USA - engelsk - NLM (National Library of Medicine)

synthon pharmaceuticals, inc. - fluvoxamine maleate (unii: 5lgn83g74v) (fluvoxamine - unii:o4l1xpo44w) - tablet, film coated - 25 mg - fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd), as defined in the dsm-iii-r. the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. the efficacy of fluvoxamine maleate tablets was established in three 10-week trials with obsessive compulsive outpatients with the diagnosis of obsessive compulsive disorder as defined in dsm-iii-r. (see clinical trials under clinical pharmacology.) obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego- dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. the effectiveness of fluvoxamine maleate tablets for long-term use, i.e., for more than 10 weeks, has not been systematically evaluated in placebo-controlled trials. therefore, t

USA - engelsk - NLM (National Library of Medicine)

synthon pharmaceuticals, inc. - bicalutamide (unii: a0z3nau9dp) (bicalutamide - unii:a0z3nau9dp) - bicalutamide 50 mg - bicalutamide tablets, usp 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (lhrh) analog for the treatment of stage d2 metastatic carcinoma of the prostate. bicalutamide tablets, usp 150 mg daily are not approved for use alone or with other treatments [see clinical studies (14.2)]. bicalutamide tablets, usp are contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet's components. hypersensitivity reactions including angioneurotic edema and urticaria have been reported [see adverse reactions (6.2)] . bicalutamide tablets, usp have no indication for women, and should not be used in this population. bicalutamide tablets, usp may cause fetal harm when administered to a pregnant woman. bicalutamide tablets, usp are contraindicated in women, including those who are or may become pregnant. there are no studies in pregnant women using bicalutamide tablets, usp. if this drug is used during pregnancy, or if the pat

USA - engelsk - NLM (National Library of Medicine)

synthon pharmaceuticals, inc. - 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)]. risk summary tamsulosin hydrochloride capsules are not indicated for use in women. there are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride capsules in pregnant women. no adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (gd 7 to 17 in the rat and gd 6 to 18 in the rabbit)  [see  data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. data administration of tamsulosin hydrochloride to pregnant female rats during the period of organogenesis 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 during the period of organogenesis 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. there are no data on the presence of tamsulosin hydrochloride in human milk, the effects of tamsulosin hydrochloride on the breastfed infant, or the effects of tamsulosin hydrochloride on milk production. tamsulosin hydrochloride is present in the milk of lactating rats [see data]. data oral administration of radiolabeled tamsulosin hydrochloride to rats demonstrated that tamsulosin hydrochloride and/or its metabolites are excreted into the milk of rats. infertility males abnormal ejaculation including ejaculation failure, ejaculation disorder, retrograde ejaculation, and ejaculation decrease has been associated with tamsulosin hydrochloride capsules  [see  adverse reactions (6.1)].  studies in rats revealed significantly reduced fertility in males considered to be due to impairment of ejaculation, which was reversible  [see  nonclinical toxicology (13.1)]. females tamsulosin hydrochloride capsules are not indicated for use in women. female fertility in rats was significantly reduced, considered to be due to impairment of fertilization  [see  nonclinical toxicology (13.1)]. tamsulosin hydrochloride capsules are not indicated for use in pediatric populations. efficacy and positive benefit/risk of tamsulosin hydrochloride was not demonstrated in two studies conducted in patients 2 years to 16 years of age with elevated detrusor leak point pressure (>40 cm h 2 o) associated with known neurological disorder (e.g., spina bifida). patients in both studies were treated on a weight-based mg/kg schema (0.025 mg, 0.05 mg, 0.1 mg, 0.2 mg, or 0.4 mg tamsulosin hydrochloride) for the reduction in detrusor leak point pressure below 40 cm h 2 o. in a randomized, double-blind, placebo-controlled, 14-week, pharmacokinetic, safety and efficacy study in 161 patients, no statistically significant difference in the proportion of responders was observed between groups receiving tamsulosin hydrochloride and placebo. in an open-label, 12-month safety study, 87 patients were treated with tamsulosin hydrochloride. the most frequently reported adverse events (≥5%) from the pooled data of both studies were urinary tract infection, vomiting, pyrexia, headache, nasopharyngitis, cough, pharyngitis, influenza, diarrhea, abdominal pain, and constipation. of the total number of subjects (1783) in clinical studies of tamsulosin, 36% were 65 years of age and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see clinical pharmacology (12.3)] . patients with renal impairment do not require an adjustment in tamsulosin hydrochloride capsules dosing. however, patients with end-stage renal disease (cl cr <10 ml/min/1.73 m 2 ) have not been studied [see clinical pharmacology (12.3)] . patients with moderate hepatic impairment do not require an adjustment in tamsulosin hydrochloride capsules dosage. tamsulosin hydrochloride capsules have not been studied in patients with severe hepatic impairment [see clinical pharmacology (12.3)] .

USA - engelsk - NLM (National Library of Medicine)

synthon pharmaceuticals, inc. - levocetirizine dihydrochloride (unii: sod6a38aga) (levocetirizine - unii:6u5ea9rt2o) - levocetirizine dihydrochloride 5 mg - levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. pediatric use information in pediatric patients (age 2 to 5 years) with seasonal allergic rhinitis is approved for ucb inc.'s levocetirizine dihydrochloride drug product. however, due to ucb inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 years of age and older. pediatric use information in pediatric patients (age 6 months to 5 years) with perennial allergic rhinitis is approved for ucb inc.'s levocetirizine dihydrochloride drug product. however, due to ucb inc.'s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients. levocetirizine dihydrochloride tablets are indicated for the trea

USA - engelsk - NLM (National Library of Medicine)

synthon pharmaceuticals, inc. - simvastatin (unii: agg2fn16ev) (simvastatin - unii:agg2fn16ev) - tablet, orally disintegrating - 20 mg - lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol (see national cholesterol education program [ncep] treatment guidelines, below). in patients with chd or at high risk of chd, simvastatin orally disintegrating tablets can be started simultaneously with diet. in patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin orally disintegrating tablets are indicated to: - reduce the risk of total mortality by reducing chd deaths. - reduce the risk of non-fatal myocardial infarction and stroke. - reduce the need for coronary and non-coronary revascularization procedures. simvastatin orally disintegrating tablets are indicated to: - reduce elevated total-c, ldl-c, apo b, and tg, and to increase hdl-c in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (fredrickson types iia and iib3

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

synthon au pty ltd - anastrozole -

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

synthon au pty ltd - olanzapine benzoate -

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

synthon au pty ltd - quetiapine fumarate -

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

synthon au pty ltd - simvastatin -

USA - engelsk - NLM (National Library of Medicine)

synthon pharmaceuticals, inc. - anastrozole (unii: 2z07myw1az) (anastrozole - unii:2z07myw1az) - anastrozole 1 mg - anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. anastrozole tablets are indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. anastrozole tablets are indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. patients with er-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets. anastrozole tablets may cause fetal harm when administered to a pregnant woman and offers no clinical benefit to premenopausal women with breast cancer. anastrozole tablets are contraindicated in women who are or may become pregnant. there are no adequate and well-controlled studies in pregnant women using anastrozole tablets. if anastrozole tablets are used during pregnancy, or if the patient becomes