Drug Guide
Alogliptin benzoate and Metformin hydrochloride
Classification
Therapeutic: antidiabetic, combination oral hypoglycemic
Pharmacological: Dipeptidyl peptidase-4 (DPP-4) inhibitor and Biguanide
FDA Approved Indications
- Management of type 2 diabetes mellitus as an adjunct to diet and exercise
Mechanism of Action
Alogliptin inhibits DPP-4 enzyme, increasing incretin levels which stimulate insulin release and decrease glucagon levels; Metformin reduces hepatic glucose production, decrease intestinal absorption of glucose, and improves insulin sensitivity.
Dosage and Administration
Adult: Typically, 25 mg alogliptin and 1000 mg metformin once daily, adjusted based on glycemic response and tolerability.
Pediatric: Not approved for use in pediatric patients.
Geriatric: Use with caution; start at lower doses due to potential renal impairment and comorbidities.
Renal Impairment: Adjust dosage based on renal function; contraindicated if eGFR <30 mL/min/1.73 m².
Hepatic Impairment: Use with caution; contraindicated in severe hepatic impairment.
Pharmacokinetics
Absorption: Alogliptin absorbed with moderate bioavailability; Metformin absorbed slowly from the gastrointestinal tract.
Distribution: Alogliptin protein binding approximately 20%; Metformin minimal protein binding.
Metabolism: Alogliptin undergoes minimal metabolism; Metformin is not metabolized.
Excretion: Primarily renal excretion for both components.
Half Life: Alogliptin approximately 12 hours; Metformin about 5 hours.
Contraindications
- Severe renal impairment (eGFR <30 mL/min/1.73 m²)
- History of hypersensitivity to components
Precautions
- Renal function monitoring; risk of lactic acidosis with metformin; pancreatitis with alogliptin
Adverse Reactions - Common
- nasopharyngitis (common)
- headache (common)
- hypoglycemia (when used with insulin or sulfonylureas) (less common)
Adverse Reactions - Serious
- acute pancreatitis (rare)
- lactic acidosis (due to metformin accumulation) (rare)
Drug-Drug Interactions
- Other antidiabetic drugs increasing hypoglycemia risk
- Cationic drugs affecting renal clearance
Drug-Food Interactions
- Alcohol may increase risk of lactic acidosis
Drug-Herb Interactions
N/ANursing Implications
Assessment: Monitor blood glucose levels, renal function, and signs of hypoglycemia and lactic acidosis.
Diagnoses:
- Risk for hypoglycemia
- Impaired renal function
Implementation: Administer with meals to reduce GI side effects; monitor labs regularly.
Evaluation: Assess glycemic control and renal parameters periodically.
Patient/Family Teaching
- Take medication as directed, preferably with meals.
- Recognize symptoms of hypoglycemia and lactic acidosis.
- Maintain hydration and regular medical follow-up.
Special Considerations
Black Box Warnings:
- Lactic acidosis, especially in renal impairment or conditions predisposing to hypoxia
Genetic Factors: Genetic variations affecting drug metabolism are not well-established.
Lab Test Interference: None reported.
Overdose Management
Signs/Symptoms: Lactic acidosis, hypoglycemia (if combined with other agents)
Treatment: Discontinue medication; provide supportive care; consider hemodialysis for severe metformin overdose.
Storage and Handling
Storage: Store at room temperature, away from moisture and heat.
Stability: Stable for the shelf life listed in the package insert.