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ranbaxy pharmaceuticals inc. - flecainide acetate (unii: m8u465q1wq) (flecainide - unii:k94fts1806) - flecainide acetate 50 mg - in patients without structural heart disease, flecainide is indicated for the prevention of: - paroxysmal supraventricular tachycardias (psvt), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms - paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms flecainide is also indicated for the prevention of: - documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained vt), that in the judgment of the physician are life threatening. use of flecainide for the treatment of sustained vt, like other antiarrhythmics, should be initiated in the hospital. the use of flecainide is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. because of the proarrhythmic effects of flecainide, its use should be reserved for patients in whom, in th

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primus pharmaceuticals - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj), aloe vera leaf (unii: zy81z83h0x) (aloe vera leaf - unii:zy81z83h0x), iodoquinol (unii: 63w7ie88k8) (iodoquinol - unii:63w7ie88k8) - hydrocortisone acetate 20 mg in 1 g - based on a review of a related drug by the national research council and subsequent fda classification for that drug, the indications are as follows: "possibly" effective: contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); monliasis; intertrigo. final classification of the less-than-effective indications requires further investigation. alcortin a is contraindicated in those patients with a history of hypersensitivity to hydrocortisone acetate, iodoquinol, aloe vera, glycine, histidine, lysine, palmitic acid or any other components of the preparation.

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preferred pharmaceuticals, inc - medroxyprogesterone acetate (unii: c2qi4ioi2g) (medroxyprogesterone - unii:hsu1c9yres) - medroxyprogesterone 150 mg in 1 ml - medroxyprogesterone acetate injectable suspension, usp is indicated only for the prevention of pregnancy. the loss of bone mineral density (bmd) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in bmd that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use medroxyprogesterone acetate injectable suspension, usp long-term [see warnings and precautions (5.1) ]. the use of medroxyprogesterone acetate injectable suspension, usp is contraindicated in the following conditions: - known or suspected pregnancy or as a diagnostic test for pregnancy. - active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see warnings and precautions (5.2)] . - known or suspected malignancy of breast [see warnings and precautions (5.3)] . - known hypersensitivity to medroxyprogesterone acetate injectable suspension, usp (medroxyprogesterone acetate) or any of its other ingredie

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camber pharmaceuticals, inc. - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). patients with hypercalcemia. pregnancy category c calcium acetate capsules contain calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions (5.1)]. maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium acetate on labor and delivery are unknown. a

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exelan pharmaceuticals, inc. - calcium acetate (unii: y882yxf34x) (calcium cation - unii:2m83c4r6zb) - calcium acetate 667 mg - calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (esrd). patients with hypercalcemia. pregnancy category c calcium acetate capsules contains calcium acetate. animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see warnings and precautions (5.1)] . maintenance of normal serum calcium levels is important for maternal and fetal well being. hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. the effects of calcium acetate on labor and delivery are unknown.

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sagent pharmaceuticals - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide 50 ug in 1 ml - octreotide acetate injection is indicated to reduce blood levels of growth hormone (gh) and insulin growth factor-1 (igf-1; somatomedin c) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. the goal is to achieve normalization of gh and igf-1 (somatomedin c) levels (see dosage and administration ). in patients with acromegaly, octreotide acetate injection reduces gh to within normal ranges in 50% of patients and reduces igf-1 (somatomedin c) to within normal ranges in 50% to 60% of patients. since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of gh and igf-1 (somatomedin c) offers potential benefit before the effects of irradiation are manifested. improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials p

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marnel pharmaceuticals, inc. - vitamin a acetate (unii: 3le3d9d6oy) (vitamin a - unii:81g40h8b0t), .alpha.-tocopherol acetate (unii: 9e8x80d2l0) (.alpha.-tocopherol - unii:h4n855pnz1), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), thiamine mononitrate (unii: 8k0i04919x) (thiamine ion - unii:4abt0j945j), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), biotin - vitamin a 2000 [iu] - bacmin is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. these include: conditions causing depletion, reduced absorption or bioavailability of essential vitamins and minerals- - inadequate intake due to highly restricted or unbalanced diets such as those frequently associated with anorexic conditions and other states of severe malnutrition. - gastrointestinal disorders, chronic alcoholism, chronic or acute infections (especially those involving febrile illness), prolonged or wasting disease, congestive heart failure, hyperthyroidism, poorly controlled diabetes or other physiologic stress. - also, patients on estrogenic oral contraceptives or other estrogen therapy, anti-bacterials which affect intestinal microflora, or other interfering drugs. certain conditions resulting from severe b-vitamin or ascorbic acid deficiency- - recovery from surgery or trauma involving severe burns, fractures or other extensive tissue damage. - also, pregnant women a

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west-ward pharmaceutical corp - fludrocortisone acetate (unii: v47if0pvh4) (fludrocortisone - unii:u0476m545b) - fludrocortisone acetate 0.1 mg - fludrocortisone acetate tablets, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in addison’s disease and for the treatment of salt-losing adrenogenital syndrome. corticosteroids are contraindicated in patients with systemic fungal infections and in those with a history of possible or known hypersensitivity to these agents.

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athenex pharmaceutical division, llc. - caspofungin acetate (unii: vuw370o5qe) (caspofungin - unii:f0xdi6zl63) - caspofungin acetate 50 mg in 10.8 ml - caspofungin acetate for injection is indicated as empirical therapy for presumed fungal infections in febrile, neutropenic adult and pediatric patients (3 months of age and older) [see clinical studies ( 14.1, 14.5)]. caspofungin acetate for injection is indicated for the treatment of candidemia and the following candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections in adult and pediatric patients (3 months of age and older) [see clinical studies ( 14.2, 14.5)] . limitations of use : caspofungin acetate for injection has not been studied in endocarditis, osteomyelitis, and meningitis due to candida. caspofungin acetate for injection is indicated for the treatment of esophageal candidiasis in adult and pediatric patients (3 months of age and older) [see clinical studies ( 14.3, 14.5)] . limitations of use : caspofungin acetate for injection has not been approved for the treatment of oropharyngeal candidiasis (opc). in the study that evaluated the efficacy of caspofungin in the treatment of esophageal candidiasis, patients with concomitant opc had higher relapse rate of the opc [see clinical studies ( 14.3)] . caspofungin acetate for injection is indicated for the treatment of invasive aspergillosis in adult and pediatric patients (3 months of age and older) who are refractory to or intolerant of other therapies [see clinical studies ( 14.4, 14.5)] . limitations of use : caspofungin acetate for injection has not been studied as initial therapy for invasive aspergillosis. caspofungin is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to any component of this product [see adverse reactions ( 6)]. risk summary based on animal data, caspofungin may cause fetal harm (see data) . there are insufficient human data to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with caspofungin use in pregnant women. in animal studies, caspofungin caused embryofetal toxicity, including increased resorptions, increased peri-implantation loss, and incomplete ossification at multiple fetal sites when administered intravenously to pregnant rats and rabbits during organogenesis at doses up to 0.8 and 2 times the clinical dose, respectively ( see data ). advise patients of the potential risk to the fetus. 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. data animal data in animal reproduction studies, pregnant rats dosed intravenously with caspofungin during organogenesis (gestational days [gd] 6 to 20) at 0.5, 2, or 5 mg/kg/day (up to 0.8 times the clinical dose based on body surface area comparison) showed increased resorptions and peri-implantation losses at 5 mg/kg/day. incomplete ossification of the skull and torso and increased incidences of cervical rib were noted in offspring born to pregnant rats treated at doses up to 5 mg/kg/day. in pregnant rabbits treated with intravenous caspofungin during organogenesis (gd 7 to 20) at doses of 1, 3, or 6 mg/kg/day (approximately 2 times the clinical dose based on body surface area comparison), increased fetal resorptions and increased incidence of incomplete ossification of the talus/calcaneus in offspring were observed at the highest dose tested. caspofungin crossed the placenta in rats and rabbits and was detectable in fetal plasma. in peri- and postnatal development study in rats, intravenous caspofungin administered at 0.5, 2 or 5 mg/kg/day from day 6 of gestation through day 20 of lactation was not associated with any adverse effects on reproductive performance or subsequent development of first generation (f1) offspring or malformations in second generation (f2) offspring. risk summary there are no data on the presence of caspofungin in human milk, the effects on the breast-fed child, or the effects on milk production. caspofungin was found in the milk of lactating, drug-treated rats. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for caspofungin and any potential adverse effects on the breastfed child from caspofungin or from the underlying maternal condition. the safety and effectiveness of caspofungin in pediatric patients 3 months to 17 years of age are supported by evidence from adequate and well-controlled studies in adults, pharmacokinetic data in pediatric patients, and additional data from prospective studies in pediatric patients 3 months to 17 years of age for the following indications [see indications and usage ( 1)]: - empirical therapy for presumed fungal infections in febrile, neutropenic patients. - treatment of candidemia and the following candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections. - treatment of esophageal candidiasis. - treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies (e.g., amphotericin b, lipid formulations of amphotericin b, itraconazole). the efficacy and safety of caspofungin has not been adequately studied in prospective clinical trials involving neonates and infants under 3 months of age. although limited pharmacokinetic data were collected in neonates and infants below 3 months of age, these data are insufficient to establish a safe and effective dose of caspofungin in the treatment of neonatal candidiasis. invasive candidiasis in neonates has a higher rate of cns and multi-organ involvement than in older patients; the ability of caspofungin to penetrate the blood-brain barrier and to treat patients with meningitis and endocarditis is unknown. caspofungin has not been studied in pediatric patients with endocarditis, osteomyelitis, and meningitis due to candida . caspofungin has also not been studied as initial therapy for invasive aspergillosis in pediatric patients. in clinical trials, 171 pediatric patients (0 months to 17 years of age), including 18 patients who were less than 3 months of age, were given intravenous caspofungin. pharmacokinetic studies enrolled a total of 66 pediatric patients, and an additional 105 pediatric patients received caspofungin in safety and efficacy studies [see clinical pharmacology ( 12.3) and clinical studies ( 14.5)] . the majority of the pediatric patients received caspofungin at a once-daily maintenance dose of 50 mg/m 2 for a mean duration of 12 days (median 9, range 1-87 days). in all studies, safety was assessed by the investigator throughout study therapy and for 14 days following cessation of study therapy. the most common adverse reactions in pediatric patients treated with caspofungin were pyrexia (29%), blood potassium decreased (15%), diarrhea (14%), increased aspartate aminotransferase (12%), rash (12%), increased alanine aminotransferase (11%), hypotension (11%), and chills (11%) [see adverse reactions ( 6.2)]. postmarketing hepatobiliary adverse reactions have been reported in pediatric patients with serious underlying medical conditions [see warnings and precautions ( 5.3)]. clinical studies of caspofungin did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. although the number of elderly patients was not large enough for a statistical analysis, no overall differences in safety or efficacy were observed between these and younger patients. plasma concentrations of caspofungin in healthy older men and women (65 years of age and older) were increased slightly (approximately 28% in auc) compared to young healthy men. a similar effect of age on pharmacokinetics was seen in patients with candidemia or other candida infections (intra-abdominal abscesses, peritonitis, or pleural space infections). no dose adjustment is recommended for the elderly; however, greater sensitivity of some older individuals cannot be ruled out. adult patients with mild hepatic impairment (child-pugh score 5 to 6) do not need a dosage adjustment. for adult patients with moderate hepatic impairment (child-pugh score 7 to 9), caspofungin 35 mg once daily is recommended based upon pharmacokinetic data [see clinical pharmacology ( 12.3)]. however, where recommended, a 70 mg loading dose should still be administered on day 1 [see dosage and administration ( 2.4) and clinical pharmacology ( 12.3)]. there is no clinical experience in adult patients with severe hepatic impairment (child-pugh score greater than 9) and in pediatric patients 3 months to 17 years of age with any degree of hepatic impairment. no dosage adjustment is necessary for patients with renal impairment. caspofungin is not dialyzable; thus, supplementary dosing is not required following hemodialysis [see clinical pharmacology ( 12.3)].

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par pharmaceutical, inc. - megestrol acetate (unii: tj2m0fr8es) (megestrol - unii:ea6ld1m70m) - megestrol acetate 20 mg - megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). it should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy. history of hypersensitivity to megestrol acetate or any component of the formulation.