Sitavia-M
Generic Name
Sitagliptin and Metformin Hydrochloride Tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sitavia m 50 mg tablet | ৳ 18.00 | ৳ 180.00 |
Description
Overview of the medicine
Sitavia-M 50 mg tablet is a combination medication containing Sitagliptin and Metformin, used to improve glycemic control in adults with type 2 diabetes mellitus.
Uses & Indications
Dosage
Adults
The usual starting dose is Sitagliptin 50 mg / Metformin HCl 500 mg, taken twice daily with meals. Dosage may be adjusted based on efficacy and tolerability, up to a maximum daily dose of Sitagliptin 100 mg / Metformin HCl 2000 mg.
Elderly
Dose adjustment should be based on renal function. Close monitoring of renal function is recommended.
Renal_impairment
Not recommended for patients with eGFR less than 30 mL/min/1.73m². Dose adjustment required for moderate renal impairment (eGFR 30-60 mL/min/1.73m²).
How to Take
Take orally with meals to reduce gastrointestinal side effects associated with metformin. Do not crush, cut, or chew the tablet.
Mechanism of Action
Sitagliptin inhibits dipeptidyl peptidase-4 (DPP-4), increasing levels of active incretin hormones (GLP-1 and GIP), which in turn increases insulin synthesis and release from pancreatic beta cells and decreases glucagon secretion from alpha cells. Metformin works by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Sitagliptin: Peak plasma concentrations reached within 1-4 hours. Metformin: Onset of action is gradual.
Excretion
Sitagliptin is primarily excreted renally, with approximately 79% excreted unchanged in urine. Metformin is primarily excreted renally unchanged.
Half life
Sitagliptin: Approximately 12.4 hours. Metformin: Approximately 6.2 hours (plasma), 17.6 hours (blood).
Absorption
Sitagliptin is rapidly absorbed with an absolute bioavailability of approximately 87%. Metformin's bioavailability is about 50-60% after an oral dose, with absorption incomplete and delayed.
Metabolism
Sitagliptin is minimally metabolized, primarily by CYP3A4 and CYP2C8. Metformin is not metabolized in humans.
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.
- History of lactic acidosis.
- Severe heart failure, dehydration, acute myocardial infarction, or sepsis (conditions that may increase the risk of lactic acidosis).
Drug Interactions
Alcohol
Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis.
Iodinated contrast agents
Temporarily discontinue Sitavia-M at the time of or prior to an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73m², in patients with a history of liver disease, alcoholism, or heart failure, or in patients who will be administered intra-arterial iodinated contrast. Reevaluate eGFR 48 hours after the imaging procedure, and restart Sitavia-M if renal function is stable.
Cationic drugs (e.g., cimetidine, ranitidine, amiloride, trimethoprim)
May increase metformin concentration by competing for renal tubular transport.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose of Sitavia-M can lead to hypoglycemia (especially if combined with other antidiabetics), lactic acidosis (due to metformin), and gastrointestinal symptoms. Management involves supportive care, correction of hypoglycemia, and prompt treatment of lactic acidosis, which may require hemodialysis.
Pregnancy & Lactation
Generally not recommended during pregnancy or lactation. The benefits and risks should be carefully weighed by a physician if use is considered essential. Consult your doctor for specific advice.
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.
- History of lactic acidosis.
- Severe heart failure, dehydration, acute myocardial infarction, or sepsis (conditions that may increase the risk of lactic acidosis).
Drug Interactions
Alcohol
Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis.
Iodinated contrast agents
Temporarily discontinue Sitavia-M at the time of or prior to an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73m², in patients with a history of liver disease, alcoholism, or heart failure, or in patients who will be administered intra-arterial iodinated contrast. Reevaluate eGFR 48 hours after the imaging procedure, and restart Sitavia-M if renal function is stable.
Cationic drugs (e.g., cimetidine, ranitidine, amiloride, trimethoprim)
May increase metformin concentration by competing for renal tubular transport.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose of Sitavia-M can lead to hypoglycemia (especially if combined with other antidiabetics), lactic acidosis (due to metformin), and gastrointestinal symptoms. Management involves supportive care, correction of hypoglycemia, and prompt treatment of lactic acidosis, which may require hemodialysis.
Pregnancy & Lactation
Generally not recommended during pregnancy or lactation. The benefits and risks should be carefully weighed by a physician if use is considered essential. Consult your doctor for specific advice.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from the date of manufacture
Availability
Available in pharmacies and hospitals nationwide
Approval Status
Approved by regulatory authorities for Type 2 Diabetes
Patent Status
Generic versions available, likely off-patent for this combination
Clinical Trials
Sitagliptin/Metformin combinations have undergone extensive clinical trials demonstrating efficacy and safety in improving glycemic control in type 2 diabetes patients, both as initial therapy and add-on therapy.
Lab Monitoring
- HbA1c levels (regularly to assess glycemic control)
- Renal function (eGFR) before initiation and periodically thereafter (at least annually, more frequently in elderly or renally impaired patients).
- Vitamin B12 levels (annually for long-term metformin users or those with risk factors for deficiency).
- Liver function tests (periodically).
Doctor Notes
- Educate patients on the importance of diet and exercise alongside medication.
- Emphasize the symptoms of lactic acidosis and the need for urgent medical review.
- Monitor renal function carefully, especially in elderly patients and those at risk of impairment.
- Consider vitamin B12 supplementation for patients on long-term metformin therapy, particularly if they develop symptoms of neuropathy or anemia.
Patient Guidelines
- Take Sitavia-M exactly as prescribed by your doctor, usually with meals.
- Do not stop taking this medicine without consulting your doctor, even if you feel well.
- Monitor your blood sugar levels regularly as advised by your doctor.
- Be aware of the symptoms of lactic acidosis (e.g., unusual muscle pain, difficulty breathing, unusual drowsiness, stomach pain) 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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine is unlikely to affect your ability to drive or operate machinery unless you experience hypoglycemia. If you feel dizzy or experience symptoms of low blood sugar, avoid driving or operating machinery.
Lifestyle Advice
- Maintain a balanced diet and engage in regular physical activity as these are crucial for managing type 2 diabetes.
- Avoid excessive alcohol consumption, as it can increase the risk of lactic acidosis.
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