Estados Unidos - inglés - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 100 mg - nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (bsa) of 1.17 m2 or greater [see clinical studies (14.1, 14.2)] . limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in: nevirapine extended-release tablets are contraindicated: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. available data from the apr show no difference in the risk of overall major birth defects for nevirapine compared with the background rate for major birth defects of 2.7% in a u.s. reference population of the metropolitan atlanta congenital defects program (macdp) [see data] . the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15-20%. the background risk of birth defects and miscarriage for the indicated population is unknown. methodological limitations of the apr include the use of macdp as the external comparator group. the macdp population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at < 20 weeks gestation. there is a risk for severe hepatic events in pregnant women exposed to nevirapine extended-release tablets [see clinical considerations] . in animal reproduction studies, no evidence of adverse developmental outcomes was observed following oral administration of nevirapine during organogenesis in the rat and rabbit, at systemic exposures (auc) to nevirapine approximately equal (rats) and 50% higher (rabbits) than the exposure in humans at the recommended 400 mg daily dose [see data] . severe hepatic events, including fatalities, have been reported in pregnant women receiving chronic nevirapine therapy as part of combination treatment of hiv-1 infection. regardless of pregnancy status, women with cd4+ cell counts greater than 250 cells/mm3 should not initiate nevirapine unless the benefit outweighs the risk. it is unclear if pregnancy augments the risk observed in non-pregnant women [see warnings and precautions (5.1)] . based on prospective reports to the apr of exposures to nevirapine during pregnancy resulting in live births (including over 1100 exposed in the first trimester and over 1500 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.0% (95% ci: 2.1%, 4.1%) and 3.3% (95% ci: 2.4%, 4.3%) following first and second/third-trimester exposure, respectively, to nevirapine-containing regimens, compared with the background birth defect rate of 2.7% in a u.s. reference population of the macdp. nevirapine was administered orally to pregnant rats (at 0, 12.5, 25, and 50 mg/kg/day), and rabbits (at 0, 30, 100, and 300 mg/kg/day) through organogenesis (on gestation days 7 through 16 and 6 through 18, respectively). no adverse developmental effects were observed at doses producing systemic exposures (auc) approximately equivalent to (rats) or approximately 50% higher (rabbits) than human exposure at the recommended daily dose. in rats, decreased fetal body weights were observed at a maternally toxic dose at an exposure approximately 50% higher than the recommended daily dose. the centers for disease control and prevention recommend that hiv-1 infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. published data report that immediate-release nevirapine is present in human milk. there are limited data on the effects of nevirapine on the breastfed infant. there is no information on the effects of nevirapine on milk production. because of the potential for (1) hiv-1 transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants), and (3) serious adverse reactions in nursing infants, mothers should not breastfeed if they are receiving nevirapine extended-release tablets. limited human data are insufficient to determine the risk of infertility in humans. based on results from animal fertility studies conducted in rats, nevirapine extended-release tablets may reduce fertility in females of reproductive potential. it is not known if these effects on fertility are reversible [see nonclinical toxicology (13.1)] . nevirapine extended-release tablets are indicated for use in combination with other antiretroviral agents for the treatment of hiv-1 infection in children 6 years of age or older with a bsa of 1.17 m2 or greater [see indications and usage (1) and dosage and administration (2.3)]. the use of nevirapine extended-release tablets for the treatment of hiv-1 infection in pediatric patients 6 to less than 18 years of age is based on pharmacokinetic, safety, and antiviral activity data from an open-label trial with nevirapine extended-release tablets. the results of this trial were supported by previous demonstration of efficacy in adult patients [see adverse reactions (6.1) , clinical pharmacology (12.3), and clinical studies (14.2)]. nevirapine extended-release tablets are not recommended for children less than 6 years of age. trial 1100.1518 did not provide sufficient pharmacokinetic data for children 3 to less than 6 years of age to support the use of nevirapine extended-release tablets in this age group. furthermore, nevirapine extended-release tablets are not recommended for children less than 3 years of age because they are not able to swallow tablets. clinical studies of nevirapine extended-release tablets did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. in subjects with renal impairment (mild, moderate or severe), there were no significant changes in the pharmacokinetics of nevirapine. nevirapine is extensively metabolized by the liver and nevirapine metabolites are extensively eliminated by the kidney. nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known. no adjustment in nevirapine dosing is required in patients with crcl greater than or equal to 20 ml per min. the pharmacokinetics of nevirapine have not been evaluated in patients with crcl less than 20 ml per min. in patients undergoing chronic hemodialysis, an additional dose of immediate-release nevirapine (200 mg) following each dialysis treatment is indicated [see dosage and administration (2.5) and clinical pharmacology (12.3)]. nevirapine extended-release tablets have not been studied in patients with renal dysfunction. because increased nevirapine levels and nevirapine accumulation may be observed in patients with serious liver disease, do not administer nevirapine to patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see contraindications (4), warnings and precautions (5.1), and clinical pharmacology (12.3)]. nevirapine extended-release tablets have not been evaluated in subjects with hepatic impairment.

Australia - inglés - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - nevirapine, quantity: 200 mg - tablet - excipient ingredients: magnesium stearate; microcrystalline cellulose; lactose; crospovidone; copovidone - nevirapine immediate-release tablets in combination with antiretroviral agents are indicated for the treatment of hiv-1 infection in adults and adolescents over the age of 16 years.,resistant virus emerges rapidly when nevirapine is administered as monotherapy or in dual combination therapy with an antiretroviral agent. therefore, nevirapine should always be administered in combination with at least two additional antiretroviral agents.

Australia - inglés - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - nevirapine, quantity: 200 mg - tablet - excipient ingredients: lactose; copovidone; microcrystalline cellulose; magnesium stearate; crospovidone - nevirapine immediate-release tablets in combination with antiretroviral agents are indicated for the treatment of hiv-1 infection in adults and adolescents over the age of 16 years.,resistant virus emerges rapidly when nevirapine is administered as monotherapy or in dual combination therapy with an antiretroviral agent. therefore, nevirapine should always be administered in combination with at least two additional antiretroviral agents.

Australia - inglés - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - nevirapine, quantity: 200 mg - tablet, uncoated - excipient ingredients: povidone; magnesium stearate; microcrystalline cellulose; lactose monohydrate; colloidal anhydrous silica; sodium starch glycollate type a - nevirapine in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and adolescents over the age of 16 years.,resistant virus emerges rapidly when nevirapine is administered as monotherapy or in dual combination therapy with an antiretroviral agent. therefore, nevirapine should always be administered in combination with at least two additional antiretroviral agents.

Australia - inglés - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - nevirapine, quantity: 200 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; magnesium stearate; povidone; sodium starch glycollate type a - nevirapine in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and adolescents over the age of 16 years.,resistant virus emerges rapidly when nevirapine is administered as monotherapy or in dual combination therapy with an antiretroviral agent. therefore, nevirapine should always be administered in combination with at least two additional antiretroviral agents.

Australia - inglés - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - nevirapine hemihydrate, quantity: 10.35 mg/ml (equivalent: nevirapine, qty 10 mg/ml) - oral liquid, suspension - excipient ingredients: purified water; sorbitol solution (70 per cent) (non-crystallising); propyl hydroxybenzoate; sodium hydroxide; carbomer 934p; polysorbate 80; sucrose; methyl hydroxybenzoate - viramune (nevirapine) oral suspension in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and children over the age of 2 months. viramune xr (nevirapine) extended-release tablets in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and children over the age of three years. extended-release tablets are not suitable for the 14 day lead-in period for patients starting nevirapine. other nevirapine formulations, such as immediate-release tablets or oral suspension should be used. resistant virus emerges rapidly when viramune is administered as monotherapy or in dual combination therapy with an antiretroviral agent. therefore, viramune should always be administered in combination with at least two additional antiretroviral agents.

Australia - inglés - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - nevirapine, quantity: 400 mg - tablet, modified release - excipient ingredients: methylcellulose; iron oxide yellow; hypromellose; magnesium stearate - nevirapine modified release tablet in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and children over the age of three years.,modified release tablets are not suitable for the 14 day lead-in period for patients starting nevirapine. other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.,resistant virus emerges rapidly when nevirapine is administered as monotherapy or in dual combination therapy with an antiretroviral agent. therefore, nevirapine should always be administered in combination with at least two additional antiretroviral agents.

Australia - inglés - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - nevirapine, quantity: 400 mg - tablet, modified release - excipient ingredients: methylcellulose; iron oxide yellow; hypromellose; magnesium stearate - nevirapine modified release tablet in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and children over the age of three years.,modified release tablets are not suitable for the 14 day lead-in period for patients starting nevirapine. other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.,resistant virus emerges rapidly when nevirapine is administered as monotherapy or in dual combination therapy with an antiretroviral agent. therefore, nevirapine should always be administered in combination with at least two additional antiretroviral agents.

Israel - inglés - Ministry of Health

boehringer ingelheim israel ltd. - nevirapine - tablets - nevirapine 200 mg - nevirapine - nevirapine - for use in combination with other antiretroviral agents for the treatment of hiv-1 infection.

Unión Europea - inglés - EMA (European Medicines Agency)

teva b.v.  - nevirapine - hiv infections - antivirals for systemic use - nevirapine teva is indicated in combination with other anti-retroviral medicinal products for the treatment of hiv 1 infected adults, adolescents, and children of any age.most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (nrtis). the choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing.