FDA

Metformin Hydrochloride

Approved 1 Aug 2012OralTablet, extended release

The FDA lists this product in 60 strengths and forms.

Boxed warningThe FDA label of this medicine carries a boxed warning, the strongest warning the FDA gives. Read it under warnings and precautions.

Indications

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 a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )

Contraindications

Metformin hydrochloride extended-release tablets are contraindicated in patients with:

Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [ see Warnings and Precautions (5.1) ].
Hypersensitivity to metformin.
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) ( 4 , 5.1 )
Hypersensitivity to metformin ( 4 )
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma ( 4 )

Warnings and precautions

Lactic Acidosis: See boxed warning ( 5.1 )
Vitamin B 12 Deficiency: Metformin may lower vitamin B 12 levels. Measure hematological parameters annually and vitamin B 12 at 2 to 3 year intervals and manage any abnormalities ( 5.2 )
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required ( 5.3 )

FDA

Metformin Hydrochloride

Approved 1 Aug 2012OralTablet, extended release

The FDA lists this product in 60 strengths and forms.

Official labelAsk Osler about it

Boxed warningThe FDA label of this medicine carries a boxed warning, the strongest warning the FDA gives. Read it under warnings and precautions.

Indications

Contraindications

Metformin hydrochloride extended-release tablets are contraindicated in patients with:

Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [ see Warnings and Precautions (5.1) ].
Hypersensitivity to metformin.
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) ( 4 , 5.1 )
Hypersensitivity to metformin ( 4 )
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma ( 4 )

Warnings and precautions

Lactic Acidosis: See boxed warning ( 5.1 )
Vitamin B 12 Deficiency: Metformin may lower vitamin B 12 levels. Measure hematological parameters annually and vitamin B 12 at 2 to 3 year intervals and manage any abnormalities ( 5.2 )
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required ( 5.3 )

Metformin Hydrochloride

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Metformin Hydrochloride

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Lactic Acidosis

5.2Vitamin B 12 Deficiency

Interactions

1.00AUC

0.91Ratio

0.93Furosemide

1.22Nifedipine

1.21Propranolol

0.94Ibuprofen

1.00AUC

0.78Ratio

0.63Furosemide

0.69Nifedipine

1.10AUC

1.08Propranolol

1.02Ibuprofen

0.97Ratio

1.01Cimetidine

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Studies Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance