Sigtil-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 |
|---|---|---|
| sigtil m 50 mg tablet | ৳ 18.00 | ৳ 180.00 |
Description
Overview of the medicine
Sigtil-M 50 mg tablet is a combination oral antidiabetic drug 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
The usual starting dose is Sitagliptin 50 mg / Metformin 500 mg once or twice daily with meals. The dose may be gradually titrated based on efficacy and tolerability, up to a maximum of Sitagliptin 100 mg / Metformin 2000 mg daily (split into two doses).
Elderly
Dose adjustment should be made carefully based on renal function. Elderly patients are more likely to have decreased renal function, so eGFR should be assessed before initiating therapy and monitored regularly.
Renal_impairment
Contraindicated in patients with eGFR <30 mL/min/1.73 m². Dose reduction is required for moderate renal impairment (eGFR 30-60 mL/min/1.73 m²).
How to Take
Take orally, generally with meals to reduce gastrointestinal side effects associated with Metformin. Swallow the tablet whole with a glass of water, do not crush or chew.
Mechanism of Action
Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that enhances the levels of active incretin hormones (GLP-1 and GIP), thereby increasing glucose-dependent insulin secretion and decreasing glucagon secretion. Metformin is a biguanide that primarily decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Sitagliptin's glucose-lowering effect is noticeable within hours. Metformin's full therapeutic effect typically takes several days to weeks to develop.
Excretion
Sitagliptin: Primarily excreted unchanged in urine (79%). Metformin: Excreted unchanged in the urine (primarily via tubular secretion).
Half life
Sitagliptin: Approximately 12.4 hours. Metformin: Plasma elimination half-life is approximately 6.2 hours; blood half-life is approximately 17.6 hours.
Absorption
Sitagliptin: Rapidly absorbed, peak plasma concentrations typically achieved within 1-4 hours. Oral bioavailability is approximately 87%. Metformin: Slowly and incompletely absorbed from the gastrointestinal tract. Absolute bioavailability is approximately 50-60%.
Metabolism
Sitagliptin: Limited metabolism, primarily by CYP3A4, with minor contribution from CYP2C8. Metformin: Not metabolized in the liver or excreted via bile.
Side Effects
Contraindications
- Hypersensitivity to Sitagliptin or Metformin.
- Renal dysfunction (eGFR <30 mL/min/1.73 m²).
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis (DKA), with or without coma.
- Acute conditions with potential for altered renal function (e.g., dehydration, severe infection, shock).
- Acute heart failure requiring pharmacological treatment.
- Hepatic impairment.
- Acute or chronic alcoholism.
Drug Interactions
Alcohol
Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis, especially in cases of fasting or malnutrition.
Cationic drugs
Concomitant use with cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, ranitidine, triamterene, trimethoprim, vancomycin) that are eliminated by renal tubular secretion may increase metformin concentrations.
Carbonic Anhydrase Inhibitors
Co-administration with carbonic anhydrase inhibitors (e.g., topiramate, acetazolamide) may increase the risk of lactic acidosis.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose of Metformin can lead to lactic acidosis, which is a medical emergency. Sitagliptin overdose has shown no significant adverse effects in clinical trials up to 800 mg. Management involves symptomatic and supportive treatment. Hemodialysis may be useful for removing Metformin from the body.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of teratogenicity for Sitagliptin. Metformin crosses the placenta. This combination is generally not recommended during pregnancy or lactation unless the potential benefit justifies the potential risk to the fetus/infant. Consult a doctor for advice.
Side Effects
Contraindications
- Hypersensitivity to Sitagliptin or Metformin.
- Renal dysfunction (eGFR <30 mL/min/1.73 m²).
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis (DKA), with or without coma.
- Acute conditions with potential for altered renal function (e.g., dehydration, severe infection, shock).
- Acute heart failure requiring pharmacological treatment.
- Hepatic impairment.
- Acute or chronic alcoholism.
Drug Interactions
Alcohol
Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis, especially in cases of fasting or malnutrition.
Cationic drugs
Concomitant use with cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, ranitidine, triamterene, trimethoprim, vancomycin) that are eliminated by renal tubular secretion may increase metformin concentrations.
Carbonic Anhydrase Inhibitors
Co-administration with carbonic anhydrase inhibitors (e.g., topiramate, acetazolamide) may increase the risk of lactic acidosis.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Overdose of Metformin can lead to lactic acidosis, which is a medical emergency. Sitagliptin overdose has shown no significant adverse effects in clinical trials up to 800 mg. Management involves symptomatic and supportive treatment. Hemodialysis may be useful for removing Metformin from the body.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of teratogenicity for Sitagliptin. Metformin crosses the placenta. This combination is generally not recommended during pregnancy or lactation unless the potential benefit justifies the potential risk to the fetus/infant. Consult a doctor for advice.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture.
Availability
Available in pharmacies, hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Sitagliptin patents are expiring or expired in many regions. Metformin is off-patent.
Clinical Trials
Both Sitagliptin and Metformin have undergone extensive clinical trials for efficacy and safety as monotherapy and in combination, demonstrating significant reductions in HbA1c and improved glycemic control in patients with type 2 diabetes.
Lab Monitoring
- Renal function (eGFR) at baseline and at least annually (more frequently for elderly or those with impaired renal function).
- HbA1c levels regularly to assess glycemic control.
- Blood glucose levels (fasting and postprandial).
- Vitamin B12 levels (especially for patients on long-term Metformin therapy or with risk factors for deficiency).
- Liver function tests (baseline and if clinically indicated).
Doctor Notes
- Emphasize the importance of renal function monitoring, especially in elderly patients or those with pre-existing renal impairment.
- Educate patients on the signs and symptoms of lactic acidosis and pancreatitis, advising immediate medical consultation if observed.
- Stress the critical role of diet and exercise alongside medication for optimal glycemic control.
Patient Guidelines
- Take Sigtil-M exactly as prescribed by your doctor.
- Follow your diet and exercise plan diligently while taking this medication.
- Monitor your blood glucose levels regularly as advised by your doctor.
- Be aware of symptoms of hypoglycemia (e.g., dizziness, sweating, confusion) and know how to treat them.
- Report any unusual or severe symptoms, especially signs of lactic acidosis (e.g., unusual muscle pain, trouble breathing, stomach pain) or pancreatitis (e.g., severe stomach pain, vomiting).
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Sigtil-M alone is not expected to cause hypoglycemia and therefore should not affect the ability to drive or operate machinery. However, if used in combination with sulfonylureas or insulin, or if a patient experiences hypoglycemia, caution is advised.
Lifestyle Advice
- Maintain a healthy and balanced diet, focusing on whole grains, lean proteins, and plenty of fruits and vegetables.
- Engage in regular physical activity for at least 30 minutes most days of the week.
- Achieve and maintain a healthy weight.
- Limit alcohol intake.
- Quit smoking.
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