Viramune

A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV infection and AIDS. .
[PubChem].

Medicinal name:
  • Nevirapine 200 MG Oral Tablet [Viramune]
  • 24 HR Nevirapine 100 MG Extended Release Oral Tablet [Viramune]
  • 24 HR Nevirapine 400 MG Extended Release Oral Tablet [Viramune]

Viramune - Pharmacology:

Viramune binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site. The activity of nevirapine does not compete with template or nucleoside triphosphates.

Viramune mini report

Viramune NDA
NDA - A product marketed under an approved New Drug Application
Viramune SUSPENSION
SUSPENSION
Viramune TABLET
TABLET
Viramune TABLET, EXTENDED RELEASE
TABLET, EXTENDED RELEASE
Viramune HUMAN PRESCRIPTION DRUG
HUMAN PRESCRIPTION DRUG
Start - Stop data
START DATA:
2001-Oct-01
Start - Stop data
STOP DATA
not occurred

Viramune for patients

Patients should be informed of the possibility of severe liver disease or skin reactions associated with VIRAMUNE that may result in death. Patients developing signs or symptoms of liver disease or severe skin reactions should be instructed to discontinue VIRAMUNE and seek medical attention immediately, including performance of laboratory monitoring. Symptoms of liver disease include fatigue, malaise, anorexia, nausea, jaundice, acholic stools, liver tenderness or hepatomegaly. Symptoms of severe skin or hypersensitivity reactions include rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema and/or hepatitis.

Intensive clinical and laboratory monitoring, including liver function tests, is essential during the first 18 weeks of therapy with VIRAMUNE to detect potentially life-threatening hepatotoxicity and skin reactions. However, liver disease can occur after this period, therefore monitoring should continue at frequent intervals throughout VIRAMUNE treatment. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of hepatic events and skin reactions. Patients with signs and symptoms of hepatitis should discontinue VIRAMUNE and seek medical evaluation immediately. If VIRAMUNE is discontinued due to hepatotoxicity, do not restart it. . Patients, particularly women, with increased CD4+ cell count at initiation of VIRAMUNE therapy (>250 cells/mm3 in women and >400 cells/mm3 in men) are atsubstantially higher risk for development of symptomatic hepatic events, oftenassociated with rash. Patients should be advised that co-infection with hepatitis B or C and/or increased liver function tests at the start of therapy with VIRAMUNE are associated with a greater risk of later symptomatic events (6 weeks or more after starting VIRAMUNE) and asymptomatic increases in AST or ALT.

The majority of rashes associated with VIRAMUNE occur within the first 6 weeks of initiation of therapy. Patients should be instructed that if any rash occurs during the two week lead-in period, the VIRAMUNE dose should not be escalated until the rash resolves. Any patient experiencing a rash should have their liver function evaluated immediately. Patients with severe rash or hypersensitivity reactions should discontinue VIRAMUNE immediately and consult a physician. VIRAMUNE should not be restarted following severe skin rash or hypersensitivity reaction. Women tend to be at higher risk for development of VIRAMUNE associated rash.

Oral contraceptives and other hormonal methods of birth control should not be used as the sole method of contraception in women taking VIRAMUNE, since nevirapine may lower the plasma levels of these medications. Additionally, when oral contraceptives are used for hormonal regulation during VIRAMUNE therapy, the therapeutic effect of the hormonal therapy should be monitored.

Based on the known metabolism of methadone, nevirapine may decrease plasma concentrations of methadone by increasing its hepatic metabolism. Narcotic withdrawal syndrome has been reported in patients treated with VIRAMUNE and methadone concomitantly. Methadonemaintained patients beginning nevirapine therapy should be monitored for evidence of withdrawal and methadone dose should be adjusted accordingly.

VIRAMUNE may interact with some drugs, therefore, patients should be advised to report to their doctor the use of any other prescription, non-prescription medication or herbal products, particularly St. Johns wort.

Patients should be informed that VIRAMUNE therapy has not been shown to reduce the risk of transmission of HIV-1 to others through sexual contact or blood contamination. The long-term effects of VIRAMUNE are unknown at this time.

VIRAMUNE is not a cure for HIV-1 infection; patients may continue to experience illnesses associated with advanced HIV-1 infection, including opportunistic infections. Patients should be advised to remain under the care of a physician when using VIRAMUNE.

Patients should be informed to take VIRAMUNE every day as prescribed. Patients should not alter the dose without consulting their doctor. If a dose is missed, patients should take the nextdose as soon as possible. However, if a dose is skipped, the patient should not double the next dose. Patients should be advised to report to their doctor the use of any other medications.

Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long term health effects of these conditions are not known at this time.

The Medication Guide provides written information for the patient, and should be dispensed with each new prescription and refill.

MEDICATION GUIDE

VIRAMUNEÒ (VIH-rah-mune) Tablets

VIRAMUNEÒ Oral Suspension

Generic name: nevirapine tablets and oral suspension

Read this Medication Guide before you start taking VIRAMUNEÒ and each time you get a refill because there may be new information. This information does not take the place of talking with your doctor. You and your doctor should discuss VIRAMUNE when you start taking your medicine and at regular checkups. You should stay under a doctors care while using VIRAMUNE. You should consult with your doctor before making any changes to your medications, except in any of the special circumstances described below regarding rash or liver problems.

What is the most important information I should know about VIRAMUNE?

Patients taking VIRAMUNE may develop severe liver disease or skin reactions that can cause death. The risk of these reactions is greatest during the first 18 weeks of treatment, but these reactions also can occur later.

Liver Reactions

Any patient can experience liver problems while taking VIRAMUNE. However, women and patients who have higher CD4 counts when they begin VIRAMUNE treatment have agreater chance of developing liver damage. Women with CD4 counts higher than 250 cells/mm3 are at the greatest risk of these events. If you are a woman with CD4>250 cells/mm3 or a man with CD4>400 cells/mm3 you should not begin taking VIRAMUNE unless you and your doctor have decided that the benefit of doing so outweighs the risk. Liver problems are often accompanied by a rash.

Patients starting VIRAMUNE with abnormal liver function tests and patients with hepatitis B or C have a greater chance of developing further increases in liver function tests after starting VIRAMUNE and throughout therapy.

In rare cases liver problems have led to liver failure and can lead to a liver transplant or death. Therefore, if you develop any of the following symptoms of liver problems stop taking VIRAMUNE and call your doctor right away:

· general ill feeling or "flu-like" symptoms · dark urine (tea colored)

· tiredness · pale stools (bowel movements)

· nausea (feeling sick to your stomach) · pain, ache, or sensitivity to touch

· lack of appetite on your right side below your ribs

· yellowing of your skin or whites of your eyes

Your doctor should check you and do blood tests often to check your liver function during the first 18 weeks of therapy. Checks for liver problems should continue regularly during treatment with VIRAMUNE.

Skin Reactions

Skin rash is the most common side effect of VIRAMUNE. Most rashes occur in the first 6 weeks of treatment. In a small number of patients, rash can be serious and result in death. Therefore,

if you develop a rash with any of the following symptoms stop using VIRAMUNE and call your doctor right away:

· general ill feeling or "flu-like" symptoms · blisters

· fever · mouth sores

· muscle or joint aches · swelling of your face

· conjunctivitis (red or inflamed eyes, like "pink eye · tiredness

· any of the symptoms of liver problems discussed above

If your doctor tells you to stop treatment with VIRAMUNE because you have experienced the serious liver or skin reactions described above, never take VIRAMUNE again.

These are not all the side effects of VIRAMUNE. Tell your doctor if you have any side effects from VIRAMUNE.

What is VIRAMUNE?

VIRAMUNE is a medicine used to treat Human Immunodeficiency Virus (HIV), the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

VIRAMUNE is a type of anti-HIV medicine called a "non-nucleoside reverse transcriptase inhibitor" (NNRTI). It works by lowering the amount of HIV in the blood ("viral load"). You must take VIRAMUNE with other anti-HIV medicines. When taken with other anti-HIV medicines, VIRAMUNE can reduce viral load and increase the number of CD4 cells ("T cells"). CD4 cells are a type of immune helper cell in the blood. VIRAMUNE may not have these effects in every patient.

VIRAMUNE does not cure HIV or AIDS, and it is not known if it will help you live longer with HIV. People taking VIRAMUNE may still get infections common in people with HIV (opportunistic infections). Therefore, it is very important that you stay under the care of your doctor.

Who should not take VIRAMUNE?

· Do not take VIRAMUNE if you are allergic to VIRAMUNE or any of its ingredients. The active ingredient is nevirapine. Your doctor or pharmacist can tell you about the inactive ingredients.

· Do not restart VIRAMUNE after you recover from serious liver or skin reactions that happened when you took VIRAMUNE.

· Do not take VIRAMUNE if you take certain medicines.

· Do not take VIRAMUNE if you are not infected with HIV.

What should I tell my doctor before taking VIRAMUNE?

Before starting VIRAMUNE, tell your doctor about all of your medical conditions, including if you:

· have problems with your liver or have had hepatitis

· are undergoing dialysis

· have skin conditions, such as a rash

· are pregnant, planning to become pregnant, or are breast feeding

How should I take VIRAMUNE?

· Take the exact amount of VIRAMUNE your doctor prescribes. The usual dose for adults is one tablet daily for the first 14 days followed by one tablet twice daily. Starting with one dosea day lowers the chance of rash, which could be serious. Therefore, it is important to strictly follow the once daily dose for the first 14 days. Do not start taking VIRAMUNE twice a day if you have any symptoms of liver problems or skin rash.

· The dose of VIRAMUNE for children is based on their age and weight. Childrenís dosing also starts with once a day for 14 days and then twice a day after that.

· You may take VIRAMUNE with water, milk, or soda, with or without food.

· If you or your child uses VIRAMUNE suspension (liquid), shake it gently before use. Use an oral dosing syringe or dosing cup to measure the right dose. After drinking the medicine, fill the dosing cup with water and drink it to make sure you get all the medicine. If the dose is less than 5 mL (one teaspoon), use the syringe.

· Do not miss a dose of VIRAMUNE, because this could make the virus harder to treat. If you forget to take VIRAMUNE, take the missed dose right away. If it is almost time for your next dose, do not take the missed dose. Instead, follow your regular dosing schedule by taking the next dose at its regular time.

· If you stop taking VIRAMUNE for more than 7 days, ask your doctor how much to take before you start taking it again. You may need to start with once-a-day dosing.

· If yo suspect that you have taken too much VIRAMUNE, contact your local poison control center or emergency room right away.

Can I take other medicines with VIRAMUNE?

· VIRAMUNE may change the effect of other medicines, and other medicines can change the effect of VIRAMUNE. Tell your doctors and pharmacists about all medicines you take, including non-prescription medicines, vitamins and herbal supplements.

· Do not take NizoralÒ (ketoconazole) or RifadinÒ/RifamateÒ/RifaterÒ (rifampin) with VIRAMUNE.

· Tell your doctor if you take BiaxinÒ (clarithromycin), DiflucanÒ (fluconazole), methadone, or MycobutinÒ (rifabutin). VIRAMUNE may not be right for you, or you may need care ul monitoring.

· It is recommended that you not take products containing St. Johnís wort, which can reduce the amount of VIRAMUNE in your body.

· If you take birth control pills, you should not rely on them to prevent pregnancy. They may not work if you take VIRAMUNE. Talk with your doctor about other types of birth control hat you can use.

What should I avoid while taking VIRAMUNE?

Avoid doing things that can spread HIV infection, as VIRAMUNE does not stop you from passing HIV infection to others. Do not share needles, other injection equipment or personal items that can have blood or body fluids on them, like toothbrushes and razor blades. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

The Centers for Disease Control and Prevention advises mothers with HIV not to breast feed so they will not pass HIV to the infant through their milk. Ask your doctor about the best way to feed your infant.

What are the possible side effects?

VIRAMUNE can cause serious liver damage and skin reactions that can cause death. Any patient can experience such side effects, but some patients are more at risk than others.

Other common side effects of VIRAMUNE include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, and myalgia. This list of side effects is not complete. Ask your doctor or pharmacist for more information.

Changes in body fat have also been seen in some patients taking antiretroviral therapy. The changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time

How do I store VIRAMUNE?

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

General information about VIRAMUNE

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VIRAMUNE for a condition for which it was not prescribed. Do not give VIRAMUNE to other people, even if they have the same condition you have. It may harm them.

This Medication Guide summarizes the most important information about VIRAMUNE. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about VIRAMUNE that is written for health professionals, or you can visit www.viramune.com or call 1-800-542-6257 for additional information.

This Medication Guide has been approved by the US Food and Drug Administration.

Viramune Interactions

Viramune is principally metabolized by the liver via the cytochrome P450 isoenzymes, 3A4 and 2B6. Viramune is known to be an inducer of these enzymes. As a result, drugs that are metabolized by these enzyme systems may have lower than expected plasma levels when coadministered with nevirapine.

The specific pharmacokinetic changes that occur with co-administration of nevirapine and other drugs are listed in CLINICAL PHARMACOLOGY, Table 1. Clinical comments about possible dosage modifications based on these pharmacokinetic changes are listed in Table 3. The data inTables 1 and 3 are based on the results of drug interaction studies conducted in HIV-1 seropositive subjects unless otherwise indicated.

In addition to established drug interactions, there may be potential pharmacokinetic interactions between nevirapine and other drug classes that are metabolized by the cytochrome P450 system. These potential drug interactions are listed in Table 4. Although specific drug interaction studies in HIV-1 seropositive subjects have not been conducted for the classes of drugs listed in Table 4, additional clinical monitoring may be warranted when co-administering these drugs.

The in vitro interaction between nevirapine and the antithrombotic agent warfarin is complex. As a result, when giving these drugs concomitantly, plasma warfarin levels may change with the potential for increases in coagulation time. When warfarin is co-administered with nevirapine, anticoagulation levels should be monitored frequently.

Table 3 Established Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies
Drug Name
Effect on Concentration of Viramune or Concomitant Drug
Clinical Comment
Clarithromycin
¯ Clarithromycin ­14OH- clarithromycin
Clarithromycin exposure was significantly decreased by nevirapine; however, 14-OH metabolite concentrations were increased.Because clarithromycin active metabolite has reduced activity against Mycobacteriumavium-intracellulare complex, overallactivity against this pathogen may bealtered. Alternatives to clarithromycin,such as azithromycin, should be considered.
Efavirenz
¯ Efavirenz
Appropriate doses for this combination are not established.
Ethinyl estradiol and Norethindrone
¯ Ethinyl estradiol ¯Norethindrone
Oral contraceptives and other hormonalmethods of birth control should not be usedas the sole method of contraception inwomen taking nevirapine, since nevirapinemay lower the plasma levels of thesemedications. An alternative or additional method of contraception is recommended.
Fluconazole
­ Viramune
Because of the risk of increased exposure tonevirapine, caution should be used inconcomitant administration, and patients should be monitored closely for nevirapine-associated adverse events.
Indinavir
¯ Indinavir
Appropriate doses for this combination arenot established, but an increase in thedosage of indinavir may be required.
Ketoconazole
¯ Ketoconazole
Viramune and ketoconazole should not beadministered concomitantly becausedecreases in ketoconazole plasmaconcentrations may reduce the efficacy of the drug.
Lopinavir/Ritonavir
¯ Lopinavir
A dose increase of lopinavir/ritonavir to 533/133 mg twice daily with food isrecommended in combination with nevirapine.
Methadone
¯ Methadonea
Methadone levels may be decreased;increased dosages may be required toprevent symptoms of opiate withdrawal.Methadone maintained patients beginningnevirapine therapy should be monitored forevidence of withdrawal and methadone dose should be adjusted accordingly.
Nelfinavir
¯ Nelfinavir M8 Metabolite ¯NelfinavirCmin

 

The appropriate dose for nelfinavir incombination with nevirapine, with respectto safety and efficacy, has not been established.
Rifabutin
­Rifabutin
Rifabutin and its metabolite concentrationswere moderately increased. Due to highintersubject variability, however, somepatients may experience large increases inrifabutin exposure and may be at higher riskfor rifabutin toxicity. Therefore, caution should be used in concomitant administration.
Rifampin
¯ Viramune
Viramune and rifampin should not beadministered concomitantly becausedecreases in nevirapine plasmaconcentrations may reduce the efficacy ofthe drug. Physicians needing to treatpatients co-infected with tuberculosis andusing a nevirapine containing regimen mayuse rifabutin instead.
Saquinavir
¯Saquinavir
Appropriate doses for this combination arenot established, but an increase in thedosage of saquinavir may be required.

aBased on reports of narcotic withdrawal syndrome in patients treated with nevirapine and methadone concurrently, and evidence of decreased plasma concentrations of methadone.

Table 4        Potential Drug Interactions:Use With Caution, Dose Adjustment of Co-administered Drug May Be Needed due to Possible Decrease in Clinical Effect
Examples of Drugs in Which Plasma Concentrations May Be Decreased By Co-administration With Viramune
Drug Class Examples of Drugs
Antiarrhythmics
Amiodarone, disopyramide, lidocaine
Anticonvulsants
Carbamazepine, clonazepam, ethosuximide
Antifungals
Itraconazole
Calcium channel blockers
Diltiazem, nifedipine, verapamil
Cancer chemotherapy
Cyclophosphamide
Ergot alkaloids
Ergotamine
Immunosuppressants
Cyclosporin, tacrolimus, sirolimus
Motility agents
Cisapride
Opiate agonists
Fentanyl
Examples of Drugs in Which Plasma Concentrations May Be Increased By Co-administration With Viramune
Antithrombotics
Warfarin
Potential effect on anticoagulation. Monitoring of
anticoagulation levels is recommended.

Fat redistribution: Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. The mechanism and long-term consequences of these events are currently unknown. A causal relationship has not been established.

 

Viramune Contraindications

VIRAMUNE (nevirapine) is contraindicated in patients with clinically significant hypersensitivity to any of the components contained in the tablet or the oral suspension.

Manufacturers name:

  • Boehringer Ingelheim Pharmaceuticals Inc
  • State of Florida DOH Central Pharmacy
  • Boehringer Ingelheim Pharmaceuticals, Inc
  • Physicians Total Care, Inc

Generic name, Overdose, Half Life Viramune, Food Interactions, Chemical, etc..

Viramune see also FDA report Saw Palmetto

General health