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Indications

• Steglatro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• It is approved for use as monotherapy or in combination with other antihyperglycemic agents, including insulin, metformin, sulfonylureas, or thiazolidinediones, when these medications alone or in combination with metformin do not provide adequate glycemic control.
• Steglatro belongs to the class of sodium-glucose cotransporter 2 (SGLT2) inhibitors, which work by inhibiting the reabsorption of glucose in the kidneys, leading to increased glucose excretion in the urine and lower blood glucose levels.
• The medication is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
• Steglatro is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
• It is important for healthcare providers to assess renal function before initiating Steglatro and periodically thereafter due to the risk of acute kidney injury and adverse renal events associated with SGLT2 inhibitors.

Dosage and administration

• The recommended starting dosage of Steglatro is 5 mg once daily, taken orally, with or without food.
• For patients tolerating Steglatro and requiring additional glycemic control, the dosage may be increased to 15 mg once daily.
• Steglatro can be taken as monotherapy or in combination with other antihyperglycemic agents, including metformin, sulfonylureas, thiazolidinediones, or insulin.
• It is important to assess renal function before initiating Steglatro and periodically thereafter, as dosage adjustments may be necessary based on renal function.
• No dosage adjustment is required for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m²). However, Steglatro is not recommended for use in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) or end-stage renal disease requiring dialysis.
• If a dose of Steglatro is missed, it should be taken as soon as the patient remembers, unless it is within 12 hours of the next dose. In that case, the missed dose should be skipped and the next dose taken at the regular time.
• Steglatro tablets should be swallowed whole and should not be split, crushed, or chewed.
• Patients should be advised to stay well-hydrated while taking Steglatro to reduce the risk of volume depletion and hypotension, especially in patients with impaired renal function or elderly patients.
• If hypoglycemia occurs when Steglatro is used in combination with insulin or insulin secretagogues (e.g., sulfonylureas), the dosage of insulin or insulin secretagogues may need to be reduced to reduce the risk of hypoglycemia.

Side effects

• Common side effects may include:
  • Genital mycotic infections (e.g., yeast infections in the vagina or penis)
  • Urinary tract infections (UTIs)
  • Increased urination
  • Thirst
  • Hypoglycemia (when used in combination with insulin or insulin secretagogues)
• Less common side effects may include:
  • Hypotension (low blood pressure)
  • Dizziness
  • Dehydration
  • Ketoacidosis (a serious complication characterized by high levels of ketones in the blood)
  • Acute kidney injury
  • Hyperkalemia (high levels of potassium in the blood)
• Rare but serious side effects may include:
  • Fournier’s gangrene (a rare but serious infection of the genital area)
  • Allergic reactions such as rash, itching, or swelling of the face, lips, tongue, or throat
  • Pancreatitis (inflammation of the pancreas)
  • Increased cholesterol levels
• Patients should be advised to report any new or worsening symptoms to their healthcare provider promptly, especially symptoms of genital infections, urinary tract infections, or signs of dehydration such as dizziness or thirst.
• It’s important for healthcare providers to monitor patients regularly for signs of ketoacidosis, acute kidney injury, or other serious adverse reactions while taking Steglatro.

Precautions

• If you have severe kidney problems or are on dialysis, Steglatro may not be suitable for you.
• Keep yourself well-hydrated, especially if you’re elderly or have kidney issues. This can help prevent dehydration, which may occur with Steglatro use.
• Be aware of symptoms like dizziness or feeling faint, especially if you’re already on medications for high blood pressure or have kidney problems.
• Pay attention to any signs of genital yeast infections or urinary tract infections. These can occur more frequently with Steglatro, and it’s important to treat them promptly.
• Keep an eye out for signs of hypoglycemia (low blood sugar), such as shakiness, sweating, or confusion, if you’re taking insulin or other medications that can lower blood sugar.
• Learn about the signs of ketoacidosis, such as nausea, vomiting, stomach pain, and difficulty breathing. Contact your healthcare provider immediately if you notice these symptoms.
• If you experience any unusual genital symptoms like pain, tenderness, or swelling, see your healthcare provider right away, as these could be signs of a rare but serious condition called Fournier’s gangrene.
• Watch out for persistent severe abdominal pain, as this could indicate pancreatitis. If you experience such symptoms, stop taking Steglatro and seek medical help.
• If you develop a rash, itching, or swelling of the face, lips, tongue, or throat, seek immediate medical attention as these could be signs of an allergic reaction.