الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

doh central pharmacy - lopinavir (unii: 2494g1jf75) (lopinavir - unii:2494g1jf75), ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - lopinavir 200 mg - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. the following points should be considered when initiating therapy with kaletra: - the use of other active agents with kaletra is associated with a greater likelihood of treatment response [see clinical pharmacology (12.4) and clinical studies (14)] . - genotypic or phenotypic testing and/or treatment history should guide the use of kaletra [see clinical pharmacology (12.4)] . the number of baseline primary protease inhibitor mutations affects the virologic response to kaletra [see clinical pharmacology (12.4)] . - once daily administration of kaletra is not recommended for therapy-experienced adult patients or any pediatric patients. ● kaletra is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme) to any of its ingredients, including ritonavir. ●  co-administration of kaletra is contraindicated with drugs t

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

rebel distributors corp - lopinavir (unii: 2494g1jf75) (lopinavir - unii:2494g1jf75), ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - lopinavir 200 mg - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. the following points should be considered when initiating therapy with kaletra: - the use of other active agents with kaletra is associated with a greater likelihood of treatment response [see clinical pharmacology (12.4) and clinical studies (14)] . - genotypic or phenotypic testing and/or treatment history should guide the use of kaletra [see clinical pharmacology (12.4)] . the number of baseline lopinavir resistance-associated substitutions affects the virologic response to kaletra [see clinical pharmacology (12.4)] . - once daily administration of kaletra is not recommended for any pediatric patients. ● kaletra is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, stevens-johnson syndrome, erythema multiforme) to any of its ingredients, including ritonavir. ●  co-administration of kaletra is contraindicated with drugs th

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

hhs/program support center/supply service center - lopinavir (unii: 2494g1jf75) (lopinavir - unii:2494g1jf75), ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - lopinavir 200 mg - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. the following points should be considered when initiating therapy with kaletra: - the use of other active agents with kaletra is associated with a greater likelihood of treatment response [see clinical pharmacology (12.4) and clinical studies (14)] . - genotypic or phenotypic testing and/or treatment history should guide the use of kaletra [see clinical pharmacology (12.4)] . the number of baseline lopinavir resistance-associated substitutions affects the virologic response to kaletra [see clinical pharmacology (12.4)] . - once daily administration of kaletra is not recommended for any pediatric patients. - kaletra is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, stevens-johnson syndrome, erythema multiforme) to any of its ingredients, including ritonavir. - co-administration of kaletra is contraindicated with drugs th

الولايات المتحدة - الإنجليزية - 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

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

amneal pharmaceuticals llc - 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 tablets are 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: dihydroergotamine, ergotamine, methylergonovine gi motility agent: cisapride hmg-coa reductase inhibitors: lovastatin, simvastatin microsomal triglyceride transfer protein (mttp) inhibitor: lomitapide pde5 inhibitor: sildenafil (revatio® ) when used for the treatment of pulmonary arterial hypertension sedative/hypnotics: triazolam, orally administered midazolam - alpha 1- adrenoreceptor antagonist: alfuzosin - antianginal: ranolazine - antiarrhythmics: amiodarone, dronedarone, flecainide, propafenone, quinidine - antifungal: voriconazole - anti-gout: colchicine - antipsychotics: lurasidone, pimozide - ergot derivatives: dihydroergotamine, ergotamine, methylergonovine - gi motility agent: cisapride - hmg-coa reductase inhibitors: lovastatin, simvastatin - microsomal triglyceride transfer protein (mttp) inhibitor: lomitapide - pde5 inhibitor: sildenafil (revatio® ) when used for the treatment of pulmonary arterial hypertension - sedative/hypnotics: triazolam, orally administered midazolam - ritonavir is contraindicated with drugs that are potent cyp3a inducers where significantly reduced ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance and cross-resistance [see drug interactions (7.2) and clinical pharmacology (12.3)] . - anticancer agents: apalutamide - herbal products: st. john's wort (hypericum perforatum) 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 alcohol 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 alcohol and propylene glycol and is not recommended during pregnancy because there is no known safe level of alcohol exposure during pregnancy [see dosage and administration (2.3)  and warnings and precautions (5.2)] . human data based on prospective reports to the apr of approximately 6100 live births following exposure to ritonavir-containing regimens (including over 2800 live births exposed in the first trimester and over 3200 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)] .

أيرلندا - الإنجليزية - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - ritonavir - film-coated tablet - 100 milligram(s) - protease inhibitors; ritonavir

إسرائيل - الإنجليزية - Ministry of Health

abbvie biopharmaceuticals ltd, israel - lopinavir; ritonavir - solution (oral) - ritonavir 20 mg/ml; lopinavir 80 mg/ml - ritonavir - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection.

إسرائيل - الإنجليزية - Ministry of Health

abbvie biopharmaceuticals ltd, israel - lopinavir; ritonavir - solution (oral) - ritonavir 20 mg/ml; lopinavir 80 mg/ml - ritonavir - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection.

تانزانيا - الإنجليزية - Tanzania Medicinces & Medical Devices Authority

mylan laboratories limited, india - lopinavir , ritonavir - tablets - 100+25

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - lopinavir (unii: 2494g1jf75) (lopinavir - unii:2494g1jf75), ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 14 days and older. limitations of use:  • genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. the number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see microbiology (12.4)]. • lopinavir and ritonavir tablets are contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, stevens-johnson syndrome, erythema multiforme, urticaria, angioedema) to any of its ingredients, including ritonavir. • lopinavir and ritonavir tablets are contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious an