Metformin hydrocloride; Glibenclamide

Visa No.: 893110242300

Product: Glipeform 500/5

API: Metformin hydrocloride; Glibenclamide

Product Category: Cardiovascular & Metabolism

Version approved leaflet: 273/QĐ-QLD_15/06/2020_166

INDICATIONS

This medicine is indicated for the treatment of type 2 diabetes mellitus to control blood glucose levels.

DOSAGE AND ADMINISTRATION

Route of administration: Oral use. For adults only.
General: As with all antihyperglycemic agents, the dose of Glipeform should be inpidualized based on each patient’s metabolic response (blood glucose, HbA1c).
Initial dose (patients not previously treated with metformin): The recommended starting dose is 500 mg once daily. If the patient does not experience gastrointestinal adverse reactions and further dose escalation is required, the dose may be increased by 500 mg at intervals of 1–2 weeks. Dose adjustment should be based on efficacy and tolerability. The maximum recommended dose is 2000 mg/day.
Use in patients with renal impairment:
Metformin is contraindicated in patients with eGFR < 30 mL/min/1.73 m² Initiation of metformin is not recommended in patients with eGFR 30–45 mL/min/1.73 m². In patients already receiving metformin whose eGFR falls below 45 mL/min/1.73 m², the    benefit–risk of continued treatment should be assessed. 
In patients already receiving metformin whose eGFR falls below 45 mL/min/1.73 m², the    benefit–risk of continued treatment should be assessed.
Discontinue metformin if eGFR decreases to < 30 mL/min/1.73 m² (see Contraindications and Precautions).
Discontinuation of metformin with iodinated contrast imaging:
In patients with eGFR 30–60 mL/min/1.73 m², those with a history of hepatic disease, alcoholism, or heart failure, or those receiving intra-arterial iodinated contrast media, metformin should be discontinued prior to or at the time of the imaging procedure. Reassess eGFR 48 hours after the procedure and restart metformin if renal function is stable (see Precautions).

Initiation of combination treatment:
Treatment with the combination product should be initiated based on the previous doses of metformin and glibenclamide used by the patient. It is recommended to start at a low dose and titrate gradually according to blood glucose results.

Dosage adjustment
Dose adjustment should be made at intervals of 2 weeks or longer, with increments of one tablet, based on blood glucose results. Gradual dose titration may improve gastrointestinal tolerability and help prevent the onset of hypoglycemia.

Maximum recommended daily dose: The maximum recommended daily dose is 3 tablets of Glipeform 500/5. In exceptional cases, a maximum of 4 tablets of Glipeform 500/5 per day may be considered.

Dosing frequency: The medicine should be taken at the start of a meal. The dosing frequency depends on the daily dose, as follows
Once daily, in the morning with breakfast, for a dose of 1 tablet/day.
Twice daily, in the morning and evening, for a dose of 2 or 4 tablets/day.
Three times daily, in the morning, at noon, and in the evening, for a dose of 3 tablets/day.
Dosing frequency should be adjusted according to the patient’s eating habits. However, each dose must be taken with a meal containing sufficient carbohydrates to prevent hypoglycemia.

Elderly
Dosage should be adjusted according to renal function parameters. Treatment should be initiated with one tablet of metformin hydrochloride 250 mg/glibenclamide 1.25 mg once daily. Renal function should be frequently monitored to allow dose adjustment based on laboratory results.

Children: Use in children and adolescents is not recommended.
 

CONTRAINDICATIONS

Do not use in the following cases:
Patients with a history of hypersensitivity to metformin hydrochloride, glibenclamide, other sulfonylureas or sulfonamides, or to any component of the product.

• Acute or chronic metabolic acidosis (including diabetic ketoacidosis and lactic acidosis).
• Diabetic pre-coma.
• Renal impairment (creatinine clearance < 60 mL/min); patients with severe renal failure (eGFR < 30 mL/min/1.73 m²) [see Warnings and Precautions].
• Acute conditions with the potential to alter renal function, such as dehydration, severe infection, shock, or intravascular administration of iodinated contrast media.
• Acute or chronic conditions that may cause tissue hypoxia, such as cardiac or respiratory failure, recent myocardial infarction, shock, acute significant blood loss, infection, or necrosis
   

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children