Siglimet 50/500mg Tablet 1 Strip

✔️ Dosage & Administration of Siglimet 50/500

Immediate-Release Tablet

• Dosed twice daily with meals.
• Initial dosage depends on the patient's existing therapy.
• Do not exceed 100 mg of sitagliptin and 2000 mg of metformin per day.

Gradual dose escalation is advised to minimize gastrointestinal side effects from metformin.

Extended-Release Tablet

• Taken once daily with the evening meal.
• Can be adjusted based on tolerance and effectiveness.
• Two extended-release tablets (e.g., 50/500 or 50/1000) should be taken together once daily.

Maintain the same total daily dose when switching between immediate and extended-release forms.

In Combination with Insulin or Sulfonylureas

May require dose adjustments to prevent hypoglycemia.

✔️ Side Effects of Siglimet 50/500

• Common (≥5%): Diarrhea, headache, upper respiratory infections, nasopharyngitis.
• Combination with sulfonylurea or insulin: Risk of hypoglycemia increases.
• Metformin-specific: Nausea, vomiting, flatulence, abdominal discomfort, fatigue.

✔️ Drug Interactions

• Cationic drugs (excreted via renal tubules): Use with caution.
• Phenprocoumon: Metformin may reduce its anticoagulant effect; monitor INR.
• Levothyroxine: Can reduce metformin’s effectiveness; monitor glucose levels when initiating or stopping thyroid hormone therapy.

✔️ Contraindications

Do not use in patients with:

• Renal impairment (e.g., serum creatinine ≥1.5 mg/dL for men, ≥1.4 mg/dL for women).
• Acute or chronic metabolic acidosis.
• Known hypersensitivity to sitagliptin or the combination tablet.
• Undergoing radiologic procedures with iodinated contrast (risk of acute kidney injury).

✔️ Use in Pregnancy & Lactation

• Pregnancy Category B: Use only if needed. No adequate studies in humans.
• Unknown if sitagliptin is excreted in breast milk. Use with caution during lactation.

✔️ Precautions & Warnings

• Lactic Acidosis: Rare but serious. Risk factors include renal impairment, liver disease, alcohol abuse, and acute illness.
• Pancreatitis: Discontinue if suspected.
• Renal Function: Assess before starting and at least annually.
• Vitamin B12 Deficiency: May occur with long-term metformin use.
• Hepatic Disease: Avoid use.
• Allergic Reactions: Rare but may include anaphylaxis, angioedema, and skin reactions such as Stevens-Johnson syndrome.
• May need temporary insulin substitution during periods of stress (fever, surgery, trauma, etc.).
• No proven benefit in reducing macrovascular complications.

✔️ Storage:

• Store below 25°C, away from moisture and light.
• Keep out of reach of children.
• Do not use beyond expiry date.
• Dispense only on prescription.