Gluokan             Film Coated Tablets

5mg Glyburide + 500mg Metformin HCL

 

Usage and indications:

Gluokan is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage & administration

Dosage of Gluokan must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 20 mg glyburide/2000 mg metformin.

Gluokan should be given with meals and should be initiated at a low dose, with gradual dose escalation as described below, in order to avoid hypoglycemia (largely due to glyburide), reduce GI side effects (largely due to metformin), and permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient.

  • Gluokan 5 mg/500 mg should not be used as initial therapy due to an increased risk of hypoglycemia.
  • Gluokan Use in Patients with Inadequate Glycemic Control on a Sulfonylurea and/or Metformin

Recommended starting dose: 2.5 mg/500 mg or 5 mg/500 mg twice daily with meals.

For patients not adequately controlled on either glyburide (or another sulfonylurea) or metformin alone, the recommended starting dose of Gluokan is 2.5 mg/500 mg or 5 mg/500 mg twice daily with the morning and evening meals. In order to avoid hypoglycemia, the starting dose of Gluokan should not exceed the daily doses of glyburide or metformin already being taken.

Undesirable effects:

The most common adverse reactions were:

upper respiratory infection, diarrhea, headache, nausea, vomiting, abdominal pain, dizziness and / or hypoglycemia. 

Warnings and precautions:                                                                                                                                   Metformin Hydrochloride:

  • Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with the drug when it occurs, it is fatal in approximately 50% of cases.
  • Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute   congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis.
  • Gluokan treatment should not be initiated in patients ≥ 80 years of age unless measurement of   creatinine clearance demonstrates that renal function is not reduced, hemodialysis is recommended to    correct the acidosis and remove the accumulated metformin.

Special warning on increased risk of cardiovascular mortality:

The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular    mortality as compared to treatment with diet alone or diet plus insulin.

Pack: carton box containing 1 strip of PVC/AL of 10 tablets.

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