Saxagliptin And Metformin
Generic Name: saxagliptin and metformin
Brand Names:
Saxagliptin And Metformin
11 DESCRIPTION Saxagliptin and metformin hydrochloride extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes mellitus: saxagliptin and metformin HCl. Saxagliptin Saxagliptin is an orally active inhibitor of the dipeptidyl-peptidase-4 (DPP4) enzyme.
Overview
11 DESCRIPTION Saxagliptin and metformin hydrochloride extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes mellitus: saxagliptin and metformin HCl. Saxagliptin Saxagliptin is an orally active inhibitor of the dipeptidyl-peptidase-4 (DPP4) enzyme.
Uses
1 INDICATIONS AND USAGE Saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [ see Clinical Studies (14) ]. Saxagliptin and metformin hydrochloride extended-release tablets are a combination of saxagliptin, a dipeptidyl peptidase-4 (DPP4) 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. ( 1 ) Limitations of Use: • Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Dosage
2 DOSAGE AND ADMINISTRATION • Administer once daily with the evening meal. ( 2.1 ) • Individualize the starting dosage based on the patient’s current regimen then adjust the dosage based on effectiveness and tolerability. ( 2.1 ) • Do not exceed a daily dosage of 5 mg saxagliptin/2,000 mg metformin HCl extended-release. ( 2.1 ) • Swallow whole. Never crush, cut, or chew. ( 2.1 ) • Limit the saxagliptin dosage to 2.5 mg daily for patients also taking strong cytochrome P450 3A4/5 inhibitors (e.g., ketoconazole). ( 2.3 , 7.1 ) • Assess renal function prior to initiation of saxagliptin and metformin hydrochloride extended-release tablets and periodically thereafter. ( 2.2 ) o Do not use in patients with eGFR below 30 mL/min/1.73 m 2 .
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Lactic Acidosis [ see Boxed Warning and Warnings and Precautions (5.1) ] • Pancreatitis [ see Warnings and Precautions (5.2) ] • Heart Failure [ see Warnings and Precautions (5.3) ] • Vitamin B 12 Concentrations [ see Warnings and Precautions (5.4) ] • Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues [ see Warnings and Precautions (5.5) ] • Hypersensitivity Reactions [ see Warnings and Precautions (5.6) ] • Severe and disabling arthralgia [ see Warnings and Precautions (5.7) ] • Bullous pemphigoid [ see Warnings and Precautions (5.8) ] • Most common adverse reactions with metformin HCl extended release (incidence > 5% and more often than placeb...
Interactions
7 DRUG INTERACTIONS • Strong CYP3A4/5 inhibitors (e.g., ketoconazole): Coadministration with saxagliptin and metformin hydrochloride extended-release tablets significantly increases saxagliptin concentrations. Limit saxagliptin and metformin hydrochloride extended-release tablets dosage to 2.5 mg/1,000 mg once daily when coadministered with a strong CYP3A4/5 inhibitor. ( 2.3 , 7.1 ) • Carbonic anhydrase inhibitors: May increase risk of lactic acidosis. Consider more frequent monitoring. ( 7.2 ) • Drugs that reduce metformin clearance : May increase risk of lactic acidosis. Consider benefits and risks of concomitant use. ( 7.3 ) • See full prescribing information for additional drug interactions.
Warnings
WARNING: LACTIC ACIDOSIS • Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. 5 WARNINGS AND PRECAUTIONS • Pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue saxagliptin and metformin hydrochloride extended-release tablets. ( 5.2 ) • Heart Failure: Consider the risks and benefits of saxagliptin and metformin hydrochloride extended-release tablets in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. ( 5.3 ) • Vitamin B 12 Deficiency: Metformin may lower vitamin B 12 levels. Measure hematological parameters annually. 4 CONTRAINDICATIONS Saxagliptin and metformin hydrochloride extended-release tablets are contraindicated in patients with: • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ). • Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
Pregnancy
8.1 Pregnancy Risk Summary Limited available data with saxagliptin and metformin hydrochloride extended-release tablets or saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. Published trials with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [ see Data ].
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Saxagliptin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, are pink, film-coated, round, unscored tablets imprinted with SM3 over M in black ink on one side of the tablet and blank on the other side.
Frequently Asked Questions
What is Saxagliptin And Metformin used for?▼
1 INDICATIONS AND USAGE Saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [ see Clinical Studies (14) ]. Saxagliptin and metformin hydrochloride extended-release tablets are a combination of saxagliptin, a dipeptidyl peptidase-4 (DPP4) 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. ( 1 ) Limitations of Use: • Not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
What are the side effects of Saxagliptin And Metformin?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Lactic Acidosis [ see Boxed Warning and Warnings and Precautions (5.1) ] • Pancreatitis [ see Warnings and Precautions (5.2) ] • Heart Failure [ see Warnings and Precautions (5.3) ] • Vitamin B 12 Concentrations [ see Warnings and Precautions (5.4) ] • Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues [ see Warnings and Precautions (5.5) ] • Hypersensitivity Reactions [ see Warnings and Precautions (5.6) ] • Severe and disabling arthralgia [ see Warnings and Precautions (5.7) ] • Bullous pemphigoid [ see Warnings and Precautions (5.8) ] • Most common adverse reactions with metformin HCl extended release (incidence > 5% and more often than placeb...
Can I take Saxagliptin And Metformin during pregnancy?▼
8.1 Pregnancy Risk Summary Limited available data with saxagliptin and metformin hydrochloride extended-release tablets or saxagliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. Published trials with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [ see Data ].
What are the important warnings for Saxagliptin And Metformin?▼
WARNING: LACTIC ACIDOSIS • Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. 5 WARNINGS AND PRECAUTIONS • Pancreatitis: There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue saxagliptin and metformin hydrochloride extended-release tablets. ( 5.2 ) • Heart Failure: Consider the risks and benefits of saxagliptin and metformin hydrochloride extended-release tablets in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. ( 5.3 ) • Vitamin B 12 Deficiency: Metformin may lower vitamin B 12 levels. Measure hematological parameters annually. 4 CONTRAINDICATIONS Saxagliptin and metformin hydrochloride extended-release tablets are contraindicated in patients with: • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ). • Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.