MFT XR

COMPOSITION:

MFT-500 XR

Each uncoated extended-release tablet contains: Metformin Hydrochloride USP 500 mg

MFT-850 XR

Each uncoated extended-release tablet contains: Metformin Hydrochloride USP 850 mg

MFT-1000 XR

Each uncoated extended-release tablet contains: Metformin Hydrochloride USP 1000 mg

CLINICAL PHARMACOLOGY:

Mechanism of Action: 

Metformin is an antihyperglycemic agent that improves glucose tolerance in type 2 diabetes by reducing hepatic glucose production, decreasing intestinal absorption, and enhancing insulin sensitivity. Unlike sulfonylureas, it does not cause hypoglycemia or hyperinsulinemia and does not affect insulin secretion. It helps lower both basal and postprandial plasma glucose levels.

Pharmacokinetics:

Absorption: Fenofibrate reaches peak plasma concentration in 7 hours, with food increasing AUC by 50% but not affecting Cmax or Tmax.

Distribution: It has a large volume of distribution (654 ± 358 L) with minimal plasma protein binding. Metabolism: The drug is not metabolized hepatically or excreted biliary and achieves steady-state plasma levels (<1 mcg/mL) within 24–48 hours. 

Elimination: It is primarily renal (90% within 24 hours), with a plasma half-life of 6.2 hours and a blood half-life of 17.6 hours.

INDICATIONS AND USAGE: 

Metformin Hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

DOSAGE AND ADMINISTRATION: 

Metformin Hydrochloride extended-release tablets' dosage must be individualized based on effectiveness and tolerance, with a maximum recommended dose of 2500 mg daily. The tablets should be taken once daily with the evening meal and a full glass of water. Treatment should begin at a low dose, with gradual escalation to minimize gastrointestinal side effects and achieve proper glycemic control.

WARNING AND PRECAUTIONS:

Warning: 

Lactic acidosis is a rare but serious complication of Metformin Hydrochloride extended-release (XR), with a 50% fatality rate in affected cases. If lactic acidosis occurs, Metformin XR should be discontinued immediately, and supportive measures should be provided.

Precautions: 

Metformin XR may not reduce macrovascular risks and should be used cautiously in patients with renal or hepatic issues due to lactic acidosis risk. It should be stopped during hypoxic conditions, surgery, or cardiovascular collapse, and alcohol can increase lactate metabolism effects. Hypoglycemia may occur with other glucose-lowering agents, requiring insulin during stress or illness if blood glucose control is impaired.

ADVERSE REACTIONS:  

Common adverse reactions to Metformin Hydrochloride extended-release include diarrhea (9.6%), nausea/vomiting (6.5%), and less frequently abdominal pain, constipation, flatulence, dizziness, and headache, with safety in pediatric patients not established. 

DRUG INTERACTIONS: 

Co-administration of Metformin with glyburide decreases glyburide AUC and Cmax, while drugs like furosemide and nifedipine increase Metformin's plasma levels. Cationic drugs and certain others, such as diuretics and corticosteroids, may interact with Metformin or cause hyperglycemia, leading to loss of glycemic control.

SPECIAL POPULATIONS

Pregnancy: Metformin should not be used during pregnancy unless clearly needed, as it may pose risks to the fetus; insulin is often preferred for managing gestational diabetes. Pregnancy Category B

Nursing Mothers: It is also contraindicated in breastfeeding due to potential adverse effects on the infant.

Pediatrics: After administration of a single oral Metformin 500 mg tablet with food, geometric Metformin Cmax and AUC differ less than 5 % between pediatric type 2 diabetic patients (12 to 16 years of age) and gender- and weight-matched healthy adults (20 to 45 years of age), all with normal renal failure.

Geriatrics: Limited data from controlled pharmacokinetic studies of Metformin Hydrochloride tablets in healthy elderly subjects suggest that total plasma clearance of metformin is decreased, the half-life is prolonged, and Cmax is increased, compared to healthy young subjects.

CONTRAINDICATIONS: 

Metformin Hydrochloride extended-release is contraindicated in patients with renal disease, congestive heart failure requiring treatment, hypersensitivity to metformin, and acute or chronic metabolic acidosis, including diabetic ketoacidosis, which should be treated with insulin.

OVERDOSE:  

Metformin overdose, including ingestion of more than 50 grams, may lead to lactic acidosis in about 32% of cases, with hypoglycemia reported in 10%, though no direct link to Metformin has been established. Hemodialysis can be effective in removing accumulated drug in overdose cases, with a clearance of up to 170 mL/min.

STORAGE:

 Store in tightly closed original container between temperatures 15-30°C. 

PRESENTATION: 

 A box containing 10 blister strips of 10 tablets for MFT-500 XR, MFT-850 XR and MFT 1000 XR.