Taglimet 50/1000mg Tablet

✔️ Dosage & Administration

Film-coated tablet

The dosage should be individualized according to the patient’s current treatment regimen, response, and tolerability, without exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin.

• Generally administered twice daily with meals to minimize gastrointestinal side effects associated with metformin.
• Dose escalation should be gradual.

Recommended starting doses:

• Patients not currently taking metformin: 50 mg sitagliptin/500 mg metformin twice daily.
• Patients already on metformin: Use a dose providing sitagliptin 50 mg twice daily with the patient’s current metformin dose.
• Patients taking metformin 850 mg twice daily: Recommended dose is 50 mg sitagliptin/1000 mg metformin twice daily.

Switching from other oral antidiabetic therapies should be done carefully with appropriate monitoring because glycemic control may fluctuate.

Extended-release tablet

• Administer once daily with a meal, preferably in the evening.
• Gradually increase the dose to reduce gastrointestinal side effects.
• Do not exceed the maximum daily dose of 100 mg sitagliptin and 2000 mg metformin extended-release.

Patients transitioning between immediate-release and extended-release formulations should maintain the same total daily dose of sitagliptin and metformin.

• Patients using two extended-release tablets should take both tablets together once daily.
• The 100 mg sitagliptin/1000 mg metformin XR tablet should be taken as a single tablet once daily.

When used together with insulin or insulin secretagogues such as sulfonylureas, dose reduction of those agents may be necessary to minimize the risk of hypoglycemia.

✔️ Overdose Effects

Sitagliptin:
Supportive treatment should be provided, including removal of unabsorbed drug and ECG monitoring. Sitagliptin is moderately removed by hemodialysis.

Metformin:
Large overdoses may lead to severe lactic acidosis. Metformin is dialyzable and hemodialysis may help remove accumulated drug. Pancreatitis may also occur in overdose situations.

✔️ Metformin accumulation may lead to lactic acidosis, especially in patients with:

• Renal impairment
• Hepatic insufficiency
• Sepsis
• Dehydration
• Excess alcohol intake
• Acute heart failure

Symptoms may include malaise, muscle pain, breathing difficulty, abdominal discomfort, drowsiness, low body temperature, and laboratory abnormalities such as elevated lactate levels and low blood pH. Immediate discontinuation and hospitalization are required if lactic acidosis is suspected.

✔️ Side Effects

Common adverse effects may include:

• Diarrhea
• Headache
• Upper respiratory tract infection
• Nasopharyngitis
• Nausea and vomiting
• Flatulence
• Abdominal discomfort
• Weakness (asthenia)
• Hypoglycemia, especially when combined with insulin or sulfonylureas

✔️ Pregnancy & Lactation

Pregnancy:
Classified as Pregnancy Category B. Adequate studies in pregnant women are lacking. Use during pregnancy only if clearly needed.

Lactation:
It is unknown whether sitagliptin passes into human breast milk. Caution is advised when administering this medication to breastfeeding mothers.

✔️ Interaction

• Cationic drugs eliminated through renal tubular secretion should be used cautiously as they may interfere with metformin elimination.
• Phenprocoumon: Metformin may reduce its anticoagulant effect; INR monitoring is recommended.
• Levothyroxine: May decrease the glucose-lowering effect of metformin, requiring monitoring of blood glucose and possible dose adjustment.

✔️ Metformin Hydrochloride + Sitagliptin

• Renal disease or impaired kidney function, including elevated serum creatinine or reduced creatinine clearance
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis
• Previous serious hypersensitivity reactions to sitagliptin or this combination, including anaphylaxis or angioedema
• Patients undergoing radiologic procedures involving iodinated contrast agents should temporarily discontinue therapy due to the risk of acute renal dysfunction

✔️ Storage:

Store below 25°C in a dry place away from heat and light. Keep out of the reach of children. Use only under the prescription of a registered physician.