Sitagil-M
Generic Name
Sitagliptin and Metformin Hydrochloride
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sitagil m 100 mg tablet | ৳ 35.00 | ৳ 210.00 |
Description
Overview of the medicine
Sitagil-M 100 mg tablet is a combination medicine containing Sitagliptin and Metformin. It is used to improve blood sugar control in adults with type 2 diabetes mellitus when diet and exercise alone do not provide adequate control.
Uses & Indications
Dosage
Adults
One tablet (Sitagliptin 100 mg / Metformin 1000 mg) once or twice daily, or as directed by the physician. Dosage should be individualized based on the patient's current regimen, effectiveness, and tolerability, not exceeding 100 mg sitagliptin and 2000 mg metformin daily.
Elderly
Dose adjustments may be necessary based on renal function. Initiate with lower doses and monitor renal function frequently.
Renal_impairment
Contraindicated in patients with eGFR < 30 mL/min/1.73m². Dose reduction required for eGFR 30-45 mL/min/1.73m² (Metformin dose reduced, Sitagliptin max 50 mg daily). Not recommended for eGFR < 45 ml/min/1.73m² with Metformin component.
How to Take
Take orally with food to reduce gastrointestinal side effects, typically in the morning and/or evening as directed by your doctor. Swallow the tablet whole, do not crush or chew.
Mechanism of Action
Sitagliptin, a DPP-4 inhibitor, increases incretin hormones (GLP-1 and GIP) to enhance glucose-dependent insulin secretion and suppress glucagon release. Metformin, a biguanide, reduces hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Within hours for both components.
Excretion
Sitagliptin: Primarily excreted unchanged in urine. Metformin: Excreted unchanged in urine.
Half life
Sitagliptin: ~12.4 hours. Metformin: ~6.2 hours.
Absorption
Sitagliptin: Rapidly absorbed, bioavailability ~87%. Metformin: Slowly and incompletely absorbed, bioavailability ~50-60%.
Metabolism
Sitagliptin: Limited metabolism. Metformin: Not metabolized in humans.
Side Effects
Contraindications
- Hypersensitivity to sitagliptin or metformin or any excipients.
- Renal dysfunction (eGFR < 30 mL/min/1.73m²).
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- Acute conditions with potential for renal impairment (e.g., dehydration, severe infection, shock).
- Heart failure requiring pharmacological intervention.
- Hepatic impairment (for metformin component).
Drug Interactions
Alcohol
Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis.
Cationic drugs (e.g., cimetidine)
May increase metformin concentration.
Corticosteroids, Diuretics, Thyroid products
May reduce the glycemic effect of Sitagil-M.
Carbonic Anhydrase Inhibitors (e.g., topiramate)
May increase risk of lactic acidosis.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose of metformin can lead to lactic acidosis, which requires immediate medical attention. Sitagliptin overdose experience is limited, but generally, supportive measures are adequate. Hemodialysis can remove metformin; sitagliptin is modestly removed by hemodialysis.
Pregnancy & Lactation
Category B for Sitagliptin, Category B for Metformin (animal studies). Not recommended during pregnancy unless potential benefits outweigh risks. Metformin and Sitagliptin are excreted in breast milk. Use with caution or avoid during lactation.
Side Effects
Contraindications
- Hypersensitivity to sitagliptin or metformin or any excipients.
- Renal dysfunction (eGFR < 30 mL/min/1.73m²).
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- Acute conditions with potential for renal impairment (e.g., dehydration, severe infection, shock).
- Heart failure requiring pharmacological intervention.
- Hepatic impairment (for metformin component).
Drug Interactions
Alcohol
Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis.
Cationic drugs (e.g., cimetidine)
May increase metformin concentration.
Corticosteroids, Diuretics, Thyroid products
May reduce the glycemic effect of Sitagil-M.
Carbonic Anhydrase Inhibitors (e.g., topiramate)
May increase risk of lactic acidosis.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose of metformin can lead to lactic acidosis, which requires immediate medical attention. Sitagliptin overdose experience is limited, but generally, supportive measures are adequate. Hemodialysis can remove metformin; sitagliptin is modestly removed by hemodialysis.
Pregnancy & Lactation
Category B for Sitagliptin, Category B for Metformin (animal studies). Not recommended during pregnancy unless potential benefits outweigh risks. Metformin and Sitagliptin are excreted in breast milk. Use with caution or avoid during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies, hospitals
Approval Status
Approved by DGDA, Bangladesh
Patent Status
Patent expired for generic forms
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of sitagliptin and metformin in improving glycemic control in type 2 diabetes patients, both as monotherapy and in combination with other agents.
Lab Monitoring
- Renal function (eGFR) before initiation and at least annually (more frequently for elderly or those at risk of renal impairment).
- Glycated hemoglobin (HbA1c) every 3-6 months.
- Vitamin B12 levels periodically (especially in long-term metformin users).
- Liver function tests (LFTs) if clinically indicated.
Doctor Notes
- Ensure patient's renal function is assessed before starting treatment and periodically thereafter.
- Educate patients on symptoms of lactic acidosis and hypoglycemia.
- Consider vitamin B12 supplementation for long-term metformin users.
- Advise patients on lifestyle modifications (diet, exercise) as foundational therapy.
Patient Guidelines
- Follow your doctor's instructions regarding dose and frequency.
- Maintain a healthy diet and regular exercise regimen.
- Monitor blood sugar levels regularly as advised.
- Report any unusual symptoms, especially severe abdominal pain (possible pancreatitis) or muscle pain/fatigue (possible lactic acidosis).
- Inform your doctor about all other medications you are taking.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine generally does not affect the ability to drive or operate machinery. However, if used in combination with other anti-diabetic agents (e.g., sulfonylureas, insulin), the risk of hypoglycemia increases, which can impair concentration and reaction time. Patients should be aware of hypoglycemia symptoms.
Lifestyle Advice
- Regular physical activity and a balanced diet are crucial for managing type 2 diabetes.
- Limit consumption of sugary drinks and processed foods.
- Maintain a healthy weight.
- Avoid excessive alcohol consumption.
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