Canada - inglese - Health Canada

torrent pharmaceuticals limited - levetiracetam - tablet - 750mg - levetiracetam 750mg - miscellaneous anticonvulsants

Canada - inglese - Health Canada

torrent pharmaceuticals limited - pioglitazone (pioglitazone hydrochloride) - tablet - 15mg - pioglitazone (pioglitazone hydrochloride) 15mg - thiazolidinediones

Canada - inglese - Health Canada

torrent pharmaceuticals limited - pioglitazone (pioglitazone hydrochloride) - tablet - 30mg - pioglitazone (pioglitazone hydrochloride) 30mg - thiazolidinediones

Canada - inglese - Health Canada

torrent pharmaceuticals limited - pioglitazone (pioglitazone hydrochloride) - tablet - 45mg - pioglitazone (pioglitazone hydrochloride) 45mg - thiazolidinediones

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

torrent pharmaceuticals limited - nebivolol hydrochloride (unii: jgs34j7l9i) (nebivolol - unii:030y90569u) - nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [see clinical studies (14.1)] . nebivolol tablets may be used alone or in combination with other antihypertensive agents [see drug interactions (7)] . lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with nebivolol tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. nebivolol is contraindicated in the following conditions: - severe bradycardia - heart block greater than first degree - patients with cardiogenic shock - decompensated cardiac failure - sick sinus syndrome (unless a permanent pacemaker is in place) - patients with severe hepatic impairment (child-pugh >b) - patients who are hypersensitive to any component of this product. risk summary available data regarding use of nebivolol tablets in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes.  there are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy.  the use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in the neonate [see clinical considerations] . oral administration of nebivolol to pregnant rats during organogenesis resulted in embryofetal and perinatal lethality at doses approximately equivalent to the maximum recommended human dose (mrhd). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 disease-associated maternal and/or embryo/fetal risk hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. fetal/neonatal adverse reactions neonates of women with hypertension, who are treated with beta-blockers during the third trimester of pregnancy, may be at increased risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. observe newborns for symptoms of hypotension, bradycardia, hypoglycemia and respiratory depression and manage accordingly. data animal data nebivolol was shown to increase embryo-fetal and perinatal lethality in rats at approximately 1.2 times the mrhd or 40 mg/day on a mg/m2 basis. decreased pup body weights occurred at 1.25 and 2.5 mg/kg in rats, when exposed during the perinatal period (late gestation, parturition and lactation). at 5 mg/kg and higher doses (1.2 times the mrhd), prolonged gestation, dystocia and reduced maternal care were produced with corresponding increases in late fetal deaths and stillbirths and decreased birth weight, live litter size and pup survival. these events occurred only when nebivolol was given during the perinatal period (late gestation, parturition and lactation). insufficient numbers of pups survived at 5 mg/kg to evaluate the offspring for reproductive performance. in studies in which pregnant rats were given nebivolol during organogenesis, reduced fetal body weights were observed at maternally toxic doses of 20 and 40 mg/kg/day (5 and 10 times the mrhd), and small reversible delays in sternal and thoracic ossification associated with the reduced fetal body weights and a small increase in resorption occurred at 40 mg/kg/day (10 times the mrhd). no adverse effects on embryo-fetal viability, sex, weight or morphology were observed in studies in which nebivolol was given to pregnant rabbits at doses as high as 20 mg/kg/day (10 times the mrhd). risk summary there is no information regarding the presence of nebivolol in human milk, the effects on the breastfed infant, or the effects on milk production.  nebivolol is present in rat milk [see data]. because of the potential for β-blockers to produce serious adverse reactions in nursing infants, especially bradycardia, nebivolol tablets are not recommended during nursing. data in lactating rats, maximum milk levels of unchanged nebivolol were observed at 4 hours after single and repeat doses of 2.5 mg/kg/day. the daily dose (mg/kg body weight) ingested by a rat pup is 0.3% of the dam dose for unchanged nebivolol. safety and effectiveness in pediatric patients have not been established. pediatric studies in ages newborn to 18 years old have not been conducted because of incomplete characterization of developmental toxicity and possible adverse effects on long-term fertility [see nonclinical toxicology (13.1)] . juvenile animal toxicity data daily oral doses of nebivolol to juvenile rats from post-natal day 14 to post-natal day 27 showed sudden unexplained death at exposures equal to those in human poor metabolizers given a single dose of 10 mg. no mortality was seen at half the adult human exposure. in surviving rats, cardiomyopathy was seen at exposures greater than or equal to the human exposure. male rat pups exposed to twice the human exposure showed decreases in total sperm count as well as decreases in the total and percentage of motile sperm. of the 2,800 patients in the u.s. sponsored placebo-controlled clinical hypertension studies, 478 patients were 65 years of age or older. no overall differences in efficacy or in the incidence of adverse events were observed between older and younger patients. in a placebo-controlled trial of 2,128 patients (1,067 nebivolol, 1,061 placebo) over 70 years of age with chronic heart failure receiving a maximum dose of 10 mg per day for a median of 20 months, no worsening of heart failure was reported with nebivolol compared to placebo. however, if heart failure worsens consider discontinuation of nebivolol tablets.

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

torrent pharmaceuticals limited - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - sirolimus oral solution is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. in patients at low-to moderate-immunologic risk , it is recommended that sirolimus oral solution be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see dosage and administration ( 2.2)] . in patients at high-immunologic risk (defined as black recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high panel-reactive antibodies [pra;peak pra level >80%]), it is recommended that sirolimus oral solution be used in combination with cyclosporine and corticosteroids for the first year following transplantation [see dosage and administration ( 2.3), clinical studies ( 14.3) ]. cyclosporine withdrawal has not be

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

torrent pharmaceuticals limited - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpidem tartrate tablets, usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets, usp have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see clinical studies (14)] . the clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients  - who have experienced complex sleep behaviors after taking zolpidem tartrate tablets [see warnings and precautions ( 5.1)] .  - with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions ( 5.4)] . risk summary neonates born to mothers using zolpidem late in the third trimester

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

torrent pharmaceuticals limited - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic

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

torrent pharmaceuticals limited - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 25 mg - sertraline tablets is indicated for the treatment of the following [see clinical studies (14)]: •    major depressive disorder (mdd) •    obsessive-compulsive disorder (ocd) •    panic disorder (pd) •    posttraumatic stress disorder (ptsd) •    social anxiety disorder (sad) •    premenstrual dysphoric disorder (pmdd) sertraline tablets is contraindicated in patients: •     taking, or within 14 days of stopping, maois, (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)]. •    taking pimozide [see drug interactions (7.1)]. •   with known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [see adverse reactions (6.1, 6.2)]. risk summary overall, available published epidemiologic studies of pregnant women exposed to sertraline hydrochloride in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in

Regno Unito - inglese - MHRA (Medicines & Healthcare Products Regulatory Agency)

torrent pharma (uk) ltd - montelukast sodium - oral tablet - 10mg