre-spray) the device.
• Your neffy comes in a carton with 2 nasal sprays. You may need to use a second neffy nasal spray if symptoms continue or get worse.
• You should always carry 2 neffy nasal sprays with you.

neffy dosing information

neffy is for use in the nose only.

• neffy is given as 1 dose in either nostril.
• If a second dose of neffy is needed, it should be given in the same nostril, starting 5 minutes after the first dose.
• Do not sniff during or after receiving a dose of neffy.

If any liquid drips out of the nose, you may not receive the full dose of medicine.

If your symptoms continue or get worse, give a second dose of neffy in the same nostril, starting 5 minutes after the first dose.

Get emergency help for further treatment of the anaphylactic episode, if needed, after using neffy. Before you receive neffy, your healthcare provider should talk to you about when to get emergency help.

Symptoms of anaphylaxis

Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes. Symptoms of anaphylaxis may include:

• trouble breathing
• wheezing
• hoarseness (changes in the way your voice sounds)
• hives (raised reddened rash that may itch)
• severe itching
• swelling of your face, lips, mouth, or tongue
• skin rash, redness, or swelling
• fast heartbeat
• weak pulse
• feeling very anxious
• confusion
• stomach pain
• losing control of urine or bowel movements (incontinence)
• diarrhea or stomach cramps
• dizziness, fainting, or “passing out” (unconsciousness).

What other drugs will affect neffy?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider of all known allergies. Especially tell your healthcare provider if you take or use:

• other nasal sprays
• water pills (diuretics)
• medicines to treat depression such as tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors)
• medicines to treat abnormal heartbeats (arrhythmias) such as cardiac glycosides
• medicines to treat Parkinson’s disease such as catechol-O-methyl-transferase inhibitors (COMT inhibitors) and ergot alkaloids
• medicines for heart disease including alpha-blockers (such as phentolamine) and beta-blockers (such as propranolol)
• medicines for thyroid disease such as levothyroxine sodium
• medicines used in labor
• medicines to treat allergies such as diphenhydramine, tripelennamine, or chlorpheniramine (antihistamines).

neffy may affect the way other medicines work, and other medicines may affect how neffy works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the neffy Prescribing Information for a full list of interactions.

neffy storage

Store neffy at room temperature between 68°F to 77°F (20°C to 25°C).

• Do not freeze. If neffy freezes, the device will not spray.

Your neffy has an expiration date. Replace neffy before the expiration date.

Keep out of the reach of children.

neffy ingredients

Active Ingredient: epinephrine 2 mg.

Inactive Ingredients: benzalkonium chloride, disodium edetate, n-dodecyl beta-D-maltoside, sodium chloride, sodium metabisulfite, and hydrochloric acid or sodium hydroxide to adjust pH, in water for injection.

Each neffy nasal spray contains 1 mg/0.1 mL or 2 mg/0.1 mL of epinephrine per spray.

Who makes neffy?

neffy is made by ARS Pharmaceuticals a pharmaceutical company based in San Diego, California. They specialize in the development of innovative drug delivery technologies, particularly focusing on emergency treatments.

What is neomycin?

Neomycin is an antibiotic that is used to prevent bacterial infection in the intestines. Neomycin is also used to reduce the symptoms of hepatic coma.

Neomycin is sometimes given with another antibiotic.

Neomycin may also be used for purposes not listed in this medication guide.

Neomycin side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Neomycin may cause serious side effects. Call your doctor at once if you have:

• numbness or tingly feeling under your skin;
• hearing problems (even long after you stop taking neomycin);
• muscle twitching, seizure;
• weak or shallow breathing; or
• kidney problems–swelling, urinating less, feeling tired or short of breath.

Common side effects of neomycin may include:

• nausea, vomiting; or
• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Neomycin can harm your kidneys or cause hearing problems. Hearing loss may be permanent if you take too much neomycin or take it for longer than recommended.

Before taking this medicine

You should not take neomycin if you are allergic to it, or if you have:

• ulcerative colitis, Crohn’s disease, or other inflammatory bowel disease;
• a blockage in your intestines; or
• an allergy to similar antibiotics such as amikacin, gentamicin, kanamycin, paromomycin, streptomycin, or tobramycin.

Tell your doctor if you have ever had:

• kidney disease;
• myasthenia gravis; or
• Parkinson’s disease.

May harm an unborn baby. Tell your doctor if you are pregnant.

Do not breastfeed.

Do not give neomycin to a child without medical advice.

How should I take neomycin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Never take more than prescribed, or take for longer than 2 weeks. High doses or long-term use of neomycin can cause permanent hearing loss.

Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. Neomycin will not treat a viral infection (flu or a common cold).

Drink plenty of water each day to stay hydrated.

Your hearing and kidney function may need to be tested.

For hepatic coma, neomycin is usually taken for only 5 to 6 days. Avoid eating foods high in protein during this time. Follow all instructions of your doctor or dietitian about adding protein back to your diet after treatment.

Tell your doctor if you have a planned surgery.

Store tightly closed at room temperature, away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking neomycin?

Do not share neomycin with another person, even if they have the same symptoms you have.

What other drugs will affect neomycin?

Neomycin can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your other medicines, especially:

• any other antibiotics;
• digoxin;
• fluorouracil;
• methotrexate;
• vitamin B-12;
• a blood thinner–warfarin, Coumadin, Jantoven; or
• a diuretic or “water pill”–furosemide or ethacrynic acid.

Uses for Neosporin

Neomycin, polymyxin B, and gramicidin is a combination antibiotic medicine used to treat infections of the eye.

Neomycin, polymyxin B, and gramicidin combination is available only with your doctor’s prescription.

Before using Neosporin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this combination in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of neomycin, polymyxin B, and gramicidin combination in the elderly with use in other age groups.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper use of Neosporin

The bottle is only partially full to provide proper drop control.

To use:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• To keep the medicine as germ-free as possible, do not touch the applicator tip or dropper to any surface (including the eye). Also, keep the container tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For eye infections:
  • For eye drops dosage form:
    • Adults and children—Use one drop in the eye two to four times a day for seven to ten days. If you have a more serious infection, your doctor may want you to use one drop in the eye every fifteen to thirty minutes at first. Then your doctor may have you use the medicine less often.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions while using Neosporin

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Side Effects of Neosporin

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Itching, rash, redness, swelling, or other sign of irritation in or around the eye not present before use of this medicine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Burning or stinging sensation in the eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

What is Neurontin?

Neurontin is an anti-epileptic drug, also called an anticonvulsant. It affects chemicals and nerves in the body that are involved in the cause of seizures and some types of pain.

Neurontin is used in adults to treat neuropathic pain (nerve pain) caused by herpes virus or shingles (herpes zoster).

Neurontin is also used to treat seizures in adults and children who are at least 3 years old.

Use only the brand and form of gabapentin your doctor has prescribed. Check your medicine each time you get a refill to make sure you receive the correct form.

Warnings

Do not stop using Neurontin suddenly, even if you feel fine.

Gabapentin can cause life-threatening breathing problems, especially if you already have a breathing disorder or if you use other medicines that can make you drowsy or slow your breathing. Seek emergency medical attention if you have very slow breathing.

Some people have thoughts about suicide or behavior changes while taking Neurontin. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Before taking this medicine

You should not use Neurontin if you are allergic to gabapentin.

To make sure Neurontin is safe for you, tell your doctor if you have ever had:

• breathing problems or lung disease, such as chronic obstructive pulmonary disease (COPD);
• kidney disease (or if you are on dialysis);
• diabetes;
• depression, a mood disorder, or suicidal thoughts or actions;
• a drug addiction;
• a seizure (unless you take Neurontin to treat seizures);
• liver disease;
• heart disease; or
• (for patients with RLS) if you are a day sleeper or work a night shift.

Some people have thoughts about suicide while taking this medicine. Children taking Neurontin may have behavior changes. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking Neurontin for seizures without your doctor’s advice, and tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of gabapentin on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I take Neurontin?

Take Neurontin exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

If your doctor changes your brand, strength, or type of gabapentin, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of gabapentin you receive at the pharmacy.

Neurontin can be taken with or without food.

If you break a tablet and take only half of it, take the other half at your next dose. Any tablet that has been broken should be used as soon as possible or within a few days.

Swallow the capsule or tablet whole and do not crush, chew, break, or open it.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Do not stop using Neurontin suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor’s instructions about tapering your dose.

In case of emergency, wear or carry medical identification to let others know you have seizures.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Neurontin.

Store Neurontin tablets and capsules at room temperature away from light and moisture.

Store the liquid medicine in the refrigerator. Do not freeze.

Dosing information

Usual Adult Dose for Epilepsy:

Initial dose: 300 mg orally on day one, 300 mg orally 2 times day on day two, then 300 mg orally 3 times a day on day three
Maintenance dose: 300 to 600 mg orally 3 times a day
Maximum dose: 3600 mg orally daily (in 3 divided doses)
-Maximum time between doses in the 3 times a day schedule should not exceed 12 hours

Comment:
-May be taken with or without food.
-Half-tablets not used within 28 days of breaking the scored tablet should be discarded.

Use: Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization

Usual Adult Dose for Postherpetic Neuralgia:

-Initial dose: 300 mg orally on day one, 300 mg orally 2 times day on day two, then 300 mg orally 3 times a day on day three
-Titrate up as needed for pain relief
-Maximum dose: 1800 mg per day (600 mg orally 3 times a day)
COMMENT:
-May be taken with or without food.
-Half-tablets not used within 28 days of breaking the scored tablet should be discarded.

Usual Pediatric Dose for Epilepsy:

Less than 3 years: Not recommended

Greater than or equal to 3 and less than 12 years:
Starting Dose: Ranges from 10 to 15 mg/kg/day in 3 divided doses
Effective Dose: Reached by upward titration over a period of approximately 3 days; the effective dose in patients 5 years of age and older is 25 to 35 mg/kg/day in divided doses (3 times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (3 times a day). Gabapentin may be administered as capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long term clinical study. The maximum time interval between doses should not exceed 12 hours.

Greater than 12 years:
-Initial dose: 300 mg orally on day one, 300 mg orally 2 times a day on day two, then 300 mg orally 3 times a day on day three
-Maintenance dose: 900 to 1800 mg orally in 3 divided doses; the dose may be increased up to 1800 mg/day. Dosages up to 2400 mg/day have been well tolerated in long term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. The maximum time between doses in the three times a day schedule should not exceed 12 hours.

Use: Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization in patients 3 years of age and older

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid taking an antacid within 2 hours before you take Neurontin. Antacids can make it harder for your body to absorb gabapentin.

Avoid drinking alcohol while taking Neurontin.

Neurontin side effects

Get emergency medical help if you have signs of an allergic reaction to Neurontin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, upper stomach pain, or yellowing of your skin or eyes.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• weak or shallow breathing;
• blue-colored skin, lips, fingers, and toes;
• confusion, extreme drowsiness or weakness;
• problems with balance or muscle movement;
• unusual or involuntary eye movements; or
• increased seizures.

Gabapentin can cause life-threatening breathing problems. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. Breathing problems may be more likely in older adults or in people with COPD.

Some side effects are more likely in children taking Neurontin. Contact your doctor if the child taking this medicine has any of the following side effects:

• changes in behavior;
• memory problems;
• trouble concentrating; or
• acting restless, hostile, or aggressive.

Common Neurontin side effects may include:

• fever, chills, sore throat, body aches, unusual tiredness;
• jerky movements;
• headache;
• double vision;
• swelling of your legs and feet;
• tremors;
• trouble speaking;
• dizziness, drowsiness, tiredness;
• problems with balance or eye movements; or
• nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect Neurontin?

Using Neurontin with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, cold or allergy medicine, a muscle relaxer, or medicine for anxiety or seizures.

other drugs may interact with gabapentin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is Nexium?

Nexium is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Nexium is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. It is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).

Nexium may also be given to prevent gastric ulcer caused by infection with Helicobacter pylori (H. pylori), or by the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Nexium is not for immediate relief of heartburn symptoms.

Warnings

Nexium can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Esomeprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking this medicine long term or more than once per day.

Before taking this medicine

You should not use Nexium if you are allergic to esomeprazole or to similar medicines such as lansoprazole (Prevacid), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix), or rabeprazole (AcipHex).

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.

You should not use this medicine if you have had kidney problems.

Tell your doctor if you have ever had:

• severe liver disease;
• lupus;
• osteoporosis or low bone mineral density (osteopenia); or
• low levels of magnesium in your blood.

You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

How should I take Nexium?

Use Nexium exactly as directed on the label, or as prescribed by your doctor.

Take each dose with a full glass (8 ounces) of water.

Nexium should be taken at least one hour before a meal.

Do not crush or chew a delayed-release capsule. However to make swallowing easier, you may open the capsule and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow right away without chewing. Do not save the mixture for later use.

The capsule can be given through a nasogastric (NG) feeding tube. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Esomeprazole is usually given for 4 to 8 weeks only. Your doctor may recommend a second course of treatment if you need additional healing time.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Call your doctor if your symptoms do not improve or if they get worse while you are taking this medicine.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using esomeprazole.

Some conditions are treated with a combination of esomeprazole and antibiotics. Use all medications as directed.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

This medicine can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Nexium side effects

Get emergency medical help if you have signs of an allergic reaction ro Nexium: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• seizure (convulsions);
• kidney problems – fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;
• low magnesium – dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
• new or worsening symptoms of lupus – joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking esomeprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use esomeprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common Nexium side effects may include:

• headache;
• diarrhea;
• nausea, stomach pain, gas, constipation; or
• dry mouth.

What is Nexplanon?

Nexplanon (etonogestrel implant) is a long-term, reversible birth control for women. It is a contraceptive implant that is a flexible, thin plastic rod that is about the length of a matchstick (4cm by 2mm), which is placed under the skin on the inner side of the upper arm by your doctor or other healthcare provider.

Once you have it placed in your arm you don’t need to think about contraception for the next three years, you don’t need to worry about forgetting to take it, whether you have used it correctly and there is no need to interrupt sex to organise contraception.

Nexplanon can be removed at any time and your fertility will return to normal.

How does Nexplanon work?

The rod contains a hormone called etonogestrel that slowly and steadily releases to prevent pregnancy. It does this by stopping the release of an egg from your ovary, thinning the lining of your uterus and thickening mucus in your cervix.

The implant is made of a material that can be seen on X-rays and sometimes your health provider may use an X-ray to help locate it for removal.

How is the Nexplanon implant used?

Nexplanon is inserted through a needle (under local anesthesia) into the skin of your upper arm, just inside and above the elbow. After the implant is inserted, your arm will be covered with 2 bandages. Remove the top bandage after 24 hours, but leave the smaller bandage on for 3 to 5 days. Keep the area clean and dry.

The timing of when you receive the Nexplanon implant depends on whether you were using birth control before, and what type it was. For more information about how quickly it works as a contraceptive see dosing information below.

You should be able to feel the implant under your skin. Tell your doctor if you cannot feel the implant at any time while it is in place.

The Nexplanon implant can remain in place for up to 3 years. If the implant is placed correctly, you will not need to use back-up birth control. Follow your doctor’s instructions.

You may have irregular and unpredictable periods while using Nexplanon. Tell your doctor if your periods are very heavy or long-lasting, or if you miss a period (you may be pregnant).

If you need major surgery or will be on long-term bed rest, or if you need medical tests, may need to have your Nexplanon implant removed for a short time. Any doctor or surgeon who treats you should know that you have a Nexplanon implant.

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using this medicine.

Call your doctor at once if it feels like the Nexplanon implant may be bent or broken while it is in your arm.

How do they remove Nexplanon?

To remove the device, your health care provider will inject a local anesthetic in your arm beneath the implant. They will make a small incision in your skin and will push the implant toward the incision until the tip is visible and can be grasped with forceps.

Your health care provider will then pull out the implant, close the incision and apply a pressure bandage. Contraceptive implant removal typically takes less than five minutes.

If you choose, a new device can be implanted as soon as the original device is removed. Be prepared to use another type of contraception right away if you don’t have a new device inserted.

For information on ‘Problems with Insertion and Removal’ see the section below called ‘What are the possible risks of using Nexplanon?’

How well does Nexplanon work?

If your Nexplanon implant is inserted correctly, it is one of the most effective types of birth control. Your chance of getting pregnant is very low, less than 1 pregnancy per 100 women.

This medicine may be less effective in overweight women.

Can you get pregnant using Nexplanon?

Yes, you can become pregnant using Nexplanon, but it is very rare. If you do become pregnant it is important to see your healthcare provider to make sure it is not an ectopic pregnancy, which is when the pregnancy is outside of the womb. Women on Nexplanon have a slightly higher risk of ectopic pregnancy compared to women not using birth control.

It is important to have the implant removed if you become pregnant and plan on maintaining the pregnancy. This medicine is not likely to cause birth defects if you become pregnant while using it.

Dosing information

How long does Nexplanon last?

Nexplanon lasts for 3 years and at the end of the 3 years your implant must be removed. If you still require contraception a new implant may be inserted at the time of removal. You can have Nexplanon removed at any time and you will return to your normal fertility.

How long does it take for Nexplanon to work?

How long before Nexplanon starts to working as a contraceptive depends on if you have previously been using no contraception, or another form of contraception or whether you have recently had a baby, miscarriage or abortion.

No previous contraception

• If you get Nexplanon inserted in the first 5 days of your period then you are protected from pregnancy right away and back-up contraception is not needed.
• If you get Nexplanon inserted at any other time of your period you will need to use a barrier form contraception for the first week of using Nexplanon.

Previous combination hormonal contraception (eg combined hormonal pills, vaginal ring or transdermal patch)

• If you have Nexplanon inserted on the day after the last active pill, or on the day of removal of the vaginal ring or transdermal patch, then you are protected from pregnancy right away and you won’t need a back-up contraception.
• If you have Nexplanon inserted after the above time you will need to use a barrier method until 7 days after insertion, and if unprotected intercourse has already occurred, pregnancy should be excluded.

Previous progestin-only contraceptives

• Injectable progestin contraceptives. The Nexplanon should be inserted on the day that the next injection is due, then you are protected from pregnancy right away and you don’t need to use any extra contraception.
• Progestin mini pill. Nexplanon should be inserted within 24 hours after taking the last tablet, so you are protected from pregnancy right away and you don’t need to use any extra contraception.
• Progestin contraceptive implant or intrauterine device (IUD). If Nexplanon is inserted on the same day the previous contraceptive implant or IUD is removed you will be protected from pregnancy right away and you don’t need to use any extra contraception.
• If you have Nexplanon insert after the above times you will need to use a barrier method of contraception until 7 days after insertion, and if unprotected intercourse has already occurred, pregnancy should be excluded.

Previous miscarriage or abortion

• First Trimester: Nexplanon should be inserted within 5 days following a first trimester abortion or miscarriage, to be protected from pregnancy right away and for back-up contraception not to be needed.
• Second Trimester: If Nexplanon is inserted between 21 to 28 days following second trimester abortion or miscarriage, you will be protected from pregnancy right away and back-up contraception will not be needed.
• If Nexplanon is inserted after the above times you will need to use a barrier method of contraception until 7 days after insertion, and if unprotected intercourse has already occurred, pregnancy should be excluded.

After giving birth

• Not Breastfeeding: When Nexplanon is inserted between 21 to 28 days postpartum then back-up contraception is not necessary. If inserted after this time then you should use a barrier method of contraception until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
• Breastfeeding: If you are breastfeeding you should not have Nexplanon inserted until 4 weeks after you have given birth. You should use a barrier method until 7 days after insertion. If unprotected intercourse has already occurred, pregnancy should be excluded.

How soon can you get pregnant after Nexplanon removal?

Your fertility will return to normal after removal of Nexplanon, with women in studies becoming pregnant 7 to 14 days after removal. If you do not want to become pregnant then it is important to consider having another Nexplanon inserted at the same time as removal or starting another form of birth control.

What happens if I miss a dose?

Nexplanon is an implant that lasts for 3 years. It is not intended for contraceptive use after 3 years and should be replaced with a new one if you want to continue having contraceptive cover.

You should keep a record of when you had Nexplanon inserted and just before the end of the third year make an appointment for removal of the implant. You may have your Nexplanon replaced with a new one at the same appointment if you want to continue with contraception.

Warnings

Do not use Nexplanon if you are:

• pregnant or
• if you have had a baby less than 4 weeks ago and you are breastfeeding or
• if you have had a baby less than 3 weeks ago and you are not breastfeeding

You should not use a Nexplanon implant if you have: undiagnosed vaginal bleeding, liver disease or liver cancer, if you will be having major surgery, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Using a Nexplanon implant can increase your risk of blood clots, stroke, or heart attack.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not smoke while using a Nexplanon implant.

Important information

Nexplanon will not protect you from sexually transmitted diseases–including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Using a Nexplanon implant can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of using this medicine.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke.

Do not use it if you are pregnant. If you become pregnant, the Nexplanon implant should be removed if you plan to continue the pregnancy.

You may need to have a negative pregnancy test before receiving the implant.

You should not use hormonal birth control if you have:

• a history of heart attack, stroke, or blood clot
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina
• unusual vaginal bleeding that has not been checked by a doctor or
• liver disease or liver cancer.

To make sure Nexplanon is safe for you, tell your doctor if you have ever had:

• diabetes
• high cholesterol or triglycerides
• high blood pressure
• headaches
• gallbladder disease
• kidney disease
• depression or
• an allergy to numbing medicines.

Nexplanon may not be as effective in women who are overweight.

The Nexplanon implant should not be used in women younger than 18 years old.

Etonogestrel can pass into breast milk. Tell your doctor if you are breast-feeding. See breastfeeding information below for more information on Nexplanon and breastfeeding .

What are the side effects of Nexplanon?

What are the most common side effects I can expect while using Nexplanon?

Changes in Menstrual Bleeding Patterns (menstrual periods)

• The most common side effect of Nexplanon is a change in your normal menstrual bleeding pattern. In studies, one out of ten women stopped using the implant because of an unfavorable change in their bleeding pattern.
• You may experience longer or shorter bleeding during your periods or have no bleeding at all. The time between periods may vary, and in between periods you may also have spotting.

Tell your healthcare provider right away if:

• You think you may be pregnant
• Your menstrual bleeding is heavy and prolonged

Besides changes in menstrual bleeding patterns, other frequent side effects that caused women to stop using the implant include:

• Mood swings
• Weight gain
• Headache
• Acne
• Depressed mood

Other common side effects include:

• Headache
• Vaginitis (inflammation of the vagina)
• Weight gain
• Acne
• Breast pain
• Viral infections such as sore throats or flu-like symptoms
• Stomach pain
• Painful periods
• Mood swings, nervousness, or depressed mood
• Back pain
• Nausea
• Dizziness
• Pain
• Pain at the site of insertion

Implants have been reported to be found in a blood vessel, including a blood vessel in the lung which can be associated with shortness of breath, cough and/or the coughing up of blood or blood-stained mucus.

This is not a complete list of possible side effects. For more information, ask your healthcare provider for advice about any side effects that concern you. You may report side effects to the FDA .

What are the possible risks of using Nexplanon?

Problems with Insertion and Removal

The implant may not be placed in your arm at all due to a failed insertion. If this happens, you may become pregnant. Immediately after insertion, and with help from your healthcare provider, you should be able to feel the implant under your skin. If you can’t feel the implant, tell your healthcare provider.

Location and removal of the implant may be difficult or impossible because the implant is not where it should be. Special procedures, including surgery in the hospital, may be needed to remove the implant. If the implant is not removed, then the effects of Nexplanon will continue for a longer period of time.

Implants have been found in the pulmonary artery (a blood vessel in the lung). If the implant cannot be found in the arm, your healthcare provider may use x-rays or other imaging methods on the chest. If the implant is located in the chest, surgery may be needed.

Other problems related to insertion and removal are:

• Pain, irritation, swelling, or bruising at the insertion site
• Numbness and tingling at the insertion site
• Scarring, including a thick scar called a keloid around the insertion site
• Infection
• Scar tissue may form around the implant making it difficult to remove
• The implant may come out by itself. You may become pregnant if the implant comes out by itself. Use a back-up birth control method and call your healthcare provider right away if the implant comes out.
• The need for surgery in the hospital to remove the implant
• Injury to nerves or blood vessels in your arm
• The implant breaks making removal difficult

Ectopic Pregnancy

If you become pregnant while using Nexplanon, you have a slightly higher chance that the pregnancy will be ectopic (occurring outside the womb) than do women who do not use birth control. Unusual vaginal bleeding or lower stomach (abdominal) pain may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancies can cause serious internal bleeding, infertility, and even death. Call your healthcare provider right away if you think you are pregnant or have unexplained lower stomach (abdominal) pain.

Ovarian Cysts

Cysts may develop on the ovaries and usually go away without treatment but sometimes surgery is needed to remove them.

Breast Cancer

It is not known whether Nexplanon use changes a woman’s risk for breast cancer. If you have breast cancer now, or have had it in the past, do not use this medicine because some breast cancers are sensitive to hormones.

Serious Blood Clots

Nexplanon may increase your chance of serious blood clots, especially if you have other risk factors such as smoking. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke.

Some examples of serious blood clots are blood clots in the:

• Legs (deep vein thrombosis)
• Lungs (pulmonary embolism)
• Brain (stroke)
• Heart (heart attack)
• Eyes (total or partial blindness)

The risk of serious blood clots is increased in women who smoke. If you smoke and want to use Nexplanon you should quit smoking. Talk to your healthcare provider as they may be able offer you solutions to help you quit.

Tell your healthcare provider at least 4 weeks before if you are going to have surgery or will need to be on bed rest. You have an increased chance of getting blood clots during surgery or bed rest.

Other Risks

A few women who use birth control that contains hormones may get:

• High blood pressure
• Gallbladder problems
• Rare cancerous or noncancerous liver tumors

Broken or Bent Implant

Can Nexplanon break in my arm? Yes, the implant can break or bend due to external forces (e.g., manipulation of the implant or contact sports). A broken implant may move from the insertion site. If you feel that the implant may have broken or bent while in your arm, contact your healthcare provider.

When should I call my healthcare provider?

Call your healthcare provider right away if you have:

• Pain in your lower leg that does not go away
• Severe chest pain or heaviness in the chest
• Sudden shortness of breath, sharp chest pain, or coughing blood
• Symptoms of a severe allergic reaction, such as swollen face, tongue or throat; trouble breathing or swallowing
• Sudden severe headache unlike your usual headaches
• Weakness or numbness in your arm, leg, or trouble speaking
• Sudden partial or complete blindness
• Yellowing of your skin or whites of your eyes, especially with fever, tiredness, loss of appetite, dark colored urine, or light-colored bowel movements
• Severe pain, swelling, or tenderness in the lower stomach (abdomen)
• Lump in your breast
• Problems sleeping, lack of energy, tiredness, or you feel very sad
• Heavy menstrual bleeding

Interactions

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Certain medicines may make Nexplanon less effective, including:

• aprepitant
• barbiturates
• bosentan
• carbamazepine
• felbamate
• griseofulvin
• oxcarbazepine
• phenytoin
• rifampin
• St. John’s wort
• topiramate
• HIV medicines
• Hepatitis C Virus medicines

Ask your healthcare provider if you are not sure if your medicine is one listed above.

If you are taking medicines or herbal products that might make Nexplanon less effective, you and your healthcare provider may decide to leave Nexplanon in place; in that case, an additional non-hormonal contraceptive should be used. Because the effect of another medicine on Nexplanon may last up to 28 days after stopping the medicine, it is necessary to use the additional non-hormonal contraceptive for that long.

When you are using Nexplanon, tell all of your healthcare providers that you have this medicine in place in your arm.

Pregnancy and breastfeeding

Pregnancy: You should not use Nexplanon if you are pregnant. You may need to have a negative pregnancy test before Nexplanon is inserted. If you become pregnant while using Nexplanon you should have it removed if you plan to continue with the pregnancy.

Breastfeeding: If you are breastfeeding your child, you may use Nexplanon if 4 weeks have passed since you had your baby. A small amount of the hormone contained in Nexplanon passes into your breast milk. The health of breast-fed children whose mothers were using the implant has been studied up to 3 years of age in a small number of children. No effects on the growth and development of the children were seen.

Hormonal contraceptives, including etonogestrel, can sometimes reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women.

If you are breastfeeding and want to use Nexplanon, you should talk with your healthcare provider who can provide more information on hormonal or non-hormonal contraceptives.

What is Ngenla?

Ngenla is a long-acting human growth hormone used to treat children aged 3 and older who are not growing because of growth hormone deficiency (GHD). It is given by injection under the skin (subcutaneously) once a week, and older children and caregivers can be taught how to administer it.

Ngenla (somatrogon) gained FDA approval on June 28, 2023 and is manufactured by Pfizer Ireland Pharmaceuticals. There is no generic or biosimilar.

How does Ngenla work?

Ngenla works by binding to growth hormone receptors throughout the body, particularly in the liver, muscles, bones and other tissues. This stimulates the production of a substance called Insulin-Like Growth Factor (IGF-1) that mediates metabolic and other changes to regulate metabolism, stimulate the growth plates in long bones, and enhance growth.

Ngenla has a modified structure that allows one-weekly administration compared with other growth hormone treatments that are given daily. It contains human growth hormone fused with a portion of human chorionic gonadotropin (hCG) to make a larger protein (somatrogon) that stays in the blood stream longer. Somatrogon has a half-life of about 70-80 hours compared to the 3.8-hour half-life of natural growth hormone.

Side effects

The most common side effects of Ngenla are:

• injection site reactions (such as pain, swelling, rash, itching, bleeding)
• common cold
• headache
• fever
• low red blood cells (anemia)
• cough
• vomiting
• decrease in thyroid hormone levels
• stomach (abdominal) pain
• rash
• throat pain.

Serious side effects and warnings

Ngenla may cause the following serious side effects:

• high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems
• serious allergic reactions. Get medical help right away if your child has the following symptoms:
  • swelling of the face, lips, mouth, or tongue
  • trouble breathing
  • wheezing
  • severe itching
  • skin rashes, redness, or swelling
  • dizziness or fainting
  • fast heartbeat or pounding in the chest
  • sweating.
• increased risk of growth of cancer or a tumor that is already present, and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your child’s healthcare provider will need to monitor your child for a return of cancer or a tumor. Contact your child’s healthcare provider if your child starts to have headaches, or has changes in behavior, changes in vision, or changes in moles, birthmarks, or the color of the skin
• new or worsening high blood sugar (hyperglycemia) or diabetes. Your child’s blood sugar may need to be monitored during treatment with Ngenla
• increase in pressure inside the skull (intracranial hypertension). If your child has headaches, eye problems, nausea or vomiting, contact your child’s healthcare provider
• your child’s body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in the joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Fluid retention can happen in children during treatment with NGENLA. Tell your child’s healthcare provider if your child has any of these signs or symptoms of fluid retention
• decrease in a hormone called cortisol. Your child’s healthcare provider will do blood tests to check your child’s cortisol levels. Tell your child’s healthcare provider if your child has severe fatigue, dizziness, weakness, vomiting, dehydration, or weight loss
• decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well NGENLA works. Your child’s healthcare provider will do blood tests to check your child’s hormone levels
• hip and knee pain or limp (slipped capital femoral epiphysis). Tell your child’s healthcare provider if your child has any of these signs or symptoms
• worsening of curvature of the spine (scoliosis). If your child has scoliosis, your child will need to be checked often for an increase in the curve of the spine
• severe and constant stomach (abdominal) pain. This could be a sign of pancreatitis. Tell your child’s healthcare provider if your child has any new abdominal pain
• loss of fat and tissue weakness in the area of skin you inject. Talk to your child’s healthcare provider about rotating the areas where you inject Ngenla
• high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea
• increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in the blood.

Before receiving

Your child should not receive Ngenla if they:

• have a critical illness caused by certain types of heart or stomach surgery, trauma, or breathing (respiratory) problems
• are allergic to somatrogon-ghla or any of the ingredients in Ngenla
• have closed bone growth plates (epiphyses)
• have cancer or other tumors
• have certain eye problems caused by diabetes (such as diabetic retinopathy)
• have Prader-Willi syndrome, are severely obese, or have breathing problems including sleep apnea.

Tell your healthcare provider about all the medical conditions your child has, including if your child:

• has had heart or stomach surgery, trauma or serious breathing (respiratory) problems
• has had a history of problems breathing while they slept (sleep apnea)
• has or has had cancer or any tumor
• has diabetes
• is pregnant or plans to become pregnant
• is breastfeeding or plans to breastfeed.

Pregnancy

It is not known if Ngenla will harm your child’s unborn baby. Talk to your child’s healthcare provider if your child is pregnant or plans to become pregnant.

Breastfeeding

It is not known if Ngenla passes into breast milk. You and your child’s healthcare provider should decide if they will receive it while breastfeeding.

How is Ngenla administered?

Read the detailed Instructions for Use that come with Ngenla.

• Ngenla comes in 2 different dosage strengths. Your child’s healthcare provider will prescribe the dose of medicine and the dosage strength that is right for your child.
• Your child’s healthcare provider will show you how to inject Ngenla before it is used for the first time. Do not try to inject Ngenla until you have been shown the right way by your child’s healthcare provider.
• Inject Ngenla exactly as your child’s healthcare provider tells you to.

Ngenla is injected under the skin (subcutaneously) and can be given in the stomach (abdomen), thighs, buttocks, or upper arms. Rotate the site of injection weekly.

• Inject Ngenla 1 time each week, on the same day each week, at any time of the day.
• You may change the day of the week Ngenla is used as long as the last dose was injected 3 or more days before. After the new day of the week has been chosen, continue with the 1 time a week schedule.

Ngenla prefilled pens are for use by 1 person only.

• Do not share your child’s Ngenla prefilled pens and needles with another person, even if the needle has been changed. Your child may give another person an infection or get an infection from them.

Dosing information

The recommended dosage is 0.66 mg/kg based on actual body weight administered once weekly.

• Individualize dosage for each patient based on the growth response.
• If you are switching from daily growth hormone injections, you may start treatment with once-weekly Ngenla on the day following your last daily injection.
• If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site.

Ngenla pen directions

The Ngenla pen is available in 2 strengths:

• 24 mg/1.2 mL (20 mg/mL) that delivers a dose in 0.2 mg increments
• 60 mg/1.2 mL (50 mg/mL) that delivers a dose in 0.5 mg increments.

Each turn (click) of the dose knob dials 0.2mg or 0.5 mg of medicine, depending on the pen’s strength.

Always use a new sterile needle for each injection. This will decrease the risk of contamination, infection, leakage of medicine, and blocked needles leading to the wrong dose.

Do not shake your pen. Shaking can damage the medicine.

24 mg/1.2 mL Pen

• You can give from 0.2 mg to 12 mg in a single injection with the 24 mg/1.2mL pen.
• If your dose is more than 12 mg, you will need to give more than 1 injection or ask for the higher strength pen.

60 mg/1.2 mL pen

• You can give from 0.5 mg to 30 mg in a single injection with the 60 mg/1.2mL pen.
• If your dose is more than 30 mg, you will need to give more than 1 injection.
• A new pen may contain slightly more than 60 mg of medicine, this is normal.

What happens if I miss a dose?

If your child misses a dose of Ngenla the missed dose should be injected as soon as possible within 3 days after the missed dose. If more than 3 days have passed, skip your child’s missed dose. Inject the next dose on the regularly scheduled day.

What happens if I overdose?

An acute overdosage may lead initially to low blood glucose levels and subsequently to high blood glucose levels. Overdose with growth hormone may cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism consistent with the effects of excess growth hormone.

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Ngenla?

Do not share your pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

The pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.

What other drugs will affect Ngenla?

Tell your child’s healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Medications that may interact with Ngenla include:

• Glucocorticoid treatment
• Cytochrome P450-metabolized drugs (Ngenla may alter their clearance)
• Oral estrogen (larger doses of Ngenla may be required)
• Insulin and/or other antihyperglycemics (a dosage adjustment of these may be required).

This list is not complete. Other drugs may affect Ngenla, including prescription and over-the-counter medicines, vitamins, and herbal products.

How should I store Ngenla?

• Do not freeze your pen or expose it to heat.
• Do not use your pen if it has been frozen or stored in direct sunlight.
• Do not use after the expiration date printed on the label has passed or if it has been more than 28 days after first use.

Before you use Ngenla pens for the first time (unused pens):

• Store in the original carton.
• Store the new, unused Ngenla pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Unused prefilled pens may be used until the expiration date printed on the pen label, if kept in the refrigerator.

After you use Ngenla pens and there is still medicine left (up to 28 days of use):

• To help you remember when to dispose of (throw away) the pen, write the date of first use on the pen label.
• Store remaining Ngenla in the refrigerator between 36°F to 46°F (2°C to 8°C) and use within 28 days.
• Keep the pen cap on the Ngenla pen when it is not in use.
• Do not store the remaining Ngenla pen with a needle attached.
• Do not use the Ngenla pen if it has been more than 28 days after first use, even if it contains unused medicine.

Keep Ngenla and all medicines out of the reach of children.

Ingredients

Active ingredient: somatrogon-ghla

Inactive ingredients: citric acid monohydrate, histidine, metacresol (as a preservative), poloxamer 188, sodium chloride, sodium citrate, and water for injection.

Available in two different strengths:

• 24 mg/1.2 mL (20 mg/mL) single-patient-use prefilled pen that delivers the dose in 0.2 mg increments
• 60 mg/1.2 mL (50 mg/mL) single-patient-use prefilled pen that delivers the dose in 0.5 mg increments.

The pens are disposable and should be thrown away in a sharps bin once empty. You can give more than 1 dose from the pen.

Manufacturer

Ngenla (somatrogon) is manufactured by Pfizer Ireland Pharmaceuticals, and distributed by Pfizer Labs, a division of Pfizer Inc., one of the world’s largest pharmaceutical companies.

Ngenla Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Ngenla.Ngenla (somatrogon-ghla) – Pfizer Ireland Pharmaceuticals

What is niacin?

Niacin, also called nicotinic acid, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. It is also present in many multiple vitamins and nutritional supplements.

Niacin is used to lower blood levels of “bad” cholesterol (low-density lipoprotein, or LDL) and triglycerides, and increase levels of “good” cholesterol (high-density lipoprotein, or HDL).

Niaspan is used to lower the risk of a heart attack in people who have high cholesterol and who have a history of heart attacks. Niaspan can also be used with another cholesterol medicine to slow down the build-up of fatty deposits in your arteries.

Warnings

You should not take niacin if you have severe liver disease, a stomach ulcer, or active bleeding.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take this medicine. These effects should disappear over time as you keep taking the medication.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid taking colestipol (Colestid) or cholestyramine (Locholest, Prevalite, Questran) at the same time you take niacin. If you take either of these other medications, take them at least 4 to 6 hours before or after you take this medicine.

Niacin is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Before taking this medicine

You should not take niacin if you are allergic to it.

To make sure you can safely take niacin, tell your doctor if you have ever had:

• severe liver disease;
• a stomach ulcer; or
• active bleeding.

Tell your doctor if you have ever had:

• liver disease;
• kidney problems;
• heart disease, chest pain (angina);
• gout; or
• diabetes.

It is not known whether niacin will harm an unborn baby. You may not be able to use this medicine during pregnancy. Tell your doctor right away if you become pregnant.

You should not breastfeed while using this medicine.

Do not give niacin to a child without medical advice.

How should I take niacin ?

Use niacin exactly as directed on the label, or as prescribed by your doctor. Read all medication guides or instruction sheets.

Niacin can cause flushing (warmth, itching, redness, or tingly feeling under your skin). These effects should disappear over time as you keep taking the medicine. Flushing may be worse if you drink alcohol or hot beverages shortly after taking niacin.

Swallow the capsule or tablet whole and do not crush, chew, break, or open it.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.

If you stop taking niacin for any length of time, talk with your doctor before starting the medication again. You may need to restart the medication at a lower dose.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Niacin is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Your doctor may recommend you take aspirin or an NSAID (such as ibuprofen, Advil, or Aleve) to help prevent flushing. Keep using these medicines for as long as your doctor has prescribed.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid drinking alcohol. It may increase your risk of liver damage, and can also worsen the flushing effects of niacin.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid eating foods high in fat or cholesterol, or niacin will not be as effective.

Niacin side effects

Get emergency medical help if you have signs of an allergic reaction to niacin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor;
• unexplained muscle pain, tenderness or weakness;
• a light-headed feeling, like you might pass out;
• irregular heartbeats;
• severe warmth or redness under your skin;
• vision problems; or
• jaundice (yellowing of the skin or eyes).

Common niacin side effects may include:

• flushing (sudden warmth, redness, or tingly feeling);
• upset stomach, nausea, vomiting, diarrhea;
• abnormal liver function tests;
• itching, rash, dry skin;
• cough;
• skin discoloration; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA

What other drugs will affect niacin?

You should not take colesevelam, colestipol, or cholestyramine within 4 hours before or 4 hours after taking niacin.

Tell your doctor about all your other medicines, especially:

• other medicines to lower cholesterol or triglycerides;
• aspirin;
• blood pressure medicine; or
• a blood thinner – warfarin, Coumadin, Jantoven.

Introduction

Ganglionic (nicotinic) cholinergic-receptor agonist.

Uses for Nicotine

Smoking Cessation

Used for nicotine replacement therapy as a temporary adjunct in the cessation of cigarette smoking either unsupervised (self-medication) or in conjunction with a behavior modification program under clinician supervision.

Nicotine replacement therapy considered one of several first-line therapies by USPHS for treatment of tobacco dependence. For additional information, consult the most current USPHS clinical practice guideline available at 

Nicotine replacement therapy provides alternative sources of nicotine that help reduce the withdrawal symptoms associated with nicotine dependence. Chewing the resin complex-containing gum may act as a substitute oral activity in behavior modification.

Electronic nicotine delivery systems (ENDS) such as electronic cigarettes (e-cigarettes) have been used to aid smoking cessation attempts; however, these products are not approved by FDA for this use and evidence is limited regarding their efficacy and safety. The role of ENDS relative to conventional nicotine replacement therapies for smoking cessation remains to be established.

Ulcerative Colitis

Transdermal nicotine has been used in the management of ulcerative colitis^{† [off-label]}.

Nicotine Dosage and Administration

General

• To increase smoking cessation rate, use as part of a comprehensive program of multiple treatment strategies, including behavioral modification.
• Individualize duration of therapy based on patient response and degree of nicotine dependence.
• Stop smoking prior to initiating nicotine replacement therapy; self-medication not recommended in patients who continue to smoke, chew tobacco, or use snuff or other nicotine-containing preparations.
• Discontinue therapy in patients who continue to smoke 4 weeks after initiating treatment; may use nicotine replacement therapy again in subsequent attempts to quit smoking.

Administration

Administer nicotine percutaneously by topical application of a transdermal system.

Administer nicotine transmucosally by oral inhalation using a special nicotine oral inhaler or intranasally using a metered-dose spray pump.

Administer nicotine polacrilex intrabuccally (transmucosally) as a lozenge or chewing gum.

May be administered as a single nicotine preparation (i.e., intrabuccally, intranasally, percutaneously, or by oral inhalation); however, if single therapy does not enable patients to quit smoking, use of transdermal nicotine may be combined with another form of nicotine replacement (i.e., either buccal nicotine polacrilex or nicotine nasal spray).

Buccal Administration

Chewing Gum

Self-administer one piece of gum in response to the urge to smoke.

Chew gum very slowly until a distinctive peppery taste of nicotine, minty, cinnamon, or orange taste of the gum, or a slight tingling in the mouth is perceived (typically about 15 chews); stop chewing gum and park between cheek and gum; once tingling is almost gone (about 1 minute), repeat chewing procedure. Continue for about 30 minutes or until taste dissipates. Do not swallow gum.

Do not eat or drink anything other than water for 15 minutes before and during chewing of gum.

Do not chew multiple pieces of gum simultaneously; do not chew too rapidly or chew pieces in succession. May cause excessive release of nicotine and result in adverse effects (e.g., lightheadedness, nausea, vomiting, irritation of the throat and mouth, hiccups, indigestion).

Chew at least 9 pieces of gum daily to improve chances of quitting.

Do not attempt to discontinue nicotine polacrilex gum therapy until craving is satisfied by 1 or 2 pieces of the gum daily, but do not continue therapy for >6 months, unless otherwise instructed by clinician.

4-mg strength gum recommended in highly dependent smokers because of evidence of increased efficacy.

Lozenges

Suck on lozenge until dissolved; do not swallow, bite, or chew. Allow to slowly dissolve in the mouth over 20–30 minutes, periodically moving the lozenge (e.g., with the tongue) from one side of the mouth to the other; minimize swallowing. A warm or tingling sensation may be perceived.

Do not eat or drink anything other than water for 15 minutes before and during sucking on the lozenge.

Use at least 9 lozenges daily for the first 6 weeks to improve chances of quitting.

Using >1 lozenge simultaneously or using one lozenge after another in uninterrupted sequence may result in adverse effects (e.g., hiccups, heartburn, nausea).

Self-administer lozenge in response to nicotine craving; decrease frequency of administration over time.

Topical Administration

Administer percutaneously by topical application of a transdermal system once daily.

Apply at the same time each day, usually after awakening.

Expose the adhesive surface of the system by peeling and discarding the protective liner just prior to application and apply system immediately to avoid loss of nicotine through volatilization.

Apply transdermal system to a clean, dry, hairless area of intact skin on the trunk or upper outer arm by firmly pressing the system with the adhesive side touching the skin. Press system firmly in place with heel of hand for about 10 seconds, ensuring good contact, particularly around the edges. Do not apply to sites that are oily, damaged, or irritated; if necessary, hair may be clipped, but do not shave area.

System may be worn for 16 or 24 hours. If cravings begin upon awakening, wear patch for 24 hours. If vivid dreams or sleep disruptions occur, wear patch for 16 hours; remove at bedtime and apply new patch upon awakening.

If system inadvertently comes off during the period of use, apply a new system; continue current application schedule or change so that the next system is applied 24 hours later.

Rotate application sites to minimize potential skin irritation; allow ≥1 week before reusing a given site. (See Dermatologic Effects under Cautions.)

Avoid unnecessary contact with transdermal systems. Avoid touching eyes after handling; wash hands with water alone as soap may enhance percutaneous absorption.

Intranasal Administration

Administer intranasally using a metered-dose spray pump.

Prime spray pump prior to initial use by spraying into a tissue until a fine spray is seen (6–8 times); discard tissue.

If spray pump is not used for 24 hours, reprime pump by spraying into a tissue 1–2 times.

Clear nasal passages prior to administration.

Tilt the head back slightly; insert tip of bottle into one nostril as far as is comfortable. Breathe through the mouth and spray once into nostril; do not sniff, swallow, or inhale through the nose while administering. Repeat this procedure for the other nostril.

If nose runs, sniff gently to keep nasal spray in nose; wait 2–3 minutes before blowing nose.

Avoid contact with skin, eyes, and mouth; if contact occurs, rinse with plain water immediately. If intranasal bottle breaks, wear protective gloves, wipe with paper towels, and wash surfaces thoroughly.

Oral Inhalation

Administer transmucosally as an inhaled vapor by oral inhalation using a special nicotine oral inhaler that mimics smoking cigarettes.

Hold the oral inhaler with two hands; separate the top and bottom pieces by pushing and turning the pieces until markings line up. Insert one nicotine cartridge and push the cartridge until it pops into place. Line up markings on the top and bottom pieces of the inhaler and push pieces together tightly; lock inhaler by turning pieces until markings do not line up.

Place the mouthpiece of the inhaler between lips and puff on the inhaler using rapid shallow sucking (“buccal mode”); alternatively, inhale slowly and deeply into back of throat (“pulmonary mode”). Nicotine is vaporized and absorbed in mouth and throat. (See Absorption under Pharmacokinetics.) Shallow puffing method generally is preferred. Deep inhalation technique requires considerable effort and does not result in substantially increased drug delivery or other benefits.

Individualize orally inhaled dosage to the level of nicotine replacement required; optimum results generally achieved by frequent continuous puffing of the inhaler over 20 minutes.

Nicotine is used up from cartridge after about four 5-minute sessions or one 20-minute session of active puffing.

When cartridge is empty, remove top of mouthpiece; discard empty cartridge away from children and pets. Store with mouthpiece in locked position and cartridges in plastic case. Clean reusable mouthpiece regularly with soap and water.

Use inhaler at temperatures >60°F; cold temperatures decrease the amount of nicotine inhaled.

Also administered transmucosally as an inhaled vapor by oral inhalation via electronic nicotine delivery systems (ENDS) such as e-cigarettes and vape pens; however, safety and efficacy in smoking cessation not evaluated by FDA.

Dosage

Chewing gum and lozenges available as nicotine polacrilex; dosage expressed in terms of nicotine.

Nicotine oral inhaler cartridges labeled as containing 10 mg of nicotine deliver ≤4 mg total with repeated inhalation. The amount of nicotine released depends on the volume and temperature of the air passing through the inhaler. An intensive inhalation regimen (80 deep inhalations over 20 minutes) releases approximately 4 mg of nicotine.

Metered nasal spray delivers 0.5 mg of the nicotine per metered spray and about 200 sprays (i.e., 100 doses) per 100-mg container.

Adults

Smoking Cessation

Buccal (Chewing Gum)

Patients who smoke <25 cigarettes daily: Chew a 2-mg piece of gum every 2 hours during weeks 1–6; chew a 2-mg piece every 2–4 hours during weeks 7–9; and chew a 2-mg piece every 4–8 hours during weeks 10–12 of therapy. Alternatively, chew a 2-mg piece of gum whenever the urge to smoke occurs; do not exceed 2 pieces (4 mg) per hour.

Patients who smoke ≥25 cigarettes daily: Chew a 4-mg piece of gum every 2 hours during weeks 1–6; chew a 4-mg piece every 2–4 hours during weeks 7–9; and chew a 4-mg piece every 4–8 hours during weeks 10–12 of therapy. Alternatively, chew a 4-mg piece whenever the urge to smoke occurs; do not exceed 2 pieces (8 mg) per hour.

Taper dosage by chewing each piece for only 10–15 minutes and gradually reducing the number of pieces chewed, or chew each piece for longer than 30 minutes but reduce the total pieces per day, or substitute regular chewing gum for some pieces.

Buccal (Lozenges)

Patients who smoke first cigarette >30 minutes after waking: One 2-mg lozenge every 1–2 hours during weeks 1–6; then one 2-mg lozenge every 2–4 hours during weeks 7–9; and one 2-mg lozenge every 4–8 hours during weeks 10–12.

Patients who smoke first cigarette ≤30 minutes after waking: One 4-mg lozenge every 1–2 hours during weeks 1–6; then one 4-mg lozenge every 2–4 hours during weeks 7–9; and one 4-mg lozenge every 4–8 hours during weeks 10–12.

Do not exceed 5 lozenges in 6 hours or 20 lozenges daily.

Discontinue therapy if mouth problems, persistent indigestion, severe sore throat, irregular heartbeat, palpitations, or symptoms suggestive of overdosage (nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat) develop.

Transdermal

Patients who smoke ≤10 cigarettes daily: Initially, 14 mg daily for 6 weeks, then 7 mg daily for 2 weeks, then discontinue.

Patients who smoke >10 cigarettes daily: Initially, 21 mg daily for 4–6 weeks; then 14 mg daily for 2 weeks; then 7 mg daily for 2 weeks; then discontinue therapy.

Intranasal

Initially, 1–2 sprays (0.5–1 mg) in each nostril per hour (1–2 mg per hour total); may increase up to a maximum of 5 sprays (5 mg) in each nostril per hour (10 mg total) or a maximum total of 80 sprays (40 mg) daily.

Initially, use at least 16 sprays (8 mg total) daily to increase chance of efficacy. Then, individualize dosage based on nicotine dependence and occurrence of symptoms of nicotine excess.

Continue treatment in successfully abstinent patients for up to 8 weeks then discontinue over 4–6 weeks.

Taper dosage by using only 1 spray at a time, using the spray less frequently, keeping a tally of daily usage, trying to meet a steadily reducing usage target, skipping a dose by not medicating every hour, or setting a planned “quit date” for stopping use of the spray. Some patients may not require tapering.

Oral Inhalation

Initially, 6–16 cartridges daily for up to 12 weeks, then gradually decrease daily dosage over 6–12 weeks.

Use ≥6 cartridges daily for the first 3–6 weeks to increase chance of efficacy. Individualize dosage based on nicotine dependence and occurrence of symptoms of nicotine excess.

Taper dosage by using less frequently, keeping a tally of daily usage, trying to meet a steadily reducing usage target, or setting a planned “quit date” for stopping use of the inhaler. Some patients may not require tapering.

Prescribing Limits

Adults

Smoking Cessation

Buccal (Chewing Gum)

Maximum 2 pieces of 2-mg gum per hour (i.e., maximum 24 pieces [48 mg nicotine] daily). Maximum 12 weeks of therapy.

Maximum 2 pieces of 4-mg gum per hour (i.e., maximum 24 pieces [96 mg nicotine] daily). Maximum 12 weeks of therapy.

Clinician supervised: Maximum 30 pieces of 2-mg gum daily (i.e., 60 mg nicotine) or 24 pieces of 4-mg gum daily (i.e., 96 mg nicotine).

Buccal (Lozenges)

Maximum 5 lozenges in 6 hours or 20 lozenges daily. Maximum 12 weeks of therapy.

Transdermal

Patients who smoke ≤10 cigarettes daily: Maximum 8 weeks of therapy.

Patients who smoke >10 cigarettes daily: Maximum 10 weeks of therapy.

Continued therapy for periods longer than usually recommended may be appropriate for certain patients to promote extended abstinence. Continuation of therapy >12 weeks not recommended by manufacturer.

Intranasal

Maximum 5 sprays (5 mg) in each nostril per hour (maximum 10 mg total) or a maximum total of 80 sprays (40 mg) daily.

Manufacturer states that continuing therapy >12 weeks does not improve outcome. Safety of continuing therapy >6 months not established.

Oral Inhalation

Maximum 16 cartridges daily for up to 12 weeks.

Manufacturer states that safety of continuing therapy >6 months not established.

Special Populations

No special population dosage recommendations at this time.

Cautions for Nicotine

Contraindications

• Known hypersensitivity to nicotine, menthol (oral inhaler), or any ingredient in the formulation.
• Nicotine polacrilex gum in patients with temporomandibular joint disease. (See Oral and Dental Effects under Cautions.)

Warnings/Precautions

Warnings

Nicotine Toxicity

Risk of nicotine toxicity (e.g., nausea, hypersalivation, abdominal pain, vomiting, diarrhea, perspiration, headache, dizziness, hearing and visual disturbances, mental confusion, weakness) and addiction. Sustained use of nicotine preparations is not recommended. Weigh risk of nicotine replacement against hazard of continued smoking concurrent with nicotine replacement therapy and likelihood of smoking cessation without nicotine replacement.

Discontinue nicotine polacrilex lozenges if symptoms suggestive of overdosage (nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat) occur.

Fetal/Neonatal Morbidity

Animal studies indicate fetal harm; pregnant women should attempt smoking cessation with educational and behavioral interventions before considering nicotine therapy.

Use during pregnancy only if the increased likelihood of smoking cessation justifies potential risk to the fetus and patient of nicotine replacement and possible continued smoking. If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.

General Precautions

Respiratory Effects

Possible exacerbation of bronchospasm. Use oral inhaler with caution in patients with bronchospastic disease; other dosage forms may be preferable.

Intranasal nicotine is not recommended in patients with severe reactive airway disease.

Nasopharyngeal Effects

Nicotine nasal spray may irritate nasal mucosa; use of nasal spray not recommended in patients with a history of chronic nasal disorders (e.g., allergy, rhinitis, polyps, sinusitis).

Discontinue nicotine polacrilex lozenges if severe sore throat occurs.

Cardiovascular Effects

Possible increased risk of adverse cardiovascular effects; however, causal relationship between nicotine replacement therapy and cardiac complications not established.

Discontinue therapy if irregular heartbeat or palpitations occur.

Use with caution and only after careful evaluation in patients with coronary heart disease (i.e., history of MI, angina pectoris), serious cardiac arrhythmias, or vasospastic diseases (e.g., Buerger’s disease, Prinzmetal’s variant angina, Raynaud’s phenomena). Benefit of nicotine replacement therapy must outweigh risks of continued cigarette smoking.

Self-medication not recommended in patients in the immediate post-MI period, with serious arrhythmias, or with severe or worsening angina.

Endocrine Effects

Possible hyperinsulinemia and insulin resistance with prolonged nicotine replacement therapy. Use with caution in hyperthyroidism, pheochromocytoma, or insulin-dependent diabetes.

GI Effects

Possible delayed healing of peptic ulcer disease; use with caution.

Discontinue nicotine polacrilex lozenges if persistent indigestion develops.

Use nicotine polacrilex gum with caution in patients with a history of esophagitis.

Hypertension

Possible increased risk of malignant hypertension in patients with accelerated hypertension; use with caution in such patients.

Possible perpetuation of hypertension; use with caution in patients with systemic hypertension.

Nicotine Dependence

Transference of dependence on nicotine may occur; potential for abuse and dependence on nicotine nasal spray appears to be greater than that for other formulations of nicotine (i.e., nicotine polacrilex gum, transdermal nicotine systems) but less than that of cigarettes.

To minimize withdrawal symptoms and the risk of dependence on nicotine, withdraw gradually or discontinue use of nicotine polacrilex gum or transdermal or intranasal nicotine after 2–3 months of therapy.

Concern exists regarding possible risk of nicotine dependence transference from use of electronic nicotine delivery systems (ENDS) such as e-cigarettes and vape pens in individuals, particularly adolescents, not previously dependent on nicotine but who subsequently transition to actual cigarette use.

Phenylketonuria

Commit nicotine polacrilex lozenges contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 3.4 mg of phenylalanine per lozenge.

Oral and Dental Effects

Risk of occlusal stress when nicotine polacrilex gum is chewed for long periods of time; may result in displaced dental restorations or loosening of dental inlays or fillings. Gum may stick to dentures, dental caps, or partial bridges; if excessive sticking or damage to dental work occurs, discontinue gum and consult clinician.

Use nicotine polacrilex gum with caution in patients with a history of oral or pharyngeal inflammation, or dental conditions exacerbated by chewing gum.

Discontinue nicotine polacrilex lozenges if mouth problems develop.

Dermatologic Effects

Possible skin reactions (e.g., urticaria, hives, rash) with transdermal systems. Increased risk of such reactions in patients with some dermatologic conditions (e.g., psoriasis, atopic or eczematous dermatitis).

If skin reaction occurs, discontinue transdermal system and contact clinician; topical corticosteroids and/or oral antihistamines recommended.

Risk of contact sensitization with transdermal systems; serious reaction may occur with re-exposure to smoking or other nicotine products.

Nervous System Effects

Potential adverse nervous system effects (e.g., insomnia, headache, dizziness, lightheadedness).

Specific Populations

Pregnancy

Category D. (See Fetal/Neonatal Morbidity under Cautions.)

Lactation

Distributed into milk. Use caution.

Weigh risk of exposure to nicotine in drug versus risk of nicotine and other components of tobacco smoke from cigarettes.

Pediatric Use

Safety and efficacy not established.

Use or ingestion of used or unused nicotine replacement systems by children may cause poisoning or be fatal; keep used and unused containers out of reach of children.

Risk of choking if nicotine oral inhalers are swallowed; keep out of reach of children.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease.

Hepatic Impairment

Not studied in patients with hepatic impairment; use with caution.

Renal Impairment

Not studied in patients with renal impairment; clearance may be decreased in patients with severe renal impairment.

Common Adverse Effects

Buccal therapy (gum): Indigestion; nausea; hiccups; traumatic injury to oral mucosa and/or teeth; irritation and/or tingling of the tongue, mouth, and throat; oral mucosal ulceration; jaw-muscle ache; eructation; gum sticking to teeth; unpleasant taste; dizziness; lightheadedness; headache; insomnia.

Buccal therapy (lozenges): Nausea, dyspepsia, flatulence, headache, upper respiratory tract infections.

Transdermal therapy: Application site reactions (i.e., pruritus, burning, or erythema), diarrhea, dyspepsia, abdominal pain, dry mouth.

Intranasal therapy: Runny nose, throat irritation, watery eyes, sneezing, cough.

Oral inhalation therapy: Dyspepsia, oropharyngeal irritation (e.g., coughing, mouth and throat irritation), rhinitis, headache.

Drug Interactions

Cigarette smoke and nicotine induce hepatic enzymes.

Smoking Cessation

Cessation of smoking may alter the response to concomitant administration of various drugs in patients who previously smoked.

Potential pharmacokinetic interaction (decreased metabolism and increased blood concentrations of certain drugs) with cessation of smoking.

Consider the effect of smoking cessation in patients receiving nicotine replacement therapy when patient is receiving other drugs concomitantly.

Sympathomimetic and Sympatholytic Drugs

Potential pharmacodynamic interaction (increased circulating plasma concentrations of cortisol and catecholamines); may require dosage adjustment of sympathomimetic (adrenergic) or sympatholytic (adrenergic blocking) drugs.

Possible altered absorption of transdermal nicotine from drugs producing cutaneous vasoconstriction (e.g., sympathomimetic agents) or vasodilation (e.g., antihypertensive agents).

Foods Affecting Salivary Acidity

Transient decrease of salivary pH may inhibit buccal absorption of nicotine from gum, lozenge, or oral inhaler.

Specific Drugs and Foods

Nicotine Pharmacokinetics

Absorption

Bioavailability

Readily absorbed transmucosally following intrabuccal administration via chewing gum or sucking a lozenge, and following oral inhalation and intranasal administration; absorbed minimally from the GI tract.

Readily absorbed percutaneously following topical application of a transdermal system.

Gum: Averages 53–55%, with peak concentrations achieved within 25–30 minutes.

Lozenge: Approximately 25–27% more of an equivalent dose absorbed with lozenge than with gum.

Transdermal: Approximately 68–98%, with peak concentrations achieved within 2–10 hours.

Intranasal: Approximately 53%, with peak concentrations achieved within 4–15 minutes.

Oral inhalation: Approximately 60%, mostly absorbed in the mouth, with peak concentrations achieved within 15–30 minutes.

Food

Acidic beverages may interfere with buccal absorption. (See Specific Drugs and Foods under Interactions.)

Plasma Concentrations

Gum: Relatively constant blood nicotine concentrations attained following repeated administration are similar to those produced by smoking cigarettes.

Transdermal: Plasma nicotine concentrations generally lower and fluctuate less than those produced by smoking cigarettes.

Intranasal: Plasma nicotine concentrations similar to those produced by smoking cigarettes.

Oral inhalation: Lower plasma nicotine concentrations compared with nasal spray.

Special Populations

Common cold or rhinitis may decrease extent of absorption and peak plasma concentrations of intranasal nicotine.

Obesity decreases peak plasma concentration and AUC of transdermal systems.

Distribution

Extent

Following IV administration in animals, rapidly distributes into most body tissues and fluids with highest concentrations in the cerebral cortex and adrenal medulla, and lower concentrations in spleen, adrenal cortex, kidney, and pancreas.

Nicotine crosses the placenta and is distributed into milk.

Plasma Protein Binding

<5%.

Elimination

Metabolism

Rapidly and extensively metabolized, principally in the liver, to >20 primarily inactive metabolites.

Elimination Route

Excreted in urine mainly as metabolites (70–90%) and as unchanged drug (10–30%).

Half-life

Biphasic; terminal half-life averages 2 hours (range: 1–4 hours).

Following removal of a transdermal system, apparent half-life averages 3–6 hours.

Special Populations

Hepatic impairment may reduce clearance.

Severe renal failure may reduce clearance.

Stability

Storage

Oral

Gum

<30°C; protect from light.

Lozenge

20–25°C; protect from light.

Transdermal

20–25°C in unopened, protective pouch.

Intranasal

Solution

<30°C.

Oral Inhalation

<30°C; protect cartridges from light.

Actions

• A ganglionic (nicotinic) cholinergic-receptor agonist; exhibits stereospecific binding to receptors in autonomic ganglia, the adrenal medulla, the neuromuscular junction, and the brain.
• Exhibits both stimulant (e.g., marked CNS and respiratory stimulation) and depressant effects in the CNS and peripheral nervous system.
• Behavior-reinforcing properties of nicotine result from dose-related effects on the CNS.
• Low doses produce stimulant effects (e.g., increased alertness and cognitive performance) in the cerebral cortex by stimulating autonomic ganglia and facilitating neurotransmission.
• High doses produce reward effects mediated through the mesolimbic dopaminergic system, with initial ganglionic stimulation, which is quickly followed by inhibition of neurotransmission.
• Activates neurohormonal pathways, releasing acetylcholine, norepinephrine, dopamine, serotonin, vasopressin, beta-endorphin, growth hormone, and ACTH.
• Cardiovascular effects mediated principally via stimulation of sympathetic ganglia and the adrenal medulla and via release of catecholamines from neuronal tissue. Low doses produce peripheral vasoconstriction and increase heart rate, myocardial contractile force, cardiac output, stroke volume, velocity of myocardial contraction, and BP, resulting in an increase in cardiac work and oxygen consumption; however, large doses may cause hypotension.
• GI effects mediated principally via cholinergic stimulation; results in increased tone and motor activity of GI smooth muscle. Systemic absorption may cause nausea, vomiting, and diarrhea.
• Chronic use may result in psychologic and physical dependence; tolerance to some of the pharmacologic effects may occur.

Advice to Patients

• Importance of not smoking or using other tobacco products during nicotine replacement therapy.
• Advise patient of improved smoking cessation success with a comprehensive treatment approach (e.g., support groups, counseling, or specific behavior change techniques).
• Importance of providing patient a copy of the manufacturer’s patient information. When used for self-medication, importance of reading patient instructions provided by the manufacturer.
• Importance of patient understanding the proper use (see Administration under Dosage and Administration) and disposal of nicotine preparations.
• Importance of avoiding unnecessary contact with transdermal systems. Advise patients to discard transdermal system carefully; fold so adhesive side sticks to itself, place in empty protective pouch, and dispose of immediately. Importance of washing hands with water alone; importance of not touching eyes prior to handwashing.
• Importance of keeping used and unused transdermal systems, intranasal containers, oral inhaler cartridges, gum, and lozenges out of the reach of children and pets. Importance of contacting clinician or poison control immediately if a child or pet chews or swallows a nicotine product.
• Importance of calling clinician or poison control center if symptoms of nicotine overdose occur (e.g., bad headaches, dizziness, upset stomach, drooling, vomiting, diarrhea, cold sweat, blurred vision, hearing difficulties, mental confusion, weakness, fainting).
• Advise patients of symptoms of nicotine withdrawal (e.g., craving, nervousness, restlessness, irritability, mood lability, anxiety, drowsiness, sleep disturbances, impaired concentration, increased appetite, minor somatic complaints [headache, myalgia, constipation, fatigue], weight gain).
• For transdermal therapy, importance of consulting clinician before initiating therapy if patient has a dermatologic condition or is allergic to adhesive tape. (See Dermatologic Effects under Cautions.) Importance of discontinuing use and contacting clinician if severe or persistent skin reaction occurs at transdermal site (e.g., severe erythema, pruritus, edema).
• Advise patients receiving nicotine polacrilex gum that chewing gum too rapidly may result in lightheadedness, nausea, vomiting, irritation of throat and mouth, hiccups, and indigestion.
• Advise patients receiving intranasal therapy of likelihood of nasal irritation; may become less bothersome with continued use.
• Advise patients receiving nicotine for oral inhalation of likelihood of mild irritation of the mouth or throat and cough; may become tolerant of these effects.
• Importance of patients taking lozenges to stop use and contact clinician if mouth problems, persistent indigestion, severe sore throat, irregular heartbeat or palpitations occur. Patients receiving nicotine polacrilex gum should stop use and contact clinician if mouth, teeth, or jaw problems, or irregular heartbeat or palpitations occur.
• Importance of informing patients with phenylketonuria that Commit nicotine polacrilex lozenges contain aspartame.
• Importance of consulting clinician if patient feels the need for continued nicotine replacement therapy at the end of regimen.
• Risk of dependence to nicotine in oral inhaler and nasal spray; importance of using inhaler and nasal spray only as long as directed by clinician.
• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.
• Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., chronic nasal problems, heart problems, high blood pressure, stomach ulcers, wheezing or asthma, overactive thyroid, diabetes requiring insulin, kidney or liver disease).
• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

What is Nexletol?

Nexletol (bempedoic acid) is an oral pill for high cholesterol that may be used to reduce the risk of heart attacks and other heart problems in adults with heart disease or at high risk OR lower LDL (“bad”) cholesterol levels in adults with high cholesterol.

Nexletol works by blocking an enzyme in your liver called ACL. This enzyme helps make cholesterol, so blocking it helps lower your cholesterol levels.

Nexletol was first FDA-approved on February 21, 2020. It is only available as the brand Nexletol, there is no bempedoic acid generic.

What is Nexletol used for?

Nexletol is an oral prescription medicine used:

• to lower the risk of heart attack and heart procedures like stent placement or bypass surgery, in
  adults who are unable to take recommended statin treatment (a cholesterol-lowering medicine), or
  are not taking a statin, who:
  • have known heart disease, or
  • are at high risk for heart disease but without known heart disease.
• along with diet and other cholesterol-lowering medicines, or alone when use with other cholesterol-lowering medicines is not possible, to reduce low-density lipoprotein (LDL, or bad cholesterol) in adults with high blood cholesterol levels called primary hyperlipidemia, including a type of high blood cholesterol called heterozygous familial hypercholesterolemia (HeFH).

It is not known if Nexletol is safe and effective in children.

Nexletol side effects

The most common side effects of Nexletol are:

• symptoms of the common cold, flu, or flu-like symptoms
• back pain
• stomach pain
• high uric acid levels
• increased liver enzymes
• muscle spasms
• pain in the shoulder, legs, or arms
• anemia
• bronchitis.

There’s no evidence that Nexletol affects your weight. Any weight changes are likely due to diet and exercise, not the medication. It is important to follow a healthy diet while taking Nexletol to manage your cholesterol or reduce your risk of a major heart event.

Serious side effects and warnings

Serious hypersensitivity reactions have occurred with Nexletol, including angioedema (swelling of the face and airways), wheezing, rash, and urticaria (hives). Do not take Nexletol if you are allergic to it or any of its inactive ingredients.

Nexletol may cause the following serious side effects.

Increased levels of uric acid in your blood (hyperuricemia). This can happen within 4 weeks of starting treatment and continue throughout. Your healthcare provider will monitor your blood uric acid levels while you are taking Nexletol. High levels of blood uric acid may lead to gout. Call your healthcare provider if you have the following symptoms of hyperuricemia and gout:

• severe foot pain especially in the toe joint
• warm joints
• swelling
• tender joints
• joint redness.

Gout may happen more in people who have had gout before but can also happen in people who have never had it before.

Tendon rupture or injury. Tendon problems can happen in people who take Nexletol. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include pain, swelling, tears, and inflammation of tendons including the arm, shoulder, and back of the ankle (Achilles).

• Tendon rupture can happen while you are taking Nexletol. Tendon ruptures can happen within days or months of starting Nexletol.
• The risk of getting tendon problems while you take Nexletol is higher if you:
  • are over 60 years of age
  • are taking antibiotics (fluoroquinolones)
  • have had tendon problems
  • are taking steroids (corticosteroids)
  • have renal failure.
• Stop taking Nexletol immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
  • hear or feel a snap or pop in a tendon area
  • bruising right after an injury in a tendon area
  • unable to move the affected area or put weight on the affected area
• If you suspect a tendon rupture, do not take Nexletol until this has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common areas of pain and swelling are the rotator cuff (the shoulder), the biceps tendon (upper arm), and the Achilles tendon at the back of the ankle. This can happen with other tendons.
• Talk to your healthcare provider about the risk of tendon rupture with the continued use of Nexletol. You may need a different lipid-lowering medicine to treat your cholesterol levels.

May cause harm to an unborn baby. Breastfeeding is not recommended.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Nexletol. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

Before taking Nexletol

It is not known if Nexletol is safe and effective in:

• people with severe liver problems
• severe kidney problems including people with end-stage kidney disease who are on dialysis
• children under 18 years of age.

Do not take Nexletol if you are allergic to bempedoic acid or any of the inactive ingredients in Nexletol (see Nexletol ingredients below for a list of ingredients). Stop taking Nexletol and call your healthcare provider or go to the nearest hospital emergency room right away if you have any signs or symptoms of an allergic reaction including:

• swelling of your face, lips, mouth, or tongue
• trouble breathing
• wheezing
• skin rashes, redness, or swelling
• severe itching
• dizziness or fainting
• fast heartbeat or pounding in your chest.

Before you start taking Nexletol, tell your healthcare provider about all your medical conditions, including if you:

• have or had gout.
• have or had tendon problems
• have severe kidney problems.
• have severe liver problems
• are pregnant, think you might be pregnant, or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Nexletol may cause harm to your unborn baby. You and your healthcare provider will decide if you should take
it while you are pregnant. If you become pregnant during Nexletol treatment, tell your healthcare provider right away and call Esperion at 1-833-377-7633 to share information about the health of you and your baby.

Breastfeeding

It is not known if Nexletol passes into your breast milk. You and your healthcare provider should decide if you will take Nexletol or breastfeed. You should not do both.

How should I take Nexletol?

Take Nexletol exactly as your healthcare provider tells you to take it. Check with your healthcare provider or pharmacist if you are not sure.

• Take 1 Nexletol 180 mg tablet by mouth each day. Each tablet contains 180mg of bempedoic acid.
• You may take it with or without food.

What happens if I miss a dose?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and just go back to your regular dosing schedule. Do not take two doses at once.

What happens if I overdose?

If you take too much Nexletol, call your poison control center or go to the nearest hospital emergency room right away.

What other drugs will affect Nexletol?

Nexletol may affect the way other medicines work, and other medicines may affect how Nexletol works. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you take simvastatin or pravastatin (other cholesterol-lowering medicines). Taking statins with Nexletol may increase your risk of developing muscle pain or weakness (myopathy).

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

What is nifedipine?

Nifedipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.

Nifedipine is used to treat hypertension (high blood pressure) and angina (chest pain).

Nifedipine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about nifedipine?

You should not use nifedipine if you have severe coronary artery disease, or if you have had a heart attack within the past 2 weeks.

Before taking nifedipine, tell your doctor if you have kidney or liver disease, a blockage in your digestive tract (stomach or intestines), a history of stomach surgery, coronary artery disease, or congestive heart failure.

If you need surgery, tell the surgeon ahead of time that you are using nifedipine. You may need to stop using the medicine for a short time.

Do not stop taking nifedipine without first talking to your doctor, even if you feel fine. Stopping suddenly may make your condition worse. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Before taking this medicine

You should not use this medicine if you are allergic to nifedipine, if you have severe coronary artery disease, or if you have had a heart attack within the past 2 weeks.

To make sure nifedipine is safe for you, tell your doctor if you have:

• kidney disease;
• congestive heart failure; or
• if you take other medications, especially an antibiotic or antifungal medicine, an antidepressant, heart or blood pressure medicine, or drugs to treat HIV/AIDS or hepatitis C.

It is not known whether nifedipine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Nifedipine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

The nifedipine extended-release tablet may contain lactose. Talk to your doctor before using this form of nifedipine if you have galactose intolerance, or severe problems with lactose (milk sugar).

How should I take nifedipine?

Take nifedipine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may need to take an extended-release tablet on an empty stomach. Follow the directions on your medicine label about taking this medication with or without food.

Do not crush, chew, or break a nifedipine extended-release tablet. Swallow it whole.

Your blood pressure will need to be checked often and you may need other blood tests at your doctor’s office.

Some tablet forms of nifedipine are made with a shell that is not absorbed or melted in the body. Part of the tablet shell may appear in your stool. This is a normal side effect of nifedipine and will not make the medication less effective.

If you need surgery, tell the surgeon ahead of time that you are using nifedipine. You may need to stop using the medicine at least 36 hours before surgery.

You may have very low blood pressure while taking this medication. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

If you are also taking a beta-blocker (atenolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, sotalol, and others) you should not stop using the beta-blocker suddenly or you could have serious heart problems that will not be prevented by nifedipine. Follow your doctor’s instructions about tapering your beta-blocker dose.

You should not stop using nifedipine suddenly. Stopping suddenly may make your condition worse.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid?

Grapefruit and grapefruit juice may interact with nifedipine and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Nifedipine side effects

Get emergency medical help if you have any signs of an allergic reaction to nifedipine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• worsening angina;
• a light-headed feeling, like you might pass out;
• pounding heartbeats or fluttering in your chest;
• chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;
• swelling in your ankles or feet; or
• upper stomach pain, jaundice (yellowing of the skin or eyes).

Common nifedipine side effects may include:

• mild dizziness;
• flushing (warmth, redness, or tingly feeling);
• weakness, headache, mood changes;
• heartburn, nausea;
• tremors, muscle cramps; or
• cough, wheezing, sore throat, stuffy nose.

What is Nilandron?

Nilandron is used to treat prostate cancer that has spread to other parts of the body.

Nilandron is for use in men who have undergone surgical castration.

Nilandron may also be used for purposes not listed in this medication guide.

Nilandron side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Nilandron may cause serious side effects. Call your doctor at once if you have:

• chest pain, wheezing, dry cough, fever;
• new or worsening shortness of breath;
• flu symptoms, pale skin, feeling tired; or
• liver problems–nausea, vomiting, loss of appetite, right-sided upper stomach pain, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of Nilandron may include:

• hot flashes;
• dizziness;
• constipation;
• nausea or vomiting, loss of appetite;
• skin rash;
• decreased libido, impotence; or
• vision changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects .

Warnings

You should not use Nilandron if you have severe liver disease or severe breathing problems.

Nilandron can cause serious lung problems. Call your doctor right away if you have chest pain, wheezing, dry cough, fever, and new or worsening shortness of breath.

Before taking this medicine

You should not use Nilandron if you are allergic to it, or if you have:

• severe liver disease; or
• severe breathing problems.

Tell your doctor if you have ever had:

• liver disease; or
• asthma or another lung disease.

Nilandron is not for use in women, and the effects of Nilandron during pregnancy or in breastfeeding women are unknown.

How should I take Nilandron?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Treatment with Nilandron should be started on the day of or on the day after surgical castration.

You may take Nilandron with or without food.

Do not stop taking this medication without first talking to your doctor.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Nilandron?

Nilandron may cause a delay in your ability to see in the dark after you have been in a lighted area. Be careful when driving at night, when entering a tunnel, and in similar situations. Wearing tinted glasses may help lessen this effect.

Drinking alcohol with Nilandron may cause dizziness, flushing (warmth, redness, or tingly feeling), or other unpleasant symptoms.

What is nilutamide?

Nilutamide is used to treat prostate cancer that has spread to other parts of the body.

Nilutamide is for use in men who have undergone surgical castration.

Nilutamide may also be used for purposes not listed in this medication guide.

Nilutamide side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Nilutamide may cause serious side effects. Call your doctor at once if you have:

• chest pain, wheezing, dry cough, fever;
• new or worsening shortness of breath;
• flu symptoms, pale skin, feeling tired; or
• liver problems–nausea, vomiting, loss of appetite, right-sided upper stomach pain, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of nilutamide may include:

• hot flashes;
• dizziness;
• constipation;
• nausea or vomiting, loss of appetite;
• skin rash;
• decreased libido, impotence; or
• vision changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not use nilutamide if you have severe liver disease or severe breathing problems.

Nilutamide can cause serious lung problems. Call your doctor right away if you have chest pain, wheezing, dry cough, fever, and new or worsening shortness of breath.

Before taking this medicine

You should not use nilutamide if you are allergic to it, or if you have:

• severe liver disease; or
• severe breathing problems.

Tell your doctor if you have ever had:

• liver disease; or
• asthma or another lung disease.

Nilutamide is not for use in women, and the effects of nilutamide during pregnancy or in breastfeeding women are unknown.

How should I take nilutamide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Treatment with nilutamide should be started on the day of or on the day after surgical castration.

You may take nilutamide with or without food.

Do not stop taking this medication without first talking to your doctor.

Store at room temperature away from moisture and heat.

Nilutamide dosing information

Usual Adult Dose for Prostate Cancer:

-Initial dose: 300 mg orally once a day for first 30 days

-Maintenance dose: 150 mg orally once a day after first 30 days

-Comments: For maximum benefit, treatment should begin on the same day or the day after surgical castration.

Use: Treatment of metastatic prostate cancer (Stage D2) in combination with surgical castration.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking nilutamide?

Nilutamide may cause a delay in your ability to see in the dark after you have been in a lighted area. Be careful when driving at night, when entering a tunnel, and in similar situations. Wearing tinted glasses may help lessen this effect.

Drinking alcohol with nilutamide may cause dizziness, flushing (warmth, redness, or tingly feeling), or other unpleasant symptoms.

What is nystatin?

Nystatin when taken by mouth is used to treat yeast infections in the mouth.

Oral nystatin is not absorbed into your bloodstream and will not treat fungal infections in other parts of the body or on the skin.

Nystatin may also be used for purposes other than those listed in this medication guide.

Nystatin side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using nystatin if you have mouth irritation.

Nystatin may cause serious side effects. Call your doctor at once if you have:

• fast heart rate;
• trouble breathing; or
• severe skin reaction–fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects of nystatin may include:

• mouth irritation;
• upset stomach, nausea, vomiting, diarrhea; or
• skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use nystatin if you are allergic to it.

Tell your doctor if you are pregnant or breastfeeding.

Do not give nystatin to a child without medical advice.

How should I take nystatin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take this medicine with a full glass of water.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

When taking liquid nystatin to treat a yeast infection of the mouth, you may need to hold the medicine in your mouth for as long as possible. This allows the medicine to stay in contact with the infected area. Follow your doctor’s instructions.

Do not share this medicine with another person, even if they have the same symptoms you have.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medicine. Nystatin will not treat a viral infection such as the flu or a common cold.

Nystatin is usually given for up to 48 hours after lab tests show that the infection has cleared.

Store the Bio-Statin brand of nystatin in the refrigerator. Do not freeze.

Other brands or forms of this medicine may be stored at room temperature away from moisture and heat.

Nystatin dosing information

Usual Adult Dose for Oral Thrush:

Recommended dose: 400,000 to 600,000 units of the oral suspension orally 4 times a day
Duration of therapy: At least 48 hours after symptoms have disappeared and cultures demonstrate eradication

Comment:
-For the treatment of oral candidiasis, the suspension should be retained in the mouth for as long as possible before swallowing.

Usual Adult Dose for Intestinal Candidiasis:

Recommended dose: 500,000 to 1,000,000 units of the tablet formulation orally 3 times a day
Duration of therapy: At least 48 hours after clinical cure

Usual Pediatric Dose for Oral Thrush:

1 month to 12 months:
-Recommended dose: 200,000 units of the oral suspension orally 4 times a day
1 year to 18 years:
-Recommended dose: 400,000 to 600,000 units of the oral suspension orally 4 times a day
-Duration of therapy: At least 48 hours after symptoms have disappeared and cultures demonstrate eradication

Comments:
-Limited data in premature and low birth weight infants indicated efficacy with 100,000 units orally 4 times a day.
-Infants should avoid feeding for 5 to 10 minutes after administration.
-For the treatment of oral candidiasis, the suspension should be retained in the mouth for as long as possible before swallowing.

Use: Treatment of oral candidiasis in the oral cavity

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking nystatin?

Do not use nystatin to treat any condition that has not been checked by your doctor.

What other drugs will affect nystatin?

Other drugs may affect nystatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

What is nystatin topical?

Nystatin is an antifungal medication. Nystatin prevents fungus from growing on your skin.

Nystatin topical (for the skin) is used to treat skin infections caused by yeast.

Nystatin topical is not for use to treat a vaginal yeast infection.

Nystatin topical may also be used for purposes not listed in this medication guide.

Nystatin topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using nystatin topical and call your doctor at once if you have severe burning, itching, rash, pain, or other irritation where the medicine is applied.

Less serious side effects may include mild itching or irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Do not use nystatin topical to treat any skin condition that has not been checked by your doctor.

Nystatin topical (for the skin) is not for use to treat a vaginal yeast infection.

Avoid getting this medication in your eyes or mouth. If this does happen, rinse with water.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Call your doctor if your symptoms do not improve, or if they get worse while using nystatin topical.

Do not share this medication with another person, even if they have the same symptoms you have.

Before taking this medicine

You should not use nystatin topical if you have ever had an allergic reaction to it.

FDA pregnancy category C. It is not known whether nystatin topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether nystatin topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use nystatin topical?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use nystatin topical to treat any skin condition that has not been checked by your doctor.

Wash your hands before and after using this medication.

Clean and dry the skin before you apply nystatin topical.

Do not cover treated skin with bandages or dressings that do not allow air circulation unless your doctor tells you to.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Call your doctor if your symptoms do not improve, or if they get worse while using nystatin topical.

Do not share this medication with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture and heat.

Nystatin topical dosing information

Usual Adult Dose for Cutaneous Candidiasis:

Apply nystatin topical cream, ointment or powder in a quantity sufficient to cover the affected area and immediately surrounding skin 2 to 4 times a day.

The powder formulation is useful for the treatment of moist areas or lesions.

Therapy should be continued for 2 to 8 weeks, depending on the nature and severity of the infection.

Usual Adult Dose for Vaginal Candidiasis:

Insert one nystatin vaginal tablet (100,000 units) vaginally once a day, preferably at bedtime, for a total of 14 days.

Usual Pediatric Dose for Cutaneous Candidiasis:

Apply nystatin topical cream, ointment or powder in a quantity sufficient to cover the affected area and immediately surrounding skin 2 to 4 times a day.

The powder formulation is useful for the treatment of moist areas or lesions.

Therapy should be continued for 2 to 8 weeks, depending on the nature and severity of the infection.

Usual Pediatric Dose for Vaginal Candidiasis:

>13 <18 years: Insert one nystatin vaginal tablet (100,000 units) vaginally once a day, preferably at bedtime, for a total of 14 days.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using nystatin topical?

Avoid getting this medication in your eyes or mouth. If this does happen, rinse with water.

Avoid wearing tight-fitting, synthetic clothing (such as nylon) that doesn’t allow air circulation. Wear clothing made of loose cotton and other natural fibers until your infection is healed.

What other drugs will affect nystatin topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied nystatin topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.