Glimepiride

Visa No.: 893110178324

Product: Diaprid 4

API: Glimepiride

Product Category: Cardiovascular & Metabolism

Version approved leaflet: 547/QĐ-QLD_15/11/2016_156

INDICATIONS

Type 2 diabetes mellitus not requiring insulin in adults, when blood glucose levels cannot be adequately controlled by diet, exercise, and weight reduction alone.

DOSAGE AND ADMINISTRATION

Method of administration: The medicine is usually taken once daily immediately before or during breakfast or lunch. Tablets should be swallowed whole, must not be broken or crushed. 
Dosage
The initial dose is 1 mg once daily. Thereafter, the dose may be increased by 1 mg/day at intervals of 1–2 weeks if blood glucose is not adequately controlled, until satisfactory glycemic control is achieved.
The maximum daily dose of glimepiride is 8 mg. Most patients respond to doses of 1–4 mg/day; doses of 6 or 8 mg/day are rarely required. Doses above 4 mg/day provide additional benefit only in exceptional cases.

Dose adjustment is required in the following situations:
If hypoglycemia occurs after administration of 1 mg glimepiride, the patient may be managed with diet and exercise alone.
When the disease is controlled and blood glucose becomes stable, insulin sensitivity may improve; therefore, the requirement for glimepiride may decrease after a period of treatment. Dose adjustment is necessary to avoid hypoglycemia when:

• The patient’s body weight changes
• The patient’s lifestyle changes, or
• Concomitant medications or other factors affecting blood glucose are introduced or withdrawn.

Hepatic or renal impairment: 
In patients with renal impairment, the initial dose should be limited to 1 mg once daily. The dose may be increased if fasting blood glucose remains elevated. If creatinine clearance is below 22 ml/min, the dose is generally limited to 1 mg once daily and should not be increased. Use in hepatic impairment has not been studied. In patients with severe renal or severe hepatic impairment, treatment should be switched to insulin.

Switching from other antidiabetic agents to glimepiride: 
Treatment should be initiated at 1 mg/day and titrated gradually as described above, even if the patient was previously receiving the maximum dose of another antidiabetic agent. If the previous agent has a long duration of action or additive interactions with glimepiride, a washout period of 1–3 days may be required, depending on the previously used drug.

Combination therapy with glimepiride and metformin or a glitazone:
If glimepiride monotherapy no longer provides adequate glycemic control, combination therapy with metformin or a glitazone may be considered. Dose adjustment is required, starting with low doses of each drug and titrating upward until blood glucose is controlled. When glimepiride is used in combination with metformin, the risk of hypoglycemia associated with glimepiride persists and may be increased.

Combination therapy with glimepiride and insulin: If glycemic control cannot be achieved with glimepiride monotherapy at a dose of 8 mg/day, insulin may be added. Insulin should be initiated at a low dose and titrated upward until adequate glycemic control is achieved. Once stable control is obtained, combination therapy should be closely monitored by daily blood glucose measurements.

CONTRAINDICATIONS

Insulin-dependent diabetes mellitus. Severe renal or hepatic impairment.
Diabetic ketoacidosis. Hypersensitivity to the active substance or to other sulfonylureas.
Pregnancy or planned pregnancy. Breast-feeding.
Pre-coma or coma due to diabetes mellitus, and hyperosmolar diabetic coma.
Acute illness.

WARNINGS AND PRECAUTIONS

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