Glimepiride
Visa No.: 893110178224
Product: Diaprid 2
API: Glimepiride
Product Category: Cardiovascular & Metabolism
Version approved leaflet: 297/QĐ-QLD_15/07/2016_154
INDICATIONS
Diapid 2 is indicated for the treatment of type 2 diabetes mellitus in adults whose blood glucose levels cannot be adequately controlled by diet, exercise, and weight reduction alone.
DOSAGE AND ADMINISTRATION
Route of administration: Oral use. The medicine is taken once daily on the day and immediately before or during breakfast or the first main meal of the day. Swallow tablets whole with water.
Dosage:
Initial dose: 1 mg once daily. After 1–2 weeks, if glycemic control is not achieved, the dose may be increased to 1 mg/day, then further increased depending on glycemic response.
The maximum recommended daily dose of glimepiride is 8 mg/day.
In most patients, effective control is achieved with doses of 1–4 mg/day; doses up to 6 or 8 mg/day are used only in special cases.
Dose adjustment is required in the following situations: If treatment with glimepiride alone does not adequately control blood glucose, insulin therapy or combination therapy may be required.
When blood glucose levels are stabilized, insulin requirements may decrease over time. Dose adjustment is necessary to avoid hypoglycemia in cases of:
- Changes in body weight.
- Changes in lifestyle.
- Concomitant use of other medicines or factors that may increase or decrease blood glucose levels.
Patients with renal or hepatic impairment: In patients with impaired renal function, the initial dose should be 1 mg once daily. The dose may be increased if fasting blood glucose levels remain elevated. If creatinine clearance is below 22 mL/min, the usual dose is 1 mg once daily, and dose escalation is generally not required.
Hepatic impairment has not been studied. In cases of severe renal or hepatic impairment, treatment should be switched to insulin.
Switching from other antidiabetic agents to glimepiride:
Start with 1 mg/day, followed by gradual dose titration as described above, depending on the maximum dose of the previously used antidiabetic medicine. If the prior antidiabetic agent has a prolonged duration of action or additive interaction with glimepiride, a washout period may be required before initiation (1, 2, or 3 days, depending on the previously used medicine).
Combination treatment with glimepiride and metformin or a glitazone:
If glycemic control is no longer achieved with glimepiride monotherapy, combination therapy with metformin or a glitazone may be initiated. Dose adjustment is required, starting with low doses of each medicine and gradually increasing until adequate glycemic control is achieved. When glimepiride is used concomitantly with metformin, the risk of hypoglycemia associated with glimepiride persists and may be increased.
Combination treatment with glimepiride and insulin:
After a period of treatment with glimepiride, if glycemic control is not achieved with glimepiride 8 mg/day alone, insulin may be added. Insulin should be initiated at a low dose and titrated gradually until adequate glycemic control is obtained. Once stable, the effectiveness of combination therapy should be monitored by daily blood glucose monitoring
CONTRAINDICATIONS
- Hypersensitivity to glimepiride or other sulfonylureas, sulfonamides, or any excipients of the product.
- Type 1 diabetes mellitus.
- Diabetic ketoacidosis or diabetic coma.
- Severe hepatic or renal impairment.
- Pregnancy and breastfeeding.
- Pre-coma or coma due to diabetes mellitus.
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.
