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Saxagliptin and Metformin

SAXAGLIPTIN AND METFORMIN

Manufacturer: Mylan Pharmaceuticals 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 drug combines two antihyperglycemic medications, saxagliptin, a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin hydrochloride, a biguanide. Key clinical findings indicate that the drug is effective in improving glycemic control, but it has important safety information, including a boxed warning for lactic acidosis and contraindications such as severe renal impairment and hypersensitivity reactions. The main dosing recommendations include administering the drug once daily with the evening meal, with a maximum daily dosage of 5 mg saxagliptin and 2000 mg metformin extended-release. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, with specific recommendations and precautions for each group.

Key Clinical Findings and Indications

  • Improvement of glycemic control in adults with type 2 diabetes mellitus
  • Combination of saxagliptin, a DPP4 inhibitor, and metformin hydrochloride, a biguanide
  • Effective in reducing HbA1c levels and improving fasting plasma glucose

Important Safety Information

Warning

Lactic acidosis, pancreatitis, heart failure, hypoglycemia, and hypersensitivity reactions

Contraindications

  • Severe renal impairment (eGFR below 30 mL/min/1.73 m^2)
  • Hypersensitivity to metformin hydrochloride
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis
  • History of a serious hypersensitivity reaction to saxagliptin and metformin hydrochloride extended-release tablets or saxagliptin

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 for patients also taking strong cytochrome P450 3A4/5 inhibitors

Type 2 diabetes mellitus

Adult Dose

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 during pregnancy not recommended unless potential benefits justify potential risks

Nursing Mothers

  • Caution advised
  • Monitor breastfed infant for hypoglycemia

Pediatric Use

  • Not established
  • Safety and effectiveness not studied in pediatric patients under 18 years of age

Geriatric Use

  • Assess renal function more frequently
  • Greater sensitivity to adverse effects in elderly patients

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