Nevirapine Er

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Rarely, nevirapine has caused severe (sometimes fatal) liver problems. Get medical help right away if you develop symptoms of liver problems, such as nausea that doesn't stop, loss of appetite, vomiting, stomach/abdominal pain, dark urine, pale stools, yellowing eyes/skin, unusual tiredness, rash.

Rarely, nevirapine has also caused serious (sometimes fatal) skin/allergic reactions. Get medical help right away if you have any signs of skin/allergic reactions, including sore throat that doesn't go away, rash, itching/swelling/redness (especially of the eyes/face), blisters, fever, unusual tiredness, mouth sores, severe dizziness, trouble breathing, signs of kidney problems (such as change in the amount of urine), muscle pain/tenderness/weakness, joint pain.

Women are at increased risk for developing these severe reactions. To help decrease the risk of skin/allergic reactions in all patients, nevirapine is started at a lower dose for the first 14 days. Also, people with higher T-cell counts at the start of nevirapine treatment are at greater risk for liver problems. Nevirapine is usually only started if the T-cell count is fewer than 250 in women or fewer than 400 in men.

Keep all medical and lab appointments so your doctor can monitor how you are responding to nevirapine. The risk of these serious side effects is high in the first 18 weeks and highest during the first 6 weeks of nevirapine treatment. However, these side effects may occur at any time while taking this medication.

If you have stopped taking nevirapine because of liver problems or skin/allergic reactions, you must never take any form of nevirapine again. Tell all of your doctors and pharmacists if you have ever stopped taking nevirapine because of these types of reactions.

Read the Medication Guide provided by your pharmacist before you start using nevirapine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Do not crush, chew, or split the tablets. Doing so can release all of the drug at once and increase the risk of side effects.

If you have never taken nevirapine before, you must take the immediate-release form of nevirapine for 14 days, before starting to take the extended-release form. If you have already taken the immediate-release form of nevirapine for more than 14 days, you may start taking the extended-release tablets right away. However, never take two different forms of nevirapine at the same time.

The dosage is based on your medical condition and response to treatment. Children's dosage is also based on body size.

If you stop taking this medication for more than 7 days for reasons other than the serious reactions described in the Warning section, ask your doctor for directions on how to restart treatment. You may need to take the immediate-release form of this medication once daily again for the first 14 days to decrease the risk of serious side effects.

It is very important to keep taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.

See also Warning section.

Tiredness, nausea, vomiting, or diarrhea may occur. Drowsiness may rarely occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

You may see the empty extended-release tablet shell in your stool. This is harmless.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes).

Nevirapine can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare, but get medical help right away if it occurs. See the Warning section for more details.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking nevirapine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (such as hepatitis B or C, cirrhosis), kidney dialysis.

This drug may rarely make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and nevirapine may be part of that treatment. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Because breast milk may transmit HIV, consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: orlistat, rifabutin, warfarin.

Other medications can affect the removal of nevirapine from your body, which may affect how nevirapine works. Examples include rifamycins (such as rifampin), St. John's wort, among others.

Nevirapine can speed up the removal of many other medications from your body, which may affect how they work. Examples of affected drugs include antiarrhythmics (such as amiodarone), asunaprevir, atazanavir, cobicistat, elvitegravir, some drugs used to treat seizures (such as clonazepam), azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin), methadone, among others.

Do not use prednisone to prevent a rash because it can actually increase the risk of a rash during the first 6 weeks of nevirapine treatment. Ask your doctor for more details.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, viral load, T-cell counts) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.