Glifo-M XR
Generic Name
Teneligliptin and Metformin Hydrochloride Extended-Release
Manufacturer
Reputable Pharmaceutical Company
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| glifo m xr 5 mg tablet | ৳ 0.01 | ৳ 0.01 |
Description
Overview of the medicine
Glifo-M XR is an oral antidiabetic medication combining Teneligliptin, a DPP-4 inhibitor, and Metformin Hydrochloride, a biguanide, in an extended-release formulation. It is used to improve glycemic control in adults with type 2 diabetes mellitus.
Uses & Indications
Dosage
Adults
The usual starting dose is one tablet (Teneligliptin 5 mg and Metformin HCl ER 500 mg) once daily with the evening meal. Dosage may be adjusted based on efficacy and tolerability, up to a maximum of Teneligliptin 20 mg and Metformin HCl ER 1000 mg daily.
Elderly
Careful dose titration is recommended for elderly patients, with regular monitoring of renal function, as age is associated with reduced renal function.
Renal_impairment
Not recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73m²). Dose adjustment may be necessary for moderate impairment; consult prescribing information.
How to Take
Take Glifo-M XR orally once daily with the evening meal. Swallow the tablet whole; do not crush, chew, or break it, as this may affect the extended-release properties of the medication.
Mechanism of Action
Teneligliptin inhibits DPP-4 enzyme, which increases incretin hormone levels (GLP-1 and GIP), leading to glucose-dependent insulin secretion and reduced glucagon secretion. Metformin decreases hepatic glucose production, reduces intestinal glucose absorption, and improves insulin sensitivity in peripheral tissues.
Pharmacokinetics
Onset
Glycemic effects can be observed within hours; full therapeutic effects on HbA1c are typically seen after several weeks of consistent use.
Excretion
Teneligliptin is excreted via both renal and hepatic routes. Metformin is primarily eliminated unchanged by renal excretion.
Half life
Teneligliptin has an elimination half-life of approximately 15-24 hours. Metformin has an elimination half-life of approximately 4-9 hours.
Absorption
Teneligliptin is rapidly absorbed with Cmax achieved in 1-2 hours. Metformin XR has slower absorption, with Cmax at 4-8 hours; food slightly increases absorption.
Metabolism
Teneligliptin is primarily metabolized by CYP3A4 and flavin-containing monooxygenase 3 (FMO3). Metformin is not metabolized and is excreted unchanged.
Side Effects
Contraindications
- Hypersensitivity to Teneligliptin, Metformin, or any components of the formulation.
- Metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Severe renal impairment (eGFR <30 mL/min/1.73m²).
- Acute or chronic metabolic acidosis, including lactic acidosis history.
- Acute or chronic disease that may cause tissue hypoxia (e.g., cardiac or respiratory failure, recent myocardial infarction, shock).
- Severe hepatic impairment or alcoholism.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis with Metformin, especially in cases of fasting or malnutrition.
Glucocorticoids, diuretics, thyroid hormones, sympathomimetics
May reduce the glucose-lowering effect of Glifo-M XR, requiring closer glucose monitoring.
Cimetidine, trimethoprim, ranolazine, dolutegravir, crizotinib, olaparib
May increase Metformin exposure, potentially increasing the risk of lactic acidosis.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Overdose of Metformin can lead to lactic acidosis, characterized by symptoms like unusual muscle pain, difficulty breathing, stomach discomfort, dizziness, and low body temperature. Teneligliptin overdose symptoms are less defined but supportive measures are indicated. Management involves supportive care and, in severe Metformin overdose, hemodialysis may be necessary to remove Metformin.
Pregnancy & Lactation
Not recommended during pregnancy or breastfeeding due to insufficient safety data. Use only if the potential benefit justifies the potential risk to the fetus or infant, and consult a doctor for alternative management strategies.
Side Effects
Contraindications
- Hypersensitivity to Teneligliptin, Metformin, or any components of the formulation.
- Metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Severe renal impairment (eGFR <30 mL/min/1.73m²).
- Acute or chronic metabolic acidosis, including lactic acidosis history.
- Acute or chronic disease that may cause tissue hypoxia (e.g., cardiac or respiratory failure, recent myocardial infarction, shock).
- Severe hepatic impairment or alcoholism.
Drug Interactions
Alcohol
Increases the risk of lactic acidosis with Metformin, especially in cases of fasting or malnutrition.
Glucocorticoids, diuretics, thyroid hormones, sympathomimetics
May reduce the glucose-lowering effect of Glifo-M XR, requiring closer glucose monitoring.
Cimetidine, trimethoprim, ranolazine, dolutegravir, crizotinib, olaparib
May increase Metformin exposure, potentially increasing the risk of lactic acidosis.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Overdose of Metformin can lead to lactic acidosis, characterized by symptoms like unusual muscle pain, difficulty breathing, stomach discomfort, dizziness, and low body temperature. Teneligliptin overdose symptoms are less defined but supportive measures are indicated. Management involves supportive care and, in severe Metformin overdose, hemodialysis may be necessary to remove Metformin.
Pregnancy & Lactation
Not recommended during pregnancy or breastfeeding due to insufficient safety data. Use only if the potential benefit justifies the potential risk to the fetus or infant, and consult a doctor for alternative management strategies.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture
Availability
Pharmacies nationwide
Approval Status
Approved by regulatory authorities (e.g., DGDA)
Patent Status
Likely off-patent for generics
Clinical Trials
Clinical trials have demonstrated that the combination of Teneligliptin and Metformin significantly improves glycemic control (HbA1c reduction) compared to monotherapy, with an acceptable safety profile in patients with type 2 diabetes.
Lab Monitoring
- Renal function (eGFR) should be assessed prior to initiation of Glifo-M XR and at least annually thereafter (more frequently in elderly or renally impaired patients).
- 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 lifestyle modifications (diet and exercise) as cornerstone therapy for type 2 diabetes.
- Educate patients on symptoms of lactic acidosis and acute pancreatitis, stressing the need for immediate medical attention.
- Regularly monitor renal function (eGFR) and vitamin B12 levels, especially in elderly or at-risk patients.
Patient Guidelines
- Take Glifo-M XR exactly as prescribed by your doctor, usually once daily with your evening meal.
- Do not crush, chew, or break the tablet, swallow it whole.
- Inform your doctor immediately if you experience symptoms of lactic acidosis (e.g., severe muscle pain, unusual fatigue, stomach pain, difficulty breathing).
- Report any signs of pancreatitis (severe, persistent abdominal pain, radiating to the back) or severe allergic reactions.
- Always inform your healthcare provider about all other medications, herbal products, and supplements you are taking.
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 with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medication alone is unlikely to cause hypoglycemia and affect driving. However, if Glifo-M XR is used in combination with other antidiabetic agents (e.g., sulfonylureas, insulin) that can cause hypoglycemia, or if you experience symptoms such as dizziness or blurred vision, exercise caution when driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet and engage in regular physical activity as part of your diabetes management plan.
- Limit or avoid alcohol consumption to minimize the risk of lactic acidosis and other adverse effects.
- Regularly monitor your blood glucose levels as advised by your doctor to ensure effective diabetes control.
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