United States - English - NLM (National Library of Medicine)

carlsbad technology, inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine is indicated for combination antiretroviral treatment of hiv-1 infection in adults and in pediatrics patients 15 days and older [ see clinical studies ( 14.1), ( 14.2) ]. additional important information regarding the use of nevirapine for the treatment of hiv-1 infection: - based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine should not be initiated in adult females with cd4 + cell counts greater than 250 cells/mm3 or in adult males with cd4 + cell counts greater than 400 cells/mm 3 unless the benefit outweighs the risk [ see boxed warning and warnings and precautions ( 5.1) ]. - the 14-day lead-in period with nevirapine 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [ see dosage and administration (

United States - English - NLM (National Library of Medicine)

macleods pharmaceuticals limited - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 400 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: • adult females with cd4+ cell counts greater than 250 cells/mm3 or • adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)]. nevirapine extended-release tablets are contraindicated: • in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1) and use in specific populations (8.7)] . • for use as part of occupational and non-occupational

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - 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 to less than 18 years of age [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: - adult females with cd4+ cell counts greater than 250 cells/mm3 or - adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)]. nevirapine extended-release tablets are contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1) and use in specific populations (8.7)]. - for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and prec

United States - English - NLM (National Library of Medicine)

sandoz inc - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 400 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: pregnancy exposure registry 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. risk summary available data for nevirapine in pregnant women is from the use of nevirapine immediate-release. available data from the ap

United States - English - NLM (National Library of Medicine)

strides pharma science limited - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine tablets, usp is 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, usp is not recommended to be initiated, unless the benefit outweighs the risk, in: -   adult females with cd4+ cell counts greater than 250 cells/mm3 or -   adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)] . nevirapine tablets, usp are contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1) and use in specific populations (8.7)] - for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1)] . pregnancy exposure registry th

United States - English - NLM (National Library of Medicine)

cipla ltd. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine is 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 is not recommended to be initiated, unless the benefit outweighs the risk, in: -   adult females with cd4+ cell counts greater than 250 cells/mm3 or -   adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)] . nevirapine tablets are contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1) and use in specific populations (8.7)] - for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1)] . teratogenic effects pregnancy exposur

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

alphapharm pty ltd - nevirapine, quantity: 200 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; colloidal anhydrous silica; microcrystalline cellulose; sodium starch glycollate type a; magnesium stearate; povidone - nevirapine viatris in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults. 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 - English - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - nevirapine -

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

sun pharma anz pty ltd - nevirapine -

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

sun pharma anz pty ltd - nevirapine, quantity: 200 mg - tablet, uncoated - excipient ingredients: magnesium stearate; povidone; colloidal anhydrous silica; sodium starch glycollate type a; lactose monohydrate; microcrystalline cellulose - 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.