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Nevirapine information from DrugsUpdate  

See Available Brands of Nevirapine in India

P - Caution when used during pregnancy
L - Contraindicated in lactation
FI - Food *

Nevirapine, also marketed under the trade name Viramune (Boehringer Ingelheim), is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used to treat HIV-1 infection and AIDS.

As with other antiretroviral drugs, HIV rapidly develops resistance if nevirapine is used alone, so recommended therapy consists of combinations of three or more antiretrovirals.

Pharmacodynamics

Pharmacokinetics

Information Not Available

Nevirapine Indications / Nevirapine Uses

Nevirapine in triple combination therapy has been shown to suppress viral load effectively when used as initial antiretroviral therapy (i.e., in antiretroviral-naive patients). Some clinical trials have demonstrated comparable HIV suppression with nevirapine-based regimens to that achieved with protease inhibitors (PIs) or efavirenz. Although concerns have been raised about nevirapine-based regimens in those starting therapy with high viral load or low CD4 count, some analyses suggest that nevirapine may be effective in these patients.

Nevirapine may also form a useful component of salvage regimens after virological failure, usually in combination with one or more PIs as well as nRTIs, especially in those who have not previously taken an NNRTI.

Nevirapine Adverse Reactions / Nevirapine Side Effects

Skin rash, nausea, vomiting, headache, abnormal LFT, fatigue, diarrhoea, abdominal pain. Severe & life- threatening hepatoxic & skin reactions.

Precautions

Warnings
Dermal reactions

Severe, life-threatening skin reactions (sometimes fatal) occurred during therapy. Cases include Stevens-Johnson syndrome, TEN, and hypersensitivity reactions.

Dosing
A 14-day initiation period (200 mg/day) must be strictly followed.

Hepatotoxicity
Severe, life-threatening, and in some cases, fatal hepatotoxicity has been reported, especially in the first 18 weeks. These events are often associated with a rash. The risk of reactions is increased in women and in patients with higher CD4 counts at the start of therapy. Women with CD4 counts higher than 250 cells/mm 3 receiving nevirapine with other antiretroviral agents are at the greatest risk. If clinical hepatitis or transaminase elevations combined with rash or other systemic symptoms occur, permanently discontinue therapy.

Patient monitoring

Closely monitor for first 18 weeks to detect signs and symptoms of skin/hepatic reactions.


Monitor
Check transaminases immediately if a patient experiences signs or symptoms suggestive of hepatitis and/or hypersensitivity reactions. Check transaminases immediately for all patients who develop a rash in the first 18 weeks of treatment. Monitor patients intensively during the first 18 weeks of therapy to detect potentially life-threatening hepatotoxicity or skin reactions. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk.

Special Precautions

Pregnancy. Interupt treatment if severe hepatoxicity or life- threatening skin reactions develop. Renal or hepatic insufficiency. Monitor liver function periodically.

Other Drug Interactions

Mutually increased levels effects when used with drugs extensively metabolised by CYP3A. Reduced levels/ effects of methadone.

Other Interactions

Food Interaction

Dosage

Oral
HIV infection combined with other antiretrovirals:
Adult: 200mg once daily for the first 14 days; increase to 200mg bid if rash does not develop. Interupting the treatment for >7 days necessiate reintroduction at a lower dose for the 1st 14 days.
Child: 2 months to eight years: 4mg/kg once daily for the 1st 14 days; increase to 7mg/kg bid if no rash is present. 8- 16 years4mg/kg once daily for 14 days followed by 4 mg/kg bid. Max: 400mg daily. Interrupting the treatment for >7 days necessiate reintroduction at a lower dose for the 1st 14 days.

Food(before/after)

Information Not Available

List of Contraindications

Nevirapine and Pregnancy

Caution when used in pregnancy

Nevirapine and Lactation

Contraindicated in lactation

Nevirapine and Children

For use in children 15 days of age and older

Nevirapine and Geriatic

Select dose with caution, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Nevirapine and Other Contraindications

Hypersensitivity. Lactation. Severe hepatic impairment.

Storage

Store tablets and oral suspension at 59° to 86°F.

Lab interference

Store tablets and oral suspension at 59° to 86°F.

Nevirapine brands in India:

Nev Neve Nevimune Nevipan Nevir Neviretro Nevivir

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