Sitagliptin and metformin hydrochloride

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Manufacturer: Zydus Pharmaceuticals (USA) Inc.

Score: 148.0

Quick Summary

Sitagliptin and metformin hydrochloride tablets is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin and 500 mg metformin HCl twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin. The drug has several important safety considerations, including a boxed warning for lactic acidosis, and is contraindicated in patients with severe renal impairment, acute or chronic metabolic acidosis, and a history of serious hypersensitivity reaction to sitagliptin, metformin, or any of the excipients.

Key Clinical Findings and Indications

Improves glycemic control in adults with type 2 diabetes mellitus
Combination of sitagliptin and metformin hydrochloride
Indicated as an adjunct to diet and exercise

Important Safety Information

Warning

Lactic acidosis, pancreatitis, heart failure, acute renal failure, and severe hypersensitivity reactions

Contraindications

Severe renal impairment
Acute or chronic metabolic acidosis
History of serious hypersensitivity reaction to sitagliptin, metformin, or any of the excipients

Adverse Reactions

Diarrhea
Upper respiratory tract infection
Headache
Hypoglycemia
Nasopharyngitis

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with renal impairment

Type 2 diabetes mellitus

Adult Dose

50 mg sitagliptin and 500 mg metformin HCl twice daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Use during pregnancy only if potential benefit justifies potential risk to fetus
No adequate and well-controlled studies in pregnant women

Nursing Mothers

Sitagliptin is present in rat milk and possibly present in human milk
Metformin is present in human milk

Pediatric Use

Not established in pediatric patients
No clinical trials have been conducted in pediatric patients

Geriatric Use

Dose selection should be cautious, usually starting at the low end of the dosing range
Renal function should be assessed more frequently in elderly patients