Sitagil-M
Generic Name
Sitagliptin and Metformin Hydrochloride
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sitagil m 50 mg tablet | ৳ 18.00 | ৳ 108.00 |
Description
Overview of the medicine
Sitagil-M 50 mg tablet is a combination oral antidiabetic medicine containing Sitagliptin and Metformin HCl. It is used to improve glycemic control in adults with type 2 diabetes mellitus when diet and exercise alone do not provide adequate control, or when other antidiabetic agents are insufficient.
Uses & Indications
Dosage
Adults
The usual starting dose is Sitagliptin 50 mg/Metformin 500 mg, taken twice daily with meals. Dosage may be titrated based on efficacy and tolerability.
Elderly
Careful dose titration may be necessary due to potential for decreased renal function. Renal function should be monitored.
Renal_impairment
Contraindicated in severe renal impairment (eGFR <30 mL/min/1.73m2). For moderate impairment, dose adjustment may be required. Consult a physician.
How to Take
Take orally, twice daily with meals to minimize gastrointestinal side effects associated with metformin.
Mechanism of Action
Sitagliptin works by inhibiting the enzyme dipeptidyl peptidase-4 (DPP-4), which increases the levels of active incretin hormones (GLP-1 and GIP). These hormones enhance glucose-dependent insulin secretion and suppress glucagon secretion from the pancreas, leading to improved glycemic control. Metformin works primarily by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Within hours for both components, sustained over 24 hours.
Excretion
Sitagliptin: Primarily renally excreted (87% unchanged). Metformin: Primarily renally excreted (unchanged).
Half life
Sitagliptin: Approximately 12.4 hours. Metformin: Approximately 6.2 hours.
Absorption
Sitagliptin: Rapidly absorbed, peak plasma concentration (Tmax) in 1-4 hours. Metformin: Slowly and incompletely absorbed, Tmax in 2-3 hours.
Metabolism
Sitagliptin: Limited metabolism, primarily by CYP3A4 and CYP2C8. Metformin: Not metabolized.
Side Effects
Contraindications
- Hypersensitivity to sitagliptin, metformin, or any component of the formulation.
- Severe renal impairment (eGFR <30 mL/min/1.73m2).
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- Acute conditions with potential to alter renal function (e.g., dehydration, severe infection, shock).
- Congestive heart failure requiring pharmacological treatment.
Drug Interactions
Alcohol
Increases risk of lactic acidosis with metformin.
Cimetidine
May increase metformin blood levels.
Corticosteroids
May increase blood glucose, requiring dose adjustment of antidiabetic drugs.
Diuretics (Thiazide)
May reduce metformin excretion.
Iodinated Contrast Agents
Temporarily discontinue before and for 48 hours after procedure.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, discontinue Sitagil-M and initiate appropriate supportive treatment. Metformin overdose can lead to lactic acidosis, which requires emergency medical attention and often hemodialysis.
Pregnancy & Lactation
Pregnancy Category B. Not recommended during pregnancy unless clearly needed. Exercise caution when administered to a nursing woman; it is not known whether sitagliptin is excreted in human milk, but metformin is.
Side Effects
Contraindications
- Hypersensitivity to sitagliptin, metformin, or any component of the formulation.
- Severe renal impairment (eGFR <30 mL/min/1.73m2).
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- Acute conditions with potential to alter renal function (e.g., dehydration, severe infection, shock).
- Congestive heart failure requiring pharmacological treatment.
Drug Interactions
Alcohol
Increases risk of lactic acidosis with metformin.
Cimetidine
May increase metformin blood levels.
Corticosteroids
May increase blood glucose, requiring dose adjustment of antidiabetic drugs.
Diuretics (Thiazide)
May reduce metformin excretion.
Iodinated Contrast Agents
Temporarily discontinue before and for 48 hours after procedure.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, discontinue Sitagil-M and initiate appropriate supportive treatment. Metformin overdose can lead to lactic acidosis, which requires emergency medical attention and often hemodialysis.
Pregnancy & Lactation
Pregnancy Category B. Not recommended during pregnancy unless clearly needed. Exercise caution when administered to a nursing woman; it is not known whether sitagliptin is excreted in human milk, but metformin is.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from the date of manufacture (check product specific packaging for exact details).
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory bodies (e.g., FDA, DGDA)
Patent Status
Sitagliptin patent expired in many regions; Metformin is off-patent.
Clinical Trials
Sitagliptin/Metformin combination has been extensively studied in various clinical trials demonstrating its efficacy and safety in improving glycemic control in patients with type 2 diabetes.
Lab Monitoring
- HbA1c (every 3-6 months)
- Renal function (eGFR) before initiation and annually (more frequently in elderly or at-risk patients)
- Vitamin B12 levels (periodically, especially with long-term metformin use)
Doctor Notes
- Assess renal function (eGFR) prior to initiation and periodically thereafter.
- Educate patients on the symptoms of lactic acidosis and advise them to seek immediate medical attention if symptoms occur.
- Consider vitamin B12 monitoring in patients on long-term metformin therapy.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Take with meals to help reduce stomach upset.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- Be aware of the symptoms of lactic acidosis (unusual muscle pain, troubled breathing, unusual stomach discomfort, dizziness, feeling cold) and seek immediate medical attention if they occur.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medicine alone does not usually cause hypoglycemia, which can affect driving. However, if used in combination with other antidiabetic agents (e.g., sulfonylureas or insulin) that can cause hypoglycemia, caution is advised.
Lifestyle Advice
- Follow a balanced diet plan recommended by your doctor or a dietitian.
- Engage in regular physical activity as advised.
- Monitor your blood glucose levels regularly.
- Limit or avoid alcohol consumption.
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