Nevirapine immediate-release tablets

What is this medication?

NEVIRAPINE (ne VYE ra peen) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. This medicine can lower, but not fully prevent, the risk of spreading HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Viramune

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• kidney disease
• liver disease
• skin condition or rash
• an unusual or allergic reaction to nevirapine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You may take this medicine with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 15 days old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• itraconazole
• ketoconazole
• rifampin
• rifapentine
• St. John's Wort

This medicine may also interact with the following medications:

• cisapride
• clarithromycin
• cyclophosphamide
• cyclosporine
• ergotamine
• estrogens or progestins
• fentanyl
• fluconazole
• medicines for blood pressure like diltiazem, nifedipine, verapamil
• medicines for irregular heart beat like amiodarone, disopyramide, lidocaine
• medicines for seizures like carbamazepine, clonazepam, ethosuximide
• methadone
• other medicines for HIV
• rifabutin
• sirolimus
• tacrolimus
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care provider for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom or diaphragm.

Severe liver reactions or skin rashes are seen in some patients taking this medicine. The risk of these reactions is greatest during the first 18 weeks of treatment, but can happen anytime. Be sure to carefully monitor for the mentioned side effects and contact your doctor when necessary.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, blisters, itching or hives, swelling of the face, lips, or tongue
• dark urine
• fever
• general ill feeling or flu-like symptoms
• light-colored stools
• loss of appetite, nausea
• muscle or joint aches
• rash, fever, and swollen lymph nodes
• red or swollen eyes
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• right upper belly pain
• unusually weak or tired
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• headache
• weight gain around waist, back, or thinning of face, arms, legs

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medication that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.