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

ohm laboratories inc. - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate tablets, usp are indicated for the suppressive treatment and treatment of acute attacks of malaria due to plasmodium vivax , p. malariae , p. ovale , and susceptible strains of p. falciparum . hydroxychloroquine sulfate tablets, usp are also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis. use of this drug is contraindicated (1) in the presence of retinal or visual field changes attributable to any 4-aminoquinoline compound, (2) in patients with known hypersensitivity to 4-aminoquinoline compounds, and (3) for long-term therapy in children.

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

ranbaxy pharmaceuticals inc. - clorazepate dipotassium (unii: 63fn7g03xy) (clorazepic acid - unii:d51wo0g0l4) - clorazepate dipotassium 3.75 mg - clorazepate dipotassium tablets, usp are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. clorazepate dipotassium tablets, usp are indicated as adjunctive therapy in the management of partial seizures. the effectiveness of clorazepate dipotassium tablets, usp in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. long-term studies in epileptic patients, however, have shown continued therapeutic activity. the physician should reassess periodically the usefulness of the drug for the individual patient. clorazepate dipotassium tablets, usp are indicated for the symptomatic relief of acute alcohol withdrawal. clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.

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

ranbaxy laboratories limited - nortriptyline hydrochloride (unii: 00fn6ih15d) (nortriptyline - unii:bl03sy4lxb) - solution - 10 mg in 5 ml - nortriptyline hydrochloride is indicated for the relief of symptoms of depression. endogenous depressions are more likely to be alleviated than are other depressive states. the concurrent use of nortriptyline hydrochloride or other tricyclic antidepressants with a monoamine oxidase (mao) inhibitor is contraindicated. hyperpyretic crises, severe convulsions, and fatalities have occurred when similar tricyclic antidepressants were used in such combinations. it is advisable to discontinue the mao inhibitor at least 2 weeks before treatment with nortriptyline hydrochloride is to be started. patients hypersensitive to nortriptyline hydrochloride should not be given the drug. cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.

United States - English - 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.

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

ohm laboratories inc. - ezetimibe (unii: eor26lqq24) (ezetimibe - unii:eor26lqq24) - ezetimibe 10 mg - ezetimibe tablets are indicated: - in combination with a statin, or alone when additional low-density lipoprotein cholesterol (ldl-c) lowering therapy is not possible, as an adjunct to diet to reduce elevated ldl-c in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh). - in combination with a statin as an adjunct to diet to reduce elevated ldl-c in pediatric patients 10 years of age and older with hefh. - in combination with fenofibrate as an adjunct to diet to reduce elevated ldl-c in adults with mixed hyperlipidemia. - in combination with a statin, and other ldl-c lowering therapies, to reduce elevated ldl-c levels in adults and in pediatric patients 10 years of age and older with homozygous familial hypercholesterolemia (hofh). - as an adjunct to diet for the reduction of elevated sitosterol and campesterol levels in adults and in pediatric patients 9 years of age and older with homozygous familial sitosterolemia. when ezetimibe tablets are used in combination with a statin, fenofibrate, or other ldl-c lowering therapies, refer to the prescribing information of these products for information on the safe and effective use. ezetimibe tablets are contraindicated in patients with a known hypersensitivity to ezetimibe or any of the excipients in ezetimibe tablets. hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported [ see adverse reactions (6.2)]. when used in combination with a statin, fenofibrate, or other ldl-c lowering therapy, ezetimibe tablets are contraindicated in patients for whom a statin, fenofibrate, or other ldlc lowering therapy are contraindicated. refer to the prescribing information of these products for a list of their contraindications [see warnings and precautions (5.1)] risk summary there are insufficient data on ezetimibe use in pregnant women to evaluate for 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 in pregnant rats and rabbits orally administered ezetimibe during the period of organogenesis at doses that resulted in up to 10 and 150 times, respectively, the human exposure at the mrhd, based on auc (see data) . ezetimibe tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when ezetimibe tablets are administered with a statin, refer to the prescribing information for the statin. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in oral (gavage) embryo-fetal development studies of ezetimibe conducted in rats (gestation days 6-15) and rabbits (gestation days 7-19), there was no evidence of maternal toxicity or embryolethal effects at the doses tested (250, 500, 1,000 mg/kg/day). in rats, increased incidences of common fetal skeletal findings (extra pair of thoracic ribs, unossified cervical vertebral centra, shortened ribs) were observed at 1,000 mg/kg/day (~10 times the human exposure at 10 mg daily based on auc 0-24hr for total ezetimibe). in rabbits treated with ezetimibe, an increased incidence of extra thoracic ribs was observed at 1,000 mg/kg/day (150 times the human exposure at 10 mg daily based on auc 0-24hr for total ezetimibe). the animal-to-human exposure multiple for total ezetimibe at the no-observed effect level was 6 times for rat and 134 times for rabbit. fetal exposure to ezetimibe (conjugated and unconjugated) was confirmed in subsequent placental transfer studies conducted using a maternal dose of 1,000 mg/kg/day. the fetal maternal plasma exposure ratio (total ezetimibe) was 1.5 for rats on gestation day 20 and 0.03 for rabbits on gestation day 22. the effect of ezetimibe on prenatal and postnatal development and maternal function was evaluated in pregnant rats at doses of 100, 300 or 1,000 mg/kg/day from gestation day 6 through lactation day 21. no maternal toxicity or adverse developmental outcomes were observed up to and including the highest dose tested (17 times the human exposure at 10 mg daily based on auc 0-24hr for total ezetimibe). multiple-dose studies of ezetimibe given in combination with statins in rats and rabbits during organogenesis resulted in higher ezetimibe and statin exposures. reproductive findings occurred at lower doses in combination therapy compared to monotherapy. risk summary there is no information about the presence of ezetimibe in human milk. ezetimibe is present in rat milk (see data) . when a drug is present in animal milk, it is likely that the drug will be present in human milk. there is no information about the effects of ezetimibe on the breastfed infant or the effects of ezetimibe on milk production. ezetimibe tablets should not be used in nursing mothers unless the potential benefit justifies the potential risk to the infant. data ezetimibe was present in the milk of lactating rats. the pup to maternal plasma ratio for total ezetimibe was 0.5 on lactation day 12. the safety and effectiveness of ezetimibe tablets in combination with a statin as an adjunct to diet to reduce ldl-c have been established in pediatric patients 10 years of age and older with hefh. use of ezetimibe tablets for this indication is based on a double-blind, placebo-controlled clinical trial in 248 pediatric patients (142 males and 106 postmenarchal females) 10 years of age and older with hefh [ see clinical studies (14)] . in this limited controlled trial, there was no significant effect on growth or sexual maturation in the adolescent males or females, or on menstrual cycle length in females. the safety and effectiveness of ezetimibe tablets in combination with a statin, and other ldl-c lowering therapies, to reduce ldl-c have been established in pediatric patients 10 years of age and older with hofh. use of ezetimibe tablets for this indication is based on a 12-week double-blind, placebo-controlled clinical trial followed by an uncontrolled extension period in 7 pediatric patients 11 years of age and older with hofh [ see clinical studies (14)] . the safety and effectiveness of ezetimibe tablets as an adjunct to diet for the reduction of elevated sitosterol and campesterol levels have been established in adults and pediatric patients 9 years of age and older with homozygous familial sitosterolemia. use of ezetimibe tablets for this indication is based on an 8-week double-blind, placebo-controlled clinical trial in 4 patients 9 years of age and older with homozygous sitosterolemia with elevated plasma sitosterol levels (>5 mg/dl) [ see clinical studies (14)] . the safety and effectiveness of ezetimibe tablets have not been established in pediatric patients younger than 10 years of age with hefh or hofh, in pediatric patients younger than 9 years of age with homozygous familial sitosterolemia, or in pediatric patients with other types of hyperlipidemia. of the 2,396 patients who received ezetimibe tablets in clinical trials, 669 (28%) were 65 years of age and older, and 111 (5%) were 75 years of age and older. of the 11,308 patients who received ezetimibe tablets in combination with a statin in clinical trials, 3587 (32%) were 65 years of age and older, and 924 (8%) were 75 years of age and older [ see clinical studies (14)] . no overall differences in safety or effectiveness of ezetimibe tablets have been observed between patients 65 years of age and older and younger patients. no clinically meaningful differences in the pharmacokinetics of ezetimibe were observed in geriatric patients compared to younger adult patients [ see clinical pharmacology (12.3)]. no dosage adjustment of ezetimibe tablets is necessary in patients with renal impairment. ezetimibe tablets are not recommended for use in patients with moderate to severe hepatic impairment (child-pugh b or c) due to the unknown effects of the increased exposure to ezetimibe [ see clinical pharmacology (12.3)].

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

ohm laboratories inc. - loperamide hydrochloride (unii: 77ti35393c) (loperamide - unii:6x9oc3h4ii) - loperamide hydrochloride 2 mg - anti-diarrheal controls symptoms of diarrhea, including travelers' diarrhea

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

ranbaxy pharmaceuticals inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - tablet - 7.5 mg - carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). meloxicam is indicated for relief of the signs and symptoms of osteoarthritis. meloxicam is contraindicated in patients with known hypersensitivity to meloxicam. meloxicam should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings , anaphylactoid reactions , and precautions , pre-existing asthma ). meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

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

sun pharmaceutical industries, inc. - levorphanol tartrate (unii: 04wqu6t9qi) (levorphanol - unii:27618j1n2x) - levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings] , reserve levorphanol tartrate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: levorphanol tartrate tablets are contraindicated in patients with: levorphanol tartrate tablets contains levorphanol, a schedule ii controlled substance. levorphanol tartrate tablets contains levorphanol, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone and tapentadol. levorphanol can be abused and is subject to misuse, addiction, and criminal diversion [see warnings ]. all patients treated with opioids require careful monitoring for signs of abuse and

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

ohm laboratories inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - pain reliever/fever reducer

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

ohm laboratories inc. - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - acid reducer