Steglatro Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Tabs—30, 90
Manufacturer
Generic Availability
Mechanism of Action
Steglatro Indications
Indications
Limitations of Use
Not for improving glycemic control in patients with type 1 diabetes.
Steglatro Dosage and Administration
Adult
Children
Steglatro Contraindications
Not Applicable
Steglatro Boxed Warnings
Not Applicable
Steglatro Warnings/Precautions
Warnings/Precautions
Increased risk for volume depletion or hypotension in those with renal impairment (eGFR <60mL/min/1.73m2), elderly, low systolic BP, or on loop diuretics. Assess volume status, renal function before and after initiating therapy. Correct volume depletion before initiating. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected; evaluate and treat if confirmed. Monitor for resolution of ketoacidosis before restarting. Withhold (at least 4 days), if possible, prior to major surgery or procedures associated with prolonged fasting. Risk for lower limb amputations. Prior to initiation, consider factors that may predispose the need for amputations (eg, history of prior amputation, peripheral vascular disease, neuropathy, diabetic foot ulcers). Monitor for foot infection (including osteomyelitis), new pain or tenderness, sores or ulcers in lower limbs; discontinue if occur. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections or UTIs (including urosepsis, pyelonephritis); monitor and treat appropriately. Severe hepatic impairment: not recommended. Elderly. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.
Steglatro Pharmacokinetics
Absorption
Peak plasma concentrations (median Tmax): 1 hour postdose (under fasted conditions).
Distribution
Plasma protein bound: 93.6%.
Elimination
Steglatro Interactions
Interactions
Greater potential for volume depletion or hypotension with concomitant diuretics. May need a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. May antagonize serum lithium concentrations; monitor levels more frequently. May result in false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.
Steglatro Adverse Reactions
Adverse Reactions
Genital mycotic infections (esp. females), UTIs, headache, vaginal pruritus, increased urination, nasopharyngitis, back pain, weight decreased, thirst; ketoacidosis, renal impairment, angioedema; rare: Fournier's gangrene.
Steglatro Clinical Trials
See Literature
Steglatro Note
Not Applicable
Steglatro Patient Counseling
See Literature