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lake erie medical dba quality care products llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride tablets usp is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride is contraindicated in patients with: - renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings and precautions ).   - known hypersensitivity to metformin hydrochloride.   - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin hydrochloride should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (see also precautions .

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

cardinal health - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride tablets usp is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride is contraindicated in patients with: metformin hydrochloride should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (see also precautions. )

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

direct rx - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 1000 mg - metformin hydrochloride tablets usp, is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride tablets usp is contraindicated in patients with: 0.1 renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings and precautions). 0.2 known hypersensitivity to metformin hydrochloride. 0.3 acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin hydrochloride tablets usp should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.

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

contract pharmacy services-pa - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride extended-release tablet 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: - renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings and precautions ). - known hypersensitivity to metformin hydrochloride. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin hydrochloride tablets and metformin hydrochlorid

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

lake erie medical dba quality care products llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride extended - release tablets, usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. metformin hydrochloride extended-release tablets are contraindicated in patients with: - renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings and precautions ). - known hypersensitivity to metformin hydrochloride. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin hydrochloride extended - release tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acu

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

aurobindo pharma 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 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 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 women with pre-gestational diabetes mellitus with an hba1c >7 and has been reported to be as high as 20 to 25% in women with a 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 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly-controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data human data published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy. however, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups. animal data metformin hydrochloride did not adversely affect development outcomes when administered to pregnant rats and rabbits at doses up to 600 mg/kg/day. this represents an exposure of about 2 and 5 times a 2550 mg clinical dose based on body surface area comparisons for rats and rabbits, respectively. determination of fetal concentrations demonstrated a partial placental barrier to metformin. risk summary limited published studies report that metformin is present in human milk [see data]. however, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on the effects of metformin on milk production. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for metformin hydrochloride and any potential adverse effects on the breastfed child from metformin hydrochloride or from the underlying maternal condition. data published clinical lactation studies report that metformin is present in human milk which resulted in infant doses approximately 0.11% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1. however, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants. discuss the potential for unintended pregnancy with premenopausal women as therapy with metformin hydrochloride may result in ovulation in some anovulatory women. the safety and effectiveness of metformin hydrochloride for the treatment of type 2 diabetes mellitus have been established in pediatric patients 10 to 16 years old. safety and effectiveness of metformin hydrochloride have not been established in pediatric patients less than 10 years old. use of metformin hydrochloride in pediatric patients 10 to 16 years old for the treatment of type 2 diabetes mellitus is supported by evidence from adequate and well-controlled studies of metformin hydrochloride in adults with additional data from a controlled clinical study in pediatric patients 10 to 16 years old with type 2 diabetes mellitus, which demonstrated a similar response in glycemic control to that seen in adults [see clinical studies (14.1)] . in this study, adverse reactions were similar to those described in adults. a maximum daily dose of 2000 mg of metformin hydrochloride is recommended [see dosage and administration (2.2)]. controlled clinical studies of metformin hydrochloride did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis. assess renal function more frequently in elderly patients [see warnings and precautions (5.1)] . metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment. metformin hydrochloride is contraindicated in severe renal impairment, patients with an estimated glomerular filtration rate (egfr) below 30 ml/min/1.73 m2 [see dosage and administration (2.3), contraindications (4), warnings and precautions (5.1), and clinical pharmacology (12.3)]. use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis. metformin hydrochloride is not recommended in patients with hepatic impairment [see warnings and precautions (5.1)] .

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lupin pharmaceuticals, inc. - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - 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 extended-release tablets are contraindicated in patients with: - severe renal impairment (egfr below 30ml/minute/1.73 m2 ) [see warnings and precautions (5.1)] . - known hypersensitivity to metformin. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride 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 metformi

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

actavis pharma, inc. - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - 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. important limitations of use metformin hydrochloride extended-release tablets should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. metformin hydrochloride extended-release tablets are contraindicated in patients with: - severe renal impairment (egfr below 30ml/min/1.73 m2 ) [see warnings and precautions (5.1)] . severe renal impairment (egfr below 30ml/min/1.73 m2 ) [see warnings and precautions (5.1)] . - known hypersensitivity to metformin hydrochloride. known hypersensitivity to metformin hydrochloride. - acute or chronic metabolic acidosis, including diabetic ketoacidosis. diabetic ketoacidosis should be treated with insulin. acute or chronic metabolic acidosis, including diabetic ketoacidosis. diabetic ketoacidosis should be treated wit

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

ncs healthcare of ky, llc dba vangard labs - 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 children with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) (see warnings and precautions ). - known hypersensitivity to metformin hydrochloride. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin.

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

legacy pharmaceutical packaging, llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 1000 mg - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: 1. severe renal impairment (egfr below 30 ml/min/1.73 m ) (see warnings and precautions ). 2. known hypersensitivity to metformin hydrochloride. 3. acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin.