Saxagliptin and Metformin Hydrochloride

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Manufacturer: Dr.Reddys Laboratories Inc

Score: 144.0

Quick Summary

Saxagliptin and 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 tablets combine two antihyperglycemic medications, saxagliptin and metformin, with complementary mechanisms of action. Saxagliptin is a dipeptidyl peptidase-4 (DPP4) inhibitor, while metformin is a biguanide. The drug is contraindicated in patients with severe renal impairment, hypersensitivity to metformin, and acute or chronic metabolic acidosis. Important safety information includes the risk of lactic acidosis, pancreatitis, heart failure, and hypoglycemia. The recommended dosage is individualized based on the patient's current regimen, with a maximum daily dose of 5 mg saxagliptin and 2,000 mg metformin. Special population considerations include use in pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Type 2 diabetes mellitus
Adjunct to diet and exercise
Improves glycemic control

Important Safety Information

Warning

Lactic acidosis, pancreatitis, heart failure, and hypoglycemia

Contraindications

Severe renal impairment
Hypersensitivity to metformin
Acute or chronic metabolic acidosis

Adverse Reactions

Diarrhea
Nausea/vomiting
Upper respiratory tract infection
Urinary tract infection
Headache

Dosing Recommendations

General Guidance

Limit saxagliptin dosage to 2.5 mg daily when coadministered with strong CYP3A4/5 inhibitors, and adjust dosage based on renal function

Type 2 diabetes mellitus

Adult Dose

Individualized, 5 mg saxagliptin/500 mg metformin extended-release once daily with gradual dose titration

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Limited data available
Use with caution

Nursing Mothers

Not established

Pediatric Use

Not established

Geriatric Use

Assess renal function more frequently
Dose selection should be cautious

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