Stati Uniti - inglese - NLM (National Library of Medicine)

torrent pharmaceuticals limited - tadalafil (unii: 742sxx0ict) (tadalafil - unii:742sxx0ict) - tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to improve exercise ability. studies establishing effectiveness included predominately patients with nyha functional class ii – iii symptoms and etiologies of idiopathic or heritable pah (61%) or pah associated with connective tissue diseases (23%). tadalafil is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. do not use nitrates within 48 hours of the lst dose of tadalafil. tadalafil potentiates the hypotensive effect of nitrates. this potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cgmp pathway [see clinical pharmacology ( 12.2)] . coadministration of gc stimulators, such as riociguat with tadalafil is contraindicated. tadalafil may potentiate the hypotensive effects of gc stimulators. tadalafil is contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets). hypersensitivity reactions have been reported, including stevens-johnson syndrome and exfoliative dermatitis [see adverse reactions ( 6.2)] . risk summary limited data from case series with tadalafil use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures 7 times the exposure at the maximum recommended human dose (mrhd) of 40 mg/day based on auc (see data) . 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death. data animal data tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats. animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at unbound tadalafil exposures up to 7 times the exposure at the maximum recommended human dose (mrhd) of 40 mg/day during organogenesis based on auc. in one of two perinatal/postnatal developmental studies in rats, a reduction of postnatal pup survival was observed at dose levels of 60, 200 and 1,000 mg/kg. the no-observed effect-level (noel) for developmental toxicity was 30 mg/kg, which provided maternal exposure to unbound tadalafil concentrations approximately 5 times the exposure at the mrhd based on auc. signs of maternal toxicity occurred at doses greater than 200 mg/kg/day, which produced aucs greater than 8 times the exposure at the mrhd. surviving offspring had normal development and reproductive performance. risk summary there are no data on the presence of tadalafil and/or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately 2.4-times that found in the plasma. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tadalafil tablets and any potential adverse effects on the breastfed child from tadalafil tablets or from the underlying maternal condition. infertility males based on the data from 3 studies in adult males, tadalafil decreased sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months. this effect was not seen in the study of 20 mg tadalafil taken for 6 months. there was no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of testosterone, luteinizing hormone or follicle stimulating hormone. the clinical significance of the decreased sperm concentrations in the two studies is unknown. there have been no studies evaluating the effect of tadalafil on fertility in men or women [see clinical pharmacology ( 12.2)] . safety and effectiveness of tadalafil tablets in pediatric patients have not been established. of the total number of subjects in the clinical study of tadalafil for pulmonary arterial hypertension, 28 percent were 65 and over, while 8 percent were 75 and over. no overall differences in safety were observed between subjects over 65 years of age compared to younger subjects or those over 75 years of age. no dose adjustment is warranted based on age alone; however, a greater sensitivity to medications in some older individuals should be considered. [see clinical pharmacology ( 12.3)] . for patients with mild or moderate renal impairment, start tadalafil tablets at 20 mg once daily. increase the dose to 40 mg once daily based upon individual tolerability [see dosage and administration ( 2.2), and clinical pharmacology ( 12.3)] . in patients with severe renal impairment, avoid use of tadalafil tablets because of increased tadalafil exposure (auc), limited clinical experience, and the lack of ability to influence clearance by dialysis  [see clinical pharmacology ( 12.3)] . because of limited clinical experience in patients with mild to moderate hepatic cirrhosis (child-pugh class a or b), consider a starting dose of tadalafil tablets 20 mg once daily. patients with severe hepatic cirrhosis (child-pugh class c) have not been studied, thus avoid use of tadalafil tablets in such patients [see dosage and administration ( 2.3), and clinical pharmacology ( 12.3)] .

Tanzania - inglese - Tanzania Medicinces & Medical Devices Authority

torrent pharmaceuticals limited, india - alfuzosin - tablets - 10mg

Filippine - inglese - FDA (Food And Drug Administration)

torrent pharma philippines, inc.; distributor: torrent pharma philippines, inc. - valsartan , hydrochlorothiazide - film-coated tablet - 320 mg / 25 mg

Filippine - inglese - FDA (Food And Drug Administration)

torrent pharma philippines, inc.; distributor: torrent pharma philippines, inc. - valsartan , hydrochlorothiazide - film-coated tablet - 320mg / 12.5mg

Filippine - inglese - FDA (Food And Drug Administration)

torrent pharma philippines, inc.; distributor: torrent pharma philippines, inc. - clopidogrel (as bisulfate) - film coated tablet - 75mg

Stati Uniti - inglese - NLM (National Library of Medicine)

torrent pharmaceuticals limited - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 20 mg - pantoprazole sodium delayed-release tablets are indicated for: pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months.   pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. - pantoprazole sodium is contraindicated in patients with k

Stati Uniti - inglese - NLM (National Library of Medicine)

torrent pharmaceuticals limited - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride 50 mg - trazodone hydrochloride tablets, usp are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ risk summary published prospective cohort studies, case series, and case reports over several decades with trazodone use in pregnant women have not identified any drug-associ

Stati Uniti - inglese - NLM (National Library of Medicine)

torrent pharmaceuticals limited - moxifloxacin hydrochloride (unii: c53598599t) (moxifloxacin - unii:u188xyd42p) - moxifloxacin 400 mg - moxifloxacin tablets are indicated in adult patients for the treatment of community acquired pneumonia caused by susceptible isolates of streptococcus pneumoniae (including multi-drug resistant streptococcus pneumoniae [mdrsp]), homophiles influenzae, moraxella catarrhalis, methicillin-susceptible staphylococcus aureus, klebsiella pneumoniae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see clinical studies ( 14.3)]. mdrsp isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [mic] ≥ 2 mcg/ml), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. moxifloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections caused by susceptible isolates of methicillin-susceptible staphylococcus aureus or stre

Stati Uniti - inglese - NLM (National Library of Medicine)

torrent pharmaceuticals limited - felodipine (unii: ol961r6o2c) (felodipine - unii:ol961r6o2c) - felodipine 2.5 mg - felodipine extended-release tablets are indicated for the treatment of hypertension. felodipine extended-release tablets may be used alone or concomitantly with other antihypertensive agents. felodipine extended-release tablets are contraindicated in patients who are hypersensitive to this product. safety and effectiveness in pediatric patients have not been established. clinical studies of felodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. pharmacokinetics, however, indicate that the availability of felodipine is increased in older patients (see clinical pharmacology: geriatric use). 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 conco

Stati Uniti - inglese - NLM (National Library of Medicine)

torrent pharmaceuticals limited - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: • major depressive disorder (mdd) [see clinical studies ( 14.1)] • generalized anxiety disorder (gad) [see clinical studies ( 14.2)] • social anxiety disorder (sad) [see clinical studies ( 14.3)] • panic disorder (pd) [see clinical studies ( 14.4)] venlafaxine hydrochloride extended-release capsules are contraindicated in patients: • with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see adverse reactions (6.2) ] . • taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of the risk of serotonin syndrome [see dosage and administration (2.11), warnings and precautions (5.2), and drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including effexor xr, duri