Xelmet-XR
Generic Name
Metformin Hydrochloride Extended-Release
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| xelmet xr 1000 mg tablet | ৳ 10.00 | ৳ 70.00 |
Description
Overview of the medicine
Xelmet-XR 1000 mg Tablet is an extended-release medicine containing Metformin Hydrochloride. It is used to lower blood glucose levels in adults with type 2 diabetes mellitus, helping to improve the body's response to insulin and reduce glucose production.
Uses & Indications
Dosage
Adults
Initial dose is typically 500 mg once daily with the evening meal. May be increased to 1000 mg once daily after 1-2 weeks. Maximum dose usually 2000 mg daily.
Elderly
Dosage should be cautiously titrated due to potential decreased renal function. Monitor renal function regularly.
Renal_impairment
Contraindicated in severe renal impairment (eGFR <30 mL/min/1.73m²). Dose adjustment required for moderate impairment (eGFR 30-60 mL/min/1.73m²).
How to Take
Take orally with food, usually with the evening meal. Swallow the tablet whole; do not crush, chew, or break, as this may affect the extended-release properties.
Mechanism of Action
Metformin reduces hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. It does not stimulate insulin secretion.
Pharmacokinetics
Onset
Effects on blood glucose levels are typically seen within a few days, with full therapeutic effect achieved within 1-2 weeks.
Excretion
Primarily excreted unchanged in the urine. Renal clearance is approximately 3.5 times higher than creatinine clearance.
Half life
Approximately 6.2 hours for Metformin XR, with an effective plasma half-life of about 17.6 hours due to its extended-release nature.
Absorption
Incomplete and dose-dependent oral absorption. Peak plasma concentrations are achieved in 4-8 hours for XR formulation. Food may slightly increase absorption.
Metabolism
Negligible hepatic metabolism. Metformin is excreted unchanged.
Side Effects
Contraindications
- Severe renal impairment (eGFR <30 mL/min/1.73m²)
- Metabolic acidosis, including diabetic ketoacidosis
- Hypersensitivity to metformin or any component of the formulation
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
- Dehydration, severe infection, acute heart failure, or hepatic impairment
Drug Interactions
Alcohol
Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis.
Cimetidine
Increases metformin plasma concentration and AUC by reducing renal clearance.
Iodinated contrast agents
Temporarily discontinue metformin before or at the time of the procedure in patients with impaired renal function due to increased risk of lactic acidosis.
Diuretics (e.g., Furosemide)
May increase metformin plasma levels by decreasing renal clearance.
Corticosteroids, Sympathomimetics, Thiazide diuretics
May reduce the glycemic-lowering effect of metformin.
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, a medical emergency. Symptoms include malaise, myalgia, respiratory distress, increased somnolence, and abdominal distress. Management involves hemodialysis to remove metformin, along with supportive care.
Pregnancy & Lactation
Pregnancy: Metformin is generally considered safe; however, insulin is often preferred for glycemic control during pregnancy. Use only if clearly needed and the potential benefits outweigh the risks. Lactation: Metformin is excreted in breast milk in small amounts; generally considered compatible with breastfeeding, but monitor the infant for adverse effects.
Side Effects
Contraindications
- Severe renal impairment (eGFR <30 mL/min/1.73m²)
- Metabolic acidosis, including diabetic ketoacidosis
- Hypersensitivity to metformin or any component of the formulation
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
- Dehydration, severe infection, acute heart failure, or hepatic impairment
Drug Interactions
Alcohol
Potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis.
Cimetidine
Increases metformin plasma concentration and AUC by reducing renal clearance.
Iodinated contrast agents
Temporarily discontinue metformin before or at the time of the procedure in patients with impaired renal function due to increased risk of lactic acidosis.
Diuretics (e.g., Furosemide)
May increase metformin plasma levels by decreasing renal clearance.
Corticosteroids, Sympathomimetics, Thiazide diuretics
May reduce the glycemic-lowering effect of metformin.
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, a medical emergency. Symptoms include malaise, myalgia, respiratory distress, increased somnolence, and abdominal distress. Management involves hemodialysis to remove metformin, along with supportive care.
Pregnancy & Lactation
Pregnancy: Metformin is generally considered safe; however, insulin is often preferred for glycemic control during pregnancy. Use only if clearly needed and the potential benefits outweigh the risks. Lactation: Metformin is excreted in breast milk in small amounts; generally considered compatible with breastfeeding, but monitor the infant for adverse effects.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Generic
WHO Essential Medicine
YesClinical Trials
Metformin, including its extended-release formulations, has undergone extensive clinical trials demonstrating its efficacy in glycemic control for type 2 diabetes and its cardiovascular benefits. Ongoing research explores its potential in other areas like cancer prevention.
Lab Monitoring
- Renal function (eGFR) should be assessed prior to initiation and at least annually thereafter.
- Blood glucose and HbA1c levels should be monitored regularly to assess glycemic control.
- Vitamin B12 levels should be monitored, especially in patients on long-term therapy or with risk factors for deficiency.
Doctor Notes
- Assess renal function (eGFR) before initiating metformin and at least annually thereafter. Discontinue if eGFR falls below 30 mL/min/1.73m².
- Counsel patients on the symptoms of lactic acidosis and the importance of immediate medical attention if they occur.
- Consider periodic monitoring of vitamin B12 levels, especially in patients on long-term metformin therapy or those with risk factors for deficiency.
- Advise patients to temporarily withhold metformin prior to or at the time of iodinated contrast imaging procedures and for at least 48 hours afterward.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor, usually with your evening meal.
- Swallow the tablet whole; do not chew, crush, or break it.
- Inform your doctor immediately if you experience any symptoms of lactic acidosis (e.g., unusual muscle pain, difficulty breathing, unusual stomach discomfort, dizziness).
- Do not stop taking Xelmet-XR without consulting your doctor, even if you feel well.
- Maintain a healthy diet and regular exercise as advised by your healthcare provider.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next scheduled dose. Do not take a double dose to make up for a forgotten one.
Driving Precautions
Xelmet-XR generally does not cause hypoglycemia when used alone, so it usually does not affect the ability to drive or operate machinery. However, if used in combination with other antidiabetic agents that can cause hypoglycemia, caution should be exercised.
Lifestyle Advice
- Follow a balanced, low-sugar, and low-fat diet.
- Engage in regular physical activity suitable for your health condition.
- Avoid or limit alcohol consumption to minimize the risk of lactic acidosis.
- Maintain a healthy weight.
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