Home Drug Guide Dapagliflozin and Saxagliptin Monohydrate

Drug Guide

Generic Name

Dapagliflozin and Saxagliptin Monohydrate

Brand Names Qtern

Classification

Therapeutic: Antidiabetic agent for Type 2 Diabetes Mellitus

Pharmacological: Combination of SGLT2 inhibitor and DPP-4 inhibitor

FDA Approved Indications

For the treatment of adults with Type 2 Diabetes Mellitus to improve glycemic control, as an adjunct to diet and exercise.

Mechanism of Action

Dapagliflozin inhibits sodium-glucose co-transporter 2 (SGLT2) in the proximal renal tubules, reducing glucose reabsorption and increasing urinary glucose excretion. Saxagliptin inhibits dipeptidyl peptidase-4 (DPP-4), increasing levels of active incretin hormones, which increase insulin synthesis and release and decrease glucagon levels.

Dosage and Administration

Adult: Typically, one tablet once daily with or without food. Dose may be adjusted based on glycemic response.

Pediatric: Not approved for pediatric use.

Geriatric: Use with caution in the elderly; renal function should be monitored.

Renal Impairment: Adjustment may be necessary; Dapagliflozin is not recommended if eGFR is below 45 mL/min/1.73 m².

Hepatic Impairment: Use with caution; no dose adjustment required.

Pharmacokinetics

Absorption: Both components are rapidly absorbed, with peak plasma concentrations within 2 hours.

Distribution: Dapagliflozin is extensively protein-bound (~91%). Saxagliptin is ~25% protein-bound.

Metabolism: Dapagliflozin undergoes glucuronidation; Saxagliptin is metabolized by CYP3A4/5.

Excretion: Dapagliflozin is mainly excreted in feces (about 75%). Saxagliptin and its metabolites are excreted via urine and feces.

Half Life: Dapagliflozin: approximately 13 hours; Saxagliptin: approximately 2.5 hours.

Contraindications

Hypersensitivity to dapagliflozin, saxagliptin, or any component.
History of serious hypersensitivity reactions to drug components.

Precautions

Use with caution in renal impairment, risk of diabetic ketoacidosis, urinary tract infections, and in patients with a history of infections or other risk factors for infections. Not recommended in severe renal impairment or ESRD.

Adverse Reactions - Common

Genital mycotic infections (Common)
Urinary tract infections (Common)
Hypoglycemia (especially when used with insulin or sulfonylureas) (Less common)

Adverse Reactions - Serious

Ketoacidosis (Rare)
Acute kidney injury (Rare)
Pancreatitis (Rare)

Drug-Drug Interactions

Insulin or sulfonylureas (risk of hypoglycemia)
NSAIDs (risk of renal impairment)

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor blood glucose, renal function, and signs of urinary and genital infections.

Diagnoses:

Risk for hypoglycemia
Risk for urinary tract infection

Implementation: Administer as prescribed, monitor blood glucose, educate on signs of infections.

Evaluation: Assess glycemic control and monitor for adverse effects.

Patient/Family Teaching

Take medication as prescribed, do not alter dose without consulting healthcare provider.
Report signs of urinary or genital infections, or symptoms of ketoacidosis.
Maintain good hygiene, stay hydrated.

Special Considerations

Black Box Warnings:

Risk of toeamglycosuria-yeast infections and dehydration.
Increased risk of ketoacidosis, which can be life-threatening.
Not recommended in severe renal impairment.

Genetic Factors: None established.

Lab Test Interference: May cause transient increases in serum creatinine and alterations in urinary glucose testing.

Overdose Management

Signs/Symptoms: Severe hypotension, dehydration, hypoglycemia, or ketoacidosis.

Treatment: Supportive care, discontinuation of medication, intravenous fluids, metabolic stabilization.

Storage and Handling

Storage: Store at room temperature, 20-25°C (68-77°F). Keep container tightly closed.

Stability: Stable for the shelf life specified by the manufacturer under recommended storage conditions.