Description
Glybofen 1000 mg / 5 mg, 30 film-coated tablets
Composition:
Each tablet contains:
Metformin hydrochloride — 1000 mg
Glyburide (glibenclamide) — 5 mg
Description:
Glybofen is a combination oral antidiabetic medication for the treatment of type 2 diabetes mellitus. It contains two active ingredients with complementary actions: metformin, which decreases hepatic glucose production and increases insulin sensitivity, and glyburide, a sulfonylurea that stimulates pancreatic insulin secretion. It is indicated as a replacement therapy in patients previously stabilized on separate doses of metformin and glyburide.
Indications for Use:
Treatment of adults with type 2 diabetes as a replacement for prior combination therapy with metformin and glyburide, when glycemic control is stable.
Dosage and Method of Administration:
Oral use in adults only.
Initial dose should match the prior separate doses of metformin and glyburide.
Titrate every 2 weeks or more based on blood glucose control.
Max recommended dose: 3 tablets/day.
Take with meals once, twice, or three times daily depending on dose.
Dosage adjustment based on renal function is necessary.
Not recommended for children or patients with GFR <30 mL/min.
Contraindications:
Hypersensitivity to ingredients or other sulfonylureas/sulfonamides
Type 1 diabetes, diabetic pre-coma
Acute or chronic metabolic acidosis
Severe renal impairment (GFR <30 mL/min)
Acute conditions that affect renal function (e.g., dehydration, infection, shock)
Liver failure, alcoholism
Lactation
Concomitant use with miconazole
Porphyria
Precautions:
Risk of lactic acidosis (especially in renal dysfunction)
Hypoglycemia risk due to sulfonylurea component
Regular monitoring of renal function required
Caution with elderly patients (higher hypoglycemia risk)
Avoid alcohol and inform patients about symptoms of lactic acidosis and hypoglycemia
Stop treatment temporarily in dehydration or illness
Side Effects:
Lactic acidosis (rare but serious)
Hypoglycemia (headache, fatigue, confusion, seizures)
GI symptoms (nausea, diarrhea)
Skin allergic reactions
Liver function disorders (rare)
Pregnancy and Breastfeeding:
Contraindicated during breastfeeding
Not recommended during pregnancy
Storage Conditions:
Store below 30 °C in the original packaging, protected from moisture and light.
Packaging:
Carton box with blister packs of 10 tablets and a package insert.
