Viramune XR (Oral)

Nevirapine is used together with other medicines to treat the infection caused by human immunodeficiency virus (HIV). HIV is the virus that leads to acquired immune deficiency syndrome (AIDS).

Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It works by reducing the amount of HIV in the blood.

Nevirapine will not cure HIV infection or AIDS; however, it helps prevent HIV from multiplying and seems to slow down the damage to the immune system. This may help delay problems that usually arise from AIDS or HIV disease. Nevirapine will not stop you from spreading HIV to others. People taking this medicine may still experience some issues commonly associated with AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your or your child's progress to ensure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Liver problems may occur while using this medicine. Contact your doctor right away if you or your child have more than one of these symptoms: abdominal pain or tenderness, clay-colored stools, dark urine, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

Inform your doctor if you or your child develop any type of skin rash, even a mild one. Call your doctor immediately if you or your child have a rash with blisters, fever, mouth sores, red or irritated eyes, swelling of the face, muscle or joint pain, or muscle weakness.

Your immune system may become stronger when you start taking HIV medicines. Tell your doctor right away if you or your child notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (for example, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.

This medicine may cause an increase in body fat. Notify your doctor if you or your child notice changes in body shape, including more body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.

This medicine may reduce the effectiveness of some birth control pills. To avoid pregnancy, use an additional form of birth control along with your pills. Other forms of birth control include condoms, diaphragms, or contraceptive foam or jelly.

This medicine does not lower the risk of transmitting HIV to others through sexual contact or contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (for example, St. John's wort) or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

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

Pediatric

Studies done so far have not shown any specific problems in children that would limit the usefulness of nevirapine suspension or tablets. However, safety and effectiveness have not been established in infants younger than 15 days old.

Studies done so far have not shown any specific problems in children that would limit the usefulness of nevirapine extended-release tablets in children 6 years and older with a body surface area of 1.17 square meter (m) or greater. However, use is not recommended in children younger than 6 years. Safety and effectiveness have not been established in children younger than 6 years with a body surface area of less than 1.17 m.

Geriatric

Studies done so far have not shown any specific problems in elderly patients that would limit the usefulness of nevirapine. However, elderly patients are more likely to have age-related kidney, liver, or heart issues, which may require caution and an adjustment in the dose for patients taking nevirapine.

Breast Feeding

There are no adequate studies in women to determine the risks to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose or take other precautions. When you are taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Atazanavir
• Dasabuvir

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Alfentanil
• Amiodarone
• Amprenavir
• Artemether
• Atogepant
• Avanafil
• Benzhydrocodone
• Buprenorphine
• Bupropion
• Cabotegravir
• Cobicistat
• Codeine
• Cyclophosphamide
• Daclatasvir
• Darunavir
• Delavirdine
• Desogestrel
• Dexamethasone
• Dienogest
• Dihydrocodeine
• Dolutegravir
• Doravirine
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Drospirenone
• Efavirenz
• Enzalutamide
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Etravirine
• Fentanyl
• Fexinidazole
• Fluconazole
• Fosamprenavir
• Gestodene
• Hemin
• Hydrocodone
• Ifosfamide
• Itraconazole
• Ketoconazole
• Lenacapavir
• Levoketoconazole
• Levonorgestrel
• Lumateperone
• Lurasidone
• Medroxyprogesterone
• Meperidine
• Mestranol
• Methotrexate
• Nifedipine
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Orlistat
• Oxycodone
• Pentazocine
• Pexidartinib
• Piperaquine
• Quinine
• Rifampin
• Rifapentine
• Rilpivirine
• Rivaroxaban
• Saquinavir
• Segesterone
• Simeprevir
• St John's Wort
• Sufentanil
• Tacrolimus
• Tolvaptan
• Tramadol
• Ubrogepant
• Ulipristal
• Velpatasvir
• Voriconazole
• Voxilaprevir
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Caspofungin
• Cisapride
• Clarithromycin
• Clonazepam
• Cyclosporine
• Dalfopristin
• Diltiazem
• Disopyramide
• Ergotamine
• Ethosuximide
• Indinavir
• Lopinavir
• Methadone
• Nelfinavir
• Ospemifene
• Quinupristin
• Rifabutin
• Sirolimus
• Verapamil
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Hepatitis B or
• Hepatitis C—Use with caution. May worsen side effects.

• Liver disease, moderate or severe—Should not be used in patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

Less common

• Decreased appetite
• Swelling of the feet or lower legs

Rare

• Pain, numbness, or tingling in the hands, arms, legs, or feet
• Sleepiness or unusual drowsiness
• Stomach pain
• Tingling, burning, or prickly sensations

Incidence not known

• Black, tarry stools
• Blistering, peeling, or loosening of the skin
• Bone pain
• Chest pain
• Chills
• Clay-colored stools
• Cough
• Dark urine
• Diarrhea
• Difficulty swallowing
• Dizziness
• Fast heartbeat
• Fever
• General tiredness and weakness
• Headache
• Hives, itching, skin rash
• Joint or muscle pain
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• Loss of appetite
• Lower back or side pain
• Muscle cramps, spasms, pain, or stiffness
• Nausea
• Painful or difficult urination
• Pale skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Seizures
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Continuing stomach pain
• Swollen glands
• Tightness in the chest
• Trouble breathing
• Troubled breathing with exertion
• Unpleasant breath odor
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting
• Vomiting blood
• Yellow eyes and skin

Get emergency help right away if any of the following symptoms of overdose occur:

Symptoms of overdose

• Chest pain
• Cough
• Decrease in weight
• Dizziness or lightheadedness
• Feeling of constant movement of self or surroundings
• Headache
• Pain in the ankles or knees
• Painful, red lumps under the skin, mostly on the legs
• Sensation of spinning
• Trouble sleeping

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

Less common

• Difficulty with moving
• Pain in the joints

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Viramune
• Viramune O/S
• Viramune XR

Available Dosage Forms:

• Tablet, Extended Release
• Tablet
• Suspension

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Non-Nucleoside Reverse Transcriptase Inhibitor

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine comes with a Medication Guide. Read and follow these instructions carefully before starting nevirapine treatment and each time you refill your prescription. Ask your doctor if you have any questions.

Nevirapine may be taken with or without food, and with water, milk, or soda.

If you or your child are taking the oral liquid, shake it gently before use. Use an oral dosing syringe or dosing cup to measure the right dose. After drinking the medicine, rinse the dosing cup with water and drink the water to make sure you get all of the medicine. If your dose is less than 5 mL (one teaspoonful), use the dosing syringe.

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

Keep taking nevirapine for the full time of treatment, even if you or your child begin to feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

It is important to take nevirapine as part of a combination treatment. Take all other medicines your doctor has prescribed at the right time of the day. This will make your medicines work better.

This medicine works best when there is a constant amount in the blood. To help keep blood levels constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times during the day. For example, if you or your child are taking one dose per day, try to take it at the same time each day. If you are taking two doses per day, the doses should be spaced about 12 hours apart. If you need help planning the best times to take your medicine, check with your doctor.

Do not take more than one dosage form of nevirapine at the same time. Talk to your doctor if you have any questions.

If you stop taking this medicine for more than 7 days, ask your doctor how much to use before you start taking it again..

Dosing

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

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

• For treatment of HIV infection: For oral dosage form (extended-release tablets): Adults—At first, one 200 milligram (mg) Viramune® immediate-release tablet once a day for the first 14 days. This is followed by one 400 mg Viramune XR® tablet once a day, together with other HIV medicines. Children 6 to 17 years of age with a body surface area of 1.17 square meter (m2) or greater—Dose is based on body size and must be determined by your doctor. The starting dose is usually 150 milligrams (mg) per square meter (m2) of Viramune® oral suspension or tablets for the first 14 days. This is followed by 400 mg of Viramune XR® once a day, together with other HIV medicines. Children younger than 6 years of age with a body surface area of less than 1.17 m2—Use is not recommended. For oral dosage forms (suspension or tablets): Adults—200 milligrams (mg) once a day for 2 weeks, followed by 200 mg 2 times per day, together with other medicines. Children and infants 15 days of age and older—Dose is based on body size and must be determined by your doctor. Infants younger than 15 days of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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