European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - lopinavir/ritonavir - hiv infections - antivirals for systemic use, - lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infected adults, adolescents and children above the age of 2 years.the choice of lopinavir/ritonavir to treat protease inhibitor experienced hiv-1 infected patients should be based on individual viral resistance testing and treatment history of patients.

European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - lopinavir/ritonavir - hiv infections - antivirals for systemic use, - lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infected adults, adolescents and children above the age of 2 years.the choice of lopinavir/ritonavir to treat protease inhibitor experienced hiv-1 infected patients should be based on individual viral resistance testing and treatment history of patients.

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

remedyrepack inc. - ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - ritonavir 100 mg - ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. - when co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. - ritonavir is contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (ten) or stevens-johnson syndrome) to ritonavir or any of its ingredients. - ritonavir is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions. - ritonavir is contraindicated with drugs that are potent cyp3a inducers where significantly reduced lopinavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance and cross-resistance. drug class drugs within class that are contraindicated with ritonavir 2 clinical comments alpha 1 -adreno

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

zydus pharmaceuticals usa inc - ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - ritonavir 100 mg - ritonavir is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. - when co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. - ritonavir is contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (ten) or stevens-johnson syndrome) to ritonavir or any of its ingredients. - ritonavir is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see drug interactions (7.1) and clinical pharmacology (12.3)] . alpha 1- adrenoreceptor antagonist : alfuzosin antianginal: ranolazine antiarrhythmics: amiodarone, dronedarone, flecainide, propafenone, quinidine antifungal: voriconazole anti-gout: colchicine antipsychotics: lurasidone, pimozide ergot derivatives: dih

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - lopinavir 100mg; ritonavir 25mg;   - film coated tablet - 100mg/25mg - active: lopinavir 100mg ritonavir 25mg   excipient: colloidal silicon dioxide copovidone opadry white 20c580015 sodium stearyl fumarate sorbitan laurate - lopinavir/ritonavir mylan is indicated for the treatment of hiv-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - lopinavir 200mg; ritonavir 50mg;   - film coated tablet - 200mg/50mg - active: lopinavir 200mg ritonavir 50mg   excipient: colloidal silicon dioxide copovidone opadry white 20c580015 sodium stearyl fumarate sorbitan laurate - lopinavir/ritonavir mylan is indicated for the treatment of hiv-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older.

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

camber pharmaceuticals, inc. - ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. • when co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. • ritonavir is contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (ten) or stevens-johnson syndrome) to ritonavir or any of its ingredients. • ritonavir is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions  [see drug interactions ( 7.1) and clinical pharmacology ( 12.3)].     o  alpha 1- adrenoreceptor antagonist : alfuzosin     o  antianginal: ranolazine     o  antiarrhythmics: amiodarone, dronedarone, flecainide, propafenone, quinidine

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

west-ward pharmaceuticals corp. - ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - ritonavir 100 mg - ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. when co-administering ritonavir with other protease inhibitors, see the full prescribing information for the co-administered protease inhibitor including important information for use in special populations. pregnancy exposure registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ritonavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1–800–258–4263. risk summary: prospective pregnancy data from the antiretroviral pregnancy registry (apr) are not sufficient to adequately assess the risk of birth defects or miscarriage. available data from the apr show no difference in the rate of overall birth defects for ritonavir compared to the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp) [see data] . in animal reproduction studies, no evidence of adverse developmental outcomes was observed with oral administration of ritonavir to pregnant rats and rabbits. during organogenesis in the rat and rabbit, systemic exposure (auc) was approximately 1/3 lower than human exposure at the recommended daily dose. in the rat pre- and post-natal developmental study, maternal systemic exposure to ritonavir was approximately 1/2 of the exposure in humans at the recommended daily dose, based on a body surface area conversion factor [see data] . ritonavir oral solution is not recommended during pregnancy because there is no known safe level of ethanol exposure during pregnancy [see clinical considerations, dosage and administration (2.3) and warnings and precautions (5.2)] . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations: dose adjustments during pregnancy and the postpartum period: ritonavir oral solution contains approx. 43% ethanol (v/v) and approx. 27% (w/v) propylene glycol and is not recommended during pregnancy because there is no known safe level of ethanol exposure during pregnancy [see dosage and administration (2.3) and warnings and precautions (5.2)] . data: human data: based on prospective reports to the apr of approximately 6,100 live births following exposure to ritonavir-containing regimens (including over 2,800 live births exposed in the first trimester and over 3,200 live births exposed in the second and third trimesters), there was no difference in the rate of overall birth defects for ritonavir compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of birth defects in live births was 2.3% (95% ci: 1.7% to 2.9%) following first-trimester exposure to ritonavir-containing regimens and 2.9% (95% ci: 2.3% to 3.5%) following second and third trimester exposure to ritonavir-containing regimens. while placental transfer of ritonavir and fetal ritonavir concentrations are generally low, detectable levels have been observed in cord blood samples and neonate hair. animal data: ritonavir was administered orally to pregnant rats (at 0, 15, 35, and 75 mg/kg/day) and rabbits (at 0, 25, 50, and 110 mg/kg/day) during organogenesis (on gestation days 6 through 17 and 6 through 19, respectively). no evidence of teratogenicity due to ritonavir was observed in rats and rabbits at doses producing systemic exposures (auc) equivalent to approximately 1/3 lower than human exposure at the recommended daily dose. developmental toxicity observed in rats (early resorptions, decreased fetal body weight and ossification delays and developmental variations) occurred at a maternally toxic dose, at an exposure equivalent to approximately 1/3 lower than human exposure at the recommended daily dose. a slight increase in the incidence of cryptorchidism was also noted in rats (at a maternally toxic dose) at an exposure approximately 1/5 lower than human exposure at the recommended daily dose. developmental toxicity was observed in rabbits (resorptions, decreased litter size and decreased fetal weights) at maternally toxic doses approximately 1.8 times higher than the recommended daily dose, based on a body surface area conversion factor. in pre-and postnatal development study in rats, ritonavir was administered at doses of 0, 15, 35, and 60 mg/kg/day from gestation day 6 through postnatal day 20. at doses of 60 mg/kg/day, no developmental toxicity was noted with ritonavir dosage equivalent to 1/2 of the recommended daily dose, based on a body surface area conversion factor. risk summary: the centers for disease control and prevention recommend that hiv-infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv. limited published data reports that ritonavir is present in human milk. there is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. because of the potential for (1) hiv transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants) and (3) serious adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving ritonavir. contraception: use of ritonavir may reduce the efficacy of combined hormonal contraceptives. advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception [see drug interactions (7.2)] . in hiv-infected patients age greater than 1 month to 21 years, the antiviral activity and adverse event profile seen during clinical trials and through postmarketing experience were similar to that for adult patients. clinical studies of ritonavir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. no dose adjustment of ritonavir is necessary for patients with either mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment. no pharmacokinetic or safety data are available regarding the use of ritonavir in subjects with severe hepatic impairment (child-pugh class c), therefore, ritonavir is not recommended for use in patients with severe hepatic impairment [see warnings and precautions (5.3), clinical pharmacology (12.3)].

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

cipla usa inc. - ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. - when co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. - ritonavir is contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (ten) or stevens-johnson syndrome) to ritonavir or any of its ingredients. - ritonavir is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see drug interactions (7.1) and clinical pharmacology (12.3)] . o   alpha 1- adrenoreceptor antagonist: alfuzosin o   antianginal: ranolazine o   antiarrhythmics: amiodarone, dronedarone, flecainide, propafenone, quinidine o   antifungal: voriconazole o   anti-gout: colchicine o   antipsychotics: lurasidone, pimozide o   ergot derivatives: dihydroergotam

Kenya - English - Pharmacy and Poisons Board

lopinavir/ritonavir - tablet - lopinavir usp 100mg, ritonavir usp 25mg - lopinavir and ritonavir