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

aurobindo pharma limited - nevirapine hemihydrate (unii: b7xf2td73c) (nevirapine - unii:99dk7fvk1h) - nevirapine 50 mg in 5 ml - nevirapine oral suspension 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 oral suspension 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 oral suspension is 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 exp

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

cipla usa inc. - nevirapine hemihydrate (unii: b7xf2td73c) (nevirapine - unii:99dk7fvk1h) - 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 oral suspension is 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 t

Australia - English - 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.

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

state of florida doh central pharmacy - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine tablets are indicated for use in combination with other antiretroviral agents for the treatment of hiv-1 infection. this indication is based on one principal clinical trial (bi 1090) that demonstrated prolonged suppression of hiv-1 rna and two smaller supportive trials, one of which (bi 1046) is described below. additional important information regarding the use of nevirapine tablets for the treatment of hiv-1 infection: - based on serious and life threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets 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/mm3 unless the benefit outweighs the risk [see boxed warning and warnings and precautions (5.1) ]. - the 14-day lead-in period with nevirapine tablets 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [see dosage and administration (2.4) and warnings and

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

aurobindo pharma limited - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - 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 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)]. pregnancy exposure registry there is a p

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

micro labs limited - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine tablet 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 tablet is 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/mm 3 [see warnings and precautions (5.1)] . nevirapine is 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 po

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

breckenridge pharmaceutical, inc. - 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: nevirapine is 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 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 the u.s. reference population of the metropolitan atlanta congenital defects program (m

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