Estados Unidos - inglês - NLM (National Library of Medicine)

dr. reddy's laboratories limited - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficacy of venlaf

Estados Unidos - inglês - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - raloxifene hydrochloride tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)]. raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)]. raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4)] . the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4)]. twenty-seven percent of the participants received drug for 5 years. the long-term effects and the recommended length of treatment are not known. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypic

Estados Unidos - inglês - NLM (National Library of Medicine)

proficient rx lp - rabeprazole sodium (unii: 3l36p16u4r) (rabeprazole - unii:32828355ll) - rabeprazole sodium 20 mg - rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (gerd). for those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered. rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (gerd maintenance). controlled studies do not extend beyond 12 months. rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with gerd in adults for up to 4 weeks. rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. most patients heal within four weeks. rabeprazole

Estados Unidos - inglês - NLM (National Library of Medicine)

ohm laboratories inc. - valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i) - valsartan 40 mg - valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older. 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 valsartan principally belongs. there are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan 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 (e.g., 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. valsartan tablets may be used alone or in combination with other antihypertensive agents. additional pediatric use information is approved for novartis pharmaceuticals corporation's diovan (valsartan) tablets. however, due to novartis pharmaceuticals corporation's marketing exclusivity rights, this drug product is not labeled with that information. valsartan tablets are indicated to reduce the risk of hospitalization for heart failure in adult patients with heart failure (nyha class ii-iv). there is no evidence that valsartan tablets provide added benefits when it is used with an adequate dose of an angiotensin converting enzyme (ace) inhibitor [see clinical studies ( 14.2)]. in clinically stable adult patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, valsartan tablets are indicated to reduce the risk of cardiovascular mortality [see clinical studies ( 14.3)]. do not use in patients with known hypersensitivity to any component. do not coadminister aliskiren with valsartan tablets in patients with diabetes [see drug interactions ( 7.3)] . risk summary valsartan tablets can cause fetal harm when administered to a pregnant woman. use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan (see clinical considerations ). when pregnancy is detected, consider alternative drug treatment and discontinue valsartan tablets as soon as possible. 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 2-4% and 15-20%, 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 oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. in the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. in patients taking valsartan tablets during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. fetal testing may be appropriate, based on the week of gestation. patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. if oligohydramnios is observed, consider alternative drug treatment. closely observe neonates with histories of in utero exposure to valsartan tablets for hypotension, oliguria, and hyperkalemia. in neonates with a history of in utero exposure to valsartan tablets, if oliguria or hypotension occurs, support blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. data animal data no teratogenic effects were observed when valsartan was administered to pregnant mice and rats at oral doses of up to 600 mg/kg/day (9 and 18 times the maximum recommended human dose (mrhd) on a mg/m 2 basis) and to pregnant rabbits at oral doses of up to 10 mg/kg/day. in rats, oral valsartan administered at maternally toxic doses (600 mg/kg/day) during organogenesis or late gestation and lactation, resulted in decreased fetal and pup weight, pup survival and delayed developmental milestones. in rabbits administered maternally toxic doses of 5 and 10 mg/kg/day, fetotoxicity was observed. risk summary there is no information regarding the presence of valsartan tablets in human milk, the effects on the breastfed infant, or the effects on milk production. valsartan tablets are present in rat milk. because of the potential for serious adverse reactions in breastfed infants from exposure to valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with valsartan tablets. data valsartan was detected in the milk of lactating rats 15 minutes after oral administration of a 3 mg/kg dose. the antihypertensive effects of valsartan tablets have been evaluated in a clinical study in pediatric patients from 6-16 years of age [see clinical studies ( 14.1)] . the pharmacokinetics of valsartan tablets have been evaluated in pediatric patients 1 to 16 years of age [see clinical pharmacology ( 12.3)] . the adverse experience profile of valsartan tablets was similar to that described for adults [see adverse reactions ( 6.1)] . in children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated. use of valsartan tablets is not recommended in children less than 1 year of age [see nonclinical toxicology ( 13.2)] . it is not known whether post-natal use of valsartan, before maturation of renal function is complete, has a long-term deleterious effect on the kidney. no data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 ml/min/1.73 m 2 . additional pediatric use information is approved for novartis pharmaceuticals corporation's diovan (valsartan) tablets. however, due to novartis pharmaceuticals corporation's marketing exclusivity rights, this drug product is not labeled with that information. in the controlled clinical trials of valsartan, 1,214 (36.2%) hypertensive patients treated with valsartan were ≥65 years and 265 (7.9%) were ≥75 years. no overall difference in the efficacy or safety of valsartan was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out. exposure [measured by area under the curve (auc)] to valsartan is higher by 70% in the elderly than in the young, however no dosage adjustment is necessary [see clinical pharmacology (12.3)] . of the 2,511 patients with heart failure randomized to valsartan in the valsartan heart failure trial, 45% (1,141) were 65 years of age or older. in the valsartan in acute myocardial infarction trial (valiant), 53% (2,596) of the 4,909 patients treated with valsartan and 51% (2,515) of the 4,885 patients treated with valsartan + captopril were 65 years of age or older. there were no notable differences in efficacy or safety between older and younger patients in either trial. safety and effectiveness of valsartan tablets in patients with severe renal impairment (glomerular filtration rate less than 30 ml/min/1.73 m 2 ) have not been established. no dose adjustment is required in patients with mild (glomerular filtration rate 60 to 90 ml/min/1.73 m 2 ) or moderate (glomerular filtration rate 30 to 60 ml/min/1.73 m 2 ) renal impairment. no dose adjustment is necessary for patients with mild-to-moderate liver disease. no dosing recommendations can be provided for patients with severe liver disease.

Estados Unidos - inglês - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - clonazepam (unii: 5pe9fde8gb) (clonazepam - unii:5pe9fde8gb) - clonazepam 0.125 mg - seizure disorders: clonazepam orally disintegrating tablet is useful alone or as an adjunct in the treatment of the lennox-gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. in patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam orally disintegrating tablets may be useful. in some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. in some cases, dosage adjustment may reestablish efficacy. panic disorder: clonazepam orally disintegrating tablet is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-v. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of clonazepam orally disintegrating tablets was established in two 6-

Estados Unidos - inglês - NLM (National Library of Medicine)

avkare, inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 400 mg - because of its life-threatening side effects and the substantial management difficulties associated with its use (see " warnings" below), amiodarone is indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated. - recurrent ventricular fibrillation. - recurrent hemodynamically unstable ventricular tachycardia. as is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone hcl tablets favorably affects survival. amiodarone should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambulatory continuous electrocardiographic monitoring and e

Estados Unidos - inglês - NLM (National Library of Medicine)

rebel distributors corp - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride 80 mg - verapamil hydrochloride tablets are indicated for the treatment of the following: angina 1. angina at rest including: – vasospastic (prinzmetal’s variant) angina – unstable (crescendo, pre-infarction) angina 2. chronic stable angina (classic effort-associated angina) arrhythmias 1. in association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see warnings; accessory bypass tract) 2. prophylaxis of repetitive paroxysmal supraventricular tachycardia essential hypertension verapamil hydrochloride tablets are contraindicated in: 1. severe left ventricular dysfunction (see warnings) 2. hypotension (systolic pressure less than 90 mm hg) or cardiogenic shock 3. sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker) 4. second-or-third-degree av block (except in patients with a functioning artificial ventricular pacemaker) 5. patients with atrial flutter or atrial fibrillation and an

Estados Unidos - inglês - NLM (National Library of Medicine)

rebel distributors corp - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride 240 mg - verapamil hcl extended-release tablets are indicated for the management of essential hypertension. verapamil hydrochloride extended-release tablets are contraindicated in: - severe left ventricular dysfunction (see warnings ). - hypotension (systolic pressure less than 90 mm hg) or cardiogenic shock. - sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker). - second- or third-degree av block (except in patients with a functioning artificial ventricular pacemaker). - patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., wolff-parkinson-white, lown-ganong-levine syndromes) (see warnings ). - patients with known hypersensitivity to verapamil hydrochloride.

Estados Unidos - inglês - NLM (National Library of Medicine)

apotheca inc. - phendimetrazine tartrate (unii: 6985ip0t80) (phendimetrazine - unii:ab2794w8kv) - phendimetrazine tartrate 35 mg - phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (bmi) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. weight height (feet, inches) (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 phendimetrazine tartrate is indicated

Estados Unidos - inglês - NLM (National Library of Medicine)

apotheca inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights,