Sigtil M
Generic Name
Sitagliptin + Metformin
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sigtil m 50 mg tablet | ৳ 18.00 | ৳ 180.00 |
Description
Overview of the medicine
Sigtil M is a combination oral antidiabetic medication containing Sitagliptin and Metformin. It is used to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise.
Uses & Indications
Dosage
Adults
Initially, one tablet once or twice daily with meals, depending on individual patient needs and tolerability. Maximum recommended daily dose of Sitagliptin is 100 mg and Metformin is 2000 mg.
Elderly
Dosage should be individualized based on renal function. Close monitoring of renal function is recommended.
Renal_impairment
Not recommended for patients with eGFR <30 mL/min/1.73m2. Dose adjustment required for eGFR 30-60 mL/min/1.73m2.
How to Take
Take orally with meals to reduce gastrointestinal side effects associated with Metformin.
Mechanism of Action
Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which enhances the levels of active incretin hormones (GLP-1 and GIP), thereby increasing insulin synthesis and release and decreasing glucagon secretion. Metformin reduces hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Within hours for both components.
Excretion
Sitagliptin is primarily excreted renally, with about 79% excreted unchanged in urine. Metformin is primarily excreted unchanged in urine.
Half life
Sitagliptin: approx. 12.4 hours. Metformin: approx. 6.2 hours.
Absorption
Sitagliptin is rapidly absorbed with peak plasma concentrations (Tmax) reached in 1-4 hours. Metformin absorption is slower and incomplete, with absolute bioavailability of 50-60%.
Metabolism
Sitagliptin is minimally metabolized, primarily by CYP3A4 and CYP2C8. Metformin is not metabolized and is excreted unchanged.
Side Effects
Contraindications
- Hypersensitivity to sitagliptin or metformin
- Renal impairment (eGFR <30 mL/min/1.73m2)
- Metabolic acidosis (including diabetic ketoacidosis)
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
- Heart failure, unstable or acute
- History of lactic acidosis
Drug Interactions
Alcohol
Increases the risk of lactic acidosis.
Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide)
May increase risk of lactic acidosis.
Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, ranitidine, triamterene, trimethoprim, vancomycin)
May increase metformin accumulation.
Glucocorticoids, diuretics, thyroid products, estrogens, oral contraceptives, phenothiazines, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid
May lead to loss of glycemic control.
Storage
Store below 30°C in a dry place, away from light. Keep out of reach of children.
Overdose
Overdose of sitagliptin has minimal clinical significance. Metformin overdose can lead to lactic acidosis, which requires immediate medical attention, including hemodialysis.
Pregnancy & Lactation
Generally not recommended during pregnancy due to insufficient data. Benefits versus risks should be considered. Consult a doctor. Unknown if excreted in human milk, use with caution in nursing mothers.
Side Effects
Contraindications
- Hypersensitivity to sitagliptin or metformin
- Renal impairment (eGFR <30 mL/min/1.73m2)
- Metabolic acidosis (including diabetic ketoacidosis)
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
- Heart failure, unstable or acute
- History of lactic acidosis
Drug Interactions
Alcohol
Increases the risk of lactic acidosis.
Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide)
May increase risk of lactic acidosis.
Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, ranitidine, triamterene, trimethoprim, vancomycin)
May increase metformin accumulation.
Glucocorticoids, diuretics, thyroid products, estrogens, oral contraceptives, phenothiazines, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid
May lead to loss of glycemic control.
Storage
Store below 30°C in a dry place, away from light. Keep out of reach of children.
Overdose
Overdose of sitagliptin has minimal clinical significance. Metformin overdose can lead to lactic acidosis, which requires immediate medical attention, including hemodialysis.
Pregnancy & Lactation
Generally not recommended during pregnancy due to insufficient data. Benefits versus risks should be considered. Consult a doctor. Unknown if excreted in human milk, use with caution in nursing mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 24-36 months from manufacturing date.
Availability
Available in pharmacies nationwide
Approval Status
Approved by FDA and DGDA
Patent Status
Generic versions available, original patent expired for sitagliptin in many regions
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of sitagliptin and metformin combination in improving glycemic control in type 2 diabetes patients, both as initial therapy and as an add-on to existing treatments.
Lab Monitoring
- Renal function (eGFR) should be assessed before initiating Sigtil M and at least annually thereafter (more frequently in patients at risk of renal impairment).
- Hematologic parameters and vitamin B12 levels (for metformin).
- Glycated hemoglobin (HbA1c) and fasting plasma glucose regularly.
Doctor Notes
- Counsel patients on the symptoms of lactic acidosis and pancreatitis.
- Regularly monitor renal function and vitamin B12 levels.
- Individualize dosage based on efficacy and tolerability, particularly in patients with renal impairment or elderly patients.
Patient Guidelines
- Take Sigtil M exactly as prescribed by your doctor.
- Take with meals to reduce stomach upset.
- Inform your doctor about all other medications you are taking.
- Report any signs of lactic acidosis immediately (e.g., unusual muscle pain, difficulty breathing, unusual sleepiness, stomach pain).
- Do not stop taking the medicine without consulting your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember unless it's almost time for your next dose. Do not take a double dose to make up for a missed one.
Driving Precautions
Sigtil M itself is not known to impair the ability to drive or operate machinery. However, if used with insulin or a sulfonylurea, hypoglycemia may occur, which can affect concentration. Patients should be aware of hypoglycemia symptoms.
Lifestyle Advice
- Maintain a balanced diet appropriate for diabetes.
- Engage in regular physical activity.
- Monitor blood glucose levels regularly as advised by your doctor.
- Limit alcohol intake.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.