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cipla usa inc. - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - gemfibrozil 600 mg - gemfibrozil tablets are indicated as adjunctive therapy to diet for: 1. treatment of adult patients with very high elevations of serum triglyceride levels (types iv and v hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. patients who present such risk typically have serum triglycerides over 2,000 mg/dl and have elevations of vldl-cholesterol as well as fasting chylomicrons (type v hyperlipidemia). subjects who consistently have total serum or plasma triglycerides below 1,000 mg/dl are unlikely to present a risk of pancreatitis. gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 mg/dl who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. it is recognized that some type iv patients with triglycerides under 1,000 mg/dl may, through dietary or alcoholic indiscretion, convert to a type v pattern with massive triglyceride elevations accomp

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aidarex pharmaceuticals llc - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 37.5 mg - phentermine hydrochloride, usp 37.5 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2 , or≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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 x 0.0254 = meters. the limited usefulness of agents of this class, including phentermine hydrochloride, [see clinical pharmacology ( 12.1 , 12.2 ) ] should be measured against possible risk factors inherent in their use such as those described below. •history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart fail

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ncs healthcare of ky, llc dba vangard labs - folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8) - folic acid 1 mg - folic acid, usp is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid, usp (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood. folic acid, usp is contraindicated in patients who have shown previous intolerance to the drug.

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contract pharmacy services-pa - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - valproic acid 500 mg - divalproex sodium extended-release tablets, usp are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness and possible hostility. a mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). the efficacy of divalproex sodium extended-release tablets, usp is based in part on studies of divalproex sodium delayed-release tablets, usp in this indication, and was confirmed in a 3-week trial with patients meeting dsm-iv tr criteria for bipolar i disorder, manic or mixed type, who were hospitalized for acute mania

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contract pharmacy services-pa - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14)] . tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see adverse reactions (6.2)]. teratogenic effects, pregnancy category b. administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic auc exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. tamsulosin hydroch

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proficient rx lp - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14)] . tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see adverse reactions (6.2)]. teratogenic effects, pregnancy category b. administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic auc exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. tamsulosin hydrochloride capsules are not indicated for use in women. tamsulosin hydrochl

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macleods pharmaceuticals limited - montelukast (unii: mhm278sd3e) (montelukast - unii:mhm278sd3e) - montelukast 4 mg - montelukast sodium chewable tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium chewable tablet is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium chewable tablet is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies. montelukast sodium chewable tablet is not indicated for the treatment of an acute asthma attack. montelukast sodium chewable tablets is contraindicated in patients with hypersensitivity to any of its components. risk su

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lupin limited - ziprasidone hydrochloride (unii: 216x081oru) (ziprasidone - unii:6uka5vej6x) - ziprasidone 20 mg - ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. when deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the qt/qtc interval compared to several other antipsychotic drugs [see warnings and precautions (5.2)]. prolongation of the qtc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. in many cases this would lead to the conclusion that other drugs should be tried first. whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see warnings and precautions (5.2)]. ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. the efficacy of oral ziprasidone was established in four short-term (4- and 6-week) controlled trials of adult schizophrenic inpatien

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lupin pharmaceuticals, inc. - ziprasidone hydrochloride (unii: 216x081oru) (ziprasidone - unii:6uka5vej6x) - ziprasidone 20 mg - ziprasidone capsules usp are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. when deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the qt/qtc interval compared to several other antipsychotic drugs [see warnings and precautions (5.3)]. prolongation of the qtc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. in many cases this would lead to the conclusion that other drugs should be tried first. whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see warnings and precautions (5.3)]. schizophrenia •ziprasidone capsules usp are indicated for th

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kowa pharmaceuticals america, inc. - pitavastatin calcium (unii: iyd54xeg3w) (pitavastatin - unii:m5681q5f9p) - pitavastatin 1.045 mg - livalo is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (ldl-c) in: - adults with primary hyperlipidemia. - adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (hefh). livalo is contraindicated in the following conditions: - concomitant use of cyclosporine [see drug interactions (7)]. - acute liver failure or decompensated cirrhosis [see warnings and precautions (5.3)]. - hypersensitivity to pitavastatin or any excipents in livalo. hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with livalo [see adverse reactions (6)] . risk summary discontinue livalo when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. livalo decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, livalo may cause fetal harm when administered to pregnant patients based on the mechanism of action [see clinical pharmacology (12.1)]. in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. published data from prospective and retrospective observational cohort studies with statin use in pregnant women are insufficient to determine if there is a drug associated risk of miscarriage (see data) . in animal reproduction studies, no embryo-fetal toxicity or congenital malformations were observed in pregnant rats and rabbits orally administered pitavastatin during the period of organogenesis at doses which were 22 and 4 times, respectively, the human exposure at the maximum recommended human dosage (mrhd) of 4 mg, based on auc [see data]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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. data human data a medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. the relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. there were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. in the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. animal data embryo-fetal developmental studies were conducted in pregnant rats administered 3, 10, 30 mg/kg/day pitavastatin by oral gavage during organogenesis (gestation days 7-17). no adverse effects were observed at 3 mg/kg/day, systemic exposures 22 times human systemic exposure at 4 mg/day based on auc. embryo-fetal developmental studies were conducted in pregnant rabbits administered 0.1, 0.3, 1 mg/kg/day pitavastatin by oral gavage during the period of fetal organogenesis (gestation days 6-18). maternal toxicity consisting of reduced body weight and abortion was observed at all doses tested (4 times human systemic exposure at 4 mg/day based on auc). in perinatal/postnatal studies in pregnant rats given oral gavage doses of pitavastatin at 0.1, 0.3, 1, 3, 10, 30 mg/kg/day from organogenesis through weaning (gestation day 17 to lactation day 21), maternal toxicity consisting of mortality at ≥0.3 mg/kg/day and impaired lactation at all doses contributed to the decreased survival of neonates in all dose groups (0.1 mg/kg/day represents approximately 1 time human systemic exposure at 4 mg/day dose based on auc). reproductive toxicity studies have shown that pitavastatin crosses the placenta in rats and is found in fetal tissues at ≤36% of maternal plasma concentrations following a single dose of 1 mg/kg/day during gestation (at the end of organogenesis). risk summary there is no available information about the prescence of pitavastatin in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. however, it has been shown that another drug in this class passes into human milk. statins, including livalo, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. because of the potential for serious adverse reactions in a breastfed infant, based upon the mechanism of action, advise patients that breastfeeding is not recommended during treatment with livalo. [see use in specific populations (8.1), clinical pharmacology (12.1)] the safety and effectiveness of livalo as an adjunctive therapy to diet to reduce elevated ldl-c in pediatric patients aged 8 years and older with hefh have been established. use of livalo for this indication is supported by a 12-week, double-blind, placebo-controlled trial in 82 pediatric patients 8 to 16 years of age with hefh [see clinical studies (14.2)] and a 52-week open-label trial in 85 pediatric patients with hefh. the safety and effectiveness of livalo have not been established in pediatric patients younger than 8 years of age with hefh or in pediatric patients with other types of hyperlipidemia (other than hefh). in controlled clinical studies, 1,209 (43%) patients were 65 years and older. no overall differences in safety or effectiveness were observed between these patients and younger patients. advanced age (≥65 years) is a risk factor for livalo-associated myopathy and rhabdomyolysis. dose selection for a geriatric patient should be cautious, reognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. monitor geriatric patients receiving livalo for the increased risk of myopathy [see warnings and precautions (5.1)]. renal impairment is a risk factor for myopathy and rhabdomyolysis. monitor all patients with renal impairment for development of myopathy. due to the risk of myopathy, a dosage modification of livalo is recommended for patients with moderate and severe renal impairment (estimated glomerular filtration rate 30 – 59 ml/min/1.73 m2 and 15 – 29 ml/min/1.73 m2 , respectively), as well as end-stage renal disease receiving hemodialysis. [see dosage and administration (2.3), warnings and precautions (5.1), clinical pharmacology (12.3)] . livalo is contraindicated in patients with active liver failure or decompensated cirrhosis [see contraindications (4), warnings and precautions (5.3)] .