GLEAM® Tablets
Composition:
GLEAM-1
- Each uncoated tablet contains:
- Glimepiride I.P. ……………………………………………………………………………… 1 mg
- Excipients ………………………………………………………………………………………… q.s.
- Colour: Yellow Oxide of Iron.
GLEAM-2
- Each uncoated tablet contains:
- Glimepiride I.P. ………………………………………………………………………………… 2 mg
- Excipients …………………………………………………………………………………………… q.s.
- Colour: Yellow Oxide of Iron.
Description
- Glimepiride (GLEAM) is a third generation sulphonylurea (SU), which binds to the 65 kDa protein of the sulphonylurea receptor (SUR 1), which is different from the 140 kDa proteins, targeted by other SUs. This specificity, has a faster rate of association and dissociation; hence it has a rapid onset and prolonged duration of action, permitting once daily administration.
- In addition, long-term, randomized, placebo-controlled trial show that glimepiride also appears to exert an extra-pancreatic effect due to an increased sensitivity of peripheral tissues to insulin with improved postprandial insulin/C- peptide responses and overall glycaemic control without producing clinically Meaningful increase in fasting insulin/C-peptide levels.
Indications
- GLEAM® is indicated as an adjunct to diet and exercise to lower blood glucose in patients with Type 2 Diabetes whose hyperglycaemia cannot be controlled by diet and exercise alone. GLEAM may be used concomitantly with metformin when diet, exercise and metformin alone do not result in adequate glycaemic control.
Dosage
- Dosage should be individualized on the basis of both effectiveness and tolerance. There is no fixed dosage regimen for the management of diabetes mellitus with GLEAM or any other hypoglycaemic agent.
- The recommended starting dose of GLEAM® is 1 mg or 2 mg once daily, administered with breakfast or the first main meal of the day. Patients at increased risk for hypoglycaemia (e.g. the elderly or patients with renal impairment) should be started on 1 mg once daily.
- The usual maintenance dose is 1-4 mg once daily. The maximum recommended dose is 8 mg once daily. After reaching a daily dose of 2 mg, dosage increase should be made in increments of no more than 2 mg at 1 to 2 week intervals, based upon the patient's glycaemic response. A conservative titration scheme is recommended for patients at increased risk for hypoglycaemia.