What is Mavorixafor?

Mavorixafor is used to treat WHIM syndrome (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis syndrome) in adults and children 12 years of age and older. It is an oral capsule that is taken once a day.

Mavorixafor gained FDA approval on 26 April 2024 under the brand name Xolremdi. There is no generic.

Mechanism. How does mavorixafor work?

Mavorixafor works by targeting the CXCR4 receptor, preventing the binding of another substance, called stromal-derived factor-1α (SDF-1α)/CXC Chemokine Ligand 12 (CXCL12). The SDF-1/CXCR4 system is crucial for the movement of leukocytes (a type of white blood cell) to and from the bone marrow. Mavorixafor blocks the response to wild-type and mutated CXCR4 variants associated with WHIM syndrome, increasing levels of circulating mature neutrophils and lymphocytes.

Mavorixafor belongs to the drug class called oral CXCR4 antagonists.

Side effects

The most common side effects of mavorixafor are:

• low platelet levels
• a rash
• nasal congestion, sneezing, stuffiness, and nosebleeds
• vomiting
• dizziness.

Serious side effects and warnings

Mavorixafor may cause the following serious side effects:

• QTc interval prolongation. Clinical trials have reported that mavorixafor can prolong the QTc interval. Your healthcare provider should correct any risk factors that can be corrected (such as low potassium levels), assess your QTc before starting treatment, and monitor it throughout treatment. The risk of QTc prolongation is higher in those receiving other QTc prolonging drugs, such as haloperidol, amiodarone, sotalol, or ondansetron, or taking other medications that increase blood levels of mavorixafor
• Drug interactions. Mavorixafor should not be given with other medications that are highly dependent on CYP2D6 liver enzymes for clearance, such as fluoxetine or amitriptyline. Tell your healthcare provider about all the medications you take
• Harm to an unborn baby. Mavorixafor may harm a developing baby. Females who can get pregnant should use effective contraception while taking mavorixafor and for 3 weeks after the last dose.

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 X4 Pharmaceuticals, Inc. at 1-866-MED-X4MI (1-866-633-9464) or the FDA

Before taking

Do not take mavorixafor if you have severe or end-stage kidney disease, or moderate to severe liver disease.

Before taking mavorixafor, tell your healthcare provider about all your medical conditions, including if you:

• have any allergies to mavorixafor, Xolremdi, or any of the inactive ingredients in the capsule
• have preexisting heart conditions, such as an arrhythmia or QTc prolongation
• take any other medications
• have low platelet levels
• have skin conditions
• have frequent nose bleeds
• have liver or kidney disease
• are pregnant or intending to become pregnant
• are breastfeeding or intending to breastfeed.

Pregnancy

You may need to have a negative pregnancy test before starting mavorixafor. Do not take this medication if you are pregnant.

Mavorixafor may harm an unborn baby and affect the development of its placenta. Females with childbearing potential should use effective contraception while receiving mavorixafor and for 3 weeks after the last dose. If you become pregnant while receiving mavorixafor, tell your doctor right away.

Breastfeeding

You should not breastfeed while taking mavorixafor and for 3 weeks after the last dose. Talk to your healthcare provider about the best way to feed your baby.

How do I take mavorixafor?

Mavorixafor is a capsule that is taken 1 time a day before breakfast.

• Take it as soon as you wake up, at least 30 minutes before you eat food.

Dosing information

Mavorixafor dosage for WHIM syndrome: 

• More than 50 kg: 400 mg (4  capsules) orally once daily.
• Less than or equal to 50 kg: 300 mg (3 capsules) orally once daily.

What should I avoid while taking mavorixafor?

Advise eating or drinking products that contain grapefruit, because grapefruit is a strong CYP3A4 inhibitor and may increase the risk of side effects from mavorixafor.

• How magnesium supports sleep, stress relief, muscle recovery, and mental health
• The best food sources and types of magnesium supplements
• How to choose the right magnesium type for your needs
• Side effects, safety concerns, and medication interactions

Table of Contents

1. Introduction: Why Magnesium Matters
2. How Magnesium Supports Your Health
3. Signs You’re Low on Magnesium
4. Best Magnesium-Rich Foods
5. Should You Take a Supplement?
6. Choosing the Best Magnesium Type
7. The Right Daily Dosage
8. Magnesium and Medications
9. Side Effects & Safety
10. Frequently Asked Questions
11. Final Thoughts

1. Introduction: Why Magnesium Matters

Magnesium plays a crucial role in over 300 biochemical processes in the body, supporting nerve and muscle function, maintaining a steady heartbeat, and strengthening bones. It also aids in energy production, protein synthesis, and blood glucose regulation.

While magnesium is naturally found in foods like leafy greens, nuts, seeds, and whole grains, many individuals turn to supplements to ensure adequate intake. The increasing interest in magnesium supplementation stems from its potential benefits for various health conditions.

Before starting a magnesium supplement, consulting a healthcare provider is essential to determine the appropriate dosage and ensure its suitability for individual health needs. Proper guidance helps prevent potential interactions or side effects.

2. How Magnesium Supports Your Health

Magnesium is crucial for many functions in the body. Research is ongoing to learn more about how magnesium affects our health and wellbeing. It is known to play a role in the following health conditions:

• Heart health: Helps regulate blood pressure and supports normal heart rhythm.
• Bone strength: Contributes to bone formation and maintenance of bone density.
• Sleep quality: May support better sleep.
• Stress management: May help reduce levels of the stress hormone cortisol.
• Blood sugar regulation: Plays a role in insulin sensitivity and glucose control.
• Migraine headaches: Can reduce how often migraines happen.
• Muscle recovery and cramps: Associated with treatment of muscle cramps.
• Constipation: Some forms of magnesium are used as an over-the-counter laxative by keeping water into the gut.
• Respiratory: Can cause smooth muscle relaxation in the airways.

3. Signs You’re Low on Magnesium (And What to Do About It)

Low magnesium levels can be difficult to detect in its early stages. At first, there may be no obvious symptoms that you are low on magnesium. However, recognizing the signs and understanding the risk factors can help you maintain optimal magnesium levels for overall health. In general, normal blood levels of magnesium are between 1.8 mg/dL and 2.2 mg/dL.

Symptoms of Low Magnesium

Magnesium deficiency may manifest in various ways. Symptoms of low magnesium levels include:

• Low appetite
• Nausea or vomiting
• Feeling tired
• Weakness
• Numbness or tingling
• Muscle cramps
• Seizures
• Confusion
• Heart palpitations or irregular heartbeat

Hidden Causes of Low Magnesium and Risk Factors

Several factors can contribute to low magnesium levels. Some groups of people are at a higher risk for having low magnesium levels, such as those with the following health conditions:

• Gastrointestinal disorders: Conditions like Crohn’s disease, celiac disease, and chronic diarrhea can impair magnesium absorption.
• Alcohol use disorder:  Long-term alcohol use can lead to magnesium loss through increased urinary excretion and digestive system problems. Poor nutrition is also common among people with alcohol use disorder.
• Type 2 diabetes: People with type 2 diabetes tend to have increased excretion of magnesium through the urine. This is thought to be caused by having higher amounts of sugar in the kidneys, which leads to increased urination.
• Liver disease: The liver makes a protein called albumin that helps transport magnesium in the body, which is disrupted when the liver is damaged.
• Older age: As we get older, absorption of magnesium from the gut decreases and magnesium excretion through the urine increases.
• Certain medications: Some medications can contribute to low magnesium levels, including diuretics and proton pump inhibitors.
• Poor dietary intake: Insufficient consumption of magnesium-rich foods may lead to low magnesium levels.
• Stress: Growing evidence suggests that stress can increase magnesium loss.

Diagnosing Magnesium Deficiency

Detecting magnesium deficiency can be challenging, as magnesium levels in the blood don’t always reflect total body magnesium content. However, healthcare providers may use several methods to check magnesium in the body:

• Serum magnesium test: A blood test measuring magnesium levels in the bloodstream.
• 24-hour urine test: Collects urine over a full day to measure magnesium excretion.
• Magnesium tolerance test: Determines the percentage of magnesium kept in the body after intravenous administration.
• Red blood cell magnesium test: Measures magnesium levels inside red blood cells.
• Magnesium EXA test: Analyzes magnesium content in cheek cells using X-ray technology.

Your healthcare provider will also ask you about specific symptoms that are related to low magnesium levels, such as abnormal heart rhythm and tingling in the arms or legs.

What to Do About Low Magnesium

If you suspect low magnesium levels, contact your healthcare provider. They can order tests and help you determine if you are deficient in magnesium, figure out the cause, and recommend proper treatment.

Treatment options for low magnesium levels may include:

• Increasing your dietary intake of magnesium-rich foods
• Taking a magnesium supplement
• Addressing underlying conditions that may contribute to magnesium loss
• Reduce alcohol consumption, if applicable

Remember, while magnesium supplementation can be beneficial, it’s essential to consult with a healthcare professional before starting any new supplement regimen. This is especially important if you have pre-existing health conditions or are taking medications.

4. The Best Magnesium-Rich Foods (And How to Get Enough)

Magnesium is found naturally in a large variety of foods. While it is possible to get enough magnesium from diet alone, it is estimated that 48% of the United States population consume less than what is recommended. Choosing foods that are high in magnesium can help boost your levels.

What Foods are High in Magnesium?

Magnesium is found in many different foods, including animal- and plant-based foods. It is also found in certain drinks. Good sources of magnesium include:

• Seeds (e.g., pumpkin seeds, chia seeds)
• Nuts (e.g., almonds, cashews, peanuts)
• Spinach
• Fortified cereals (e.g., shredded wheat cereal)
• Soymilk
• Beans (e.g., black beans, kidney beans)
• Edamame
• Potatoes
• Brown rice
• Yogurt
• Instant oatmeal
• Banana
• Mineral water

Factors Affecting Magnesium Absorption

In general, only up to 40% of the magnesium consumed through diet is absorbed into the body. Certain factors can increase or decrease how much magnesium is absorbed.

Some health conditions, such as gastrointestinal disorders and alcohol use disorder, can cause less magnesium to get absorbed from food and drink. Excessive alcohol consumption in particular can damage the lining of the intestines, which can impair the absorption of nutrients like magnesium. Alcohol also acts as a diuretic, which means it increases urine production and loss of magnesium.

Dietary factors that are thought to affect magnesium absorption include:

• Potassium
• Calcium
• Zinc
• Proteins
• Phosphate
• Oxalate

For example, too much vitamin D, phosphorus, and calcium in the diet can lead to increased magnesium loss. Oxalates that are found in foods like rhubarb, beets, and in drinks like coffee can attach to magnesium and prevent it from getting absorbed.

Certain medications and supplements can affect magnesium absorption, too. Some types of fiber can attach to minerals, including magnesium. This prevents the magnesium from getting into the body.

Should You Take a Magnesium Supplement or Get It From Food?

The decision to take a magnesium supplement or rely on dietary sources depends on individual circumstances. Obtaining magnesium from food sources is generally the preferred and safest method:

• Dietary sources: Magnesium is abundant in leafy green vegetables, nuts, seeds, legumes, whole grains, avocados, dark chocolate, and fatty fish like salmon.
• Balanced diet: A well-balanced diet usually provides sufficient magnesium for most people.
• Absorption: The body is better equipped to regulate magnesium from food sources, with the kidneys efficiently managing excess amounts.

There are, however, certain situations where magnesium supplements may be beneficial:

• Deficiency: Supplements can be crucial for those low in magnesium.
• Dietary gaps: Some diets (e.g., Western diet) are lacking in magnesium, making it hard to get enough from food alone.
• Health conditions: Individuals with digestive disorders, diabetes, or those taking certain medications may have lower magnesium levels.
• Specific benefits: Research suggests magnesium supplements may help with bone strength, headaches, and sleep issues, though evidence is limited.

When choosing a magnesium supplement, it is important to read the label and check for quality. Choose supplements that have been third-party verified by reputable organizations for potency and contaminants. These include NSF, UL Solutions, or US Pharmacopeia (USP).

6. Choosing the Best Magnesium Supplement for Your Needs

Different magnesium types serve different purposes, and absorption varies. There are several different types of magnesium found in supplements, including inorganic and organic forms. Organic forms of magnesium are bound to carbon-containing molecules, like amino acids. Inorganic forms are bound to inorganic compounds like oxides or chlorides.

Studies show that organic forms of magnesium are better absorbed than inorganic forms. This is why you will find that organic forms of magnesium usually contain less magnesium compared to inorganic forms. Inorganic forms of magnesium may also cause digestive issues, such as diarrhea. Some examples of each type are listed below.

Organic magnesium:

• Magnesium aspartate
• Magnesium citrate
• Magnesium glycinate
• Magnesium lactate
• Magnesium malate
• Magnesium taurate

Inorganic magnesium:

• Magnesium oxide
• Magnesium chloride
• Magnesium sulfate

Studies have shown that the following forms of magnesium are better absorbed than magnesium oxide and magnesium sulfate:

• Magnesium aspartate
• Magnesium citrate
• Magnesium lactate
• Magnesium chloride
• Magnesium taurate

Additionally, certain types of magnesium may be better to treat specific conditions. For example, magnesium glycinate is made up of magnesium and the amino acid glycine. Glycine has been shown in studies to have sleep-promoting effects, making magnesium glycinate a good choice for relaxation and sleep. Studies on the different types of magnesium are limited. More research is needed to understand how different types of magnesium affect the body and help with different health conditions.

Quick-Reference Magnesium Chart

Capsules, powders, or liquids—which form absorbs best?

You can find magnesium in many different dosage forms over the counter, including capsules, tablets, powders, and liquids. There are pros and cons to all of the different dosage forms. Which form is best for you depends on individual factors and preferences.

In general, powder and liquid forms of magnesium get absorbed faster compared to tablets and capsules. This is because it usually takes longer for tablets and capsules to break down in your stomach before the magnesium can get absorbed.

What About Topical Magnesium?

There is limited research on how effective topical magnesium preparations like creams and oils are on raising magnesium levels in the body. It is not clear how much magnesium is absorbed through the skin. One study showed a slight increase in magnesium levels in people who used a topical magnesium cream containing 56 mg of magnesium compared to those using a cream without magnesium. However, the difference was not significant.

Many people use Epsom salt (magnesium sulfate) in baths as a soak for muscle pain and inflammation, but there is again not enough evidence that shows this is effective. The calming effects are likely due to the warm bath itself instead of the Epsom salt since magnesium doesn’t seem to get through the skin very effectively.

Use topical magnesium products with caution, because there is not enough research to back up their effectiveness. Similar to other supplements found over the counter, these products are not regulated the same way as prescription medications. This means they may contain different amounts of magnesium than what is advertised, or contain other ingredients that are not listed on the packaging. Talk to your healthcare provider if you need help finding a high-quality, topical magnesium product.

7. How Much Magnesium is Too Much? The Right Daily Dosage

The amount of magnesium you need depends on your gender assigned at birth, age, health conditions, medications, and whether you are pregnant or breastfeeding. For example, children need less magnesium each day than seniors. Check with your healthcare provider to find out how much magnesium you need to maintain healthy levels in your body.

The Food and Nutrition Board (FNB) at the Institute of Medicine of the National Academies recommends certain daily amounts of magnesium for people in different age groups. These recommendations, known as Recommended Dietary Allowances, meet requirements for about 98% of healthy adults.

Recommended Dietary Allowances (RDAs) for Magnesium

These amounts may be different if you have certain health conditions or are taking medications that affect the amount of magnesium in your body.

Can You Take Too Much Magnesium?

People with healthy kidneys are able to regulate how much magnesium stays in their body from their diet. This is because the kidneys get rid of extra magnesium through the urine. People with kidney problems and those taking magnesium supplements need to be more careful about getting too much magnesium.

The recommended maximum amounts of magnesium for those taking extra magnesium in supplements or medications are listed below. Keep in mind that these amounts are in addition to what you are already getting through your diet. If you have certain health conditions, your provider might recommend other amounts for you than what is listed in the table below.

Taking too much magnesium can lead to an overdose. Signs of overdose include:

• Diarrhea
• Nausea
• Stomach cramps
• Irregular heartbeat
• Low blood pressure
• Difficulty breathing
• Facial flushing

If you experience severe symptoms such as irregular heartbeat or difficulty breathing, seek immediate medical attention.

How to balance magnesium from food and supplements

Too much magnesium from foods and drinks is rarely a problem. This is because our kidneys do a great job at making sure there is just the right amount in our body. However, it is important to pay attention to how much magnesium you get from supplements or medications. Check the labels and write down how much you get in a day from these sources so you do not take too much.

8. Magnesium and Medications: What You Need to Know

Magnesium can interact with various medications. Here’s what you need to know about common potential interactions.

Which Medications Interact with Magnesium?

Examples of medications that have the potential to interact with magnesium include:

• Antibiotics: Certain antibiotics can attach to magnesium in the stomach, preventing them from getting absorbed into the body. Examples include tetracyclines (e.g., doxycycline) and fluoroquinolones (e.g., ciprofloxacin).
• Bisphosphonates: These medications are used to treat osteoporosis. Magnesium can decrease the absorption of bisphosphonates that are taken by mouth, making them less effective.
• Calcium channel blockers: Magnesium has similar effects on blood pressure as medications called calcium channel blockers, so taking these together can lead to decreased blood pressure.
• Diuretics (water pills): Diuretics are commonly used to lower blood pressure and to decrease fluid in the body. Depending on the type, they can increase or decrease magnesium in the body.
• Gabapentin: Magnesium may reduce the absorption of gabapentin by 20%, making it less effective.
• Proton pump inhibitors (PPIs): These medications are used to treat conditions related to too much stomach acid. When taken long term, they can cause low magnesium levels. This is because magnesium is best absorbed in acidic conditions.

How to Take Medications Safely With Magnesium

In some cases, there are things you can do to minimize interactions between your medication and magnesium:

• Tetracycline or fluoroquinolone antibiotics: Take the antibiotic at least 2 hours before or 4-6 hours after magnesium.
• Bisphosphonates: Separate oral bisphosphonates from magnesium by 2 hours.
• Diuretics: If you are taking a loop diuretic or thiazide diuretic, ask your healthcare provider if you need supplemental magnesium. If you are taking a potassium-sparing diuretic, take care not to consume too much magnesium.
• Gabapentin: Separate magnesium by 2 hours.
• Proton pump inhibitors: Ask your healthcare provider about whether you need to measure your magnesium level if you have been taking a PPI for a long period of time.

Always share a list of your medications and supplements with a healthcare professional so they can help you screen for interactions. They can also offer guidance on how to manage potential interactions.

9. Is Magnesium Safe? Side Effects & Who Should Avoid It

While magnesium is essential, too much can cause issues. It can cause side effects ranging from mild to life-threatening. Here’s how to use it safely.

Common side effects

The most common side effects of magnesium are stomach-related issues, and include:

• Nausea
• Diarrhea
• Stomach cramps

Side effects usually occur at higher doses. They are also more common with inorganic forms of magnesium, such as magnesium oxide.

Taking too much magnesium can lead to life-threatening side effects, like difficulty breathing and irregular heartbeat. Talk to your healthcare provider to find out what a safe amount of magnesium is for you.

Who Should Be Cautious With Magnesium Supplements?

Having certain health conditions can put you at a higher risk of having too much magnesium in your body. This can increase your risk of side effects. Always consult your healthcare provider if any of the following apply to you:

• Kidney disease: When the kidneys don’t function properly, they can’t effectively eliminate extra magnesium from the body.
• Familial hypocalciuric hypercalcemia: A genetic condition that can cause high magnesium in the body.
• Addison’s disease: A condition that increases magnesium absorption from the kidneys.
• Hypothyroidism: Low thyroid levels are sometimes associated with high magnesium.
• Taking high-dose supplements: Too much magnesium in supplements can cause high magnesium levels.
• Taking medications: Some medications can contribute to high magnesium levels.
• Dehydration: Low fluids in the body can lead to having too much magnesium.

Is Magnesium Safe During Pregnancy?

Magnesium requirements are generally higher during pregnancy. The recommended daily amount of magnesium during pregnancy is 350 mg to 400 mg, depending on your age. Pregnant teens need more magnesium than pregnant adults. Many prenatal vitamins already contain some magnesium, so it is important to keep track of how much you are getting from supplemental sources to avoid taking too much.

Some research suggests that magnesium supplementation during pregnancy may have positive effects, such as reduced risk of growth restriction and preeclampsia. However, too much magnesium can be harmful. If you are pregnant, it is important to consult with your healthcare provider before starting any supplements – including magnesium.

10. Frequently Asked Questions

When is the best time to take magnesium, morning or night?

The best time of day to take magnesium depends on your health goals and individual needs. While timing can enhance specific benefits, maintaining a consistent routine is more important for stable magnesium levels in the body. Many studies show the full benefits of magnesium occur after long-term use.

Should I take magnesium with or without food?

It is generally recommended to take magnesium with food to help lower the chances for an upset stomach and increase the absorption of the mineral into your body. If you take magnesium on an empty stomach, you increase the risk for common stomach side effects like diarrhea, nausea and abdominal cramping.

Does magnesium help with headaches and migraines?

The current evidence supports a role for magnesium in both the prevention and treatment of headache disorders, particularly migraines. Multiple clinical trials and meta-analyses demonstrate that magnesium supplementation can reduce the frequency and intensity of migraine attacks, while intravenous magnesium shows promise for acute treatment.

Does magnesium help with restless leg syndrome (RLS)?

The evidence regarding magnesium’s effectiveness for restless leg syndrome presents a complex picture. While some research suggests a beneficial effect, particularly for individuals with magnesium deficiency, other studies find no significant correlation between magnesium levels and RLS severity.

Does magnesium help with weight loss?

While magnesium alone will not lead to significant weight loss, its ability to regulate blood sugar levels, reduce inflammation, improve gut health, boost metabolism, and enhance sleep quality makes it a valuable component of a holistic approach to weight management. Individuals with magnesium deficiencies or related conditions may benefit most from supplementation or dietary adjustments.

Can magnesium help with menopause symptoms?

A placebo-controlled study showed that 800 mg to 1,200 mg per day of magnesium oxide did not have a significant effect in reducing hot flash symptoms in menopausal women with a history of breast cancer. A smaller study did show a positive effect with 400 mg to 800 mg, but did not include a placebo (control) group. Further research is needed in a more generalized population.

Does magnesium help with muscle cramps and soreness?

While magnesium is undeniably essential for proper muscle function, the evidence supporting the use of supplemental magnesium to prevent or treat common muscle cramps (nocturnal or exercise-associated) and soreness (DOMS) in individuals without a deficiency is generally weak or inconsistent according to rigorous scientific reviews.

How long does magnesium citrate take to work?

According to the information provided with magnesium citrate liquid products, you can generally expect it to cause a bowel movement anywhere from 30 minutes to 6 hours after you drink it.

How long does it take for magnesium supplements to work?

In general, most people can expect to feel some benefits of magnesium supplementation—such as muscle relaxation or better sleep—within a few days to two weeks, depending on the form and individual health status. Correcting a magnesium deficiency typically requires one to three months of consistent use.

Should I take magnesium with vitamin D?

Evidence strongly suggests that magnesium and vitamin D should be taken together for optimal health benefits. Magnesium is essential for vitamin D metabolism, and taking vitamin D without adequate magnesium can potentially worsen deficiency.

11. Final Thoughts: Should You Take Magnesium?

Magnesium is an essential mineral, but do you need a supplement? When deciding, there are several factors to consider and discuss with a healthcare professional.

• Magnesium has many health benefits, including glucose control, muscle and nerve support, and blood pressure regulation. It has also been associated with migraine prevention, bone health, and better sleep.
• The safest way to get more magnesium is through your diet, since your kidneys help regulate how much magnesium your body needs. You can get more magnesium naturally by eating leafy greens, beans, and nuts.
• If you have certain health conditions, your healthcare provider might recommend a magnesium supplement to help boost your levels.When choosing supplements, make sure to read the label to check for quality.

What is magnesium oxide?

Magnesium oxide is used as a supplement to maintain adequate magnesium in the body.

Magnesium oxide is also used to treat indigestion, upset stomach, or as a laxative to relieve occasional constipation.

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

Magnesium oxide side effects

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

Stop using magnesium oxide and call your doctor at once if you:

• have rectal bleeding; or
• do not have a bowel movement after using magnesium oxide as a laxative.

Common side effects of magnesium oxide may include:

• nausea, vomiting;
• diarrhea; or
• stomach pain, loss of appetite.

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

Follow all directions on the label and package. Use exactly as directed.

Before taking this medicine

You should not take magnesium oxide if you are allergic to it.

Ask a doctor or pharmacist if magnesium oxide is safe to use if you have or have ever had:

• stomach pain, nausea, vomiting;
• a sudden change in bowel habits that has lasted longer than 2 weeks;
• if you are on a low-magnesium diet; or
• kidney disease.

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

Do not give this medicine to a child without medical advice.

How should I take magnesium oxide?

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

Take this medicine with a full glass of water.

When using this medicine as a laxative, it may be best to take your dose at bedtime.

Magnesium oxide may be taken with food if it upsets your stomach.

Stop using magnesium oxide and call your doctor if your symptoms do not improve after 7 days of treatment, or if they get worse.

Store at cool room temperature away from moisture and heat.

What happens if I miss a dose?

Magnesium oxide is used when needed. If you are on a dosing schedule, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include nausea, vomiting, weakness, breathing problems, slow reflexes, extreme drowsiness, loss of consciousness, and feeling dizzy or light-headed.

What should I avoid while taking magnesium oxide?

Avoid taking other medications at the same time you use an antacid. Some antacids can make it harder for your body to absorb other medicines you take by mouth.

What is magnesium sulfate?

Magnesium is a naturally occurring mineral that is important for many systems in the body especially the muscles and nerves. Magnesium sulfate also increases water in the intestines.

Magnesium sulfate is used as a laxative to relieve occasional constipation.

Magnesium sulfate (Epsom salt) can also be added to a bath for use as a soaking solution to help relieve minor sprains and bruises. Not all external uses for magnesium sulfate have been approved by the FDA. Epsom salt should not be used in place of medication prescribed for you by your doctor.

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

Magnesium sulfate side effects

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

Common side effects may include diarrhea or upset stomach.

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

Never use a higher dose of magnesium sulfate than recommended on the package label, or as your doctor has directed. Using too much magnesium sulfate can cause serious, life-threatening side effects.

Do not use magnesium sulfate as a laxative without medical advice if you have: severe stomach pain, nausea, vomiting, a perforated bowel, a bowel obstruction, severe constipation, colitis, toxic megacolon, or a sudden change in bowel habits that has lasted 2 weeks or longer.

If you have rectal bleeding or if you do not have a bowel movement after using magnesium sulfate as a laxative, stop using the medication and call your doctor at once. These may be signs of a more serious condition.

Before taking this medicine

Do not use magnesium sulfate as a laxative without medical advice if you have:

• severe stomach pain;
• nausea or vomiting;
• a perforated bowel;
• a bowel obstruction or severe constipation;
• colitis or toxic megacolon; or
• a sudden change in bowel habits lasting 2 weeks or longer.

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

• diabetes;
• kidney disease;
• an eating disorder (anorexia or bulimia);
• if you have already been using a laxative for longer than 1 week; or
• if you on a low-magnesium diet.

It is not known whether magnesium sulfate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether magnesium sulfate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take magnesium sulfate?

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

Never use a higher dose of magnesium sulfate than recommended on the package label, or as your doctor has directed. Using too much magnesium sulfate can cause serious, life-threatening side effects.

Magnesium sulfate may be used orally (by mouth) or as a soak. Follow your doctor’s instructions or the directions on the package.

To take magnesium sulfate orally, dissolve one dose in 8 ounces of water. Stir this mixture and drink all of it right away. You may add a small amount of lemon juice to improve the taste of this mixture.

Magnesium sulfate taken orally should produce a bowel movement within 30 minutes to 6 hours.

Drink plenty of liquids while you are taking magnesium sulfate.

If you have rectal bleeding or if you do not have a bowel movement after using magnesium sulfate as a laxative, stop using the medication and call your doctor at once. These may be signs of a more serious condition.

To use magnesium sulfate as an epsom salt soak, dissolve in a large amount of water in a large bowl, a bucket, a foot tub, or a bath tub. Follow the directions on the product label about how much epsom salt to use per gallon of water.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since magnesium sulfate is used on an as needed basis, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of magnesium sulfate can be fatal

Overdose symptoms may include nausea, vomiting, flushing (warmth, redness, or tingly feeling), feeling very hot, slow heart rate, extreme drowsiness, or fainting.

What should I avoid while taking magnesium sulfate?

Magnesium sulfate taken orally can make it harder for your body to absorb other medications you take by mouth, especially antibiotics. Avoid taking other medicines within 2 hours before or after you take magnesium sulfate as a laxative.

What other drugs will affect magnesium sulfate?

Other drugs may interact with magnesium sulfate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What is Mavenclad?

Mavenclad is a purine antimetabolite that interferes with enzymes that are necessary for DNA synthesis.

Mavenclad is used to treat relapsing multiple sclerosis (MS) in adults. This medicine will not cure MS, it will only decrease the frequency of relapse symptoms.

Mavenclad is usually given after other treatments have failed.

Mavenclad side effects

Common Mavenclad side effects may include:

• headache;
• low white blood cell counts; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

Serious side effects

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

Mavenclad may cause a serious brain infection called Progressive multifocal leukoencephalopathy (PML) that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Mavenclad may decrease counts of lymphocytes and other types of blood cells. Your healthcare provider will obtain a blood test before starting treatment, 2 and 6 months after starting treatment, periodically thereafter, and when clinically needed. Keep all appointments for lymphocyte monitoring.

Taking Mavenclad may increase your risk of infections caused by bacteria, viruses, parasites, or fungi that may be life-threatening or cause death.

Also, call your doctor at once if you have:

• heart problems – swelling, rapid weight gain, feeling short of breath;
• low blood cell counts – fever, swollen glands, stomach pain, cough, runny nose, joint pain, mouth sores, skin sores or rash, easy bruising, unusual bleeding;
• liver problems – nausea, vomiting, stomach pain, tiredness, loss of appetite, yellowing of your skin or eyes, dark urine. Mav;enclad can cause liver injury
• signs of shingles – flu-like symptoms, tingly or painful blistering rash on one side of your body; or
• signs of tuberculosis – fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired
• signs of an infection – such as fever, aching, painful muscles, headache, generally feeling unwell, or loss of appetite.

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

Warnings

Do not take Mavenclad if you are pregnant. Both men and women should use effective birth control to prevent pregnancy while taking Mavenclad, and for 6 months after the last dose.

If you use birth control pills or other hormonal forms (implants, skin patches, vaginal rings), also use a barrier form of birth control (condom, diaphragm, cervical cap, contraceptive sponge) to prevent pregnancy while taking Mavenclad and for at least 4 weeks after your treatment course ends.

Taking cladribine may increase your risk of developing certain cancers.

Before taking this medicine

You should not take Mavenclad if you are allergic to cladribine, or if you have:

• cancer;
• an active infection such as tuberculosis or hepatitis B or C;
• moderate-to-severe liver impairment (Child-Pugh score greater than 6)
• HIV or AIDS; or
• if you are pregnant or breastfeeding.

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

• an active or chronic infection;
• heart problems;
• weak immune system (caused by disease or by using certain medicine);
• liver or kidney disease;
• cancer; or
• if you receive blood transfusions.

Tell your doctor if you have recently received a vaccine (within 4 to 6 weeks before you take Mavenclad).

Taking cladribine may increase your risk of developing certain cancers. Ask your doctor about this risk.

Do not take Mavenclad if you are pregnant. Cladribine could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

• Cladribine can harm an unborn baby if the mother or the father is using this medicine.
• If you are a woman taking Mavenclad, you may need to have a negative pregnancy test before starting this medicine. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man taking Mavenclad, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking this medicine.

Mavenclad can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while taking this medicine, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using the second form of birth control for at least 4 weeks after your Mavenclad treatment course ends.

Do not breastfeed while taking cladribine, and for at least 10 days after your last dose.

How should I take Mavenclad?

Take Mavenclad exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Your doctor will perform medical tests to make sure you do not have conditions that would prevent you from safely using Mavenclad.

Mavenclad is taken in 2 treatment courses separated by about a year. There are 2 treatment cycles in each course. During each cycle, you will take the medicine for 4 or 5 days in a row. The 2 cycles are separated by about a month. Follow your doctor’s dosing instructions very carefully.

Your doctor will determine how many treatment courses you should receive.

Take this medicine with a full glass of water. You may take Mavenclad with or without food.

Use dry hands to remove a tablet from the foil blister pack when you are ready to take the medicine.

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

Wash your hands after handling the tablet.

Do not use a broken tablet. The medicine from a broken pill can be dangerous if it gets in your eyes or nose, or on your skin. If this happens, rinse thoroughly with water. Ask your pharmacist how to safely dispose of a broken pill.

You may be given other medications to help prevent infections. Keep using these medicines for as long as your doctor has prescribed.

You will need frequent medical tests, and your next dose may be delayed based on the results.

Store at room temperature away from moisture and heat.

Cladribine can have long lasting effects on your body. Your doctor will need to check your progress on a regular basis and for another 2 years after your last dose.

What happens if I miss a dose?

Take the missed dose on the same day you remember it. If the day is almost over before you remember your dose, wait until the next day to take it.

Do not take 2 doses in one day. Take your next dose at the regular time and stay on your once-daily schedule, even if it adds an extra day to your treatment cycle for the week.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Do not receive a “live” vaccine while using Mavenclad. You could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine. Your doctor will determine when it is safe for you to receive a vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Cladribine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient’s body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What is Mavyret?

Mavyret is an oral combination medicine containing fixed doses of 2 antivirals, glecaprevir, and pibrentasvir, that may be used to treat adults and children 3 years of age and older with:

• chronic (lasting a long time) hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.
• HCV genotype 1 infection who have been previously treated with a regimen that contained an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.

The 2 ingredients in Mavyret, glecaprevir and pibrentasvir, work in different ways to prevent the replication of the HCV virus. Glecaprevir inhibits an enzyme called NS3/4A protease which is essential for cleavage of HCV into its mature forms. Pibrentasvir inhibits NS5A, a protein that also plays a key role in HCV RNA replication. Cure rates of 95% to 99% after 8 weeks of treatment have been reported in people with hep C who took Mavyret.

Mavyret was first FDA-approved on August 3, 2017.

Mavyret side effects

The most common side effects of Mavyret affecting 10% or more people who take it are headache and tiredness.

These are not all the possible side effects of Mavyret. Call your doctor for medical advice about side effects. You may report side effects to the FDA

Warnings

Do not use if you:

• have moderate to severe liver disease (Child-Pugh B or C) or with a history of liver decompensation
• take atazanavir or rifampin.

Mavyret can cause serious side effects, including:

Hepatitis B virus reactivation. If you have ever had a hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment for the hepatitis C virus with Mavyret. Hepatitis B virus that becomes active again (called reactivation) may cause serious liver problems including liver failure and death. Before starting treatment, your healthcare provider will do blood tests to check for hepatitis B virus infection and will monitor you if you are at risk for hepatitis B virus reactivation during and after treatment.

A rare risk of worsening liver problems, liver failure, and death in people who had or have advanced liver problems before starting treatment. Your healthcare provider will check you for signs and symptoms of worsening liver problems during treatment with Mavyret. Tell your healthcare provider right away if you have any of the following signs and symptoms:

• nausea
• tiredness
• yellowing of your skin or the white part of your eyes
• bleeding or bruising more easily than normal
• confusion
• dark, black, or bloody stools
• loss of appetite
• diarrhea
• dark or brown (tea-colored) urine
• swelling or pain on the upper right side of your stomach area (abdomen)
• sleepiness
• vomiting of blood
• lightheadedness.

It is unknown if Mavyret is safe and effective in children under 3 years of age.

Before taking

Do not take Mavyret if you:

• have certain liver problems
• also take atazanavir or rifampin

Before taking Mavyret, tell your healthcare provider about all of your medical conditions, including if you:

• have had hepatitis B virus infection
• have liver problems other than hepatitis C virus infection.
• have HIV-1 infection
• have had a liver or a kidney transplant
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

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

Breastfeeding

It is not known if Mavyret passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby.

How should I take Mavyret?

Take Mavyret exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking it unless your healthcare provider tells you to.

The dosage of Mavyret varies depending on age, HIV coinfection, kidney disease, and some other factors.

• Usual Mavyret dosage for adults and children aged 12 years and older or weighing at least 99 pounds (45 kg): 3 tablets (each tablet contains glecaprevir 100 mg and pibrentasvir 40 mg) once a day.
• Usual Mavyret dosage for children aged 3 to less than 12 years: dosing is based on weight. See the prescribing information.

The length of time Mavyret is taken depends on the HCV genotype and the presence or absence of Cirrhosis.

• The usual treatment duration in treatment naïve patients with HCV genotype 1,2,3,4,5, or 6 is 8 weeks.
• Treatment durations of 12 weeks or 16 weeks are recommended for others depending on previous treatments or the presence of compensated cirrhosis (Child-Pugh A).

Take Mavyret with food or a snack.

Try to take it at around the same time each day.

How should I give Mavyret oral pellets to my child?

Administer Mavyret oral pellets exactly as instructed by your healthcare provider.

Give them once a day just before or after a snack or meal.

• Do not open the packet until your child or the person you are looking after who has been prescribed Mavyret is ready to take their dose.

Mix the pellets with a small amount of recommended food, such as peanut or nut butter, strawberry jam, yogurt, or hazelnut spread, in a small bowl and swallow. Do not attempt to crush or dissolve the pellets in soft food because they will taste bitter.

• The Mavyret pellet/food mixture should be taken right away. Tell your child not to chew the pellets. Add more food to the bowl and mix until every pellet has been taken.

If you wait more than:

• 5 minutes before taking the pellet/food mixture, it will taste bitter.
• 15 minutes before taking the pellet/food mixture, it will be less effective.

Follow up the medication with a snack or a meal.

Do not store any leftover mixture for use at a later time. Throw away any unused portion.

What happens if I miss a dose?

If you miss a dose of Mavyret and:

• Less than 18 hours have passed from the time you usually take it, take the missed dose with food as soon as possible. Then take your next dose at your usual time
• It is less than 6 hours till your next dose, do not take the missed dose. Take your next dose as usual with food.

What happens if I overdose?

If you take too much Mavyret, call your healthcare provider or go to the nearest hospital emergency room right away.

What other drugs will affect Mavyret?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may reduce the effectiveness of Mavyret or may cause side effects. Keep a list of your medicines to show your healthcare provider and pharmacist. Especially tell your healthcare provider if you take:

• Carbamazepine
• Dabigatran
• Digoxin
• Ethinylestradiol-containing medications, such as combined oral contraceptives
• HIV antivirals such as atazanavir, darunavir, efavirenz, lopinavir, or ritonavir
• Immunosuppressives, such as cyclosporine
• Rifampin
• St. John’s wort
• Statins, such as atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin
• Other medications which are metabolized through the liver, such as warfarin, because clearance of HCV infection with Mavyret may lead to changes in liver function. Your healthcare provider should monitor your medications for any change in effect.

What is Mayzent?

Mayzent (siponimod) belongs to a class of medications called sphingosine l-phosphate receptor modulators.

Mayzent is used to prevent episodes of symptoms and slow the worsening of disability in adults with relapsing-remitting forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS); a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control).

Mayzent works by decreasing the action of immune cells that may cause nerve damage. It is only used if you have a specific genotype. Your doctor will test you for this genotype.

Mayzent was FDA-approved on March 26, 2019.

Mayzent side effects

Common Mayzent side effects may include:

• headache;
• increased blood pressure; or
• abnormal liver function tests.

Serious side effects

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

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

• slow or irregular heartbeats;
• vision problems such as increased sensitivity to light, blurred vision, eye pain, having a blind spot or shadows in the center of your vision, or unusual color to your vision (vision problems may occur 1 to 4 months after you start taking Mayzent). S1P receptor modulators, including Mayzent, have been associated with an increased risk of macular edema. Your healthcare provider should send you for an eye examination before starting treatment, 3 to 4 months into treatment, periodically thereafter, and any time there is a vision change. Patients with diabetes or a history of uveitis are more at risk;
• headache, confusion, change in mental status;
• a seizure;
• sores in your mouth and throat, cold sores, sores on your genital or anal area;
• skin changes, unusual moles that change in color or size;
• shortness of breath;
• liver problems – nausea, vomiting, upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or
• symptoms of meningitis – fever, chills, body aches, tiredness, nausea and vomiting, neck stiffness, increased sensitivity to light.

Longer treatment durations of Mayzent (more than 18 months) increase the risk of developing progressive multifocal leukoencephalopathy (PML), a rare brain infection.

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 use Mayzent if you have a serious heart condition such as “sick sinus syndrome” or “AV block” (unless you have a pacemaker), or if you’ve recently had heart block, heart failure, a heart rhythm disorder, chest pain, heart attack, or stroke.

Mayzent can slow your heart rate when you start taking it. You may receive your first dose in a setting where your heart rhythm can be monitored. If you miss any doses, you may need to restart taking this medicine under medical observation.

You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, vomiting, confusion, neck stiffness, or problems with coordination, thought, vision, or muscle movement. Your risk of infection could last for 3 to 4 weeks after you stop taking this medicine.

You may have increased sensitivity to light, blurred vision, eye pain, or have a blind spot or shadows in the center of your vision, unusual color to your vision, or other vision problems while you are taking Mayzent, which may occur 1 to 4 months after your first dose.

You should not use Mayzent if you have a specific genotype. Your doctor will perform tests to make sure this medicine is the right treatment for you.

Before taking this medicine

You should not use Mayzent if you are allergic to siponimod or any of the ingredients in Mayzent tablets, or if you have:

• a specific genotype;
• “AV block” (2nd or 3rd degree);
• irregular or abnormal heart rhythm (unless you have a pacemaker); or
• recent (within the past 6 months) heart failure, heart attack, stroke, ‘mini-stroke’ or TIA, chest pain (unstable angina), or other serious heart problem.

Some heart rhythm medications can cause unwanted or dangerous effects when used with Mayzent. Your doctor may change your treatment plan if you also use: amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, procainamide, propafenone, quinidine, or sotalol.

Before you take Mayzent, tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine. You may need to receive the vaccine and then wait 1 month before taking Mayzent.

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

• weak immune system (caused by disease or by using certain medicines);
• fever or an active or chronic infection;
• high blood pressure;
• slow or irregular heart beats;
• heart problems, a heart attack, a stroke, or chest pain;
• asthma, sleep apnea (breathing stops during sleep), or other breathing disorder;
• skin cancer (melanoma);
• an eye condition called uveitis;
• diabetes; or
• liver disease.

Tell your doctor if you have recently received a vaccine, or if you are scheduled to receive a vaccine.

Siponimod may harm an unborn baby. Use effective birth control while using Mayzent and for at least 10 days after your last dose. Tell your doctor if you become pregnant .

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

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

How should I take Mayzent?

Take Mayzent exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your dose will be increased gradually during the first 5 to 6 days of taking Mayzent.

You may need medical tests before you start taking Mayzent including blood tests, ECG, eye evaluation, heart and liver function tests, and skin exam.

Siponimod can slow your heart rate when you start taking it. You may receive your first dose in a medical setting. Your blood pressure and heart rate may be constantly monitored for at least 6 hours after your first dose of Mayzent.

Siponimod affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis. Your risk of infection could last 3 to 4 weeks after you stop taking this medicine.

Always ask your doctor before you stop taking Mayzent for any reason. When you stop taking Mayzent, your MS symptoms may return. In rare cases, some people who stopped taking Mayzent had MS symptoms that were worse than before or during treatment with this medicine.

If you stop taking Mayzent, do not start taking it again without asking your doctor. You may need to be under medical observation when you restart this medication.

Do not crush, break, or split a Mayzent tablet. Swallow the tablet whole.

You may take Mayzent with or without food.

Store unopened tablets in the refrigerator, do not freeze.

After opening, store Mayzent in the original container at room temperature away from moisture and heat for up to 3 months.

If you stop taking this medicine, watch for signs of worsening MS, and call your doctor right away if any new or worsening symptoms appear.

Dosing information

Usual Adult Dose for Multiple Sclerosis:

CYP450 2C9 Genotype *1/*1, *1/*2, or *2/*2:
-Titration regimen: 0.25 mg orally once daily on Days 1 and 2, then 0.5 mg orally once daily on Day 3, then 0.75 mg orally once daily on Day 4, then 1.25 mg orally once daily on Day 5
-Maintenance dose: 2 mg orally once daily beginning on Day 6
NOTE: Use a starter pack for patients who will be titrated to the 2 mg maintenance dose.

CYP450 2C9 Genotype *1/*3 or *2/*3:
-Titration regimen: 0.25 mg orally once daily on Days 1 and 2, then 0.5 mg orally once daily on Day 3, then 0.75 mg orally once daily on Day 4
-Maintenance dose: 1 mg orally once daily beginning on Day 5
NOTE: Do not use the starter pack for patients who will be titrated to the 1 mg maintenance dose.
-If one titration dose is missed for more than 24 hours, therapy needs to be reinitiated with Day 1 of the titration regimen.

Comments:
-If one titration dose is missed for more than 24 hours, therapy needs to be reinitiated with Day 1 of the titration regimen.
-First-dose monitoring is recommended for patients with sinus bradycardia, first- or second-degree atrioventricular (AV) block, or a history of myocardial infarction or heart failure.
-Administer the first dose in a setting equipped to manage symptomatic bradycardia.
-Monitor patients for 6 hours after the first dose for bradycardia with hourly pulse and blood pressure measurements. Obtain an ECG in these patients at the end of Day 1.
-If any of the following abnormalities are present after 6 hours (even in the absence of symptoms), continue monitoring until the abnormality resolves: the heart rate 6 hours post dose is less than 45 bpm; the heart rate 6 hours post dose is at the lowest value post dose, suggesting that the maximum pharmacodynamic effect on the heart may not have occurred; the ECG 6 hours post
dose shows new onset second-degree or higher AV block.
-If post dose symptomatic bradycardia, bradyarrhythmia, or conduction related symptoms occur, or if ECG 6 hours post dose shows new onset second degree or higher AV block or QTc greater than or equal to 500 msec, initiate management, begin continuous ECG monitoring, and continue monitoring until the symptoms have resolved if no treatment is required. If treatment is required, continue monitoring overnight and repeat 6-hour monitoring after the second dose.
-After the initial titration is complete, if treatment is interrupted for 4 or more consecutive daily doses, reinitiate therapy with Day 1 of the titration regimen; also complete first-dose monitoring in patients for whom it is recommended.

Use: For relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults

What happens if I miss a dose?

Call your doctor for instructions. If you miss 1 or more of your first doses, or 4 or more of your maintenance doses, you may need to take your next dose under medical observation in a medical setting.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

What should I avoid while taking Mayzent?

Avoid receiving a vaccine without asking your doctor. The vaccine may not work as well while you are using Mayzent. Receiving a “live” vaccine while using Mayzent may cause you to develop an infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

If you need to receive a vaccine, you should stop taking Mayzent for at least 1 week ahead of time. After receiving the vaccine, you should wait another 4 weeks before you start taking Mayzent again. Do not stop taking this medicine without your doctor’s advice.

What is meclizine?

Meclizine is used in adults and children aged 12 years and older to treat or prevent nausea, vomiting and dizziness caused by motion sickness.

Meclizine is also used in adults to treat symptoms of vertigo (dizziness or spinning sensation) caused by disease that affects your inner ear.

Meclizine is most effective if taken before symptoms appear.

Meclizine side effects

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

Common meclizine side effects may include:

• drowsiness;
• dry mouth;
• headache;
• vomiting; or
• feeling tired.

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

Use meclizine only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

You should not take this medication if you are allergic to meclizine.

Before you take this medicine, tell your doctor if you have liver or kidney disease, asthma, glaucoma, an enlarged prostate, or urination problems.

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

Drinking alcohol can increase certain side effects of meclizine.

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by meclizine.

Before taking this medicine

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

Do not give meclizine to anyone younger than 12 years old without medical advice.

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

• glaucoma;
• breathing problems such as asthma, emphysema, or chronic bronchitis;
• an enlarged prostate or urination problems;
• recently used alcohol, sedatives, or tranquilizers; or
• liver or kidney disease.

Tell your doctor if you are pregnant or breastfeeding.

How should I take meclizine?

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

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

You must chew the chewable tablet before you swallow it.

To prevent motion sickness, take meclizine about 1 hour before you travel or anticipate having motion sickness. You may take meclizine once every 24 hours while you are traveling, to further prevent motion sickness.

To treat vertigo, you may need to take meclizine several times daily. Follow your doctor’s instructions.

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

Dosing information

Usual Adult Dose for Vertigo:

-25 to 100 mg orally per day in divided doses
-Dosing dependent upon clinical response.

Use: Management of vertigo associated with diseases affecting the vestibular system.

Usual Adult Dose for Motion Sickness:

-Initial Dose: 25 to 50 mg orally 1 hour before travel
-Maintenance Dose: Repeat dose every 24 hours if needed

Use: Management of nausea, vomiting, and dizziness associated with motion sickness.

Usual Pediatric Dose for Vertigo:

Age 12 years and older:
-25 to 100 mg orally per day in divided doses
-Dosing dependent upon clinical response.

Use: Management of vertigo associated with diseases affecting the vestibular system.

Usual Pediatric Dose for Motion Sickness:

Age 12 years and older:
-Initial Dose: 25 to 50 mg orally 1 hour before travel
-Maintenance Dose: Repeat dose every 24 hours if needed

Use: Management of nausea, vomiting, and dizziness associated with motion sickness.

What happens if I miss a dose?

Meclizine is used when needed. If you are on a dosing schedule, skip any missed dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking meclizine?

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

What is Medrol?

Medrol is a steroid that prevents the release of substances in the body that cause inflammation.

Medrol is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.

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

Medrol side effects

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

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

• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• bruising, thinning skin, or any wound that will not heal;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• severe depression, changes in personality, unusual thoughts or behavior;
• new or unusual pain in an arm or leg or in your back;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• seizure (convulsions); or
• low potassium–leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling.

Steroids can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Medrol.

Common side effects of Medrol may include:

• fluid retention (swelling in your hands or ankles);
• dizziness, spinning sensation;
• changes in your menstrual periods;
• headache;
• mild muscle pain or weakness; or
• stomach discomfort, bloating.

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

Warnings

You should not use this medicine if you have a fungal infection anywhere in your body.

Before taking this medicine

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

• a fungal infection anywhere in your body.

Medrol can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

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

• a thyroid disorder;
• herpes infection of the eyes;
• stomach ulcers, ulcerative colitis, or diverticulitis;
• depression, mental illness, or psychosis;
• liver disease (especially cirrhosis);
• high blood pressure;
• osteoporosis;
• a muscle disorder such as myasthenia gravis; or
• multiple sclerosis.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

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

It is not known whether methylprednisolone passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

How should I take Medrol?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Medrol is sometimes taken every other day. Follow your doctor’s dosing instructions very carefully.

Your dose needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

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

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

Wear a medical alert tag or carry an ID card stating that you take Medrol. Any medical care provider who treats you should know that you take steroid medication.

If you need surgery, tell the surgeon ahead of time that you are using Medrol. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of Medrol.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

An overdose of methylprednisolone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking Medrol?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a “live” vaccine while using Medrol. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What is medroxyprogesterone?

Medroxyprogesterone tablets are used to treat abnormal menstrual bleeding, absent or irregular menstrual periods (amenorrhea) and to prevent thickening of the lining of the uterus (endometrial hyperplasia) in postmenopausal women who are taking estrogen hormone replacement therapy. Medroxyprogesterone is a progestin hormone.

Warnings

You should not use medroxyprogesterone if you are pregnant, or if you have liver disease, a hormone-related cancer such as breast or uterine cancer, a history of stroke or blood clot, or abnormal vaginal bleeding that has not been checked by a doctor.

Medroxyprogesterone should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions. Long-term use of medroxyprogesterone may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risk.

Before taking this medicine

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

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

Medroxyprogesterone may cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Medroxyprogesterone should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions.

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

• heart problems;
• liver problems;
• asthma;
• migraine headaches;
• a thyroid disorder;
• endometriosis (severe pelvic pain);
• jaundice caused by pregnancy or birth control pills;
• kidney disease;
• high or low blood levels of calcium;
• a seizure;
• diabetes; or
• lupus.

Using this medicine can increase your risk of blood clots, stroke, or heart attack, especially if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Long-term use of medroxyprogesterone may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Do not breastfeed.

How should I take medroxyprogesterone?

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

Medroxyprogesterone is usually given for only a few days in a row each month.

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

If you need major surgery or will be on long-term bed rest, you may need to stop using medroxyprogesterone for a short time. This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using medroxyprogesterone.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Endometrial Hyperplasia — Prophylaxis:

Oral tablets:
5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16 th day of the cycle

Comments:
-Postmenopausal woman with a uterus taking estrogens should also initiate progestin therapy to reduce the risk of endometrial cancer.
-Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration. Starting dose should be the lowest.
-Periodically re-evaluation (e.g., 3 to 6 month intervals) to determine if treatment is still necessary is recommended.
-In women with uterus, endometrial sampling should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Use: Prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets

Usual Adult Dose for Abnormal Uterine Bleeding:

Oral tablets:
-5 or 10 mg daily for 5 to 10 days, beginning on the 16 th or 21 st day of the menstrual cycle

-Dose to produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen: 10 mg daily for 10 days beginning on the 16 th day of the cycle

Comments:
-Withdrawal bleeding usually occurs within 3 to 7 days after discontinuing therapy with the oral tablets.
-Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with the oral tablets.

Use: Abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer

Usual Adult Dose for Amenorrhea:

Oral tablets:
-5 or 10 mg daily for 5 to 10 days

Dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen:
-10 mg daily for 10 day

Comments:
-Therapy may be started at any time.
-Withdrawal bleeding usually occurs within 3 to 7 days after discontinuing therapy with this drug.

Use: Treatment of secondary amenorrhea due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking medroxyprogesterone?

Avoid smoking while you are taking medroxyprogesterone. Smoking greatly increases your risk of blood clots.

Medroxyprogesterone side effects

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

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

• signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot – sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems – loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• unusual vaginal bleeding;
• confusion, memory problems;
• a breast lump; or
• symptoms of depression – sleep problems, weakness, tired feeling, mood changes.

Common medroxyprogesterone side effects may include:

• spotting or breakthrough bleeding;
• changes in your menstrual periods;
• vaginal itching or discharge;
• headache, dizziness, feeling nervous or depressed;
• breast tenderness or discharge;
• stomach discomfort, bloating, nausea, vomiting;
• itching, rash, acne, hair growth, hair loss;
• premenstrual type symptoms (bloating, fluid retention, mood changes);
• weight gain;
• bruising or swelling of your veins;
• tiredness, trouble sleeping; or
• vision changes and difficulty wearing contact lenses.

What is meloxicam?

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

Meloxicam is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints).

Meloxicam is also used to relieve the pain, tenderness, swelling, and stiffness caused by juvenile rheumatoid arthritis (a type of arthritis that affects children) in children 2 years of age and older.

The Anjeso brand of this medicine is used to treat moderate to severe pain in adults.

Vivlodex is for use only in adults. Qmiiz ODT is for adults and children weighing at least 132 pounds (60 kilograms).

Warnings

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

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

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

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

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Avoid smoking and drinking alcohol as they also increase your risk of stomach bleeding.

Before taking this medicine

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

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

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

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

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

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

Meloxicam may cause a delay in ovulation (the release of an egg from an ovary). You should not take this medicine if you are undergoing fertility treatment, or are otherwise trying to get pregnant.

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

Meloxicam is not approved for use by anyone younger than 2 years old.

How is meloxicam given?

Take Meloxicam exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the lowest effective dose for your condition.

Meloxicam oral is taken by mouth.

Meloxicam injection is given as an infusion into a vein. A healthcare provider will give you this injection.

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

Meloxicam doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.

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

Store oral suspension, tablets or capsules at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

Dosing Information

Usual Adult Dose for Osteoarthritis:

Oral Tablets and Oral Disintegrating Tablets:
-Initial dose: 7.5 mg orally once a day
-Maintenance dose: 15 mg orally once a day in patients requiring additional analgesia
-Maximum dose: 15 mg orally once a day

Oral Capsules:
-Initial dose: 5 mg orally once a day
-Maintenance dose: 10 mg orally once a day in patients requiring additional analgesia
-Maximum dose: 10 mg orally once a day.

Use: For the relief of signs and symptoms of osteoarthritis pain

Usual Adult Dose for Rheumatoid Arthritis:

Oral Tablets and Oral Disintegrating Tablets:
-Initial dose: 7.5 mg orally once a day
-Maintenance dose: 15 mg orally once a day in patients requiring additional analgesia
-Maximum dose: 15 mg orally once a day.

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

Usual Adult Dose for Pain:

30 mg IV bolus (over 15 seconds) once a day

Comments:
-Median time to meaningful pain relief was 2 to 3 hours in clinical trials; a non-NSAID with a rapid onset may be needed; some patients may not experience adequate analgesia for the first 24-hours.
-The lowest effective dose for the shortest duration possible consistent with individual treatment goals should be used.

Use: For the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

2 years or older:
Oral Tablets and Oral Disintegrating Tablets:
Weight: 60 kg or greater: 7.5 mg orally once a day
-No additional benefit has been demonstrated with doses above 7.5 mg/day.

Comments:
-Oral formulations have not shown equivalent systemic exposure and are not considered interchangeable
-The oral tablets should not be used in children who weigh less than 60 kg.

Use: For the relief of signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving meloxicam?

Drinking alcohol may increase your risk of stomach bleeding.

Avoid taking aspirin while you are taking meloxicam, unless your doctor tells you to.

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

Meloxicam side effects

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

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

Meloxicam may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

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

Common meloxicam side effects may include:

• stomach pain, nausea, vomiting, heartburn;
• diarrhea, constipation, gas;
• dizziness; or
• cold symptoms, flu symptoms.

What is memantine?

Memantine is used to treat moderate to severe dementia in people with Alzheimer’s disease (AD). It is an oral tablet or capsule that is taken once or twice a day.

Memantine works to help relieve symptoms of AD by blocking NMDA receptors that, when persistently activated by glutamate, cause AD symptoms. While this mechanism helps to manage symptoms, memantine has not been shown to prevent or slow the underlying nerve degeneration associated with AD. Memantine belongs to the drug class called N-methyl-D-aspartate (NMDA) receptor antagonists. 

Memantine was FDA-approved on October 16, 2003, under the brand name Namenda. Generic memantine became available in 2010.

Side effects

The most common side effects of memantine include:

• dizziness
• headache
• confusion
• constipation.

Serious side effects and warnings

Memantine can cause serious allergic reactions, including anaphylaxis. Get emergency medical help if you have signs of an allergic reaction to memantine with symptoms such as hives, difficulty breathing, and swelling of your face, lips, tongue, or throat.

Conditions that increase the pH of the urine (such as kidney disease, prolonged vomiting, and some medications) may decrease how much memantine is excreted, which may increase blood levels of memantine. Tell your healthcare provider about all your medical conditions.

Call your doctor at once if you have:

• severe headache, blurred vision, pounding in your neck or ears
• seizure (convulsions)
• unusual changes in mood or behavior.

These are not all the possible side effects of memantine. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA

Before taking

Before taking memantine, tell your doctor if you are allergic to memantine, Namenda, or any inactive ingredients in the tablets or capsules.

Tell your healthcare provider about all your medical conditions, including if you:

• have a seizure disorder
• have cataracts
• have liver or kidney disease
• have a bladder or kidney infection
• have problems passing urine
• are pregnant or intending to become pregnant
• are breastfeeding.

It is not known if memantine is safe and effective in children.

Pregnancy

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

Breastfeeding

It is not known if memantine passes into your breast milk. Talk to your doctor about the best way to feed your baby during treatment.

How should I take memantine?

Your doctor will tell you how much memantine to take and when to take it.

Memantine tablets or extended-release capsules may be taken with food or without food.

• Do not use any tablets or capsules of memantine that are damaged or show signs of tampering.
• Memantine hydrochloride extended-release capsules should be swallowed whole or may be opened and the contents sprinkled on applesauce and then swallowed. The entire contents of each memantine hydrochloride extended-release capsule should be consumed; the dose should not be divided.

Dosing information

Memantine immediate-release tablets

Initial dose: 5 mg once daily.

Titration: Increase by 5 mg increments once a week.

Maximum dosage: 10 mg twice daily.

• In people with severe kidney disease, the maximum dose is 5mg twice daily.

Memantine extended-release capsules

Initial dose: 7 mg once daily.

Titration: Increase by 7 mg increments once a week.

Maintenance dose: 28 mg once daily.

Maximum dosage: 28 mg once daily.

• In people with severe kidney disease, the maximum dose is 14 mg once daily.

Switching from memantine tablets to memantine extended-release capsules

People on a regimen of 10 mg twice daily of memantine tablets can be switched to memantine extended-release 28 mg once daily capsules the day following the last dose of 10 mg memantine hydrochloride.

People with severe renal impairment taking 5 mg twice daily of memantine should be switched to memantine extended-release 14 mg once daily capsules the day following the last dose of 5 mg memantine tablets.

What happens if I forget a dose?

If you forget to take one dose of memantine, do not double up on the next dose. You should take only the next dose as scheduled.

If you have forgotten to take memantine for several days, you should not take the next dose until you talk to your doctor.

What happens if I overdose?

If you take too much memantine, call your doctor or poison control center right away, or go to the nearest hospital emergency room.

What should I avoid?

Memantine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What other drugs will affect memantine?

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Taking memantine with certain other medicines may affect each other or cause serious side effects. Especially tell your doctor if you take:

• other NMDA antagonists such as amantadine, ketamine, and dextromethorphan
• medicines that make your urine alkaline, such as carbonic anhydrase inhibitors and sodium bicarbonate.

Ask your doctor or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Storage

Store memantine tablets and capsules at room temperature between 59°F to 77°F (15°C to 30°C).

Ingredients

Namenda ingredients

Active ingredient: memantine hydrochloride.

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

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

Available as Namenda 5 mg and 10 mg tablets and Namenda XR (extended-release capsule) 7 mg, 14 mg, 21 mg, 28 mg.

Generic memantine ingredients

Active ingredient: memantine hydrochloride

Inactive ingredients: These vary depending on the manufacturer.

Available as memantine 5 mg and 10 mg tablets and memantine XR (extended-release capsule) 7 mg, 14 mg, 21 mg, 28 mg.

Who makes memantine?

Namenda (memantine) was originally manufactured by Forest Laboratories, which was acquired by Allergan in 2014, which was subsequently acquired by AbbVie in 2020. AbbVie is headquartered in North Chicago, Illinois, USA.

The original brand name Namenda, is now also available as a generic medication (memantine) from multiple manufacturers, including Amneal Pharmaceuticals LLC, Aurobindo Pharma Limited, and Sun Pharmaceutical Industries, Inc., as the patent protection has expired.

What is meropenem?

Meropenem is an antibiotic that is used to treat bacterial infections of the skin and stomach in adults and children at least 3 months old.

Meropenem is also used in adults and children at least 3 months old to treat bacterial meningitis (an infection that causes inflammation of the tissue that covers the brain and spinal cord) with or without bacteremia (a bacterial infection in the blood).

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

Meropenem side effects

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

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

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

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• seizures;
• signs of thrush (a fungal infection)–sores or white patches in your mouth or throat, trouble swallowing;
• pain, swelling, burning, or irritation around the IV needle; or
• confusion, weakness, numbness, tingling, burning pain.

Common side effects of meropenem may include:

• headache;
• thrush (a fungal infection), tongue swelling;
• nausea, vomiting, diarrhea, constipation;
• rash; or
• anemia (low red blood cells).

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

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use meropenem if you are allergic to it, or if you have an allergy or had a life-threatening allergic reaction to similar antibiotics such as imipenem and cilastatin, cephalexin, cefdinir, ceftriaxone, amoxicillin, ampicillin, penicillin, and others.

You should not use certain brand forms of meropenem if you need to follow a low-salt or sodium-free diet.

Tell your doctor if you have or have ever had:

• any other allergies;
• if you are on a low-salt diet;
• congestive heart failure;
• a head injury, epilepsy or other seizure disorder; or
• kidney disease (or if you are on dialysis).

Tell your doctor if you are pregnant or breastfeeding.

How should I use meropenem?

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

Meropenem is given as an infusion into a vein. A healthcare provider may give you this injection or may teach you how to properly use meropenem by yourself.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it. Ask your doctor or pharmacist if you don’t understand how to use an injection.

Be sure you understand how to properly mix this medicine and how to store the mixture, if needed.

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

Doses are based on weight in children. Your child’s dose may change if the child gains or loses weight.

Antibiotic medicines can cause diarrhea. Tell your doctor if you have diarrhea that is watery or bloody.

Your doctor will need to check your progress on a regular basis. Your blood and kidney function may need to be tested often.

Meropenem is usually given for as long as needed after lab tests show that the infection has cleared, or for several weeks for very severe infections. Your doctor will determine how long to treat you with this medicine.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using meropenem?

Avoid driving or hazardous activity until you know how meropenem will affect you. This medicine may cause dizziness, seizures, or confusion and this may impair your reactions or cause falls, accidents, or severe injuries.

What is metformin?

Metformin is an FDA-approved antidiabetic agent that manages high blood sugar levels in type 2 diabetes patients. It reduces glucose absorption from the intestines, lowers liver glucose production, and improves insulin sensitivity. Metformin is recommended with dietary changes and exercise for better results.

Managing blood sugar levels with medications like metformin can prevent complications such as kidney damage, nerve issues, blindness, amputations, and sexual dysfunction. Effective diabetes control can also lower the risk of heart attacks or strokes.

Warnings

You should not use metformin if you have severe kidney disease, metabolic acidosis, or diabetic ketoacidosis (call your doctor for treatment).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking metformin.

Though extremely rare, you may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Before taking this medicine

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

• severe kidney disease; or
• metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking metformin. Be sure your caregivers know ahead of time that you are using this medication.

Tell your doctor if you have ever had:

• kidney disease (your kidney function may need to be checked before you take this medicine);
• high ketone levels in your blood or urine;
• heart disease, congestive heart failure;
• liver disease; or
• if you also use insulin, or other oral diabetes medications.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

Follow your doctor’s instructions about using metformin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby. Tell your doctor if you become pregnant while taking metformin.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

You should not breastfeed while using this medicine.

Metformin should not be given to a child younger than 10 years old. Some forms of metformin are not approved for use by anyone younger than 18 years old.

How should I take metformin?

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

Take metformin with a meal, unless your doctor tells you otherwise. Some forms of metformin are taken only once daily with the evening meal. Follow your doctor’s instructions.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Measure liquid medicine carefully. Shake the oral suspension before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Some tablets are made with a shell that is not absorbed or melted in the body. Part of this shell may appear in your stool. This is normal and will not make the medicine less effective.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Metformin is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

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

Your doctor may have you take extra vitamin B12 while you are taking this medicine. Take only the amount of vitamin B12 that your doctor has prescribed.

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 . An overdose can cause severe hypoglycemia or lactic acidosis.

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 methocarbamol?

Methocarbamol is a muscle relaxer. It works by blocking nerve impulses (or pain sensations) that are sent to your brain.

Methocarbamol is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury.

Methocarbamol injection is sometimes used in the treatment of tetanus, (lockjaw) which causes painful tightening of the muscles.

Warnings

You should not use this medication if you are allergic to methocarbamol.

Before using methocarbamol, tell your doctor if you have myasthenia gravis.

You may need to reduce your dose after the first 2 or 3 days of treatment. Follow your doctor’s instructions regarding the number of tablets you take each day.

Methocarbamol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of this medicine.

Before taking this medicine

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

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

• kidney disease;
• a seizure; or
• myasthenia gravis.

Methocarbamol may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

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

Methocarbamol is not approved for use by anyone younger than 16 years old unless to treat tetanus.

How should I use methocarbamol?

Take methocarbamol exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Methocarbamol is only part of a complete treatment program that may also include rest, physical therapy, or other pain relief measures.

Methocarbamol oral is taken by mouth. You may need to reduce your dose after the first 2 or 3 days of treatment. Carefully follow your doctor’s dosing instructions.

Methocarbamol injection is injected into a muscle or given as an infusion into a vein. A healthcare provider will give you this injection.

The injection is usually given as a single dose before you start taking the oral form.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when methocarbamol is injected.

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

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

Dosing information

Usual Adult Dose for Muscle Spasm:

ORAL:
Initial Dose: 1500 mg orally 4 times a day
-Doses of 6000 mg per day are generally used for the first 48 to 72 hours
-In severe cases, doses up to 8000 mg per day may be used

Maintenance dose:
500 mg tablets: 1000 mg orally 4 times a day
750 mg Tablets: 750 mg orally every 4 hours OR 1500 mg orally 3 times a day

PARENTERAL:
-For the relief of moderate symptoms: 1 g IV or IM once, then switch to oral
-For relief of severe symptoms or postoperative conditions: 1 g IV or IM every 8 hours
Maximum Dose: 3 g in 24-hours
Maximum Duration: 3 consecutive days; may repeat after a drug-free interval of 48 hours

Comments:
-Higher doses are recommended in the first 48 to 72 hours of treatment, then doses can usually be reduced to approximately 4000 mg per day.
-Oral tablets should be administered whenever feasible; IV/IM therapy should not be administered for more than 3 consecutive days without a drug-free interval of 48 hours.

Use: As an adjunct to rest and physical therapy for the relief of discomfort associated with acute, painful musculoskeletal conditions.

Usual Adult Dose for Tetanus:

Initial dose: 1 to 2 g IV followed by an additional 1 to 2 g via IV infusion
Maximal Initial Dose: 3 g

Repeat initial IV dose every 6 hours until NG tube or oral therapy is possible


Once NG tube is in place, may crush tablets, suspend in water or saline and administer through tube
-Total oral doses of up to 24 g may be needed based on patient response

Comments:
-There is clinical evidence to suggest this drug may have a beneficial effect in the control of the neuromuscular manifestations of tetanus.
-This drug should not replace the usual procedure of debridement, tetanus antitoxin, penicillin, tracheotomy, attention to fluid balance, and supportive care; if used, this drug should be added to the regimen as soon as possible.

Use: To control the neuromuscular manifestations of tetanus.

Usual Pediatric Dose for Tetanus:

Initial dose: 15 mg/kg or 500 mg/m2 IV; repeat initial dose every 6 hours as needed
Maximum dose: 1.8 g/m2/day IV for 3 consecutive days

Maintenance dose: May be given by injection into tubing or by IV infusion with an appropriate quantity of fluid

Comments:
-There is clinical evidence to suggest this drug may have a beneficial effect in the control of the neuromuscular manifestations of tetanus.
-This drug should not replace the usual procedure of debridement, tetanus antitoxin, penicillin, tracheotomy, attention to fluid balance, and supportive care; if used, this drug should be added to the regimen as soon as possible.

Use: To control the neuromuscular manifestations of tetanus.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include nausea, extreme drowsiness, fainting, seizure, or coma.

What to avoid

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

Drinking alcohol with this medicine can cause side effects.

Methocarbamol side effects

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

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

• a light-headed feeling, like you might pass out;
• slow heartbeats;
• a seizure;
• jaundice (yellowing of your skin or eyes); or
• pain, bruising, swelling, or skin changes where the injection was given.

Common methocarbamol side effects may include:

• headache, dizziness, drowsiness;
• fever;
• confusion, problems with memory;
• nausea, vomiting, upset stomach;
• blurred vision, double vision;
• flushing (warmth, redness, or tingly feeling);
• sleep problems (insomnia); or
• lack of coordination.

What is methotrexate?

Methotrexate interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells.

Methotrexate is used to treat leukemia and certain types of cancer of the breast, skin, head and neck, lung, or uterus.

Methotrexate is also used to treat severe psoriasis and rheumatoid arthritis in adults. It is also used to treat active polyarticular-course juvenile rheumatoid arthritis in children.

Methotrexate is sometimes given when other medicines have not been effective.

Methotrexate side effects

Common side effects of methotrexate

Common methotrexate side effects may include:

• fever, chills, tiredness, not feeling well;
• low blood cell counts;
• mouth sores;
• nausea, stomach pain;
• abnormal liver function tests;
• hair loss;
• burning skin lesions; or
• being more sensitive to light.

Serious methotrexate side effects

Get emergency medical help if you have signs of an allergic reaction to methotrexate: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Methotrexate can cause serious or fatal side effects. Call your doctor at once if you have:

• sudden chest pain, wheezing, dry cough, cough with mucus, chest pain, feeling short of breath;
• fever, chills, swollen lymph glands, night sweats, weight loss;
• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
• vomiting, diarrhea, blood in your urine or stools;
• skin changes such as redness, warmth, swelling, or oozing;
• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• kidney problems – little or no urination, swelling in your feet or ankles;
• liver problems – swelling around your midsection, right-sided upper stomach pain, nausea, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• nerve problems – confusion, weakness, drowsiness, coordination problems, feeling irritable, headache, neck stiffness, vision problems, loss of movement in any part of your body, seizure; or
• signs of tumor cell breakdown – tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

This is not a complete list of side effects and others may occur.

Warnings

Methotrexate may cause injury or death to an unborn baby and should not be used during pregnancy to treat arthritis or psoriasis. Methotrexate is sometimes used to treat cancer during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

Do not use this medicine to treat psoriasis or rheumatoid arthritis if you have low blood cell counts, a weak immune system, alcoholism or chronic liver disease, or if you are breastfeeding.

YOU MAY NOT NEED TO TAKE METHOTREXATE EVERY DAY. Some people have died after incorrectly taking methotrexate every day. You must use the correct dose for your condition.

Methotrexate can cause serious or fatal side effects. Tell your doctor if you have diarrhea, mouth sores, cough, shortness of breath, upper stomach pain, dark urine, numbness or tingling, muscle weakness, confusion, seizure, or skin rash that spreads and causes blistering and peeling.

Before taking this medicine

You should not use methotrexate if you are allergic to it. You may not be able to take this medicine if you have:

• alcoholism, cirrhosis, or chronic liver disease;
• low blood cell counts;
• a weak immune system or bone marrow disorder; or
• if you are pregnant or breastfeeding.

Methotrexate is sometimes used to treat cancer in people who have a condition listed above. Your doctor will decide if this treatment is right for you.

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

• liver problems, especially fluid in your stomach (ascites);
• kidney disease;
• lung problems, especially fluid in the lungs (pleural effusion);
• radiation treatments; or
• a stomach ulcer or ulcerative colitis.

Tell your doctor if you are pregnant or plan to become pregnant. Methotrexate may cause injury or death to an unborn baby and should not be used during pregnancy to treat arthritis or psoriasis. However, methotrexate is sometimes used to treat cancer during pregnancy.

Methotrexate can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using methotrexate and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using methotrexate.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because methotrexate may harm the baby if a pregnancy does occur.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Do not give this medicine to a child without the advice of a doctor.

How should I take methotrexate?

YOU MAY NOT NEED TO TAKE METHOTREXATE EVERY DAY. This medicine is sometimes taken only once per week, or 2 to 4 times per week. Some conditions are treated daily for just a few days followed by a rest period of 1 week or longer before taking the medicine again.

You must use the correct dose. Some people have died after incorrectly taking methotrexate every day.

Take methotrexate exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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

Methotrexate can be toxic to your organs, and may lower your blood cell counts. You will need frequent medical tests, and you may need an occasional liver biopsy or chest X-ray. Your cancer treatments may be delayed based on the results.

If you need to be sedated for dental work, tell your dentist you currently use methotrexate.

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

You may store Xatmep in a refrigerator or at room temperature. Avoid freezing or high heat. Throw away any unused Xatmep after 60 days if kept at room temperature.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of methotrexate.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of methotrexate can be fatal.

Overdose symptoms may include bruising or unusual bleeding, mouth sores, vomiting, little or no urination, bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

What to avoid

Avoid drinking alcohol. It may increase your risk of liver damage.

Do not receive a “live” vaccine while using methotrexate, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Methotrexate could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What is methylprednisolone?

Methylprednisolone is a corticosteroid medicine that prevents the release of substances in the body that cause inflammation.

Methylprednisolone is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.

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

Warnings

You should not use this medicine if you have a fungal infection anywhere in your body.

Before taking methylprednisolone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. Do not receive a “live” vaccine while using this medicine. The vaccine may not work as well during this time, and may not fully protect you from disease.

Do not stop using methylprednisolone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Any doctor, dentist, or emergency medical professional who treats you should know that you take steroid medication.

Before taking this medicine

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

• a fungal infection anywhere in your body.

Methylprednisolone can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

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

• a thyroid disorder;
• herpes infection of the eyes;
• stomach ulcers, ulcerative colitis, or diverticulitis;
• depression, mental illness, or psychosis;
• liver disease (especially cirrhosis);
• high blood pressure;
• osteoporosis;
• a muscle disorder such as myasthenia gravis; or
• multiple sclerosis.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

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

It is not known whether methylprednisolone passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

How should I take methylprednisolone?

Take methylprednisolone exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Methylprednisolone is sometimes taken every other day. Follow your doctor’s dosing instructions very carefully.

Your dose needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

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

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

Wear a medical alert tag or carry an ID card stating that you take methylprednisolone. Any medical care provider who treats you should know that you take steroid medication.

If you need surgery, tell the surgeon ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

An overdose of methylprednisolone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What to avoid

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a “live” vaccine while using methylprednisolone. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, oral typhoid, yellow fever, varicella (chickenpox), and nasal flu (influenza) vaccine.

Methylprednisolone side effects

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

Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• bruising, thinning skin, or any wound that will not heal;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• severe depression, changes in personality, unusual thoughts or behavior;
• new or unusual pain in an arm or leg or in your back;
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• seizure (convulsions); or
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling.

Steroids can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common methylprednisolone side effects may include:

• fluid retention (swelling in your hands or ankles);
• dizziness, spinning sensation;
• changes in your menstrual periods;
• headache;
• mild muscle pain or weakness; or
• stomach discomfort, bloating.

What is methylphenidate?

Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.

Methylphenidate should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Warnings

Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Do not use methylphenidate if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Methylphenidate may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems – chest pain, feeling light-headed or short of breath; signs of psychosis – paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems – unexplained wounds on your fingers or toes.

Tell your doctor if you have a history of drug or alcohol addiction. Keep the medication where others cannot get to it.

Before taking this medicine

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

• glaucoma;
• severe high blood pressure or a heart problem;
• overactive thyroid;
• a personal or family history of tics (muscle twitches) or Tourette’s syndrome; or
• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

Do not use methylphenidate 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, and tranylcypromine.

Tell your doctor if you also use 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 methylphenidate could cause a serious condition called serotonin syndrome.

Tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• blood circulation problems in the hands or feet;
• alcoholism or drug addiction; or
• if you take Adhansia – an allergy to aspirin or yellow food dye.

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

• problems with the esophagus, stomach, or intestines; or
• seizures, epilepsy, or an abnormal brain wave test (EEG).

Becoming dependent on methylphenidate during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of methylphenidate on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine. If you are breastfeeding, tell your doctor if you notice symptoms in the baby such as agitation, sleep problems, feeding problems, or reduced weight gain.

methylphenidate is not approved for use by anyone younger than 6 years old.

How should I take methylphenidate?

Take methylphenidate exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Methylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law.

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.

Most brands of methylphenidate are taken 1 or 2 times during the day. Jornay PM is for use only at night between 6:30 and 9:30 pm.

You may take methylphenidate with or without food, but take it the same way each time.

Swallow the extended-release capsule or tablet whole and do not crush, chew, or break it.

If you cannot swallow an extended-release capsule whole, open it and mix the medicine with soft food such as applesauce, pudding or yogurt. Swallow the mixture right away without chewing.

You must chew the chewable tablet before you swallow it.

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

Allow the orally disintegrating tablet to dissolve in your mouth without chewing.

Tell your doctor if you have a planned surgery.

Your treatment may also include counseling or other treatments.

Your doctor will need to check your progress on a regular basis. Your heart and blood pressure may also need to be checked often.

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.

Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.

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 . An overdose of methylphenidate could be fatal.

Overdose symptoms may include nausea, dry mouth, vomiting, diarrhea, anxiety, agitation, restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma.

What should I avoid while taking methylphenidate?

Avoid drinking alcohol.

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

Methylphenidate side effects

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

Call your doctor at once if you have:

• signs of heart problems – chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis – hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
• signs of circulation problems – numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
• penis erection that is painful or lasts 4 hours or longer.

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.

Methylphenidate can affect growth in children. Your child’s height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

Common methylphenidate side effects may include:

• sweating, increased blood pressure;
• mood changes, anxiety, feeling nervous or irritable, trouble sleeping;
• fast heart rate, pounding heartbeats or fluttering in your chest;
• loss of appetite, weight loss;
• dry mouth, nausea, vomiting, stomach pain, indigestion; or
• headache, dizziness.

What is metoclopramide?

Metoclopramide increases muscle contractions in the upper digestive tract. This speeds up the rate at which the stomach empties into the intestines.

Metoclopramide oral (taken by mouth) is used for 4 to 12 weeks to treat heartburn caused by gastroesophageal reflux in people who have used other medications without relief.

Metoclopramide oral is also used to treat gastroparesis (slow stomach emptying) in people with diabetes, which can cause heartburn and stomach discomfort after meals.

Metoclopramide injection is used to treat severe diabetic gastroparesis. The injection is also used to prevent nausea and vomiting caused by chemotherapy or surgery, or to aid in certain medical procedures involving the stomach or intestines.

Warnings

Do not use this medicine if you’ve ever had muscle movement problems after using metoclopramide or similar medicines, or if you’ve had a movement disorder called tardive dyskinesia. You also should not use this medicine if you’ve had stomach or intestinal problems (a blockage, bleeding, or a hole or tear), epilepsy or other seizure disorder, or an adrenal gland tumor (pheochromocytoma).

NEVER USE METOCLOPRAMIDE IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use can cause a serious movement disorder that may not be reversible. The longer you use metoclopramide, the more likely you are to develop this movement disorder. The risk of this side effect is higher in diabetics and older adults (especially women).

Before you take metoclopramide, tell your doctor if you have kidney or liver disease, congestive heart failure, high blood pressure, diabetes, Parkinson’s disease, or a history of depression.

Do not drink alcohol. It can increase some of the side effects of metoclopramide.

Stop using metoclopramide and call your doctor at once if you have tremors or uncontrolled muscle movements, fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing, depressed mood, thoughts of suicide or hurting yourself, hallucinations, anxiety, agitation, seizure, or jaundice (yellowing of your skin or eyes).

Before taking this medicine

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

• tardive dyskinesia (a disorder of involuntary movements);
• stomach or intestinal problems such as a blockage, bleeding, or perforation (a hole or tear in your stomach or intestines);
• epilepsy or other seizure disorder;
• an adrenal gland tumor (pheochromocytoma); or
• if you’ve ever had muscle movement problems after using metoclopramide or similar medicines.

Tell your doctor if you have ever had:

• liver or kidney disease;
• problems with muscle movements;
• congestive heart failure or a heart rhythm disorder;
• high blood pressure;
• seizures;
• breast cancer;
• Parkinson’s disease;
• diabetes; or
• depression or mental illness.

This medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

Tell your doctor if you are pregnant. Metoclopramide may harm an unborn baby if you use the medicine during late pregnancy.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

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

How should I use metoclopramide?

Take metoclopramide exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Use the medicine exactly as directed.

A metoclopramide injection is given into a muscle or as an infusion into a vein. A healthcare provider will give the injection, usually during surgery, chemotherapy, or a medical procedure.

Metoclopramide oral is taken for only 4 to 12 weeks.

NEVER USE METOCLOPRAMIDE IN LARGER AMOUNTS THAN RECOMMENDED, OR FOR LONGER THAN 12 WEEKS. High doses or long-term use of metoclopramide can cause a serious movement disorder that may not be reversible. The longer you use metoclopramide, the more likely you are to develop this movement disorder. The risk of this side effect is higher in diabetics and older adults (especially women).

Metoclopramide is usually taken 30 minutes before meals and at bedtime, or only with meals that usually cause heartburn. Follow your doctor’s dosing instructions very carefully.

Do not use two different forms of metoclopramide (such as tablets and oral syrup) at the same time.

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

To take the orally disintegrating tablet (ODT):

• Remove a tablet from its blister pack only when you are ready to take the tablet. Use dry hands and take care not to damage a tablet while pushing it out of the blister.
• Place the tablet in your mouth and allow it to dissolve, without chewing or swallowing it whole. You may sip liquid if needed to help swallow the dissolved tablet.

Store at room temperature in a tightly-closed container, away from moisture and heat. Keep the bottle tightly closed.

After you stop taking metoclopramide, you may have unpleasant withdrawal symptoms such as headache, dizziness, or nervousness.

Dosing information

Usual Adult Dose for Nausea/Vomiting:

Postoperative nausea and vomiting:
Parenteral: 10 to 20 mg IM at or near the end of surgery

Usual Adult Dose for Gastroesophageal Reflux Disease:

Oral: 10 to 15 mg up to 4 times a day 30 minutes before meals and at bedtime, depending upon symptoms being treated and clinical response. Therapy should not exceed 12 weeks.

Usual Adult Dose for Small Intestine Intubation:

If the tube has not passed the pylorus with conventional methods in 10 minutes, a single (undiluted) dose may be administered IV slowly over 1 to 2 minutes:
Adults and pediatric patients greater than or equal to 14 years: 10 mg IV as a single dose administered over 1 to 2 minutes.

Usual Adult Dose for Radiographic Exam:

Adults and pediatric patients greater than or equal to 14 years: 10 mg IV as a single dose administered over 1 to 2 minutes to facilitate gastric emptying where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine.

Usual Adult Dose for Gastroparesis:

During the earliest manifestations of diabetic gastric stasis, oral administration may be initiated. If severe symptoms are present, therapy should begin with IM or IV administration for up to 10 days until symptoms subside at which time the patient can be switched to oral therapy. Since diabetic gastric stasis is often recurrent, therapy should be reinstituted at the earliest manifestation.

Parenteral: 10 mg 4 times daily, IV (slowly over a 1 to 2 minute period) or IM for up to 10 days.

Oral: 10 mg 4 times daily, 30 minutes before meals and at bedtime, for 2 to 8 weeks depending on clinical response.

Usual Adult Dose for Nausea/Vomiting — Chemotherapy Induced:

IV infusion: 1 to 2 mg/kg/dose (depending on the emetogenic potential of the agent) IV (infused over a period of not less than 15 minutes) 30 minutes before administration of chemotherapy. The dose may be repeated twice at 2 hour intervals following the initial dose. If vomiting is still not suppressed, the same dose may be repeated 3 more times at 3 hour intervals.

For doses higher than 10 mg, the injection should be diluted in 50 mL of a parenteral solution. Normal saline is the preferred diluent.

If acute dystonic reactions occur, 50 mg of diphenhydramine hydrochloride may be injected IM.

Usual Adult Dose for Migraine:

Use for treatment of migraine headaches is not an FDA approved indication; however, metoclopramide has shown efficacy in studies at a dose of 10 to 20 mg IV once (used in combination with analgesics or ergot derivatives).

Usual Pediatric Dose for Gastroesophageal Reflux Disease:

Metoclopramide is not approved by the FDA for gastroesophageal reflux disease in pediatric patients; however, the following doses have been studied:

Oral, IM, IV:
Infants and Children: 0.4 to 0.8 mg/kg/day in 4 divided doses

Usual Pediatric Dose for Small Intestine Intubation:

Metoclopramide IV is approved by the FDA for pediatric use to facilitate small bowel intubation by causing gastric emptying where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine.

If the tube has not passed the pylorus with conventional methods in 10 minutes, a single (undiluted) dose may be administered IV slowly over 1 to 2 minutes:

Less than 6 years: 0.1 mg/kg IV as a single dose

6 to 14 years: 2.5 to 5 mg IV as a single dose

Children greater than 14 years: 10 mg as a single dose

Usual Pediatric Dose for Nausea/Vomiting — Chemotherapy Induced:

Metoclopramide is not approved by the FDA for chemotherapy induced nausea and vomiting in pediatric patients; however, the following doses have been studied:

IV:
1 to 2 mg/kg/dose IV every 30 minutes before chemotherapy and every 2 to 4 hours

Usual Pediatric Dose for Nausea/Vomiting — Postoperative:

Metoclopramide is not approved by the FDA for postoperative nausea and vomiting in pediatric patients; however, the following doses have been studied:
IV:
Children less than or equal to 14 years: 0.1 to 0.2 mg/kg/dose (maximum dose: 10 mg/dose); repeat every 6 to 8 hours as needed
Children greater than 14 years and Adults: 10 mg; repeat every 6 to 8 hours as needed

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Overdose symptoms may include drowsiness, confusion, or uncontrolled muscle movements.

What to avoid

Drinking alcohol with this medicine can cause side effects.

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

Metoclopramide side effects

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

Stop taking metoclopramide and call your doctor at once if you have any of these SIGNS OF A SERIOUS MOVEMENT DISORDER, which may occur within the first 2 days of treatment:

• tremors or shaking in your arms or legs;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or
• any new or unusual muscle movements you cannot control.

Call your doctor at once if you have:

• confusion, depression, thoughts of suicide or hurting yourself;
• slow or jerky muscle movements, problems with balance or walking;
• mask-like appearance in your face;
• a seizure;
• anxiety, agitation, jittery feeling, trouble staying still, trouble sleeping;
• swelling, feeling short of breath, rapid weight gain; or
• severe nervous system reactionvery stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common metoclopramide side effects may include:

• feeling restless;
• feeling drowsy or tired;
• lack of energy;
• nausea, vomiting;
• headache, confusion; or
• sleep problems (insomnia).

What is metoprolol?

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

Metoprolol is used to treat angina (chest pain) and hypertension (high blood pressure).

Metoprolol is also used to lower your risk of death or needing to be hospitalized for heart failure.

Metoprolol injection is used during the early phase of a heart attack to lower the risk of death.

Warnings

You should not use metoprolol if you have a serious heart problem (heart block, sick sinus syndrome, slow heart rate), severe circulation problems, severe heart failure, or a history of slow heart beats that caused fainting.

Before taking this medicine

You should not use this medicine if you are allergic to metoprolol, or other beta-blockers (atenolol, carvedilol, labetalol, nadolol, nebivolol, propranolol, sotalol, and others), or if you have:

• a serious heart problem such as heart block, sick sinus syndrome, or slow heart rate;
• severe circulation problems;
• severe heart failure (that required you to be in the hospital); or
• a history of slow heart beats that have caused you to faint.

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

• asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
• diabetes (taking metoprolol may make it harder for you to tell when you have low blood sugar);
• liver disease;
• congestive heart failure;
• problems with circulation (such as Raynaud’s syndrome);
• a thyroid disorder; or
• pheochromocytoma (tumor of the adrenal gland).

Do not give this medicine to a child without medical advice.

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

Ask a doctor before using this medicine if you are breast-feeding. Metoprolol can pass into breast milk and may cause dry skin, dry mouth, diarrhea, constipation, or slow heartbeats in your baby.

How should I take metoprolol?

Take metoprolol exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Metoprolol should be taken with a meal or just after a meal.

Take the medicine at the same time each day.

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

A Toprol XL tablet can be divided in half if your doctor has told you to do so. Swallow the half-tablet whole, without chewing or crushing.

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

You will need frequent medical tests, and your blood pressure will need to be checked often.

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

You should not stop using this medicine suddenly. Stopping suddenly may make your condition worse.

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

Store at room temperature away from moisture and heat.

Metoprolol injection is given as an infusion into a vein. A healthcare provider will give you this injection in a medical setting where your heart and blood pressure can be monitored. The injections are given for only a short time before switching you to the oral form of this medicine.

Dosing information

Usual Adult Dose for Hypertension:

Metoprolol Tartrate Immediate Release Tablets:
Initial dose: 100 mg orally per day in single or divided doses

Maintenance dose: 100 to 450 mg orally per day.

Metoprolol Succinate Extended Release Tablets:
Initial dose: 25 to 100 mg orally once a day

Maintenance dose: 100 to 400 mg orally once a day.

Usual Adult Dose for Angina Pectoris:

Initial dose:
-Metoprolol tartrate immediate release tablets: 50 mg orally twice a day
-Metoprolol succinate extended release tablets: 100 mg orally once a day

Maintenance dose: 100 to 400 mg per day.

Usual Adult Dose for Myocardial Infarction:

Metoprolol Tartrate :
Early Treatment:
Initial dose: 5 mg IV every 2 minutes as tolerated for 3 doses
-Patients tolerant of full IV dose (15 mg): 50 mg orally every 6 hours starting 15 minutes after the last IV dose and continued for 48 hours
-Patients intolerant of full IV dose (15 mg): 25 or 50 mg orally every 6 hours depending on the degree of intolerance starting 15 minutes after the last IV dose or as soon as their clinical condition allows

Late Treatment:
Maintenance dose: 100 mg orally twice a day.

Usual Adult Dose for Congestive Heart Failure:

Metoprolol Succinate Extended Release Tablets:
25 mg orally once a day (12.5 mg orally once a day in patients with more severe heart failure); double dose every 2 weeks to highest tolerated dose or up to 200 mg orally once a day.

Usual Pediatric Dose for Hypertension:

Metoprolol Succinate Extended Release Tablets:
6 Years or Older:
Initial dose: 1 mg/kg orally once a day (not to exceed 50 mg orally once a day)

Maximum dose: 2 mg/kg (or 200 mg) orally once a day.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

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

Drinking alcohol can increase certain side effects of this medicine.

Metoprolol side effects

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

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

• very slow heartbeats;
• a light-headed feeling, like you might pass out;
• shortness of breath (even with mild exertion), swelling, rapid weight gain; or
• cold feeling in your hands and feet.

Common side effects of metoprolol may include:

• dizziness;
• tired feeling;
• depression;
• confusion;
• memory problems;
• nightmares;
• trouble sleeping;
• diarrhea;
• mild itching or rash.

What is metronidazole?

Metronidazole is an antibiotic that may be used to treat certain infections of the vagina, stomach, liver, skin, joints, brain and spinal cord, lungs, heart, or bloodstream.

Metronidazole has been approved to treat:

• Symptomatic trichomoniasis (a sexually transmitted infection) in adults that has been confirmed by culture or wet smear test
• Asymptomatic trichomoniasis in females when associated with cervical changes, and in asymptomatic sexual partners
• Amebiasis (an infection caused by a parasite) in adults and children
• Anaerobic bacterial infections (infections caused by bacteria that do not need oxygen to survive).

Metronidazole is thought to work by first diffusing into the cytoplasm of the anaerobic bacteria where it is then activated and reduced into a short-lived nitroso free radical which can interact with DNA, causing a loss of the helical DNA structure, strand breakage, and bacterial death.

Metronidazole is well absorbed after oral administration, with peak concentrations being reached in one to two hours. Although it starts to work quickly, it may take a couple of days before you start to feel better or notice an improvement in your symptoms. It is important that you still finish the course of metronidazole that your doctor has prescribed, even if you feel better, because the infection may still be present, and it could flare up or recur if you haven’t finished the course.

Metronidazole was first FDA-approved in 1963.

Warnings

To reduce the development of drug-resistant bacteria, do not use metronidazole to treat any condition that has not been checked by your doctor. This medicine will not treat a viral infection such as the common cold or flu.

Metronidazole has been shown to be carcinogenic in rats and mice and unnecessary use should be avoided.

Do not use metronidazole if you recently drank alcohol, or have taken disulfiram (Antabuse) within the past 2 weeks. Do not drink alcohol or consume foods or medicines that contain propylene glycol while you are taking metronidazole and for at least 3 days after you stop taking it.

Seizures and other nervous system abnormalities have been reported in patients treated with metronidazole. You should stop using this medicine immediately if you experience any neurological symptoms such as seizures, headaches, visual changes, weakness, numbness, or tingling.

Before taking this medicine

You should not use this medicine if you are allergic to metronidazole, secnidazole, or tinidazole, or if you:

• drank alcohol in the past 3 days
• consumed foods or medicines that contain propylene glycol in the past 3 days or
• took disulfiram (Antabuse) within the past 14 days
• have Cockayne Syndrome (a rare genetic disorder that affects growth and development).

Before taking metronidazole, tell your healthcare provider about all of your medical conditions, including if you:

• liver disease
• kidney disease (or if you are on dialysis)
• a heart rhythm disorder
• a stomach or intestinal disease such as Crohn’s disease
• a blood cell disorder such as anemia (lack of red blood cells) or low white blood cell (WBC) counts
• medical problems that affect the brain or a nerve disorder
• a yeast infection or a fungal infection anywhere in your body
• a history of blood problems
• or take any medications, especially warfarin, lithium, busulfan, cimetidine, phenytoin, or phenobarbital.

Tell your doctor if you are pregnant or intend to become pregnant. The use of metronidazole during pregnancy has been well-studied and a review of 17 studies found that treating bacterial vaginosis and trichomoniasis with metronidazole reduced the risk of preterm birth and was effective and offered no teratogen risk. Conversely, isolated studies have suggested its use may result in low birth weight or preterm delivery. Talk to your doctor about the risks and benefits of taking metronidazole during pregnancy. Some product labels for metronidazole say it is contraindicated during the first trimester.

Tell your doctor if you are breastfeeding or plan to breastfeed. Metronidazole can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking metronidazole. If you are breastfeeding, you may consider pumping and throwing away your breast milk during treatment with metronidazole and for 48 hours after your last dose and feeding your infant stored human milk or formula.

Not all uses of metronidazole are approved for treating children and teenagers. Metronidazole is not approved to treat vaginal infections in girls who have not begun having menstrual periods.

How should I take metronidazole?

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

• The dose depends on the infection being treated.
• The dosage should be reduced by 50% in those with severe hepatic impairment.
• In patients undergoing hemodialysis, consider a supplementary dose following the hemodialysis session, depending on the patient’s clinical situation.
• Metronidazole will not treat a vaginal yeast infection. You may even develop a new vaginal yeast infection, which may need to be treated with antifungal medication. Tell your doctor if you have symptoms such as itching or discharge during or after treatment with this medicine.
• If you are treating a vaginal anaerobic bacterial infection, your sexual partner may also need to take metronidazole so you don’t become reinfected.
• Do not share this medicine with another person, even if they have the same symptoms you have.
• Metronidazole is usually given for up to 10 days in a row. You may need to repeat this dosage several weeks later.
• Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. This medicine will not treat a viral infection (flu or a common cold).

Oral metronidazole

• Oral metronidazole tablets, capsules, and the suspension are taken by mouth. May be taken with or without food.
• Shake the oral suspension well before each use. Always use an accurate measuring device to measure the correct amount. Do not use a household teaspoon or tablespoon to measure your medicine. You can ask your pharmacist for the measuring device you should use and how to measure the correct dose.
• Swallow the extended-release tablet whole and do not crush, chew, or break it.

Metronidazole injection

• The injection is given as an infusion into a vein. A healthcare provider will give you the injection if you are unable to take the medicine by mouth.

Dosing information

Trichomoniasis (adults)

Treatment should be individualized. Usual dosages are:

• One-day treatment: 2 grams as a single oral dose or a split dose given on the same day
• 7-day course: 250mg three times daily for 7 consecutive days.

Amebiasis

• Adults: acute amebic dysentery. 750mg three times daily for 5 to 10 days.
• Adults: amebic liver abscess. 500mg or 750mg three times daily for 5 to 10 days.
• Children: 35mg/kg/24 hours to 50mg/kg/24 hours divided into three doses daily for 10 days.

Do not exceed adult dosages.

Anaerobic Bacterial Infections (adults)

For more serious anaerobic infections, intravenous metronidazole is usually administered initially.

• Adults: 7.5 mg/kg every 6 hours (this works out at approximately 500mg for a 70kg adult) orally for 7 to 10 days. Maximum dose 4g/24 hours.

A longer course of treatment may be required for bone, joint, lower respiratory tract, and endocardium infections.

What should I avoid while using metronidazole?

Do not drink alcohol or consume foods, medicines, or other products that contain alcohol or propylene glycol while taking metronidazole and for 3 days after your last dose. You may have unpleasant effects such as headaches, nausea, vomiting, stomach cramps, and warmth or tingling under your skin.

What are the side effects of metronidazole?

Get emergency medical help if you have signs of an allergic reaction to metronidazole (hives, itching, warmth, or tingling; fever, joint pain; dry mouth, dry vagina; stuffy nose, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Metronidazole may cause serious side effects including:

• Nervous system problems, including brain disorder (encephalopathy), inflammation of the brain and spinal cord membranes (aseptic meningitis), numbness or tingling in the hands or feet (peripheral neuropathy), and seizures (convulsions). Tell your healthcare provider right away if you have any nervous system problems while taking metronidazole
• Worsening yeast infection (candidiasis) symptoms in people with a known yeast infection or a yeast infection they were not aware of
• Low white blood cell count (leukopenia) in people with a history of blood problems. This can affect how well the body fights infection.

The most common side effects of metronidazole include

• Diarrhea
• Nausea
• Headache
• Pain in the upper abdomen and abdominal cramping
• Vomiting
• Weight loss
• Constipation

What is midazolam?

Midazolam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) that is used to help you relax before having a minor surgery, dental work, or other medical procedure.

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

Midazolam side effects

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

Midazolam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. Your caregivers will watch you for symptoms such as weak or shallow breathing.

Tell your medical caregivers right away if you have:

• cough, wheezing, trouble breathing;
• slow heart rate;
• a light-headed feeling, like you might pass out;
• tremors; or
• confusion, agitation, hallucinations, unusual thoughts or behavior.

Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.

Common side effects of midazolam may include:

• amnesia or forgetfulness after your procedure;
• drowsiness, dizziness;
• nausea, vomiting; or
• blurred vision.

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

Midazolam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. Midazolam is given in a hospital, dentist office, or other clinic setting where your vital signs can be watched closely.

Before taking this medicine

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

• narrow-angle glaucoma;
• untreated or uncontrolled open-angle glaucoma; or
• an allergy to cherries.

Tell your doctor if you have ever had:

• glaucoma;
• breathing problems; or
• congestive heart failure.

Tell your doctor if you are pregnant or breastfeeding.

How should I take midazolam?

Midazolam is usually given as a single dose just before your surgery or procedure.

Midazolam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. Midazolam should be used only in a hospital, dentist office, or other clinic setting where any serious side effects can be quickly treated.

After you take midazolam, you will be watched closely to make sure the medicine is working and does not cause harmful side effects.

What is midodrine?

Midodrine is used to treat low blood pressure (hypotension) that causes severe dizziness or a light-headed feeling, like you might pass out. midodrine is for use only when low blood pressure affects daily life. Midodrine may not improve your ability to perform daily activities

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

Midodrine side effects

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

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

• severely slowed heart rate–weak pulse, severe dizziness or light-headed feeling; or
• dangerously high blood pressure–severe headache, pounding sensation in your ears (“hearing” your heartbeats), blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure.

Common side effects of midodrine may include:

• increased blood pressure when sitting or lying down;
• chills, goosebumps;
• numbness, tingling, or itching (especially in your scalp); or
• increased urination, painful or difficult urination, or sudden urge to urinate.

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

Warnings

You should not use midodrine if you have severe heart disease, overactive thyroid, an adrenal gland tumor, kidney disease, if you are unable to urinate, or if your blood pressure is high even while lying down.

Midodrine can increase blood pressure even when you are at rest. midodrine should be used only if you have severely low blood pressure that affects your daily life. Midodrine may not improve your ability to perform daily activities.

Before taking this medicine

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

• severe heart disease;
• if you are unable to urinate;
• pheochromocytoma (tumor of the adrenal gland);
• overactive thyroid;
• high blood pressure (even while lying down); or
• kidney disease.

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

• diabetes;
• glaucoma or a history of vision problems; or
• liver disease.

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

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

How should I take midodrine?

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

Midodrine is usually taken 3 times per day, with doses spaced at least 3 hours apart. Take your last dose of the day before evening meal or 4 hours before bedtime.

You may take midodrine with or without food.

Take midodrine during your normal waking hours, when your are most likely to be upright and not lying down or napping. Ask your doctor about how to take this medicine if you normally lie down during the day.

Midodrine can increase your blood pressure even while you are lying down or sleeping (when blood pressure is usually lowest). Long-term high blood pressure (hypertension) can lead to serious medical problems.

Follow your doctor’s instructions about the best way to position your body while you are laying down or sleeping. You may need to keep your head elevated to help prevent high blood pressure.

Your blood pressure will need to be checked before and during treatment with midodrine. Check your blood pressure while you are lying down, and check it again with your head elevated.

Your kidney and liver function may also need to be checked.

Midodrine is only part of a treatment program that may also include lifestyle changes, wearing support stockings on your legs, and possibly special medical care. Follow your doctor’s instructions very carefully.

Store at room temperature away from moisture and heat.

Midodrine dosing information

Usual Adult Dose for Hypotension:

10 mg orally 3 times a day during daytime hours when the patient needs to be upright

Comments:
-The three daily doses may be given at 3-hour intervals, if needed, but not more frequently.
-This drug should not be given after the evening meal or less than 4 hours before bedtime.
-This drug should only be continued in patients who appear to attain symptomatic improvement during initial treatment.

Use: Treatment of symptomatic orthostatic hypotension (OH) in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment such as support stockings, fluid expansion, and lifestyle alterations.

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.

You may need to skip a dose if you will be resting or lying down for a long period of time during your normal waking hours. Talk to your doctor about how to adjust your dose schedule if needed.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms include increased blood pressure (flushing, headache, pounding heartbeat, blurred vision), goosebumps, feeling cold, or trouble urinating.

What should I avoid while taking midodrine?

Avoid taking a dose if it is less than 4 hours before going to bed.

Ask a doctor or pharmacist before using any over-the-counter diet or cough/cold medicine containing phenylephrine or pseudoephedrine.

What is minoxidil topical?

Minoxidil is a treatment for hair loss that helps regrow hair and prevent future hair loss in men and women with certain types of hair loss. When used regularly, new hair growth may be seen as early as 2 to 4 months.

Minoxidil for women is used to help regrow hair if you have gradually thinning hair or gradual hair loss on the top of the head, which may only become noticeable after years of gradual loss. Minoxidil for women works best when it is used at the earlier stages of female pattern hair loss. Minoxidil for women foam is applied once daily to the affected scalp area, and the solution is applied twice daily.

Minoxidil for men is used to improve hair growth if you have inherited gradually thinning hair or gradual hair loss on the vertex at the top of the scalp. It is not intended for frontal baldness or a receding hairline. This medicine works best at the earlier stages of hair loss or thinning and is less effective when there is a larger area of hair loss. Minoxidil for men is available as a foam and solution and is applied twice daily to the affected scalp area.

The foam is easier to apply to larger areas, dries faster, and is less likely to drip, while the solution is better for applying to smaller areas or when the hair is longer. Minoxidil is available as a solution and foam with specific packaging for women or men.

Minoxidil topical is available as the Rogaine brand (Women’s Rogaine, Men’s Rogaine) and generic products are also available.

What is minoxidil used for?

Minoxidil for women

Minoxidil for women is FDA-approved to treat women 18 years and older with female-pattern hair loss, with gradual thinning hair or gradual hair loss on the top of the head, and a family history of this kind of hair loss.

Minoxidil for men

Minoxidil for men is FDA-approved for the treatment of hereditary hair loss in men 18 years and older to help reverse the progression of hair loss on the scalp. Hereditary hair loss is when men experience gradually thinning hair or gradual hair loss on the top of the scalp in the vertex area, which has affected other men in their family. It is not intended for frontal baldness or a receding hairline.

Minoxidil for beards and other hair loss issues

Minoxidil has been used for beards, eyebrows, and also for alopecia areata (AA), scarring alopecia, and hair shaft disorders to improve hair growth; however, these uses are all off-label.

How long does it take for minoxidil to work?

Minoxidil starts working in the first 2 to 4 months, with new soft, colorless hairs growing. From 4 to 6 months, new, thicker hair growth may become visible. To maintain hair regrowth, it is important to continue using minoxidil regularly. In the first 1 to 3 weeks of using minoxidil, you may have increased hair shedding.

How does minoxidil work?

Minoxidil works by increasing the length of time the hair follicle is in its growth (anagen) phase, which helps increase hair length and thickness. It also shortens the length of time in the shedding (telogen) phase, which means the follicles move more quickly into the growth phase.

Minoxidil’s mechanism of action for hair loss is not fully understood, it is thought to work by activating both extracellular signal-regulated kinase (ERK) and Akt and by preventing cell death by increasing the ratio of a protein called BCl-2/Bax.

Minoxidil topical side effects

Common minoxidil side effects

Common minoxidil side effects may include changes in the color or texture of your hair.

Serious minoxidil side effects

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

Although the risk of serious side effects is low when minoxidil foam and solution is applied to the skin, side effects can occur if the medicine is absorbed into your bloodstream.

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

• severe scalp irritation;
• unwanted growth of facial hair;
• chest pain, fast heartbeats;
• swelling in your hands or feet, rapid weight gain;
• a light-headed feeling, like you might pass out;
• headache, dizziness, confusion; or
• flushing (warmth, redness, or tingly feeling).

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

Warnings

Do not use this medicine if the skin on your scalp is red, swollen, irritated, or infected.

Before taking this medicine

Do not use this medicine if the skin on your scalp is red, swollen, irritated, or infected. This may allow more of the medication to be absorbed by your body, which could be dangerous.

Check the medicine label carefully to make sure this medicine will treat your specific type of hair loss.

Use only the minoxidil foam or solution that is made for your gender. Women should not use minoxidil topical products that are made specifically for men.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially heart disease.

Do not use this medicine on anyone under 18 years old.

Preganancy

Do not use this medicine if you are pregnant.

Breastfeeding

Do not use this medicine if you are breast-feeding a baby.

How should I use minoxidil foam or solution?

Dry your hair and scalp before applying minoxidil solution or foam.

Apply the recommended amount to the affected areas of the scalp.

Minoxidil 5% for men is usually applied twice daily, in the morning and at night.

Minoxidil for women foam (5%) is applied once daily. Minoxidil for women solution (2%) is applied twice daily.

Apply this medication only on your scalp. Do not use it on any other part of your body.

Wash your hands after applying minoxidil topical.

It may take up to 4 months or longer before you notice new hair growth. New hair may be soft, colorless, and barely visible. With further treatment, the hair should start to have the same color and thickness as your existing hair.

Talk to your doctor if you do not see any hair growth after 4 months of treatment.

Use exactly as directed on the label or as your doctor prescribes. Do not use in larger or smaller amounts or for longer than recommended.

Using more of this medicine than recommended will not speed up hair growth and may cause dangerous side effects.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Store at room temperature, away from moisture and heat.

Keep the topical foam canister away from open flames or high heat, such as in a car on a hot day. If it gets too hot, the canister may explode. Do not puncture or burn an empty canister.

Minoxidil dosing information (foam and solution)

Usual Adult Men’s Dose – Solution (5%)

Apply 1 mL with the dropper twice daily to the affected hair loss area on the scalp.

Usual Adult Men’s Dose – Foam (5%)

Apply half a capful twice a day.
Rinsed fingers in cold water and dry them to prevent foam from melting on warm hands.
Hold the can straight upside down to ensure the foam dispenses properly.
Press the nozzle to dispense half a capful of foam onto a cold surface such as cold hands or a dish.
Part your hair to expose the hair loss area and massage foam into the scalp (not the hair).
Replace the cap and wash hands and any surface thoroughly after use.

Usual Adult Women’s Dose – Solution (2%)

Apply 1 mL with the dropper twice a day directly onto the scalp in the hair loss area on the scalp.

Usual Adult Women’s Dose – Foam (5%)

Apply half a capful once a day.
Rinsed fingers in cold water and dry them to prevent foam from melting on warm hands.
Hold the can straight upside down to ensure the foam dispenses properly.
Press the nozzle to dispense half a capful of foam onto a cold surface such as cold hands or a dish.
Part your hair to expose the hair loss area and massage foam into the scalp (not the hair).
Replace the cap and wash hands and any surface thoroughly after use.

Comments:
-Evidence of hair growth may take 2 months or more of twice daily applications.
-If hair regrowth occurs, use must be continued for continued hair growth; re-grown hair may disappear within 3 to 4 months of stopping and the balding process will continue.
– If you do not see any results after 4 months, speak with your doctor.

What happens if I miss a dose?

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

What happens if I overdose?

An overdose of minoxidil topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medication.

What should I avoid while using minoxidil foam or solution?

Avoid getting the foam or solution in the eyes, nose, or mouth. If this occurs, rinse the area with water.

Avoid using other skin products on the areas you treat with this medication unless your doctor tells you to.

What is mirabegron?

Mirabegron is used in adults to treat overactive bladder with symptoms of frequent or urgent urination and urinary incontinence. Mirabegron is sometimes used together with another medicine called solifenacin (Vesicare).

Mirabegron is used in children to treat neurogenic detrusor overactivity (NDO). Urinary incontinence caused by NDO is related to permanent nerve damage from conditions such as multiple sclerosis or spinal injury.

Mirabegron tablets may be used in children at least 3 years old. Mirabegron granules are for use in children at least 3 years old who also weigh at least 77 pounds (35 kilograms).

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

Mirabegron side effects

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

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

• pain or burning when you urinate; or
• dangerously high blood pressure–severe headache, blurred vision, pounding in your neck or ears.

Common side effects of mirabegron may include:

• painful urination;
• increased blood pressure;
• sinus pain, sore throat;
• constipation;
• headache; or
• dry mouth or fast heartbeats (when taken with solifenacin).

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

Warnings

You should not use mirabegron if you have uncontrolled hypertension (high blood pressure).

Before taking this medicine

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

Tell your doctor if you have ever had:

• high blood pressure;
• a bladder obstruction;
• trouble emptying your bladder (very little urine or a weak stream of urine);
• kidney disease; or
• liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Mirabegron should not be given to a child younger than 3 years old.

How should I take mirabegron?

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

If you take mirabegron with solifenacin, take both medicines at the same time each day.

Take the mirabegron tablet with a full glass of water. Swallow the tablet whole and do not crush, chew, or break it.

An adult may take a mirabegron tablet with or without food. However, a child should take the tablet with food.

Both adults and children should take mirabegron granules with food.

A pharmacist will mix mirabegron granules into a suspension (liquid) before you receive the medicine.

Shake the suspension before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If the suspension will not be used for 2 days or longer, shake the bottle vigorously for 1 minute each day to keep the granules thoroughly mixed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Your dose needs may change if you switch from using mirabegron tablets to using the suspension. Avoid medication errors by using only the form and strength your doctor prescribes.

Your blood pressure will need to be checked often.

It may take up to 8 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. Throw away any unused mirabegron suspension after the expiration date on the medicine label has passed.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the 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 may cause pounding heartbeats or fluttering in your chest.

What should I avoid while taking mirabegron?

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

What is MiraLAX?

MiraLAX is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements.

MiraLAX is used as a laxative to treat occasional constipation or irregular bowel movements.

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

Important information about MiraLAX

You should not use MiraLAX if you have a bowel obstruction or intestinal blockage. If you have any of these conditions, you could have dangerous or life-threatening side effects from MiraLAX.

People with eating disorders (such as anorexia or bulimia) should not use MiraLAX without the advice of a doctor.

Before taking MiraLAX, tell your doctor if you are allergic to any drugs, or if you have ulcerative colitis, irritable bowel syndrome, kidney disease, nausea or vomiting with severe stomach pain, or if you have had a sudden change in bowel habits that has lasted 2 weeks or longer.

MiraLAX should produce a bowel movement within 1 to 3 days of using the medication. Polyethylene glycol 3350 normally causes loose or even watery stools.

Do not use MiraLAX more than once per day. Call your doctor if you are still constipated or irregular after using this medication for 7 days in a row.

Before taking this medicine

You should not use MiraLAX if you are allergic to polyethylene glycol, or if you have a bowel obstruction or intestinal blockage. If you have any of these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol 3350.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

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

• nausea, vomiting, or severe stomach pain;
• ulcerative colitis;
• irritable bowel syndrome;
• kidney disease; or
• if you have had a sudden change in bowel habits that has lasted 2 weeks or longer.

FDA pregnancy category C. It is not known whether MiraLAX will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether polyethylene glycol 3350 passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take MiraLAX?

Use MiraLAX exactly as directed on the label, or as it has been prescribed by your doctor. Do not use this medicine in larger or smaller amounts or for longer than recommended.

To use MiraLAX powder, measure your dose with the medicine cap on the bottle. This cap should contain dose marks on the inside of it. Pour the powder into 4 to 8 ounces of a cold or hot beverage such as water, juice, soda, coffee, or tea. Stir this mixture and drink it right away. Do not save for later use.

MiraLAX should produce a bowel movement within 1 to 3 days of using the medication. Polyethylene glycol 3350 normally causes loose or even watery stools.

Do not use MiraLAX more than once per day. Call your doctor if you are still constipated or irregular after using this medication for 7 days in a row.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose of MiraLAX for Constipation:

17 g (diluted in 8 fluid ounces water, juice, soda or coffee) orally once a day

Usual Pediatric Dose for Bowel Preparation:

Occasional constipation:
Children greater than 6 months of age: 0.5 to 1.5 g/kg daily (initial dose 0.5 g/kg; titrate to effect)
Maximum dose: 17 g/day

Fecal impaction:
Children greater than 3 years of age: 1 to 1.5 g/kg daily for 3 days
Maximum dose: 100 g daily

Bowel preparation:
Children greater than 2 years of age: 1.5 g/kg/day
Maximum dose: 100 g daily

Usual Pediatric Dose of MiraLAX for Constipation — Acute:

Occasional constipation:
Children greater than 6 months of age: 0.5 to 1.5 g/kg daily (initial dose 0.5 g/kg; titrate to effect)
Maximum dose: 17 g/day

Fecal impaction:
Children greater than 3 years of age: 1 to 1.5 g/kg daily for 3 days
Maximum dose: 100 g daily

Bowel preparation:
Children greater than 2 years of age: 1.5 g/kg/day
Maximum dose: 100 g daily

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid?

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

MiraLAX side effects

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

Stop taking this medicine and call your doctor at once if you have:

• severe or bloody diarrhea;
• rectal bleeding;
• blood in your stools; or
• severe and worsening stomach pain.

Common MiraLAX side effects may include:

• bloating, gas, upset stomach;
• dizziness; or
• increased sweating.

What is mirtazapine?

Mirtazapine is an antidepressant. The way this medication works is still not fully understood. It is thought to positively affect communication between nerve cells in the central nervous system and/or restore chemical balance in the brain.

Mirtazapine is used to treat major depressive disorder in adults.

It is not known if mirtazapine is safe and effective for use to treat MDD in children.

Warnings

You should not take mirtazapine if you are also taking tryptophan (sometimes called L-tryptophan).

Do not use mirtazapine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine and others.

Some people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using mirtazapine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not give this medicine to anyone younger than 18 years old without the advice of a doctor. This medicine is not approved for use in children.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Drinking alcohol can increase certain side effects of mirtazapine.

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

Do not stop taking this medicine abruptly. Talk to your doctor before stopping this medicine.

Before taking this medicine

You should not take this medicine if you are allergic to mirtazapine.

Do not use mirtazapine 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, tranylcypromine, and others.

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

• low white blood cell counts;
• glaucoma;
• liver or kidney disease;
• low sodium levels in your blood;
• a seizure;
• depression, suicidal thoughts or actions;
• bipolar disorder (manic depression) in you or a family member;
• heart problems or stroke;
• high cholesterol or triglycerides;
• long QT syndrome (in you or a family member); or
• low blood pressure.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with mirtazapine and cause a serious condition called serotonin syndrome.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tell your doctor if you are pregnant or breastfeeding.

The orally disintegrating tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU).

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

How should I take mirtazapine?

Take mirtazapine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Take the medicine at the same time each day, usually at bedtime.

Take the regular tablet form of mirtazapine with water.

You may take mirtazapine with or without food.

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet on your tongue and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

It may take a few weeks for your symptoms to improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Do not stop using mirtazapine suddenly, or you could have unpleasant symptoms (such as dizziness, vomiting, agitation, sweating, confusion, numbness, tingling, or electric shock feelings). Ask your doctor how to safely stop using this medicine.

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

Dosing information

Usual Adult Dose for Depression:

Initial dose: 15 mg orally once a day at bedtime
Maintenance dose: 15 to 45 mg orally once a day
Maximum dose: 45 mg/day

Comments:
-May increase the dose every 1 to 2 weeks to a maximum 45 mg/day according to patient response.
-Patients should be periodically reassessed to determine the need for continued use of this drug.

Use: Treatment of major depressive disorder

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include confusion, memory problems, drowsiness, and fast heart rate.

What to avoid

Drinking alcohol with mirtazapine can cause side effects.

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

Mirtazapine side effects

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

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

Call your doctor at once if you have:

• racing thoughts, decreased need for sleep, unusual risk-taking behavior, feelings of extreme happiness or sadness, being more talkative than usual;
• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• a light-headed feeling, like you might pass out;
• severe rash, blisters, or swelling on the palms of your hands or the soles of your feet;
• a seizure;
• low white blood cell counts – fever, chills, sore throat, cough, sores in your mouth or nose, flu-like symptoms, trouble breathing; or
• low sodium level – headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

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 mirtazapine side effects include:

• drowsiness, dizziness;
• increased appetite; or
• weight gain.

What is misoprostol?

Misoprostol reduces stomach acid and helps protect the stomach lining from damage that can be caused by taking aspirin or a nonsteroidal anti-inflammatory drug (NSAID).

Misoprostol is a synthetic prostaglandin that works by “replacing” prostaglandins whose production is blocked by aspirin or NSAIDs. It is used to prevent stomach ulcers from developing during treatment with aspirin or an NSAID. Examples of NSAIDs include ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, and meloxicam.

Misoprostol is used in a hospital setting to induce cervical ripening, labor induction in women with premature rupture of membranes, and treatment of serious post-partum hemorrhage, These uses are outside of the approved indications.

Misoprostol is also in combination with mifepristone or methotrexate to end an early pregnancy (medical abortion) or alone for early pregnancy loss (miscarriage).

• Although FDA regulations allow certified healthcare professionals and pharmacies to dispense mifepristone and misoprostol for medical abortion both in healthcare facilities and by telehealth and mail, certain state laws may not allow this. For example, Louisiana has passed a bill that classifies mifepristone and misoprostol as dangerous controlled substances which, once signed, would mean anyone possessing these abortion pills without a prescription could face jail time and fines. Most abortions are already illegal in Louisiana.

When used for non-pregnancy-related conditions, misoprostol should not be used during pregnancy, and if you can become pregnant, you will need to have a negative pregnancy test before starting this treatment.

Misoprostol was FDA approved on December 27, 1988, under the brand Cytotec. Generic misoprostol is available.

Misoprostol 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.

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

• severe ongoing stomach discomfort or diarrhea; or
• dehydration–dizziness, confusion, feeling very thirsty, less urination.

Common misoprostol side effects may include:

• diarrhea and 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

Misoprostol can cause birth defects, premature birth, uterine rupture, miscarriage, or incomplete miscarriage and dangerous uterine bleeding. Do not use misoprostol to prevent stomach ulcers if you are pregnant.

If you are able to become pregnant, you will need to have a negative pregnancy test before starting this treatment. You will also need to use effective birth control to prevent pregnancy during treatment.

Before taking this medicine

You should not use this medicine if you are allergic to misoprostol or other prostaglandins.

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

• inflammatory bowel disease (IBD) or other intestinal problems;
• heart disease; or
• if you are dehydrated.

May cause birth defects. Do not use if you are pregnant, unless misoprostol is beeing used for pregnancy related conditions. You must use effective birth control while using misoprostol and for at least 1 month after your last dose. Tell your doctor if you become pregnant.

You will need to have a negative pregnancy test before starting this treatment.

Stop taking this medicine and tell your doctor right away if you become pregnant during treatment.

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

How should I take misoprostol?

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

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

Misoprostol is usually taken four times a day with meals. The last dose of the day should be at bedtime. Follow your doctor’s instructions.

You may have nausea, stomach cramps, or diarrhea while taking this medicine, especially during the first few weeks after you start taking misoprostol. These symptoms usually last for about a week.

Call your doctor if you have severe nausea, stomach pain, or diarrhea lasting longer than 8 days.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Duodenal Ulcer:

200 mcg orally 4 times a day after meals and at bedtime
-Maintenance dose: 100 to 200 mcg orally 4 times a day

Usual Adult Dose for Gastric Ulcer:

200 mcg orally 4 times a day after meals and at bedtime
-Maintenance dose: 100 to 200 mcg orally 4 times a day

Comment: Treatment should be taken for the duration of non-steroidal anti-inflammatory drug (NSAID) therapy.

Use: Reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcers (e.g., patients who are elderly, with concomitant debilitating disease) or at high risk of developing gastric ulceration (e.g., history of gastric ulcer)

Usual Adult Dose for NSAID-Induced Ulcer Prophylaxis:

200 mcg orally 4 times a day after meals and at bedtime
-Maintenance dose: 100 to 200 mcg orally 4 times a day

Comment: Treatment should be taken for the duration of non-steroidal anti-inflammatory drug (NSAID) therapy.

Use: Reducing the risk of NSAID-induced gastric ulcers in patients at high risk of complications from gastric ulcers (e.g., patients who are elderly, with concomitant debilitating disease) or at high risk of developing gastric ulceration (e.g., history of gastric ulcer)

Usual Adult Dose for Labor Induction or Cervical Ripening:

American College of Obstetricians and Gynecologists (ACOG) Recommendations:
25 mcg vaginally every 3 to 6 hours
-Some patients may require doses of 50 mcg every 6 hours

Comments:
-The manufacturer states that use outside of the approved indication should be reserved for hospital use only.
-Some experts state that this drug is a more efficient method of labor (compared to oxytocin) in patients before 28 weeks’ gestation.
-Higher doses may be associated with a higher risk of adverse events (e.g., uterine tachysystole with fetal heart rate decelerations).
-Use should be avoided during the third trimester or in patients with a history of cesarean delivery or major uterine surgery.

Use: Cervical ripening and labor induction in women with premature rupture of membranes

Usual Adult Dose for Postpartum Bleeding:

ACOG Recommendations:
800 to 1000 mcg rectally once

Use: Management of postpartum hemorrhage

International Federation of Gynecology Obstetrics (FIGO) Recommendations:
600 mcg orally OR 800 mcg sublingually once immediately after delivery

Comments:
-The manufacturer states that use outside of the approved indication should be reserved for hospital use only.
-Prior to administration of treatment, abdominal palpitation is recommended to confirm that there are no additional babies in utero.
-The dose is not based upon the patient’s weight.
-The addition of this drug to oxytocin was not shown to provide additional benefit, but may increase the risk of adverse events.

Use: Prevention of postpartum hemorrhage in settings where oxytocin is not available

Usual Adult Dose for Abortion:

ACOG Recommendations
First Trimester of Pregnancy:
-Early Pregnancy Loss: 800 mcg intravaginally once; a second dose may be given if there is no response to the first dose no sooner than 3 hours after the first dose, and usually within 7 days
-Incomplete Abortion: 600 mcg orally once
-Missed Abortion: 800 mcg intravaginally OR 600 mcg sublingually once; the dose may be repeated every 3 hours for 2 additional doses

FDA-approved use for termination of an early pregnancy

The usual dosage for a medical abortion is 200 mg of mifepristone on Day 1, followed 24 to 48 hours later by 800 mcg misoprostol taken buccally (see below).

• The pregnancy must not be over 70 days (10 weeks) gestation. This means 70 days or less have passed since the first day of the woman’s last menstrual period (10 weeks or less).
• The mifepristone tablet is swallowed whole.
• The misoprostol tablets are taken buccally which means between your top lip and gum (in your cheek pouch).
  • Place 2 misoprostol tablets in each cheek pouch for 30 minutes and then swallow anything left over with a drink of water or another liquid.
• The medicines may not work as well if you take misoprostol sooner than 24 hours after mifepristone or later than 48 hours after mifepristone.

Comments:
-Pain medications should be provided.
-Patients that are Rh(D) negative and unsensitized: Rh(D)-immune globulin should be given within 72 hours of administration of the initial dose.
-Follow-up treatment should be made within 7 to 14 days to ensure complete expulsion has occurred.
-If treatment fails, surgical options may need to be considered.

Use: Treatment of early pregnancy loss, incomplete abortion, missed abortion, or termination of an early pregnancy.

What happens if I miss a dose?

Take the missed dose of misoprostol as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking misoprostol?

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can increase your risk of diarrhea while you are taking misoprostol.

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