Kenya - English - Pharmacy and Poisons Board

concept pharmaceuticals limited. 501,jaisingh business center 119, sahar road, - tranexamic acid and etamsylate - film-coated tablet - tranexamic acid 500mg + etamsylate 250mg/ tablet - antihemorrhagics - antifibrinolytics: amino acids

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lamotrigine 100mg - chewable/dispersible tablet - 100 mg - active: lamotrigine 100mg excipient: calcium carbonate colloidal silicon dioxide crospovidone maize starch microcrystalline cellulose purified talc ribes nigrum saccharin sodium sodium stearyl fumarate sorbitol

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lamotrigine 200mg - chewable/dispersible tablet - 200 mg - active: lamotrigine 200mg excipient: calcium carbonate colloidal silicon dioxide crospovidone maize starch microcrystalline cellulose purified talc ribes nigrum saccharin sodium sodium stearyl fumarate sorbitol

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lamotrigine 25mg - chewable/dispersible tablet - 25 mg - active: lamotrigine 25mg excipient: calcium carbonate colloidal silicon dioxide crospovidone maize starch microcrystalline cellulose purified talc ribes nigrum saccharin sodium sodium stearyl fumarate sorbitol

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lamotrigine 50mg - chewable/dispersible tablet - 50 mg - active: lamotrigine 50mg excipient: calcium carbonate colloidal silicon dioxide crospovidone maize starch microcrystalline cellulose purified talc ribes nigrum saccharin sodium sodium stearyl fumarate sorbitol

United Kingdom - English - myHealthbox

mercury pharmaceuticals limited - gliclazide - modified-release tablet - 30mg - sulphonamides, urea derivative - it is indicated in adults for treatment of non-insulin dependent diabetes (type 2) when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.

United Kingdom - English - myHealthbox

mercury pharmaceuticals limited - gliclazide - modified-release tablet - 60mg - sulphonamides, urea derivative - it is indicated in adults for treatment of non-insulin dependent diabetes (type 2) when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.

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

torrent pharmaceuticals limited - lurasidone hydrochloride (unii: o0p4i5851i) (lurasidone - unii:22ic88528t) - lurasidone hydrochloride tablets are indicated for: • treatment of adult and adolescent patients (13 to 17 years) patients with schizophrenia [see clinical studies ( 14.1)] . • monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies ( 14.2)]. • adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies ( 14.2)]. • known hypersensitivity to lurasidone hcl or any components in the formulation.  angioedema has been observed with lurasidone [see adverse reactions ( 6.1)] . • strong cyp3a4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see drug interactions ( 7.1)]. • strong cyp3a4 inducers (e.g., rifampin, avasimibe, st. john's wort, phenytoin, carbamazepine, etc.) [see drug interactions ( 7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride tablets during pregnancy. for more information, contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery  [see clinical considerations] . there are no studies of lurasidone hydrochloride tablets use in pregnant women. the limited available data are not sufficient to inform a drug-associated risk of birth defects or miscarriage. in animal reproduction studies, no teratogenic effects were seen in pregnant rats and rabbits given lurasidone during the period of organogenesis at doses approximately 1.5- and 6-times, the maximum recommended human dose (mrhd) of 160 mg/day, respectively based on mg/m 2 body surface area  [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population(s) 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 fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy. these symptoms have varied in severity. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. data animal data pregnant rats were treated with oral lurasidone at doses of 3, 10, and 25 mg/kg/day during the period of organogenesis. these doses are 0.2, 0.6, and 1.5 times the mrhd of 160 mg/day based on mg/m2 body surface area. no teratogenic or embryo-fetal effects were observed up to 1.5 times the mhrd of 160 mg/day, based on mg/m 2 . pregnant rabbits were treated with oral lurasidone at doses of 2, 10, and 50 mg/kg/day during the period of organogenesis. these doses are 0.2, 1.2 and 6 times the mrhd of 160 mg/day based on mg/m2. no teratogenic or embryo-fetal effects were observed up to 6 times the mhrd of 160 mg/day based on mg/m 2 . pregnant rats were treated with oral lurasidone at doses of 0.4, 2, and 10 mg/kg/day during the periods of organogenesis and lactation. these doses are 0.02, 0.1 and 0.6 times the mrhd of 160 mg/day based on mg/m2. no pre- and postnatal developmental effects were observed up to 0.6 times the mrhd of 160 mg/day, based on mg/m 2 . risk summary lactation studies have not been conducted to assess the presence of lurasidone in human milk, the effects on the breastfed infant, or the effects on milk production. lurasidone is present in rat milk. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for lurasidone hydrochloride and any potential adverse effects on the breastfed infant from lurasidone hydrochloride or from the underlying maternal condition. schizophrenia the safety and effectiveness of lurasidone hydrochloride tablets 40-mg/day and 80-mg/day for the treatment of schizophrenia in adolescents (13 to 17 years) was established in a 6-week, placebo-controlled clinical study in 326 adolescent patients [see dosage and administration (2.1), adverse reactions (6.1), and clinical studies (14.1)]. the safety and effectiveness of lurasidone hydrochloride have not been established in pediatric patients less than 13 years of age with schizophrenia.  bipolar depression the safety and effectiveness of lurasidone hydrochloride tablets 20 to 80 mg/day for the treatment of bipolar depression in pediatric patients (10 to 17 years) was established in a 6-week, placebo-controlled clinical study in 347 pediatric patients [see dosage and administration (2.2), adverse reactions (6.1), and clinical studies (14.2)]. the safety and effectiveness of lurasidone hydrochloride have not been established in pediatric patients less than 10 years of age with bipolar depression.   irritability associated with autistic disorder the effectiveness of lurasidone hydrochloride in pediatric patients for the treatment of irritability associated with autistic disorder has not been established. efficacy was not demonstrated in a 6-week study evaluating lurasidone hydrochloride 20 mg/day and 60 mg/day for the treatment of pediatric patients 6 to 17 years of age with irritability associated with autistic disorder diagnosed by diagnostic and statistical manual of mental disorders, 4th ed., text revision [dsm-iv-tr] criteria. the primary objective of the study as measured by improvement from baseline in the irritability subscale of the aberrant behavior checklist (abc) at endpoint (week 6) was not met. a total of 149 patients were randomized to lurasidone hydrochloride or placebo. vomiting occurred at a higher rate than reported in other lurasidone hydrochloride studies (4/49 or 8% for 20mg, 14/51 or 27% for 60mg, and 2/49 or 4% for placebo), particularly in children ages 6 to 12 (13 out of 18 patients on lurasidone hydrochloride with vomiting). in a long-term, open-label study that enrolled pediatric patients (age 6 to 17 years) with schizophrenia, bipolar depression, or autistic disorder from three short-term, placebo-controlled trials, 54% (378/701) received lurasidone for 104 weeks. there was one adverse event in this trial that was considered possibly drug-related and has not been reported in adults receiving lurasidone: a 10 year old male experienced a prolonged, painful erection, consistent with priapism, that led to treatment discontinuation. in this trial, the mean increase in height from open-label baseline to week 104 was 4.94 cm. to adjust for normal growth, z-scores were derived (measured in standard deviations [sd]), which normalize for the natural growth of children and adolescents by comparisons to age- and sex-matched population standards. a z-score change <0.5 sd is considered not clinically significant. in this trial, the mean change in height z-score from open-label baseline to week 104 was +0.05 sd, indicating minimal deviation from the normal growth curve. juvenile animal studies adverse effects were seen on growth, physical and neurobehavioral development at doses as low as 0.2 times the mrhd based on mg/m 2 . lurasidone was orally administered to rats from postnatal days 21 through 91 (this period corresponds to childhood, adolescence, and young adulthood in humans) at doses of 3, 30, and 150 (males) or 300 (females) mg/kg/day which are 0.2 to 10 times (males) and 20 times (females) the maximum recommended adult human dose (mrhd) of 160 mg/day based on mg/m 2 . the adverse effects included dose-dependent decreases in femoral length, bone mineral content, body and brain weights at 2 times the mrhd in both sexes, and motor hyperactivity at 0.2 and 2 times the mrhd in both sexes based on mg/m 2 . in females, there was a delay in attainment of sexual maturity at 2 times the mrhd, associated with decreased serum estradiol. mortality occurred in both sexes during early post- weaning period and some of the male weanlings died after only 4 treatments at doses as low as 2 times the mrhd based on mg/m 2 . histopathological findings included increased colloid in the thyroids and inflammation of the prostate in males at 10 times mrhd based on mg/m 2  and mammary gland hyperplasia, increased vaginal mucification, and increased ovarian atretic follicles at doses as low as 0.2 times the mrhd based on mg/m 2 . some of these findings were attributed to transiently elevated serum prolactin which was seen in both sexes at all doses. however, there were no changes at any dose level in reproductive parameters (fertility, conception indices, spermatogenesis, estrous cycle, gestation length, parturition, number of pups born). the no effect dose for neurobehavioral changes in males is 0.2 times the mhrd based on mg/m 2  and could not be determined in females. the no effect dose for growth and physical development in both sexes is 0.2 times the mrhd based on mg/m 2 . clinical studies with lurasidone hydrochloride did not include sufficient numbers of patients aged 65 and older to determine whether or not they respond differently from younger patients. in elderly patients with psychosis (65 to 85), lurasidone hydrochloride concentrations (20 mg/day) were similar to those in young subjects. it is unknown whether dose adjustment is necessary on the basis of age alone. elderly patients with dementia-related psychosis treated with lurasidone hydrochloride are at an increased risk of death compared to placebo. lurasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis  [see boxed warning, warnings and precautions ( 5.1,  5.3)]. reduce the maximum recommended dosage in patients with moderate or severe renal impairment (clcr<50 ml/minute). patients with impaired renal function (clcr<50 ml/minute) had higher exposure to lurasidone than patients with normal renal function [ see clinical pharmacology ( 12.3) ]. greater exposure may increase the risk of lurasidone hydrochloride-associated adverse reactions [ see dosage and administration ( 2.4) ] reduce the maximum recommended dosage in patients with moderate to severe hepatic impairment (child-pugh score ≥7). patients with moderate to severe hepatic impairment (child-pugh score ≥7) generally had higher exposure to lurasidone than patients with normal hepatic function [ see clinical pharmacology ( 12.3) ]. greater exposure may increase the risk of lurasidone hydrochloride-associated adverse reactions [ see dosage and administration ( 2.5) ]. no dosage adjustment for lurasidone hydrochloride is required on the basis of a patient's sex, race, or smoking status [ see clinical pharmacology ( 12.3) ]. lurasidone hydrochloride is not a controlled substance. lurasidone hydrochloride has not been systematically studied in humans for its potential for abuse or physical dependence or its ability to induce tolerance. while clinical studies with lurasidone hydrochloride did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict the extent to which a cns-active drug will be misused, diverted and/or abused once it is marketed. patients should be evaluated carefully for a history of drug abuse, and such patients should be observed carefully for signs of lurasidone hydrochloride misuse or abuse (e.g., development of tolerance, drug-seeking behavior, increases in dose).

European Union - English - EMA (European Medicines Agency)

mylan pharmaceuticals limited - zonisamide - epilepsy - antiepileptics, - monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.

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

alembic pharmaceuticals limited - metoprolol tartrate (unii: w5s57y3a5l) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 25 mg - hypertension metoprolol tartrate tablets are indicated for the treatment of hypertension. they may be used alone or in combination with other antihypertensive agents. angina pectoris metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris. myocardial infarction metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. oral metoprolol therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event (see dosage and administration, contraindications, and warnings). hypertension and angina metoprolol tartrate tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see warnings). hypersensitivity to metoprolol and related derivatives