Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

jazeera pharmaceutical industries (jpi), saudi arabia - metformin hydrochloride,alogliptin - film-coated tablet - 1000,12.5 mg,

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

remedyrepack inc. - alogliptin benzoate (unii: een99869sc) (alogliptin - unii:jhc049lo86) - alogliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see clinical studies (14)]. limitations of use alogliptin tablets should not be used in patients with type 1 diabetes mellitus. serious hypersensitivity reaction to alogliptin or any of the excipients in alogliptin tablets. reactions such as anaphylaxis, angioedema and severe cutaneous adverse reactions have been reported [see warnings and precautions (5.3), adverse reactions (6.2)] . risk summary limited data with alogliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations]. no adverse developmental effects were observed when alogliptin was administered to pregnant rats and rabbits during organogenesis at exposures 180- and 149-times the 25 mg clinical dose, respectively, based on plasma drug exposure (auc) [see data] . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. 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 poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. data animal data alogliptin administered to pregnant rabbits and rats during the period of organogenesis did not cause adverse developmental effects at doses of up to 200 mg/kg and 500 mg/kg, or 149 times and 180 times, the 25 mg clinical dose, respectively, based on plasma drug exposure (auc). placental transfer of alogliptin into the fetus was observed following oral dosing to pregnant rats. no adverse developmental outcomes were observed in offspring when alogliptin was administered to pregnant rats during gestation and lactation at doses up to 250 mg/kg (~ 95 times the 25 mg clinical dose, based on auc). risk summary there is no information regarding the presence of alogliptin in human milk, the effects on the breastfed infant, or the effects on milk production. alogliptin is present in rat milk: however, due to species specific differences in lactation physiology, animal lactation data may not reliably predict levels in human milk . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for alogliptin tablets and any potential adverse effects on the breastfed infant from alogliptin tablets or from the underlying maternal condition. safety and effectiveness of alogliptin tablets in pediatric patients have not been established. of the total number of patients (n=9052) in clinical safety and efficacy studies treated with alogliptin tablets, 2257 (24.9%) patients were 65 years and older and 386 (4.3%) patients were 75 years and older. no overall differences in safety or effectiveness were observed between patients 65 years and over and younger patients. while this clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out. a total of 602 patients with moderate renal impairment (egfr ≥30 and <60 ml/min/1.73 m 2 ) and 4 patients with severe renal impairment/end-stage renal disease (egfr <30 ml/min/1.73 m 2 or <15 ml/min/1.73 m 2 , respectively) at baseline were treated with alogliptin tablets in clinical trials in patients with type 2 diabetes. reductions in hba1c were generally similar in this subgroup of patients. the overall incidence of adverse reactions was generally balanced between alogliptin tablets and placebo treatments in this subgroup of patients. in the examine trial of high cv risk type 2 diabetes patients, 694 patients had moderate renal impairment and 78 patients had severe renal impairment or end-stage renal disease at baseline. the overall incidences of adverse reactions, serious adverse reactions and adverse reactions leading to study drug discontinuation were generally similar between the treatment groups. no dose adjustments are required in patients with mild to moderate hepatic impairment (child-pugh grade a and b) based on insignificant change in systemic exposures (e.g., auc) compared to subjects with normal hepatic function in a pharmacokinetic study. alogliptin tablets have not been studied in patients with severe hepatic impairment (child-pugh grade c). use caution when administering alogliptin tablets to patients with liver disease [see warnings and precautions (5.4)] .

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

teijin pharma limited - alogliptin benzoate; pioglitazone hydrochloride - faintly yellowish red tablet, diameter: 8.7 mm, thickness: 5.0 mm

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

teijin pharma limited - alogliptin benzoate; pioglitazone hydrochloride - faint yellow tablet, diameter: 8.7 mm, thickness: 5.0 mm

Singapore - English - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - alogliptin benzoate 8.5mg eqv alogliptin - tablet, film coated - alogliptin benzoate 8.5mg eqv alogliptin 6.25mg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

takeda malaysia sdn bhd - alogliptin benzoate -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

takeda malaysia sdn bhd - alogliptin benzoate -

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

الشركة المتحدة لصناعة الأدوية - united pharmaceutical manufacturing co. ltd. - metformin hcl 1000 mg/1 tab , alogliptin benzoate 12.5 mg - 1000 mg/1 tab , 12.5 mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ennogen healthcare ltd - alogliptin benzoate - oral tablet - 12.5mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ennogen healthcare ltd - alogliptin benzoate - oral tablet - 25mg