Ligend-M
Generic Name
Linagliptin 2.5 mg + Metformin Hydrochloride 500 mg Tablet
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ligend m 25 mg tablet | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Ligend-M 2.5/500 Tablet is a combination medicine containing Linagliptin and Metformin Hydrochloride, used to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise. Linagliptin is a DPP-4 inhibitor, and Metformin is a biguanide, working together to lower blood sugar levels.
Uses & Indications
Dosage
Adults
The usual starting dose is Linagliptin 2.5 mg + Metformin Hydrochloride 500 mg, taken twice daily with meals. Dosage should be individualized based on the patient's current regimen, effectiveness, and tolerability, not exceeding Linagliptin 5 mg and Metformin 2000 mg per day.
Elderly
No specific dose adjustment for linagliptin based on age, but dose of metformin should be adjusted based on renal function. Initiate with a lower dose and monitor renal function regularly.
Renal_impairment
Dosage adjustment is required based on eGFR. Avoid initiation in patients with eGFR < 45 mL/min/1.73 m². Contraindicated in severe renal impairment (eGFR < 30 mL/min/1.73 m²).
How to Take
Take orally, twice daily with meals to minimize gastrointestinal adverse reactions associated with Metformin.
Mechanism of Action
Linagliptin selectively inhibits dipeptidyl peptidase-4 (DPP-4), an enzyme that degrades incretin hormones (GLP-1 and GIP). By preventing DPP-4 from breaking down incretins, Linagliptin increases their levels, which leads to enhanced glucose-dependent insulin secretion and suppressed glucagon secretion from the pancreas. Metformin reduces hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Linagliptin: onset of glucose-lowering effect within 1-2 hours. Metformin: gradual onset, takes several days to weeks for full therapeutic effect.
Excretion
Linagliptin: primarily excreted via enterohepatic circulation (about 80% in feces, 5% in urine). Metformin: primarily excreted renally (90% within 24 hours).
Half life
Linagliptin: terminal elimination half-life is long (around 100-200 hours) due to potent and selective binding to DPP-4. Metformin: plasma elimination half-life is approximately 6.2 hours.
Absorption
Linagliptin: ~30% orally absorbed, peak plasma concentration in ~1.5 hours. Metformin: well absorbed from the gastrointestinal tract, absolute bioavailability of 50-60%.
Metabolism
Linagliptin: minimally metabolized; primarily eliminated unchanged. Metformin: not metabolized, excreted unchanged in the urine.
Side Effects
Contraindications
- Hypersensitivity to linagliptin or metformin.
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²).
- Metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Acute or chronic metabolic acidosis, including lactic acidosis.
- Acute conditions with potential for renal function impairment such as dehydration, severe infection, shock.
- Acute or unstable congestive heart failure.
- Hepatic impairment.
- Alcohol intoxication.
- Acute myocardial infarction.
- Temporary discontinuation for iodinated contrast medium administration (e.g., X-ray contrast).
Drug Interactions
Alcohol
Increases the risk of lactic acidosis, especially in fasting or malnourished patients.
Diuretics (especially loop diuretics)
May increase the risk of lactic acidosis and impair renal function.
Carbonic anhydrase inhibitors (e.g., topiramate, acetazolamide)
May increase the risk of lactic acidosis.
Corticosteroids, sympathomimetics, thyroid hormones, estrogens, oral contraceptives, phenothiazines
May reduce the hypoglycemic effect of Ligend-M.
Cationic drugs (e.g., cimetidine, ranitidine, amiloride, trimethoprim, digoxin, furosemide, nifedipine)
May increase metformin plasma concentrations by competing for 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
Linagliptin overdose has shown limited clinical data and is unlikely to lead to hypoglycemia. Metformin overdose can lead to severe lactic acidosis, especially in patients with predisposing factors. Management of overdose is primarily supportive and symptomatic, which may include hemodialysis for severe metformin overdose.
Pregnancy & Lactation
Not recommended during pregnancy due to insufficient data on human fetal risk. Use only if the potential benefit justifies the potential risk to the fetus. It is unknown if linagliptin is excreted in human milk; metformin is excreted. Caution should be exercised when Ligend-M is administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to linagliptin or metformin.
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²).
- Metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Acute or chronic metabolic acidosis, including lactic acidosis.
- Acute conditions with potential for renal function impairment such as dehydration, severe infection, shock.
- Acute or unstable congestive heart failure.
- Hepatic impairment.
- Alcohol intoxication.
- Acute myocardial infarction.
- Temporary discontinuation for iodinated contrast medium administration (e.g., X-ray contrast).
Drug Interactions
Alcohol
Increases the risk of lactic acidosis, especially in fasting or malnourished patients.
Diuretics (especially loop diuretics)
May increase the risk of lactic acidosis and impair renal function.
Carbonic anhydrase inhibitors (e.g., topiramate, acetazolamide)
May increase the risk of lactic acidosis.
Corticosteroids, sympathomimetics, thyroid hormones, estrogens, oral contraceptives, phenothiazines
May reduce the hypoglycemic effect of Ligend-M.
Cationic drugs (e.g., cimetidine, ranitidine, amiloride, trimethoprim, digoxin, furosemide, nifedipine)
May increase metformin plasma concentrations by competing for 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
Linagliptin overdose has shown limited clinical data and is unlikely to lead to hypoglycemia. Metformin overdose can lead to severe lactic acidosis, especially in patients with predisposing factors. Management of overdose is primarily supportive and symptomatic, which may include hemodialysis for severe metformin overdose.
Pregnancy & Lactation
Not recommended during pregnancy due to insufficient data on human fetal risk. Use only if the potential benefit justifies the potential risk to the fetus. It is unknown if linagliptin is excreted in human milk; metformin is excreted. Caution should be exercised when Ligend-M is administered to a nursing 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 product packaging for the exact expiry date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities for Type 2 Diabetes Mellitus
Patent Status
Patent may vary by region and specific formulation
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of linagliptin and metformin combination in improving glycemic control, including HbA1c reduction and fasting plasma glucose, in adults with type 2 diabetes mellitus, both as initial therapy and in combination with other agents.
Lab Monitoring
- HbA1c levels (every 3-6 months to assess glycemic control).
- Renal function (eGFR) (before initiation and at least annually, more frequently in elderly or at-risk patients).
- Vitamin B12 levels (periodically, especially with long-term metformin use or if megaloblastic anemia is suspected).
- Liver function tests (periodically, especially if liver disease is suspected).
Doctor Notes
- Emphasize the importance of lifestyle modifications (diet and exercise) alongside pharmacotherapy.
- Educate patients on the symptoms of hypoglycemia, lactic acidosis, and pancreatitis for early detection and intervention.
- Regularly monitor renal function (eGFR) and Vitamin B12 levels, especially in elderly patients or those at risk.
- Consider temporary discontinuation of metformin in situations that may lead to renal dysfunction, hypoxia, or severe dehydration.
Patient Guidelines
- Take this medicine regularly as prescribed by your doctor.
- Do not stop taking the medicine without consulting your doctor, even if you feel better.
- Follow a healthy diet plan and regular exercise regimen as advised by your healthcare provider.
- Monitor your blood sugar levels as instructed and keep a record of the readings.
- Be aware of the symptoms of hypoglycemia (low blood sugar) and lactic acidosis (serious complication) and know how to respond.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue your regular schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Ligend-M alone does not typically cause hypoglycemia, but if used in combination with other antidiabetic agents (e.g., sulfonylureas, insulin), it may cause hypoglycemia, which can impair the ability to drive or operate machinery. Patients should be advised to take precautions.
Lifestyle Advice
- Maintain a balanced diet that is low in sugar and refined carbohydrates.
- Engage in at least 30 minutes of moderate-intensity physical activity most days of the week.
- Limit or avoid alcohol consumption to reduce the risk of lactic acidosis.
- Achieve and maintain a healthy body weight.
- Quit smoking, as it can worsen diabetes complications.
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