Eltero 15

• Type 2 Diabetes Mellitus: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use: Not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Adult Dose:

• Type 2 Diabetes Mellitus: Recommended starting dose: 5 mg PO qDay in the morning; may increase to maximum of 15 mg qDay if needed.
• Mild-to-moderate hepatic impairment: No dosage adjustment necessary.
• Severe hepatic impairment: Not recommended.

Renal Dose:

• eGFR ≥60 mL/min/1.73 m²: No dosage adjustment necessary
• eGFR 30-60 mL/min/1.73 m²: Initiation not recommended; continued use not recommended
• eGFR <30 mL/min/1.73 m², ESRD, or dialysis: Contraindicated

Child Dose (<18 years): Safety and efficacy not established.

Common Side Effects:

• Female genital mycotic infections (9.1-12.2%)
• Volume depletion adverse effects (1.9-4.4%)
• Male genital mycotic infections (3.7-4.2%)
• Urinary tract infections (4-4.1%)
• Headache (2.9-3.5%)
• Vaginal pruritus (2.4-2.8%)
• Increased urination (2.4-2.7%)
• Nasopharyngitis (2-2.5%)
• Back pain (1.7-2.5%)
• Renal adverse effects (1.3-2.5%)
• Weight decreased (1.2-2.4%)
• Thirst (1.4-2.7%)

Precautions:

• Hypotension: Causes intravascular volume contraction; caution in patients with renal impairment, low systolic BP, on diuretics, or elderly.
• Ketoacidosis: Serious life-threatening condition; risk factors include insulin deficiency, caloric restriction, alcohol abuse; temporarily discontinue in acute illness or surgery.
• Acute Kidney Injury: Risk factors include hypovolemia, chronic renal insufficiency, CHF, concomitant medications; temporarily discontinue if reduced oral intake or fluid loss.
• Genital Mycotic Infections: History or uncircumcised males are more susceptible.
• Serious UTIs: Urosepsis and pyelonephritis requiring hospitalization reported.
• LDL-C Increases: Monitor and treat as appropriate.