What is codeine?

Codeine is an opioid pain reliever which is used to treat mild to moderately severe pain and to help reduce coughing. Codeine is available as a single ingredient tablet and also available in multi ingredients products combined with other pain relieving medicines or cold and flu medicines.

Warnings

You should not use codeine if you have severe breathing problems, a blockage in your stomach or intestines, or frequent asthma attacks or hyperventilation.

Codeine can slow or stop your breathing, cause profound sedation, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Codeine is not for use in anyone under 18 years old.

Taking codeine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use codeine with alcohol, or with other drugs that cause drowsiness, sedation or slow your breathing.

Before taking this medicine

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

• severe asthma or breathing problems;
• a blockage in your stomach or intestines; or
• frequent asthma attacks or hyperventilation.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Do not give codeine to anyone younger than 18 years old.

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

• liver disease;
• breathing problems, sleep apnea;
• asthma, COPD, sleep apnea, or other breathing disorders;
• abnormal curvature of the spine that affects breathing;
• kidney disease;
• a head injury or brain tumor;
• low blood pressure;
• blockage in your digestive tract (stomach or intestines);
• a gallbladder or pancreas disorder;
• underactive thyroid;
• Addison’s disease or other adrenal gland disorder;
• enlarged prostate, urination problems; or
• mental illness, drug or alcohol addiction.

Some medicines can interact with codeine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use this 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 habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed while taking codeine. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

How should I take codeine?

Take codeine exactly as prescribed by your doctor. Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away codeine is against the law.

Take this medicine with food or milk if it upsets your stomach.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking this medicine. Do not use a stool softener (laxative) without first asking your doctor.

Do not stop using codeine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag throw the bag in the trash.

What happens if I miss a dose?

Since this medicine is used for pain, you are not likely to miss a dose. Skip any 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 . A codeine overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose can cause severe muscle weakness, cold and clammy skin, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.

What to avoid

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

Codeine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Codeine side effects

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

Like other narcotic medicines, codeine can slow your breathing. Death may occur if breathing becomes too weak.

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.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a slow heart rate or weak pulse;
• a light-headed feeling, like you might pass out;
• confusion, agitation, hallucinations, unusual thoughts or behavior;
• feelings of extreme happiness or sadness;
• seizure (convulsions);
• problems with urination; or
• low cortisol levels–nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common codeine side effects include:

• feeling dizzy or drowsy;
• nausea, vomiting, stomach pain;
• constipation;
• sweating; or
• mild itching or rash.

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

Dosing information

Usual Adult Dose for Pain:

Initial dose: 15 to 60 mg orally up to every 4 hours as needed
Maximum dose: 360 mg in 24 hours

Comments:
-Initial doses should be individualized taking into account severity of pain, response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
-Doses higher than 60 mg have not been shown to improve pain relief and are associated with an increased incidence of adverse effects.
-Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the management of mild to moderate pain where treatment with an opioid is appropriate and from which alternative treatments are inadequate.

What other drugs will affect codeine?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other narcotic medications – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body– a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

Buprenorphine is an opioid medication used to treat opioid use disorder (OUD), acute pain, and chronic pain. 

Buprenorphine is used for opioid addiction to reduce cravings and withdrawal symptoms without causing euphoria or dangerous side effects and helps prevent relapse. It works by being a substitute for the drug being abused, so the patient has minimal discomfort, which allows the patient to focus on their recovery. Buprenorphine for OUD is used as part of a complete treatment program that also includes counseling and behavioral therapy.

For opioid use disorder, buprenorphine is available as long-acting injections (Sublocade, Brixadi) and sublingual tablets (Subutex discontinued, generics available). 

Buprenorphine is used to treat acute pain that is severe enough to require an opioid analgesic and moderate to severe chronic pain that is not controlled by other medicines. For chronic around-the-clock pain, it is available as buprenorphine skin patches (Butrans) and buprenorphine buccal films (Belbuca), and for acute pain is available as an injection (Buprenex).

Buprenorphine-naloxone combinations are also available to be used for opioid addication and include sublingual film (Bunavail), sublingual film and sublingual tablets (Suboxone), and sublingual tablets (Zubsolv).

Buprenorphine’s mechanism of action is that is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor.

Is buprenorphine a controlled substance?

Yes, buprenorphine is a Schedule III controlled drug, which means it has a potential for abuse more than those in Schedules 4 and 5. If abused, it may lead to moderate or low physical dependence or high psychological dependence.

Warnings

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep buprenorphine in a place where others cannot get to it.
Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose. Patients should have access to naloxone to treat opioid overdose based on the patient’s risk factors for overdose, such as currently using a CNS depressant, a history of an opioid use disorder, or previous opioid overdose.  Having naloxone available is important if the patient has household members (including children) or other close contacts at risk for accidental exposure or overdose.

Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medication with alcohol or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use this medicine if you are allergic to buprenorphine or:

• If you have used another narcotic drug within the past 4 hours.

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

• methadone treatment;
• breathing problems, sleep apnea;
• abnormal curvature of the spine that affects breathing;
• liver disease (especially hepatitis B or C);
• kidney disease;
• enlarged prostate, urination problems;
• a head injury or brain tumor;
• alcoholism, hallucinations, mental illness; or
• problems with your stomach, gallbladder, adrenal gland, or thyroid.

Pregnancy

If you use buprenorphine 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 habit-forming medicine may need medical treatment for several weeks.

Infertility

Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible 

Breastfeeding

Buprenorphine can pass into breast milk and may cause drowsiness and breathing problems in a nursing baby. Ask your doctor about any risk to your baby.

How should I take buprenorphine?

Use buprenorphine exactly as it was prescribed for you. Follow the directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Never use this medication in larger amounts, or for longer than prescribed.

Opioid Use Disorder

Buprenorphine Sublingual (for OUD)

Buprenorphine sublingual is usually taken only at the start of treatment for addiction (induction phase). Most people are later switched to long-acting buprenorphine (Sublocade injection or Brixadi injection) or another medicine that contains buprenorphine with naloxone (Bunavail, Suboxone, Zubsolv). You may receive your first doses of buprenorphine sublingual in a hospital or clinic setting until your condition improves. Use dry hands when handling the tablet. Place the tablet under your tongue and allow it to dissolve with your mouth closed. Do not chew the tablet or swallow it whole. If your doctor has prescribed more than 2 tablets per dose, place the correct number of tablets under your tongue at the same time and allow them to dissolve completely. Do not eat or drink anything until the tablet has completely dissolved in your mouth. Never crush or break a pill to inhale the powder or mix it into a liquid to inject the drug into your vein. Doing so could result in death.

Extended-release buprenorphine subcutaneous injection (for OUD)

Buprenorphine extended-release injection is given subcutaneously (just under the skin). Sublocade and Brixadi can be given in the abdomen, thigh, buttock, or the back of the upper arm. 

Sublocade should only be used when patients have received treatment with at least one dose (eg, 4 mg) of an oral transmucosal (used under the tongue or inside the cheek) buprenorphine-containing medicine. Sublocade is injected as a liquid. After the injection, Sublocade changes to a solid form called a depot. The depot may be seen or felt as a small bump under your skin at the injection site on your abdomen, thigh, buttock, or back of the upper arm, for several weeks. The depot will get smaller over time. Do not try to remove the depot, and do not rub or massage the injection site. Sublocade is part of a complete treatment plan that should include counseling.

Brixadi should only be used if you are currently receiving buprenorphine treatment or if your healthcare provider has given you a test dose of buprenorphine first to see if you are able to tolerate it. If you are new to Brixadi treatment, the upper arm should only be used after 4 doses of Brixadi in your buttock, thigh, or stomach. Brixadi is injected as a liquid; after the injection, the liquid changes to a gel form called a depot. The depot is not always felt under the skin. Do not try to remove the depot. Brixadi is part of a complete treatment plan that should include counseling.

Pain

Buprenex (buprenorphine injection) is used for pain, it is given by deep intramuscular or slow (over at least 2 minutes) intravenous injection at up to 6-hour intervals, as needed.

Butrans skin patch is used for chronic around-the-clock pain. It is applied once a week and worn continuously for 1 week. Do not change your dose. Apply Butrans exactly as prescribed by your healthcare provider. Your doctor will prescribe you the lowest effective dose for the shortest time needed. Do not take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps as these can cause an overdose that can lead to death.

Belbuca buccal films are used for around-the-clock treatment of moderate to severe chronic pain. Using a finger, place the yellow side of the Belbuca buccal film against the inside of your moistened cheek. Press and hold the Belbuca buccal film in place for 5 seconds and then take your finger away. Once in place, the film will dissolve completely in about 30 minutes. Do not eat or drink anything until the Belbuca film has completely dissolved in your mouth. Rinse your mouth with water after the medicine dissolves. Wait one hour after the film dissolves to brush your teeth to prevent damage to the teeth and gums. Do not chew the Belbuca film or swallow it whole. You should receive regular dental checkups while using Belbuca.

General information about using this medicine.

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

You may need frequent blood tests to check your liver function.

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

Any medical care provider who treats you should know that you are being treated for opioid addiction and that you are on buprenorphine. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.

Do not stop using this medication suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. Buprenorphine is a drug of abuse, and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

For detailed dosing information click the link below.

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 . A buprenorphine overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, pinpoint pupils, slow heart rate, weak pulse, very slow breathing, or coma.

What to avoid

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

Avoid driving or operating machinery until you know how buprenorphine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Buprenorphine side effects

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• opioid withdrawal symptoms – shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain;
• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• slow heartbeat or weak pulse;
• a light-headed feeling, like you might pass out;
• chest pain, trouble breathing;
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• liver problems – nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common buprenorphine side effects may be more likely to occur, such as:

• constipation, nausea, vomiting;
• headache;
• increased sweating;
• sleep problems (insomnia); or
• pain anywhere in your body.

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

What other drugs will affect buprenorphine?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Buprenorphine can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other narcotic medications – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body – a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

Buprenex is an opioid medicine used to treat moderate to severe pain in adults and children at least 2 years old. An opioid is sometimes called a narcotic.

Buprenex Injection is used to relieve moderate pain that is severe enough to require an opiate pain killer and for which other medicines (e.g., non-opiate pain killers or opiate-containing combination medicines) have not been, or are not expected to be sufficient.

Buprenorphine belongs to a class of medications called opiate partial agonists. Buprenex works by changing the way the body senses pain.acute pain.

This medication guide provides information about the Buprenex brand of buprenorphine injection. Sublocade is another brand of buprenorphine injection used to treat opioid addiction.

Buprenex side effects

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

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

• confusion, cold and clammy skin, slow breathing (breathing may stop);
• feeling light-headed;
• fast or uneven heart rate, shortness of breath;
• blue lips or fingernails; or
• severe constipation.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Common Buprenex side effects may include:

• drowsiness, slow breathing;
• nausea, vomiting;
• dizziness, vertigo (spinning sensation);
• pinpoint pupils;
• increased sweating; or
• headache.

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

Warnings

Buprenex may be habit-forming. Misuse can cause addiction, overdose, or death.

Using Buprenex during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use Buprenex if you are allergic to buprenorphine, or if you have:

• severe asthma or breathing problems; or
• a stomach or bowel obstruction (including paralytic ileus).

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

• chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
• a head injury, brain tumor, high pressure inside the skull, or seizures;
• problems with your bile duct, gallbladder, pancreas, thyroid, or adrenal gland;
• heart problems, an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• a drug or alcohol addiction, or mental illness;
• enlarged prostate, urination problems;
• curvature of the spine that affects breathing; or
• liver or kidney disease.

Tell your doctor if you also use stimulant medicine, other opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with buprenorphine could cause a serious condition called serotonin syndrome.

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

Do not breastfeed. Buprenorphine in breast milk can cause life-threatening side effects in a nursing baby.

How is Buprenex given?

Buprenex is injected into a muscle or given as an infusion into a vein. A healthcare provider will give you this injection. Buprenex is usually given by injection only if you are unable to take the medicine by mouth or use another form of buprenorphine.

Buprenex is usually given at evenly spaced intervals, up to 6 hours apart. Tell your doctor if Buprenex does not relieve your pain within 1 hour after an injection.

Buprenex can cause irritation if it gets on your skin. If this occurs, remove any clothing the medicine has spilled onto, and rinse your skin with water.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely. You may need other medical tests.

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

Dosing information

Usual Adult Dose of Buprenex for Pain:

Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as needed
-A single 0.6 mg IM dose may be given to patients who are not in a high risk category (see Warnings)
Maximum single dose: 0.3 mg (IV) or 0.6 mg (IM)

Usual Pediatric Dose of Buprenex for Pain:

2 to 12 years:
Initial dose: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours
-Some patients may not need to be remedicated for 6 to 8 hours; fixed interval or round the clock dosing should not be used until the proper inter-dose interval has been established

Over 12 years:
Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as needed
Maximum single dose: 0.3 mg

Comments:
-Use extra caution with IV administration, especially the first dose.
-Monitor closely for respiratory depression, especially within the first 24 to 72 hours.
-Use the lowest effective dose for the shortest duration consistent with the individual patient’s treatment goals.

Use: For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

What happens if I miss a dose?

In a medical setting you are not likely to miss a dose.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving Buprenex?

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

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

What other drugs will affect Buprenex?

You may have a fatal buprenorphine overdose if you start or stop using certain other medicines. Tell your doctor about all your medications.

Many other drugs can be dangerous when used with opioid medicine. Tell your doctor if you also use:

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;
• other opioid medicines;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax; or
• sleep medicine, muscle relaxers, or other drugs that make you drowsy.

What is hydrocodone?

Hydrocodone is an opioid pain medication.

Zohydro ER and Hysingla ER are extended-release forms of hydrocodone that are used for around-the-clock treatment of severe pain.

Extended-release hydrocodone is not for use on an as-needed basis for pain.

Warnings

Hydrocodone can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

Hydrocodone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

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

Tell your doctor if you are pregnant. Hydrocodone may cause life-threatening withdrawal symptoms in a newborn if the mother has taken this medicine during pregnancy.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

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

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

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

• breathing problems, sleep apnea;
• a head injury, brain tumor, or seizures;
• drug or alcohol addiction, or mental illness;
• urination problems;
• liver or kidney disease;
• problems with your gallbladder, pancreas, or thyroid; or
• a heart rhythm disorder called long QT syndrome.

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.

Ask a doctor before using hydrocodone if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

How should I take hydrocodone?

Hydrocodone may be habit-forming, even at regular doses. Follow the directions on your prescription label and read all medication guides. Never use hydrocodone in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.

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

Your dose needs may be different if you have recently used a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose. Never crush or break a hydrocodone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This can cause death.

Do not stop using this medicine suddenly after long-term use, or you could have serious withdrawal symptoms. Ask your doctor how to safely stop using hydrocodone.

Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Dosing information

Usual Adult Dose for Chronic Pain:

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time; each patient should be managed individually.

As First Opioid Analgesic and For Patients who are NOT Opioid Tolerant:
Extended-Release Capsules (Zohydro(R) ER): Initial dose: 10 mg orally every 12 hours
Extended-Release Tablets (Hysingla(R) ER): Initial dose: 20 mg orally every 24 hours

Comments:
-Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression; monitor patients closely for respiratory depression, especially during the first 24 to 72 hours.
-An opioid tolerant patient is one who has been receiving for 1-week or longer at least: oral morphine 60 mg/day, fentanyl transdermal patch 25 mcg per hour, oral oxycodone 30 mg/day, oral hydromorphone 8 mg/day, oral oxymorphone 25 mg/day, or an equianalgesic dose of another opioid.

What happens if I miss a dose?

Since hydrocodone is used for pain, you are not likely to miss a dose. Skip any 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 . A hydrocodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What to avoid

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

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

Hydrocodone side effects

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

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

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a slow heart rate or weak pulse;
• pain or burning when you urinate;
• confusion, tremors, severe drowsiness;
• a light-headed feeling, like you might pass out;
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• high levels of serotonin in the body – agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common hydrocodone side effects may include:

• constipation, nausea, vomiting;
• dizziness, drowsiness, feeling tired;
• headache; or
• cold symptoms such as stuffy nose, sneezing, sore 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 .

What other drugs will affect hydrocodone?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body – a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

What is hydromorphone?

Hydromorphone is an opioid medication used to treat moderate to severe pain.

The extended-release form of hydromorphone is for around-the-clock treatment of moderate to severe pain, not for use on an as-needed basis for pain.

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

Hydromorphone 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.

Opioid medicine can slow or stop your breathing, and death may occur. 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.

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

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a slow heart rate or weak pulse;
• confusion, feelings of extreme happiness or sadness;
• severe weakness or drowsiness;
• a light-headed feeling, like you might pass out;
• low cortisol levels–nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects of hydromorphone may include:

• drowsiness, tiredness;
• dizziness;
• headache; or
• constipation, nausea, vomiting, stomach pain.

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

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

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not take hydromorphone if you have ever had an allergic reaction to hydromorphone or other narcotic medicines, or if you have:

• severe asthma or breathing problems;
• a blockage in your stomach or intestines; or
• a bowel obstruction called paralytic ileus.

Do not use hydromorphone if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you have ever had:

• a head injury, brain tumor, or seizures;
• breathing problems, sleep apnea;
• alcoholism, drug addiction, or mental illness;
• urination problems;
• liver or kidney disease;
• a sulfite allergy; or
• problems with your gallbladder, pancreas, or thyroid.

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.

Do not breast-feed. Hydromorphone can pass into breast milk and may cause drowsiness or breathing problems in a nursing baby.

How should I use hydromorphone?

Follow the directions on your prescription label and read all medication guides. Never use hydromorphone in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.

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

Stop taking all other around-the-clock narcotic pain medications when you start taking hydromorphone.

Swallow the capsule or tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, open, or dissolve.

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

Do not stop using hydromorphone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using hydromorphone.

Never crush or break a hydromorphone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This can cause in death.

Store at room temperature away from moisture, heat, and light. Throw away any unused liquid after 90 days.

Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

What happens if I miss a dose?

Since hydromorphone is used for pain, you are not likely to miss a dose. Skip any 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 . A hydromorphone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, very slow breathing, or coma.

What should I avoid while using hydromorphone?

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

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

What other drugs will affect hydromorphone?

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications–opioid pain medicine or prescription cough medicine;
• a sedative like Valium–diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing–a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body–a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

What is Hysingla ER?

Hysingla ER is an opioid pain medication.

Hysingla ER is an extended-release tablet that is used for around-the-clock treatment of severe pain.

Hysingla ER is not for use on an as-needed basis for pain.

Warnings

Hydrocodone can slow or stop your breathing. Never use Hysingla ER in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

Hydrocodone may be habit-forming, even at regular doses. Never share Hysingla ER with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep Hysingla ER in a place where others cannot get to it.

Tell your doctor if you are pregnant. Hydrocodone may cause life-threatening withdrawal symptoms in a newborn if the mother has taken this medicine during pregnancy.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use Hysingla ER if you are allergic to hydrocodone, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

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

• breathing problems, sleep apnea;
• a head injury, brain tumor, or seizures;
• drug or alcohol addiction, or mental illness;
• urination problems;
• liver or kidney disease;
• problems with your gallbladder, pancreas, or thyroid; or
• a heart rhythm disorder called long QT syndrome.

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.

Ask a doctor before using Hysingla ER if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

How should I take Hysingla ER?

Hysingla ER may be habit-forming, even at regular doses. Follow the directions on your prescription label and read all medication guides. Never use Hysingla ER in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.

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

Your dose needs may be different if you have recently used a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Do not crush, break, or open an extended-release tablet. Swallow the tablet whole to avoid exposure to a potentially fatal dose. Never crush or break a Hysingla ER tablet to inhale the powder or mix it into a liquid to inject the drug into your vein. This can cause death.

Do not stop using this medicine suddenly after long-term use, or you could have serious withdrawal symptoms. Ask your doctor how to safely stop using Hysingla ER.

Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Dosing information

Usual Adult Dose for Chronic Pain:

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time; each patient should be managed individually.

As First Opioid Analgesic and For Patients who are NOT Opioid Tolerant:
Extended-Release Hysingla ER Tablets: Initial dose: 20 mg orally every 24 hours

Comments:
-Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression; monitor patients closely for respiratory depression, especially during the first 24 to 72 hours.
-An opioid tolerant patient is one who has been receiving for 1-week or longer at least: oral morphine 60 mg/day, fentanyl transdermal patch 25 mcg per hour, oral oxycodone 30 mg/day, oral hydromorphone 8 mg/day, oral oxymorphone 25 mg/day, or an equianalgesic dose of another opioid.

What happens if I miss a dose?

Since Hysingla ER is used for pain, you are not likely to miss a dose. Skip any 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 . A hydrocodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What to avoid

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

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

Hysingla ER side effects

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

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

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a slow heart rate or weak pulse;
• pain or burning when you urinate;
• confusion, tremors, severe drowsiness;
• a light-headed feeling, like you might pass out;
• low cortisol levels–nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• high levels of serotonin in the body – agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Hysingla ER side effects may include:

• constipation, nausea, vomiting;
• dizziness, drowsiness, feeling tired;
• headache; or
• cold symptoms such as stuffy nose, sneezing, sore 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 .

What other drugs will affect Hysingla ER?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body – a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

What is Kadian?

Kadian is an extended-release prescription pain medicine that is used to manage pain severe enough to require daily around-the-clock, long-term treatment.

Kadian belongs to a class of medications called opiate (narcotic) analgesics. Morphine works by changing the way the brain and nervous system respond to pain.

Kadian is used when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

Kadian extended-release capsules should not be used to treat pain that can be controlled by medication that is taken as needed.

Kadian side effects

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

Opioid medicine can slow or stop your breathing, and death may occur, especially if you drink alcohol or use other drugs that cause drowsiness or slow breathing. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

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

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
• chest pain, fast or pounding heartbeats;
• extreme drowsiness, feeling like you might pass out; or
• decreased adrenal gland hormones – nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Kadian side effects may include:

• drowsiness, dizziness, tiredness, anxiety;
• nausea, vomiting, stomach pain, gas, or constipation;
• sweating, low oxygen levels (shortness of breath), feeling light-headed; or
• feelings of extreme happiness or sadness.

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 take Kadian if you have severe asthma or breathing problems, a blockage in your stomach or intestines, or a bowel obstruction called paralytic ileus.

Morphine can slow or stop your breathing, and may be habit-forming MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, , especially in a child or other person using the medicine without a prescription. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use Kadian with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not take Kadian capsules if you have ever had an allergic reaction to morphine or other opioid medicines, or if you have:

• severe asthma or breathing problems;
• a stomach or bowel obstruction (including paralytic ileus); or
• if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

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

• chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
• a head injury, brain tumor, high pressure inside the skull, or seizures;
• a drug or alcohol addiction, or mental illness;
• urination problems;
• problems with your bile duct, gallbladder, pancreas, thyroid, or adrenal gland; or
• liver or kidney disease.

Tell your doctor if you also use stimulant medicine, other opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with morphine could cause a serious condition called serotonin syndrome.

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

Long-term Kadian use may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using Kadian.

Do not breastfeed. Morphine in breast milk can cause life-threatening side effects in a nursing baby.

How should I take Kadian?

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

Never share opioid 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 Kadian is against the law.

Never crush a pill to inhale the powder or inject it into your vein. This could result in death.

Swallow the Kadian extended release capsule whole to avoid exsure to a potentially fatal overdose. Do not crush, chew, or dissolve.

If you cannot swallow a Kadian capsule whole, you can open the capsule and mix the medicine with applesauce. Open the capsule and sprinkle the pellets over about one tablespoon of applesauce. Swallow all of the applesauce and pellets right away. Do not save any of the applesauce and pellets for another dose. Rinse your mouth to make sure you have swallowed all of the pellets. Do not chew the pellets. Flush the empty capsule down the toilet right away.

Call your doctor if your symptoms do not improve, or if they get worse.

You should not stop using Kadian suddenly. Stopping suddenly may cause withdrawal symptoms. Ask your doctor before stopping the medicine.

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

Do not keep leftover medicine. Just one dose can cause death in someone using Kadian accidentally or improperly. Ask your pharmacist about a drug take-back program,or flush the unused medicine down the toilet.

Store tightly closed at room temperature, away from moisture, heat and light. Keep your medicine in a place where no one can use it improperly.

What happens if I miss a dose?

Since Kadian is used for pain, you are not likely to miss a dose. Skip any 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. An overdose can be fatal, especially in a child or person using opioid medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What should I avoid while taking Kadian?

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

Avoid driving or hazardous activity until you know how Kadian will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries. Also avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

What is methadone?

Methadone is a long-acting opioid medication that is used to reduce withdrawal symptoms in people addicted to heroin or other narcotic drugs, and it can also used as a pain reliever.  When methadone is used for Opioid Use Disorder (OUD) it reduces withdrawal symptoms and drug cravings, but does not cause the “high” associated with the drug addiction. Methadone is highly regulated medication (Schedule 2 Controlled Substances Act) and when used for OUD is only available through approved opioid treatment programs (OTP) that involves regular monitoring, counseling, and drug testing to make sure that patients are making progress in their recovery.

When methadone is used for pain it should only be used for pain that is severe enough to require daily, around-the-clock, long-term opioid treatment when no other treatment options have helped adequately. This medicine is not for use on an as-needed basis for pain.

Methadone works by activating the opioid receptors in the brain and nervous system, it is usually taken orally as a liquid or tablet.

Warnings

You should not use this medicine if you have severe asthma or breathing problems, or a blockage in your stomach or intestines.

MISUSE OF METHADONE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn. See below for more information on using this medicine in pregnancy.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Methadone may cause a life-threatening heart rhythm disorder. Call your doctor at once if you have a headache with chest pain and severe dizziness, and fast or pounding heartbeats. Your heart function may need to be checked during treatment.

Before taking this medicine

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

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

This medicine may cause a life-threatening heart rhythm disorder. Your heart function may need to be checked during treatment.

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

• heart problems, long QT syndrome (in you or a family member);
• breathing problems, sleep apnea;
• a head injury, brain tumor, or seizures;
• drug or alcohol addiction, or mental illness;
• liver or kidney disease;
• urination problems; or
• problems with your gallbladder, pancreas, or thyroid.

Pregnancy

Talk to your doctor before using opioid medicine if you are pregnant or planning a pregnancy. If you use opioid medicine during pregnancy, your baby could be born with life-threatening withdrawal symptoms, called neonatal opioid withdrawal syndrome (NOWS) which is treatable and your baby may need medical treatment for several weeks.

Breastfeeding

Ask a doctor before using opioid medicine if you are breastfeeding. This medicine passes into breast milk and may harm your baby.  Tell your doctor immediately if you notice increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness in the nursing baby. Talk to your baby’s doctor when you decide to wean your baby. It is important to wean your baby gradually so that your baby does not develop withdrawal symptoms when he or she stops receiving methadone in breastmilk.

How should I use methadone?

Use this medicine exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use this medicine 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 opioid 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.

Methadone instructions:

• Methadone oral is taken by mouth. The injection is given as an intravenous, intramuscular or subcutaneous injection.
• Measure liquid medicine with the supplied measuring device (not a kitchen spoon).
• Dissolve the dispersible tablet in water, orange juice, or other citrus-flavored non-alcoholic beverage. Stir and drink this mixture right away.
• Take this medicine regularly with or without food
• Never crush a pill to inhale the powder or inject it into your vein. This could result in death.
• You should not stop using this medicine suddenly. Ask your doctor before stopping the medicine.

Do not keep leftover medicine. Just one dose can cause death in someone using it accidentally or improperly. Ask your pharmacist about a drug take-back program, or flush the unused medicine down the toilet.

What happens if I miss a dose?

If you take methadone for pain: Take the missed dose as soon as you remember, then take your next dose 8 to 12 hours later.

If you take methadone for drug addiction: Take your missed dose the next day at the regular time. If you miss your doses for longer than 3 days in a row, call your doctor for instructions. You may need to restart your dosing schedule at a lower dose.

Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose can be fatal, especially in a child or person using opioid medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What should I avoid while using methadone?

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.

Grapefruit may interact with this medicine and cause side effects. Avoid consuming grapefruit products.

There are many dangerous drug interactions with methadone. Tell your prescribing doctor about all medications that you take. See “What other drugs will affect methadone?” section below.

Methadone side effects

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Serious methadone side effects.

Call your doctor at once if you have:

• weak or shallow breathing, breathing that stops during sleep;
• severe constipation;
• a light-headed feeling, like you might pass out;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath;
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• serotonin syndrome – agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Common methadone side effects may include:

• dizziness, drowsiness;
• nausea, vomiting;
• increased sweating; or
• pain, redness, or swelling where the medicine was injected.

What is methadone?

Methadone is a long-acting opioid medication that is used to reduce withdrawal symptoms in people addicted to heroin or other narcotic drugs, and it can also used as a pain reliever.  When methadone is used for Opioid Use Disorder (OUD) it reduces withdrawal symptoms and drug cravings, but does not cause the “high” associated with the drug addiction. Methadone is highly regulated medication (Schedule 2 Controlled Substances Act) and when used for OUD is only available through approved opioid treatment programs (OTP) that involves regular monitoring, counseling, and drug testing to make sure that patients are making progress in their recovery.

When methadone is used for pain it should only be used for pain that is severe enough to require daily, around-the-clock, long-term opioid treatment when no other treatment options have helped adequately. This medicine is not for use on an as-needed basis for pain.

Methadone works by activating the opioid receptors in the brain and nervous system, it is usually taken orally as a liquid or tablet.

Warnings

You should not use this medicine if you have severe asthma or breathing problems, or a blockage in your stomach or intestines.

MISUSE OF METHADONE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn. See below for more information on using this medicine in pregnancy.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Methadone may cause a life-threatening heart rhythm disorder. Call your doctor at once if you have a headache with chest pain and severe dizziness, and fast or pounding heartbeats. Your heart function may need to be checked during treatment.

Before taking this medicine

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

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

This medicine may cause a life-threatening heart rhythm disorder. Your heart function may need to be checked during treatment.

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

• heart problems, long QT syndrome (in you or a family member);
• breathing problems, sleep apnea;
• a head injury, brain tumor, or seizures;
• drug or alcohol addiction, or mental illness;
• liver or kidney disease;
• urination problems; or
• problems with your gallbladder, pancreas, or thyroid.

Pregnancy

Talk to your doctor before using opioid medicine if you are pregnant or planning a pregnancy. If you use opioid medicine during pregnancy, your baby could be born with life-threatening withdrawal symptoms, called neonatal opioid withdrawal syndrome (NOWS) which is treatable and your baby may need medical treatment for several weeks.

Breastfeeding

Ask a doctor before using opioid medicine if you are breastfeeding. This medicine passes into breast milk and may harm your baby.  Tell your doctor immediately if you notice increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness in the nursing baby. Talk to your baby’s doctor when you decide to wean your baby. It is important to wean your baby gradually so that your baby does not develop withdrawal symptoms when he or she stops receiving methadone in breastmilk.

How should I use methadone?

Use this medicine exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use this medicine 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 opioid 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.

Methadone instructions:

• Methadone oral is taken by mouth. The injection is given as an intravenous, intramuscular or subcutaneous injection.
• Measure liquid medicine with the supplied measuring device (not a kitchen spoon).
• Dissolve the dispersible tablet in water, orange juice, or other citrus-flavored non-alcoholic beverage. Stir and drink this mixture right away.
• Take this medicine regularly with or without food
• Never crush a pill to inhale the powder or inject it into your vein. This could result in death.
• You should not stop using this medicine suddenly. Ask your doctor before stopping the medicine.

Do not keep leftover medicine. Just one dose can cause death in someone using it accidentally or improperly. Ask your pharmacist about a drug take-back program, or flush the unused medicine down the toilet.

What happens if I miss a dose?

If you take methadone for pain: Take the missed dose as soon as you remember, then take your next dose 8 to 12 hours later.

If you take methadone for drug addiction: Take your missed dose the next day at the regular time. If you miss your doses for longer than 3 days in a row, call your doctor for instructions. You may need to restart your dosing schedule at a lower dose.

Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose can be fatal, especially in a child or person using opioid medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What should I avoid while using methadone?

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.

Grapefruit may interact with this medicine and cause side effects. Avoid consuming grapefruit products.

There are many dangerous drug interactions with methadone. Tell your prescribing doctor about all medications that you take. See “What other drugs will affect methadone?” section below.

Methadone side effects

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Serious methadone side effects.

Call your doctor at once if you have:

• weak or shallow breathing, breathing that stops during sleep;
• severe constipation;
• a light-headed feeling, like you might pass out;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath;
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• serotonin syndrome – agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Common methadone side effects may include:

• dizziness, drowsiness;
• nausea, vomiting;
• increased sweating; or
• pain, redness, or swelling where the medicine was injected.

What is morphine?

Morphine is used to treat moderate to severe pain when alternative pain relief medicines are not effective or not tolerated. Morphine is an opioid pain-relieving medication that usually provides significant pain relief for short-term or chronic pain. 

Morphine belongs to a class of medications called opiate (narcotic) analgesics. Morphine works by changing the way the brain and nervous system respond to pain; it does this by binding to the mu-opioid receptors within the central nervous system (CNS) and the peripheral nervous system (PNS).

Morphine is available as oral liquid, tablets, extended-release tablets and capsules, intravenous (IV), suppositories, and epidural.

Morphine may also be abused and may be considered contraindicated in patients with a history of substance abuse or abusing opioids. 

Morphine is a Schedule 2 controlled substance under the Controlled Substances Act (CSA).  This means that morphine has a high potential for abuse but has a currently accepted medical use as a treatment or a currently accepted medical use with severe restrictions. Abuse may lead to severe psychological or physical dependence.

Morphine side effects

Common morphine side effects

Common morphine side effects include drowsiness, dizziness, tiredness, anxiety, nausea, vomiting, stomach pain, gas, or constipation, sweating, low oxygen levels (shortness of breath), feeling light-headed or feelings of extreme happiness or sadness.

Serious morphine side effects

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

Opioid medicine can slow or stop your breathing, and death may occur, especially if you drink alcohol or use other drugs that cause drowsiness or slow breathing. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

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

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
• chest pain, fast or pounding heartbeats;
• extreme drowsiness, feeling like you might pass out; or
• decreased adrenal gland hormones – nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, 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 the FDA .

Warnings

You should not take morphine if you have severe asthma or breathing problems, a blockage in your stomach or intestines, or a bowel obstruction called paralytic ileus.

Morphine can slow or stop your breathing and may be habit-forming. MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use morphine with alcohol or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not take this medicine if you have ever had an allergic reaction to morphine or other opioid medicines or if you have:

• severe asthma or breathing problems;
• a stomach or bowel obstruction (including paralytic ileus); or
• if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

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

• chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
• a head injury, brain tumor, high pressure inside the skull, or seizures;
• a drug or alcohol addiction or mental illness;
• urination problems;
• problems with your bile duct, gallbladder, pancreas, thyroid, or adrenal gland; or
• liver or kidney disease.

Tell your doctor if you also use stimulant medicine, other opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with morphine could cause a serious condition called serotonin syndrome.

Pregnancy

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

Long-term morphine use may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

Breastfeeding 

Do not breastfeed when using morphine, as morphine in breast milk can cause life-threatening side effects in a nursing baby.

How should I take morphine?

Take morphine exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use morphine in larger amounts or for longer than prescribed. Tell your doctor if you feel an increased urge to use more morphine.

Never share opioid 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.

Never crush a pill to inhale the powder or inject it into your vein. This could result in death.

Swallow the extended-release capsule or tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, open, or dissolve.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Call your doctor if your symptoms do not improve or if they get worse.

You should not stop using morphine suddenly. Stopping suddenly may cause withdrawal symptoms. Ask your doctor before stopping the medicine.

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 medicine your doctor prescribes.

Do not keep leftover medicine. Just one dose can cause death for someone using it accidentally or improperly. Ask your pharmacist about a drug take-back program,or flush the unused medicine down the toilet.

Store tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

What happens if I miss a dose?

Since morphine is used for pain, you are not likely to miss a dose. Skip any 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 . An overdose can be fatal, especially in a child or person using opioid medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What should I avoid while taking morphine?

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

Avoid driving or hazardous activity until you know how morphine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries. Also avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

What is OxyContin?

OxyContin is an opioid (narcotic) pain medication used to relieve severe ongoing pain that is not controlled by other pain treatments. OxyContin contains oxycodone, a strong pain reliever that helps reduce pain by activating opioid receptors in the nervous system. OxyContin is an extended-release tablet that is taken every 12 hours regularly, it is not for occasional use or to be taken “as needed” for pain. As it is a long-acting opioid pain medicine it can put you at risk for overdose and death.

OxyContin can be prescribed for adult patients and patients 11 years and older who have severe persistent pain that requires long-term treatment with a daily opioid analgesic when alternative treatment options have not controlled the pain. OxyContin can only be prescribed for pediatric patients 11 years of age and older who are already taking and can tolerate a minimum daily opioid dose of at least 20 mg of oxycodone orally or its equivalent.

OxyContin has a risk of addiction, abuse, and misuse as an opioid (narcotic) medication, even if you take your dose correctly as prescribed. OxyContin (oxycodone) is a controlled substance Schedule II which means it has an accepted medical use but may lead to severe psychological or physical dependence and has abuse potential. When abused OxyContin may be called Hillbilly Heroin, Kicker, OC, Ox, Oxycotton, Roxy, Perc, and Oxy.

Warnings

Overdose. Get emergency help or call 911 right away if you take too much OxyContin (overdose). When you first start taking this medicine, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.

You should not use OxyContin if you have severe asthma or breathing problems, or a blockage in your stomach or intestines.

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

Taking oxycodone during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Taking OxyContin with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Using OxyContin with medicines that are CYP3A4 inhibitors or discontinuation of CYP3A4 inducers can result in a fatal overdose of oxycodone.

Never share this medicine. Never give anyone else your OxyContin. They could die from taking it. Selling or giving away this medicine is against the law.

Safe storage. Store tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

OxyContin side effects

Common OxyContin side effects include drowsiness, headache, dizziness, tiredness, constipation, stomach pain, nausea, and vomiting.

Serious OxyContin side effects

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue-colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• a slow heart rate or weak pulse;
• a light-headed feeling, like you might pass out;
• confusion, unusual thoughts or behavior;
• seizure (convulsions);
• low cortisol levels – nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• high levels of serotonin in the body – agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

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

Before taking this medicine

You should not use OxyContin if you are allergic to oxycodone, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

You should not use OxyContin unless you are already using a similar opioid medicine and are tolerant to it.

OxyContin should not be given to a child younger than 11 years old.

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

• breathing problems, sleep apnea;
• a head injury, or seizures;
• drug or alcohol addiction, or mental illness;
• liver or kidney disease;
• urination problems; or
• problems with your gallbladder, pancreas, or thyroid.

Tell your healthcare provider if you are living in a household where there are small children or someone who has abused street or prescription drugs, taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking OxyContin with certain other medicines can cause serious side effects that could lead to death.

If you use OxyContin 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.

Tell your doctor if you are breastfeeding or planning to breastfeed, as this medicine may harm your baby. Breastfeeding is not recommended during treatment with OxyContin.

How should I use OxyContin?

Take OxyContin exactly as prescribed. Follow the directions on your prescription label and read all medication guides. Never use oxycodone in larger amounts, or for longer than prescribed. Call your healthcare provider if the dose you are taking does not control your pain.

Take your prescribed dose every 12 hours at the same time every day. Do not take more than your prescribed dose in 12 hours. If you miss a dose, take your next dose at your usual time.

Oxycontin should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing it in your mouth to avoid choking on the tablet.

Swallow the extended-release tablet whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, or dissolve.

Never crush or break an OxyContin tablet to inhale the powder or mix it into a liquid to inject the drug into your vein. This can result in death.

You should not stop using OxyContin suddenly. Follow your doctor’s instructions about tapering your dose.

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

Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

What happens if I miss a dose?

Since OxyContin is used for pain, you are not likely to miss a dose. Skip any 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 at 1-800-222-1222. An oxycodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What should I avoid while using OxyContin?

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

Avoid driving or operating machinery until you know how oxycodone will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Avoid medication errors. Always check the brand and strength of oxycodone you get from the pharmacy.

What other drugs will affect OxyContin?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C. Using OxyContin with medicines that are CYP3A4 inhibitors or discontinuation of CYP3A4 inducers can result in a fatal overdose of oxycodone.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body – a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.