Xelmet
Generic Name
Metformin Hydrochloride
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| xelmet 500 mg tablet | ৳ 6.00 | ৳ 60.00 |
Description
Overview of the medicine
Xelmet 500 mg Tablet contains Metformin Hydrochloride, an oral antidiabetic medication used to manage type 2 diabetes mellitus. It helps control high blood sugar levels.
Uses & Indications
Dosage
Adults
Initial dose: 500 mg orally once or twice daily with meals. May be increased gradually by 500 mg weekly to a maximum of 2000-2500 mg/day, divided in 2-3 doses. For extended-release tablets, typically once daily with the evening meal.
Elderly
Start with a low dose (e.g., 500 mg once daily) and titrate carefully, monitoring renal function closely. Max dose typically lower due to potential for decreased renal function.
Renal_impairment
Contraindicated if eGFR < 30 mL/min/1.73m². Not recommended to initiate if eGFR 30-45 mL/min/1.73m². If eGFR falls to 30-45 mL/min/1.73m² during therapy, assess risks and benefits; dose reduction may be required. Discontinue if eGFR falls below 30 mL/min/1.73m².
How to Take
Take orally with meals to reduce gastrointestinal side effects. Swallow tablets whole with a glass of water, do not crush or chew, especially for extended-release forms.
Mechanism of Action
Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Glucose-lowering effect becomes apparent within hours, but full therapeutic effect may take several days to weeks.
Excretion
Excreted predominantly unchanged in the urine. Renal clearance is approximately 3.5 times greater than creatinine clearance, indicating tubular secretion.
Half life
Plasma elimination half-life is approximately 4-9 hours.
Absorption
Slow and incomplete. Absolute bioavailability of a 500 mg tablet is 50-60%. Peak plasma concentration is reached in 2-3 hours.
Metabolism
Not metabolized in the liver; excreted unchanged.
Side Effects
Contraindications
- Severe renal impairment (eGFR < 30 mL/min/1.73m²)
- Known hypersensitivity to metformin hydrochloride or any component of the formulation
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
- Acute conditions with potential to alter renal function such as dehydration, severe infection, shock
- Cardiac or respiratory failure
- Severe hepatic impairment
- Alcohol abuse
Drug Interactions
Alcohol
Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis, especially in fasting or malnourished patients.
Iodinated Contrast Agents
Increased risk of lactic acidosis. Discontinue metformin at the time of or prior to iodinated contrast imaging procedures and withhold for 48 hours afterward. Reinitiate only after renal function has been re-evaluated and found to be normal.
Carbonic Anhydrase Inhibitors (e.g., topiramate, acetazolamide)
May increase the risk of lactic acidosis.
Drugs that reduce metformin clearance (e.g., cimetidine, ranolazine, dolutegravir)
May increase systemic exposure to metformin and increase the risk of lactic acidosis.
Storage
Store below 30°C in a dry place, protected from light and moisture. Do not freeze.
Overdose
Overdose of Metformin has been reported to cause lactic acidosis. Symptoms may include abdominal discomfort, myalgia, malaise, and increased somnolence. Management involves supportive measures and prompt hemodialysis, which is effective in removing metformin from the body.
Pregnancy & Lactation
Pregnancy: Limited data suggest no increased risk of major birth defects. However, insulin is generally preferred for glycemic control during pregnancy. Lactation: Metformin is excreted into human milk. Weigh the benefits of breastfeeding against the potential risks to the infant.
Side Effects
Contraindications
- Severe renal impairment (eGFR < 30 mL/min/1.73m²)
- Known hypersensitivity to metformin hydrochloride or any component of the formulation
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
- Acute conditions with potential to alter renal function such as dehydration, severe infection, shock
- Cardiac or respiratory failure
- Severe hepatic impairment
- Alcohol abuse
Drug Interactions
Alcohol
Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis, especially in fasting or malnourished patients.
Iodinated Contrast Agents
Increased risk of lactic acidosis. Discontinue metformin at the time of or prior to iodinated contrast imaging procedures and withhold for 48 hours afterward. Reinitiate only after renal function has been re-evaluated and found to be normal.
Carbonic Anhydrase Inhibitors (e.g., topiramate, acetazolamide)
May increase the risk of lactic acidosis.
Drugs that reduce metformin clearance (e.g., cimetidine, ranolazine, dolutegravir)
May increase systemic exposure to metformin and increase the risk of lactic acidosis.
Storage
Store below 30°C in a dry place, protected from light and moisture. Do not freeze.
Overdose
Overdose of Metformin has been reported to cause lactic acidosis. Symptoms may include abdominal discomfort, myalgia, malaise, and increased somnolence. Management involves supportive measures and prompt hemodialysis, which is effective in removing metformin from the body.
Pregnancy & Lactation
Pregnancy: Limited data suggest no increased risk of major birth defects. However, insulin is generally preferred for glycemic control during pregnancy. Lactation: Metformin is excreted into human milk. Weigh the benefits of breastfeeding against the potential risks to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA/FDA
Patent Status
Off-patent (Generic)
WHO Essential Medicine
YesClinical Trials
Key trials include the UK Prospective Diabetes Study (UKPDS) which demonstrated benefits of intensive glucose control with metformin in overweight patients, and the Diabetes Prevention Program (DPP) which showed metformin's effectiveness in preventing or delaying the onset of type 2 diabetes.
Lab Monitoring
- Renal function (eGFR) should be assessed before initiation and at least annually. More frequent monitoring is recommended in elderly patients or those with risk factors for renal impairment.
- HbA1c levels to monitor glycemic control, typically every 3-6 months.
- Hematologic parameters (e.g., hemoglobin/hematocrit) and Vitamin B12 levels should be monitored periodically, especially in patients with risk factors for B12 deficiency (e.g., elderly, vegetarians, prolonged use).
Doctor Notes
- Emphasize careful patient selection, especially regarding renal function. Initiate metformin at a low dose and titrate slowly.
- Educate patients thoroughly about the symptoms of lactic acidosis and the importance of prompt medical attention if these occur.
- Monitor vitamin B12 levels periodically in patients on long-term metformin therapy, especially if they develop unexplained anemia or neuropathy.
- Advise patients to temporarily discontinue metformin before any iodinated contrast imaging procedure and major surgery, as directed by the physician.
Patient Guidelines
- Take Xelmet with food to reduce stomach upset.
- Do not stop taking Xelmet without consulting your doctor.
- Inform your doctor if you experience symptoms of lactic acidosis such as unusual muscle pain, difficulty breathing, unusual drowsiness, or stomach pain.
- Stay well-hydrated, especially in conditions that can lead to dehydration like vomiting, diarrhea, or heavy sweating.
- Avoid excessive alcohol intake while on this medication.
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 resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Xelmet (Metformin) monotherapy does not usually cause hypoglycemia, so it is unlikely to affect the ability to drive or operate machinery. However, if used in combination with other antidiabetic agents (e.g., sulfonylureas, insulin), there is a risk of hypoglycemia, which could impair driving ability. Patients should be aware of hypoglycemia symptoms.
Lifestyle Advice
- Maintain a balanced diet that is low in sugar and saturated fats.
- Engage in regular physical activity as advised by your doctor.
- Manage your weight effectively through diet and exercise.
- Monitor your blood sugar levels regularly as instructed by your healthcare provider.
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