Siglimet 50/1000

Presentation: Each film-coated tablet of Siglimet 50/1000 contains 50 mg of sitagliptin (as sitagliptin phosphate monohydrate) and 1000 mg of metformin hydrochloride.

Indications: Siglimet 50/1000 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with bothsitagliptin and metformin is appropriate. It is used in patients who are either:

• Already treated with sitagliptin and metformin as separate tablets.
• Not adequately controlled on metformin alone.
• Treatment naïve but have high initial glucose levels and are considered appropriate for combination therapy.

Dosage and Administration: Siglimet 50/1000 tablets are for oral administration and should be swallowed whole with water. It should be taken twice daily with meals to reduce the gastrointestinal side effects associated with metformin. The dosage should be individualized based on the patient's current regimen, effectiveness, and tolerability, while not exceeding the maximum recommended daily dose ofsitagliptin (100 mg) and metformin(2550 mg).

• Patients inadequately controlled on metformin monotherapy: The usual starting dose is one 50/500 mg tablet twice daily or one 50/850 mg tablet twice daily, with gradual titration up to 50/1000 mg twice daily based on glycemic control and tolerability.
• Patients switching from separate tablets of sitagliptin and metformin: Siglimet 50/1000 should be initiated at the dose of sitagliptin and metformin they were already taking.
• Treatment-naïve patients: The starting dose should be individualized based on the physician's assessment of the patient's needs and risk of metformin-associated gastrointestinal side effects. A common starting dose is 50/500 mg twice daily, with titration as needed.
• Renal Impairment: Renal function should be assessed before initiating Siglimet 50/1000 and regularly thereafter.
  • eGFR ≥ 45 to < 60 mL/min/1.73 m²: The maximum daily dose of metformin is 2000 mg. The dose of sitagliptin can remain 50 mg twice daily.
  • eGFR ≥ 30 to < 45 mL/min/1.73 m²: The maximum daily dose of metformin is 1000 mg, given as one 50/500 mg tablet twice daily. The dose of sitagliptin can remain 50 mg twice daily.
  • eGFR < 30 mL/min/1.73 m²: Use of Siglimet 50/1000 is contraindicated.
• Hepatic Impairment: Siglimet 50/1000 is generally contraindicated in patients with hepatic impairment due to the metformin component.
• Elderly: As metformin is primarily excreted by the kidney, Siglimet 50/1000 should be used with caution as age is associated with reduced renal function. Regular monitoring of renal function is advisable.

Side Effects: Common side effects may include gastrointestinal disturbances (diarrhea, nausea, vomiting, abdominal discomfort), headache, and upper respiratory tract infection. Hypoglycemia may occur when Siglimet 50/1000 is used in combination with insulin or sulfonylureas.

Less common but potentially serious side effects include lactic acidosis (related to metformin), pancreatitis (related to sitagliptin), hypersensitivity reactions, and renal impairment.

Precautions: Siglimet 50/1000 should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.  

Lactic acidosisis a rare but serious metabolic complication that can occur due to metformin accumulation. Risk factors include renal impairment, acute heart failure, dehydration, excessive alcohol intake, hepatic impairment, and sepsis.

Pancreatitis has been reported with sitagliptin. If symptoms of pancreatitis occur, Siglimet 50/1000 should be discontinued.

Assess renal function prior to initiation and regularly thereafter. Temporary discontinuation of Siglimet 50/1000 may be required for surgical procedures or iodinated contrast imaging.

Caution should be exercised when Siglimet 50/1000 is used in combination with sulfonylureas or insulin, as a reduction in the dose of the sulfonylurea or insulin may be necessary to reduce the risk of hypoglycemia.

Inform healthcare professionals regarding pregnancy and breastfeeding status before starting treatment with Siglimet 50/1000. Use during pregnancy is generally not recommended unless clearly needed. It is not recommended for use during breastfeeding.

Storage: Store at room temperature (15°C to 30°C), protected from moisture. Keep out of reach of children. Do not use after the expiry date.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.