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biocon pharma inc. - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older. pediatric use information is approved for novartis pharmaceuticals corporation’s gilenya (fingolimod) capsules. however, due to novartis pharmaceuticals corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information. fingolimod is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, tia, decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warning and precautions (5.1)] - a baseline qtc interval ≥500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with cla

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sagent pharmaceuticals - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 5 mg in 1 ml - levofloxacin injection in 5% dextrose is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli, klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae . adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (14.1)] . levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-suscep

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sagent pharmaceuticals - caffeine citrate (unii: u26eo4675q) (caffeine - unii:3g6a5w338e) - caffeine citrate 20 mg in 1 ml - caffeine citrate is indicated for the treatment of apnea of prematurity. caffeine citrate is contraindicated in patients who have demonstrated hypersensitivity to any of its components.

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preferred pharmaceuticals, inc - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride 50 mg - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: 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 hydrochloride use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximat

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nucare pharmaceuticals, inc. - diltiazem hydrochloride (unii: olh94387te) (diltiazem - unii:ee92bbp03h) - diltiazem hydrochloride 60 mg - diltiazem hydrochloride tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. diltiazem hydrochloride tablets are contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree av block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

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teva pharmaceuticals usa inc - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride 120 mg - verapamil hydrochloride extended-release 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 this drug. 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 pharmacolo

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lupin pharmaceuticals, 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 to 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 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% 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 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/m2 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 in human milk, the effects on the breastfed infant, or the effects on milk production. valsartan is 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 have been evaluated in a clinical study in pediatric patients from 6 to 16 years of age [see clinical studies (14.1)] . the pharmacokinetics of valsartan have been evaluated in pediatric patients 1 to 16 years of age [see clinical pharmacology (12.3)] . the adverse experience profile of valsartan tablet 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 tablet 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 less than 30 ml/min/1.73m2 . 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 in patients with severe renal impairment (glomerular filtration rate less than 30 ml/min/1.73 m2 ) have not been established. no dose adjustment is required in patients with mild (glomerular filtration rate 60 to 90 ml/min/1.73 m2 ) or moderate (glomerular filtration rate 30 to 60 ml/min/1.73 m2 ) 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.

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actelion pharmaceuticals us, inc. - mechlorethamine (unii: 50d9xsg0vr) (mechlorethamine - unii:50d9xsg0vr) - mechlorethamine 0.012 g in 60 g - valchlor is an alkylating drug indicated for the topical treatment of stage ia and ib mycosis fungoides-type cutaneous t-cell lymphoma in patients who have received prior skin-directed therapy. the use of valchlor is contraindicated in patients with known severe hypersensitivity to mechlorethamine. hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine. pregnancy category d [see warnings and precautions (5.5) ] risk summary mechlorethamine can cause fetal harm when administered to a pregnant woman. there are case reports of children born with malformations in pregnant women systemically administered mechlorethamine. mechlorethamine was teratogenic in animals after a single subcutaneous administration. 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 (5.5) ]. animal data mechlorethamine caused fetal malformat

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zydus pharmaceuticals (usa) inc. - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate 5 mg - dextroamphetamine sulfate extended-release capsules are indicated in: narcolepsy attention deficit disorder with hyperactivity as an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organ

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pd-rx pharmaceuticals, inc. - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 500 mg - naproxen delayed-release tablets are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - polyarticular juvenile idiopathic arthritis naproxen delayed-release tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [ see warnings and precautions ( 5.7, 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions ( 5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions ( 5.1)] risk summary use of nsaids, including naproxen delayed-release tablets, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including napr