Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

laurus labs limited - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adult and pediatric patients weighing at least 35 kg. efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are contraindicated: - in patients with a previous hypersensitivity reaction (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components contained in the formulation [see warnings and precautions (5.8)] . - when coadministered with elbasvir and grazoprevir [see warnings and precautions (5.3) and drug interactions (7.5)]. pregnancy exposure registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to efavirenz, lamivudine and tenofovir disoproxil fumarate during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary: there are r

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

laurus labs limited - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), lamivudine (unii: 2t8q726o95) (lamivudine - unii:2t8q726o95), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adult and pediatric patients weighing at least 40 kg. efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are contraindicated: - in patients with a previous hypersensitivity reaction (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components contained in the formulation [see warnings and precautions (5.8)] . - when coadministered with elbasvir and grazoprevir [see warnings and precautions (5.3) and drug interactions (7.5)]. pregnancy exposure registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to efavirenz, lamivudine and tenofovir disoproxil fumarate during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary: there are r

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

laurus labs limited - fenofibric acid (unii: bgf9mn2hu1) (fenofibric acid - unii:bgf9mn2hu1) - fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce triglycerides (tg) in patients with severe hypertriglyceridemia. improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of fenofibric acid delayed-release capsules therapy on reducing this risk has not been adequately studied. fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (ldl-c), total cholesterol (total-c), triglycerides (tg), and apolipoprotein b (apo b), and to increase high-density lipoprotein cholesterol (hdl-c) in patients with primary hypercholesterolemia or mixed dyslipidemia. fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

laurus labs limited - fenofibrate (unii: u202363uos) (fenofibric acid - unii:bgf9mn2hu1) - fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (ldl-c), total cholesterol (total-c), triglycerides and apolipoprotein b (apo b), and to increase high-density lipoprotein cholesterol (hdl-c) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dl) may increase the risk of developing pancreatitis. the effect of fenofibrate therapy on reducing this risk has not been adequately studied. fenofibrate at a dose equivalent to 145 mg of fenofibrate tablet was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 d

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

laurus labs limited - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride tablets, usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with:  - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1) ].   - hypersensitivity to metformin.  - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data]. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations]. no adverse developmental effects were observed when met

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

laurus labs limited - efavirenz (unii: je6h2o27p8) (efavirenz - unii:je6h2o27p8), emtricitabine (unii: g70b4etf4s) (emtricitabine - unii:g70b4etf4s), tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients weighing at least 40 kg. - efavirenz, emtricitabine and tenofovir disoproxil fumarate is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets [see warnings and precautions (5.2)]. - efavirenz, emtricitabine and tenofovir disoproxil fumarate is contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see drug interactions (7.3) and clinical pharmacology (12.3)] . antiretroviral pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in adults and adolescents exposed to efavirenz, emtricitabine and tenofovir disoproxil

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

laurus labs limited - pirfenidone (unii: d7nld2jx7u) (pirfenidone - unii:d7nld2jx7u) - pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (ipf). none. risk summary the data with pirfenidone use in pregnant women are insufficient to inform on drug associated risks for major birth defects and miscarriage. in animal reproduction studies, pirfenidone was not teratogenic in rats and rabbits at oral doses up to 3 and 2 times, respectively, the maximum recommended daily dose (mrdd) in adults [see data] . 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. data animal data animal reproductive studies were conducted in rats and rabbits. in a combined fertility and embryofetal development study, female rats received pirfenidone at oral doses of 0, 50, 150, 450, and 1,000 mg/kg/day from 2 weeks prior to mating, during the mating phase, and throughout the periods of early embryonic development from gestation days (gd) 0 to 5 and organogenesis from gd 6 to 17. in an embryofetal development study, pregnant rabbits received pirfenidone at oral doses of 0, 30, 100, and 300 mg/kg/day throughout the period of organogenesis from gd 6 to 18. in these studies, pirfenidone at doses up to 3 and 2 times, respectively, the maximum recommended daily dose (mrdd) in adults (on mg/m2 basis at maternal oral doses up to 1,000 mg/kg/day in rats and 300 mg/kg/day in rabbits, respectively) revealed no evidence of impaired fertility or harm to the fetus due to pirfenidone. in the presence of maternal toxicity, acyclic/irregular cycles (e.g., prolonged estrous cycle) were seen in rats  at doses approximately equal to and higher than the mrdd in adults (on a mg/m2 basis at maternal doses of 450 mg/kg/day and higher). in a pre- and post-natal development study, female rats received pirfenidone at oral doses of 0, 100, 300, and 1,000 mg/kg/day from gd 7 to lactation day 20. prolongation of the gestation period, decreased numbers of live newborn, and reduced pup viability and body weights were seen in rats at an oral dosage approximately 3 times the mrdd in adults (on a mg/m2 basis at a maternal oral dose of 1,000 mg/kg/day). risk summary no information is available on the presence of pirfenidone in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. the lack of clinical data during lactation precludes clear determination of the risk of pirfenidone to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pirfenidone and the potential adverse effects on the breastfed child from pirfenidone or from the underlying maternal condition. data animal data: a study with radio-labeled pirfenidone in rats has shown that pirfenidone or its metabolites are excreted in milk. there are no data on the presence of pirfenidone or its metabolites in human milk, the effects of pirfenidone on the breastfed child, or its effects on milk production. safety and effectiveness of pirfenidone in pediatric patients have not been established. of the total number of subjects in the clinical studies receiving pirfenidone, 714 (67%) were 65 years old and over, while 231 (22%) were 75 years old and over. no overall differences in safety or effectiveness were observed between older and younger patients. no dosage adjustment is required based upon age. pirfenidone should be used with caution in patients with mild (child pugh class a) to moderate (child pugh class b) hepatic impairment. monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone as needed [ see dosage and administration (2.3)] . the safety, efficacy, and pharmacokinetics of pirfenidone have not been studied in patients with severe hepatic impairment. pirfenidone is not recommended for use in patients with severe (child pugh class c) hepatic impairment [see clinical pharmacology (12.3)] . pirfenidone should be used with caution in patients with mild (clcr 50 to 80 ml/min), moderate (clcr 30 to 50 ml/min), or severe (clcr less than 30 ml/min) renal impairment [see clinical pharmacology (12.3)]. monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone as needed [ see dosage and administration (2.3) ] . the safety, efficacy, and pharmacokinetics of pirfenidone have not been studied in patients with end-stage renal disease requiring dialysis. use of pirfenidone in patients with end-stage renal diseases requiring dialysis is not recommended. smoking causes decreased exposure to pirfenidone [see clinical pharmacology (12.3)], which may alter the efficacy profile of pirfenidone. instruct patients to stop smoking prior to treatment with pirfenidone and to avoid smoking when using pirfenidone.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

laurus generics inc. - ranolazine (unii: a6iez5m406) (ranolazine - unii:a6iez5m406) - ranolazine extended-release tablets is indicated for the treatment of chronic angina. ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid lowering therapy, ace inhibitors, and angiotensin receptor blockers. ranolazine extended-release tablets is contraindicated in patients: - taking strong inhibitors of cyp3a [ see drug interactions (7.1) ] - taking inducers of cyp3a [ see drug interactions (7.1) ] - with liver cirrhosis [ see use in specific populations (8.6) ] risk summary there are no available data on ranolazine extended-release tablets use in pregnant women to inform any drug associated risks. studies in rats and rabbits showed no evidence of fetal harm at exposures 4 times the maximum recommended human dose (mrhd) (see data) . in the u.s. general population, the estimated background risk of major bi