Metformin Hydrochloride

METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS

Manufacturer: ScieGen Pharmaceuticals, Inc.

Score: 141.0

Quick Summary

Metformin hydrochloride extended-release tablets are used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The drug works by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity. The recommended starting dose is 500 mg orally once daily with the evening meal, with a maximum dose of 2000 mg once daily. Important safety information includes the risk of lactic acidosis, particularly in patients with renal impairment, and contraindications such as severe renal impairment and hypersensitivity to metformin. Special population considerations include use during pregnancy, pediatric use, and geriatric use, with careful monitoring and dose adjustments as needed.

Key Clinical Findings and Indications

Improves glycemic control in adults with type 2 diabetes mellitus
Decreases hepatic glucose production and intestinal absorption of glucose
Improves insulin sensitivity

Important Safety Information

Warning

Lactic acidosis, particularly in patients with renal impairment

Contraindications

Severe renal impairment (eGFR below 30 mL/min/1.73 m^2)
Hypersensitivity to metformin
Acute or chronic metabolic acidosis, including diabetic ketoacidosis

Adverse Reactions

Diarrhea
Nausea/Vomiting
Abdominal pain
Constipation
Abdomen distention
Dyspepsia/heartburn
Flatulence
Dizziness
Headache
Upper respiratory infection
Taste disturbance

Dosing Recommendations

General Guidance

Renal impairment: do not use in patients with eGFR below 30 mL/min/1.73 m^2; initiate with caution in patients with eGFR between 30-45 mL/min/1.73 m^2