Viramune XR

Name: Viramune XR

Side Effects of Viramune XR

Viramune XR may cause serious side effects, including:

  • See "Viramune XR Precautions".
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor if you start having new symptoms after starting your HIV medicine.
  • Changes in body fat can happen in some people who take antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the middle of your body (trunk). Loss of fat from your legs, arms, and face can also happen. The cause and long-term health effects of these problems are not known at this time.

The most common side effect of Viramune XR is rash. 

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of nevirapine. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Viramune XR and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B.  It is not known if Viramune XR will harm your unborn baby.

Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.

Other Requirements

  • Store Viramune XR at 59°F to 86°F (15°C to 30°C).
  • Throw away Viramune XR that is no longer needed or out-of-date.
  • Keep Viramune XR and all medicines out of the reach of children.

Manufacturer

  • Boehringer Ingelheim Pharmaceuticals, Inc.

Viramune XR Usage

Viramune XR is always taken in combination with other anti-HIV medications.

  • Take Viramune XR exactly as your doctor tells you to take it. Do not change your dose unless your doctor tells you to.
  • You should never take more than one form of Viramune at the same time. Talk to your doctor if you have any questions.
  • Do not crush or chew Viramune XR tablets.
  • You may take Viramune XR with or without food.
  • Do not miss a dose of Viramune XR, because this could make HIV harder to treat. If you miss a dose of Viramune XR, take the missed dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose, just take the next dose at your regular time. Do not take two doses at the same time.
  • If you stop taking Viramune XR for more than 7 days, ask your doctor how much to take before you start taking it again. You may need to begin taking the Viramune XR starting dose again, which is taken 1 time each day for 14 days.

1. Starting Viramune XR tablets extended-release tablets) and this is the first time you are taking any form of Viramune:

  • Your doctor should start you with 1 dose each day to lower your chance of getting a serious rash. It is important that you only take 1 dose of Viramune each day for the first 14 days.
  • Call your doctor right away if you get a skin rash during the first 14 days of Viramune treatment and do not increase your dose to 2 times a day.
  • You should never take your starting dose for longer than 28 days. If after 28 days you are still receiving this starting dose because you have a rash, you and your doctor should talk about prescribing another HIV medicine for you instead of Viramune.
  • Do not increase your dose to 2 times a day if you have a rash.
  • Day 15, you will take 1 Viramune XR tablet once daily. 

​2. Switching from Viramune immediate release tablets to Viramune XR (extended-release tablets):

  • Adult patients already on a regimen of immediate release Viramune twice daily can be switched to Viramune XR 400 mg once daily without the 14-day lead-in period of immediate-release Viramune.

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.

If you have not taken nevirapine for 7 days in a row, call your doctor before you start taking the medicine again. You may need to start with a lower dose.

Uses For Viramune XR

Nevirapine is used in combination with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

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

Nevirapine will not cure HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. Nevirapine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease.

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

Before Using Viramune XR

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nevirapine suspension or tablets in children. However, safety and efficacy have not been established in infants younger than 15 days of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nevirapine extended-release tablets in children 6 to 17 years of age. However, use is not recommended in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nevirapine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems which may require caution and an adjustment in the dose for patients receiving nevirapine.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amprenavir
  • Artemether
  • Avanafil
  • Boceprevir
  • Bosutinib
  • Cobicistat
  • Cyclophosphamide
  • Daclatasvir
  • Darunavir
  • Delavirdine
  • Dexamethasone
  • Dolutegravir
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Efavirenz
  • Enzalutamide
  • Etonogestrel
  • Etravirine
  • Fluconazole
  • Fosamprenavir
  • Ifosfamide
  • Itraconazole
  • Ketoconazole
  • Nifedipine
  • Olaparib
  • Orlistat
  • Piperaquine
  • Quinine
  • Rifampin
  • Rifapentine
  • Rilpivirine
  • Saquinavir
  • Simeprevir
  • St John's Wort
  • Tacrolimus
  • Telaprevir
  • Tolvaptan
  • Voriconazole

Using this medicine with any of the following medicines may cause an increased 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 of the medicines.

  • Amiodarone
  • 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

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Hepatitis B or
  • Hepatitis C—Use with caution. May cause side effects to become worse.
  • Liver disease, moderate or severe—Should not be used in patients with this conditions.

Uses of Viramune XR

  • It is used to treat HIV infection.

For the Consumer

Applies to nevirapine: oral elixir, oral suspension, oral tablet, oral tablet extended release

Along with its needed effects, nevirapine (the active ingredient contained in Viramune XR) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nevirapine:

More common
  • Black, tarry stools
  • blistering, peeling, or loosening of the skin
  • chills
  • clay-colored stools
  • cough
  • dark urine
  • diarrhea
  • fever
  • general tiredness and weakness
  • itching
  • joint or muscle pain
  • light-colored stools
  • lower back or side pain
  • nausea and vomiting
  • painful or difficult urination
  • pale skin
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • shortness of breath
  • skin rash
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • yellow eyes and skin
Less common
  • Decreased appetite
  • hives
  • loss of appetite
  • swelling of the feet or lower legs
Rare
  • Abdominal or stomach pain
  • pain, numbness, or tingling of the hands, arms, legs, or feet
  • sleepiness or unusual drowsiness
  • tingling, burning, or prickly sensations

Get emergency help immediately if any of the following symptoms of overdose occur while taking nevirapine:

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 of nevirapine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may 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
  • muscle pain or stiffness
  • pain in the joints

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