metformin hydrochloride

METFORMIN HYDROCHLORIDE TABLETS

Manufacturer: EPIC PHARMA, LLC

Score: 141.0

Quick Summary

Metformin hydrochloride extended-release tablets are used 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. It is contraindicated in patients with severe renal impairment, hypersensitivity to metformin, and acute or chronic metabolic acidosis. The recommended starting dose is 500 mg orally once daily with the evening meal, and the dose can be increased in increments of 500 mg weekly up to a maximum of 2,000 mg once daily. Special population considerations include use during pregnancy, pediatric use, geriatric use, and patients with renal impairment.

Key Clinical Findings and Indications

Improves glycemic control in adults with type 2 diabetes mellitus
Decreases hepatic glucose production, intestinal absorption of glucose, and improves insulin sensitivity
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Important Safety Information

Warning

Lactic acidosis can occur due to metformin accumulation, and the risk is increased in patients with renal impairment, hepatic impairment, and other conditions

Contraindications

Severe renal impairment (eGFR below 30 mL/min/1.73 m^2)
Hypersensitivity to metformin
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma

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: initiate with caution, and assess renal function before initiating; discontinue if eGFR falls below 30 mL/min/1.73 m^2

Type 2 diabetes mellitus

Adult Dose

500 mg orally once daily with the evening meal, increased in increments of 500 mg weekly up to a maximum of 2,000 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Limited data with metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage