Galet-M
Generic Name
Vildagliptin + Metformin Hydrochloride
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| galet m 50 mg tablet | ৳ 24.00 | ৳ 240.00 |
Description
Overview of the medicine
Galet-M (Vildagliptin + Metformin) is a combination medication 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 one tablet (Vildagliptin 50 mg/Metformin 500 mg) twice daily, taken with meals. The dose can be titrated based on efficacy and tolerability, up to a maximum daily dose of Vildagliptin 100 mg and Metformin 2000 mg.
Elderly
Careful dose titration and regular monitoring of renal function (eGFR) are recommended, especially for patients 65 years and older, due to the increased risk of renal impairment.
Renal_impairment
Galet-M is contraindicated in patients with an eGFR < 30 mL/min. For patients with eGFR 30-45 mL/min, dose adjustment of Metformin is necessary, and a lower dose may be required. Not recommended if eGFR is below 30 mL/min.
How to Take
Take Galet-M tablets orally with meals, typically twice daily. Taking with food helps reduce gastrointestinal side effects associated with metformin.
Mechanism of Action
Vildagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that enhances the levels of active incretin hormones (GLP-1 and GIP), leading to increased insulin secretion and decreased glucagon secretion. Metformin is a biguanide that decreases hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Blood glucose lowering effects typically observed within hours of administration.
Excretion
Vildagliptin: Primarily renal (approx. 85%) and fecal (approx. 15%). Metformin: Primarily renal excretion as unchanged drug.
Half life
Vildagliptin: Terminal elimination half-life ~3 hours. Metformin: Plasma elimination half-life ~6.2 hours.
Absorption
Vildagliptin: Rapidly absorbed with an absolute oral bioavailability of approximately 85%. Tmax ~2-3 hours. Metformin: Absolute oral bioavailability of 50-60%. Tmax ~2-2.5 hours.
Metabolism
Vildagliptin: Primary metabolic pathway is hydrolysis, no CYP450 involvement. Metformin: Excreted unchanged in the urine, no hepatic metabolism.
Side Effects
Contraindications
- Hypersensitivity to vildagliptin, metformin, or any component of the formulation.
- Renal impairment (eGFR < 30 mL/min).
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Severe heart failure (NYHA Class III-IV).
- Severe hepatic impairment.
- Acute myocardial infarction, septicaemia, or other conditions associated with hypoxemia.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis with metformin, especially during fasting, malnutrition, or hepatic impairment. Avoid excessive alcohol intake.
Iodinated Contrast Agents
Temporarily discontinue Galet-M before or at the time of an iodinated contrast imaging procedure and for 48 hours afterward in patients with an eGFR between 30 and 60 mL/min/1.73 m2, or in patients with a history of liver disease, alcoholism, or heart failure.
Carbonic Anhydrase Inhibitors (e.g., topiramate, acetazolamide)
May increase the risk of lactic acidosis by increasing systemic metformin exposure.
Cationic Drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin)
May increase metformin concentration by competing for common renal tubular transport systems.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Vildagliptin overdose is generally well-tolerated with mild gastrointestinal symptoms. Metformin overdose can lead to lactic acidosis, which is a medical emergency characterized by metabolic acidosis, often with hypothermia, hypotension, and resistant bradyarrhythmias. Management involves supportive care, correction of acidosis, and hemodialysis for severe metformin overdose.
Pregnancy & Lactation
Pregnancy Category B/C for Vildagliptin and B for Metformin. Generally, the combination is not recommended during pregnancy unless clearly necessary, as adequate data are lacking. Metformin is excreted in breast milk; therefore, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to vildagliptin, metformin, or any component of the formulation.
- Renal impairment (eGFR < 30 mL/min).
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Severe heart failure (NYHA Class III-IV).
- Severe hepatic impairment.
- Acute myocardial infarction, septicaemia, or other conditions associated with hypoxemia.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis with metformin, especially during fasting, malnutrition, or hepatic impairment. Avoid excessive alcohol intake.
Iodinated Contrast Agents
Temporarily discontinue Galet-M before or at the time of an iodinated contrast imaging procedure and for 48 hours afterward in patients with an eGFR between 30 and 60 mL/min/1.73 m2, or in patients with a history of liver disease, alcoholism, or heart failure.
Carbonic Anhydrase Inhibitors (e.g., topiramate, acetazolamide)
May increase the risk of lactic acidosis by increasing systemic metformin exposure.
Cationic Drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin)
May increase metformin concentration by competing for common renal tubular transport systems.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Vildagliptin overdose is generally well-tolerated with mild gastrointestinal symptoms. Metformin overdose can lead to lactic acidosis, which is a medical emergency characterized by metabolic acidosis, often with hypothermia, hypotension, and resistant bradyarrhythmias. Management involves supportive care, correction of acidosis, and hemodialysis for severe metformin overdose.
Pregnancy & Lactation
Pregnancy Category B/C for Vildagliptin and B for Metformin. Generally, the combination is not recommended during pregnancy unless clearly necessary, as adequate data are lacking. Metformin is excreted in breast milk; therefore, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the manufacturing date. Refer to the specific packaging for the exact expiry date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies
Patent Status
Generically available
Clinical Trials
Extensive clinical trials have evaluated the efficacy, safety, and tolerability of the vildagliptin and metformin combination in patients with type 2 diabetes, demonstrating superior glycemic control compared to monotherapy and good safety profiles.
Lab Monitoring
- Renal function (eGFR) should be assessed prior to initiation and at least annually (more frequently in elderly or patients at risk for renal impairment).
- Liver function tests (ALT) should be performed before initiation of vildagliptin and periodically thereafter.
- HbA1c levels should be monitored regularly to assess glycemic control.
- Vitamin B12 levels should be monitored periodically in patients on long-term metformin therapy.
Doctor Notes
- Emphasize the importance of adherence to diet and exercise alongside medication for optimal glycemic control.
- Educate patients on the signs and symptoms of lactic acidosis and hypoglycemia and when to seek urgent medical care.
- Periodically assess renal function and consider vitamin B12 monitoring, especially in elderly patients and those on long-term metformin therapy.
Patient Guidelines
- Take Galet-M exactly as prescribed by your doctor, usually with meals to minimize stomach upset.
- Do not crush, chew, or break the tablet; swallow it whole.
- Be aware of the symptoms of lactic acidosis (e.g., unusual muscle pain, difficulty breathing, stomach pain, extreme tiredness) and seek immediate medical attention if they occur.
- Monitor your blood glucose levels regularly as advised by your healthcare provider.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, 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
Galet-M is not expected to affect the ability to drive or use machines. However, patients should be aware of the risk of hypoglycemia when Galet-M is used in combination with sulfonylureas or insulin, which could impair driving ability.
Lifestyle Advice
- Maintain a balanced diet and engage in regular physical activity as advised by your doctor to manage diabetes effectively.
- Avoid excessive alcohol consumption, as it can increase the risk of lactic acidosis.
- Stay well-hydrated, especially in hot weather or during exercise.
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