Steglatro Ertugliflozin Tablets

1. Indications and Usage
Glycemic Control in Type 2 Diabetes:
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:
Not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Note: Ertugliflozin has not been shown to reduce cardiovascular risk.
2. Dosage and Administration
Route of Administration:
For Oral Use ONLY. Administer once daily, preferably before the first meal of the day. Can be taken with or without food.
Recommended Dosage:
Initial Dose: The recommended starting dose is 5 mg orally once daily.
Titration: For patients who tolerate the 5 mg dose but require additional glycemic control, the dose may be increased to 15 mg once daily.
Administration Instructions:
Assess renal function prior to initiation. Do not initiate in patients with an eGFR below 45 mL/min/1.73 m². Discontinue if eGFR falls persistently below 45 mL/min/1.73 m².
3. Mechanism of Action
SGLT2 Inhibition:
Ertugliflozin inhibits sodium-glucose co-transporter 2 (SGLT2), which is expressed predominantly in the proximal renal tubules.
Glycosuria:
By blocking SGLT2, ertugliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion (glycosuria) and reducing plasma glucose levels.
4. Safety and Warnings
Volume Depletion and Hypotension:
Ertugliflozin causes intravascular volume contraction. Symptomatic hypotension can occur, especially in elderly patients, those with renal impairment, or those on diuretics. Correct volume status prior to initiating therapy.
Genital Mycotic Infections:
Patients are at increased risk for vulvovaginal candidiasis and balanoposthitis. Monitor and treat appropriately if symptoms arise.
Urinary Tract Infections (UTIs):
UTIs have been reported. Evaluate and treat if suspected.
Ketoacidosis:
Diabetic ketoacidosis (DKA) has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors. DKA may present with normal blood glucose levels (euglycemic DKA). If DKA is suspected, discontinue ertugliflozin and evaluate immediately.
Acute Kidney Injury (AKI):
AKI has been reported, sometimes secondary to volume depletion. Monitor renal function periodically.
Hypoglycemia:
Risk increases when used concomitantly with insulin secretagogues (e.g., sulfonylureas) or insulin. Consider reducing the dose of the concomitant medication.
5. Adverse Reactions
Most Common:
Female genital mycotic infections, urinary tract infections, increased urination, thirst, and hypoglycemia (when combined with other antidiabetic agents).
Other Reported Reactions:
Male genital mycotic infections, nausea, dyspepsia, fatigue, abdominal pain, and decreased estimated glomerular filtration rate (eGFR).
6. Drug Interactions
Insulin and Insulin Secretagogues:
Concomitant use increases the risk of hypoglycemia. A lower dose of insulin or sulfonylureas should be considered.
Diuretics:
May increase the risk of volume depletion and hypotension.
Drugs Increasing Serum Creatinine / Decreasing eGFR:
May increase the risk of renal impairment.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Ertugliflozin (as Ertugliflozin L-pyroglutamate salt).
Available Strengths: Film-coated tablets containing 5 mg or 15 mg of ertugliflozin.
Excipients: Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl methylcellulose, titanium dioxide, iron oxide red (for 15 mg tablet), among others.
Storage:
Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). Protect from moisture.