Generic equivalent of Nevirapine
1 SKUs available · Available to order · NABP accredited · DSCSA compliant
Nevirapine is the generic equivalent of the brand-name drug Nevirapine. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Nevirapine through Premier Pharma with same-day fulfillment on in-stock SKUs.
1 INDICATIONS AND USAGE Nevirapine tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1 , 14.2) ] . Limitations of Use: Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets are not recommended to be initiated, unless the benefit outweighs the risk, in: adult females with CD4 + cell counts greater than 250 cells/mm 3 or adult males with CD4 + cell counts greater than 400 cells/mm3 [see Warnings and Precautions (5.1) ] . Nevirapine tablet is an NNRTI indicated in com…
6 ADVERSE REACTIONS The most common adverse reaction is rash. In adults, the incidence of rash is 15% versus 6% with placebo, with Grade 3/4 rash occurring in 2% of subjects. ( 6.1 ) In pediatric subjects the incidence of rash (all causality) was 21%. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adv…
7 DRUG INTERACTIONS Nevirapine is principally metabolized by the liver via the cytochrome P450 isoenzymes, 3A and 2B6. Nevirapine 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 co-administered with nevirapine. The specific pharmacokinetic changes that occur with co-administration of nevirapine and other drugs are listed in Clinical Pharmacology, Table 5. Clinical comments about possible d…
2 DOSAGE AND ADMINISTRATION The 14-day lead-in period must be strictly followed; it has been demonstrated to reduce the frequency of rash. ( 2.4 , 5.2 ) If any patient experiences rash during the 14-day lead-in period, do not increase dose until the rash has resolved. Do not continue the lead-in dosing regimen beyond 28 days. ( 2.4 ) If dosing is interrupted for greater than 7 days, restart 14-day lead-in dosing. ( 2.4 ) Adults (≥16 yrs) Pediatric Patients* (≥15 days) First 14 days 200 mg once d…
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Hepatotoxicity and Skin Reactions Inform patients of the possibility of severe liver disease or skin reactions associated with nevirapine that may result in death. Instruct patients developing signs or symptoms of liver disease or severe skin reactions to discontinue nevirapine 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 he…
Source: FDA. For professional use only. Not a substitute for prescribing information.
Premier Pharma stocks 1 Nevirapine SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Nevirapine is the generic equivalent of Nevirapine. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Nevirapine in 200 mg/1 and TABLET.
Nevirapine carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
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