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

direct_rx - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. 8.1 pregnancy risk summary limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data]. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations]. no adverse developmental effects were observed when metformin was administered to pregnant sprague dawley rats and rabbits during the period of organogenesis at doses up to 2- and 5-times, respectively, a 2550 mg clinical dose, based on body surface area [see data]. the estimated background risk of major birth defects is 6 to 10% in wo

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

amneal pharma australia pty ltd - metformin hydrochloride -

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

amneal pharma australia pty ltd - metformin hydrochloride -

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

amneal pharma australia pty ltd - metformin hydrochloride -

Philippines - English - FDA (Food And Drug Administration)

pharex health corporation - metfromin hydrochloride - film-coated tablet - 500 mg

Philippines - English - FDA (Food And Drug Administration)

hizon laboratories, inc. - metfromin hydrochloride - film-coated tablet - 500 mg

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

direct rx - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - - -

Philippines - English - FDA (Food And Drug Administration)

merck, inc.; distributor: philusa corporation - metfromin - extended release tablet - 500mg

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

macleods pharmaceuticals limited - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. metformin hydrochloride tablets  and metformin hydrochloride extended-release tablets  are contraindicated in patients with: • severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1) ]. • hypersensitivity to metformin. • acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride tablets / metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not repo

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

ascend laboratories, llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. metformin hydrochloride tablets and metformin hydrochloride extended-release tablets are contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2) [see warnings and precautions (5.1) ]. - hypersensitivity to metformin. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride tablets and metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear assoc