Bangladesh - English - DGDA (Directorate General of Drug Administration)

neptune laboratories ltd. - chirata - capsule

Bangladesh - English - DGDA (Directorate General of Drug Administration)

novarine pharmaceuticals (unani) - chirata - capsule

Bangladesh - English - DGDA (Directorate General of Drug Administration)

s. s. pharmaceuticals (unani) - chirata - capsule

Philippines - English - FDA (Food And Drug Administration)

chira pharmaceuticals, inc.; distributor: chira pharmaceuticals, inc. - clopidogrel (as bisulfate) , aspirin - capsule - 75mg/ 75mg

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

takeda pharmaceuticals america, inc. - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon 8 mg - rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)] . patients who develop angioedema after treatment with rozerem should not be rechallenged with the drug. patients should not take rozerem in conjunction with fluvoxamine [see drug interactions (7)] . risk summary available data from postmarketing reports with rozerem use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses greater than 36 times the rec

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

sun pharmaceutical industries, inc. - ambrisentan (unii: hw6nv07qec) (ambrisentan - unii:hw6nv07qec) - ambrisentan is indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1): • to improve exercise ability and delay clinical worsening. studies establishing effectiveness included predominantly patients with who functional class ii–iii symptoms and etiologies of idiopathic or heritable pah (60%) or pah associated with connective tissue diseases (34%). ambrisentan may cause fetal harm when administered to a pregnant female. ambrisentan is contraindicated in females who are pregnant. ambrisentan was consistently shown to have teratogenic effects when administered to animals. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.1, 5.2) and use in specific populations (8.1)] . ambrisentan is contraindicated in patients with idiopathic pulmonary fibrosis (ipf), including ipf patients with pulmonary hypertension (who group 3) [see clinical studies (14.4)]. risk summary based on data from animal reproduction studies, ambrisentan may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy. there are limited data on ambrisentan use in pregnant women. in animal reproduction studies, ambrisentan was teratogenic in rats and rabbits at doses which resulted in exposures of 3.5 and 1.7 times, respectively, the human dose of 10 mg per day [see animal data] . if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential hazard to a fetus [see contraindications (4.1), warnings and precautions (5.1)] . the estimated 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. data animal data ambrisentan was teratogenic at oral dosages of ≥15 mg/kg/day (auc 51.7 h•mcg/ml) in rats and ≥7 mg/kg/day (24.7 h•mcg/ml) in rabbits; it was not studied at lower dosages. these dosages are of 3.5 and 1.7 times, respectively, the human dose of 10 mg per day (14.8 h•mcg/ml) based on auc. in both species, there were abnormalities of the lower jaw and hard and soft palate, malformation of the heart and great vessels, and failure of formation of the thymus and thyroid. a preclinical study in rats has shown decreased survival of newborn pups (mid and high dosages) and effects on testicle size and fertility of pups (high dosage) following maternal treatment with ambrisentan from late gestation through weaning. the mid and high dosages were 51 x, and 170 x (on a mg/m2 body surface area basis) the maximum oral human dose of 10 mg and an average adult body weight of 70 kg. these effects were absent at a maternal dosage 17 x the human dose based on mg/m2 . risk summary it is not known whether ambrisentan is present in human milk. because many drugs are present in human milk and because of the potential for serious adverse reactions in breastfed infants from ambrisentan, a decision should be made whether to discontinue breastfeeding or discontinue ambrisentan, taking into account the importance of the drug to the mother. pregnancy testing female patients of reproductive potential must have a negative pregnancy test prior to initiation of treatment, monthly pregnancy test during treatment, and pregnancy test 1 month after stopping treatment with ambrisentan. advise patients to contact their healthcare provider if they become pregnant or suspect they may be pregnant. perform a pregnancy test if pregnancy is suspected for any reason. for positive pregnancy tests, counsel patient on the potential risk to the fetus and patient options [see boxed warning and dosage and administration (2.2)].  contraception female patients of reproductive potential must use acceptable methods of contraception during treatment with ambrisentan and for 1 month after stopping treatment with ambrisentan. patients may choose one highly effective form of contraception (intrauterine device (iud), contraceptive implant, or tubal sterilization) or a combination of methods (hormone method with a barrier method or two barrier methods). if a partner’s vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method. counsel patients on pregnancy planning and prevention, including emergency contraception, or designate counseling by another healthcare provider trained in contraceptive counseling [see boxed warning]. infertility males in a 6-month study of another endothelin receptor antagonist, bosentan, 25 male patients with who functional class iii and iv pah and normal baseline sperm count were evaluated for effects on testicular function. there was a decline in sperm count of at least 50% in 25% of the patients after 3 or 6 months of treatment with bosentan. one patient developed marked oligospermia at 3 months, and the sperm count remained low with 2 follow-up measurements over the subsequent 6 weeks. bosentan was discontinued and after 2 months the sperm count had returned to baseline levels. in 22 patients who completed 6 months of treatment, sperm count remained within the normal range and no changes in sperm morphology, sperm motility, or hormone levels were observed. based on these findings and preclinical data [see nonclinical toxicology (13.1)] from endothelin receptor antagonists, it cannot be excluded that endothelin receptor antagonists such as ambrisentan have an adverse effect on spermatogenesis. counsel patients about the potential effects on fertility [see warnings and precautions (5.5)] . safety and effectiveness of ambrisentan in pediatric patients have not been established. juvenile animal data in juvenile rats administered ambrisentan orally once daily during postnatal day 7 to 26, 36, or 62, a decrease in brain weight (−3% to −8%) with no morphologic or neurobehavioral changes occurred after breathing sounds, apnea, and hypoxia were observed, at exposures approximately 1.8 to 7.0 times human pediatric exposures at 10 mg, based on auc. in the two placebo-controlled clinical studies of ambrisentan, 21% of patients were ≥65 years old and 5% were ≥75 years old. the elderly (age ≥65 years) showed less improvement in walk distances with ambrisentan than younger patients did, but the results of such subgroup analyses must be interpreted cautiously. peripheral edema was more common in the elderly than in younger patients. the impact of renal impairment on the pharmacokinetics of ambrisentan has been examined using a population pharmacokinetic approach in pah patients with creatinine clearances ranging between 20 and 150 ml/min. there was no significant impact of mild or moderate renal impairment on exposure to ambrisentan [see clinical pharmacology (12.3)] . dose adjustment of ambrisentan in patients with mild or moderate renal impairment is therefore not required. there is no information on the exposure to ambrisentan in patients with severe renal impairment. the impact of hemodialysis on the disposition of ambrisentan has not been investigated. preexisting hepatic impairment the influence of preexisting hepatic impairment on the pharmacokinetics of ambrisentan has not been evaluated. because there is in vitro and in vivo evidence of significant metabolic and biliary contribution to the elimination of ambrisentan, hepatic impairment might be expected to have significant effects on the pharmacokinetics of ambrisentan [see clinical pharmacology (12.3)] . ambrisentan is not recommended in patients with moderate or severe hepatic impairment. there is no information on the use of ambrisentan in patients with mild preexisting impaired liver function; however, exposure to ambrisentan may be increased in these patients. elevation of liver transaminases other endothelin receptor antagonists (eras) have been associated with aminotransferase (ast, alt) elevations, hepatotoxicity, and cases of liver failure [see adverse reactions (6.1, 6.2)]. in patients who develop hepatic impairment after ambrisentan initiation, the cause of liver injury should be fully investigated. discontinue ambrisentan if elevations of liver aminotransferases are >5 x uln or if elevations are accompanied by bilirubin >2 x uln, or by signs or symptoms of liver dysfunction and other causes are excluded.

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

zydus pharmaceuticals usa inc. - ambrisentan (unii: hw6nv07qec) (ambrisentan - unii:hw6nv07qec) - ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1): - to improve exercise ability and delay clinical worsening. studies establishing effectiveness included predominantly patients with who functional class ii–iii symptoms and etiologies of idiopathic or heritable pah (60%) or pah associated with connective tissue diseases (34%). ambrisentan may cause fetal harm when administered to a pregnant female. ambrisentan is contraindicated in females who are pregnant. ambrisentan was consistently shown to have teratogenic effects when administered to animals. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.1, 5.2) and use in specific populations (8.1)] . ambrisentan is contraindicated in patients with idiopathic pulmonary fibrosis (ipf), including ipf patients with pulmonary hypertension (who group 3) [see clinic

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

zydus pharmaceuticals usa inc. - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)] . patients who develop angioedema after treatment with ramelteon should not be rechallenged with the drug. patients should not take ramelteon in conjunction with fluvoxamine [see drug interactions (7)] . risk summary available data from postmarketing reports with ramelteon use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses greater than

Malta - English - Medicines Authority

kern pharma, s.l. polígono industrial colón ii calle venus 72 08228, terrassa, barcelona , spain - film-coated tablet - sitagliptin 50 mg metformin hydrochloride 850 mg - drugs used in diabetes

Malta - English - Medicines Authority

kern pharma, s.l. polígono industrial colón ii calle venus 72 08228, terrassa, barcelona , spain - film-coated tablet - sitagliptin 50 mg metformin hydrochloride 1000 mg - drugs used in diabetes