MINIDIAB TABLET 5 MG [SIN04059P]

Product Info

MINIDIAB TABLET 5 MG

[SIN04059P]

4.1. Therapeutic Indications

Glipizide is indicated as an adjunct to diet in patients with non-insulin-dependent diabetes mellitus (NIDDM; type II), when proper dietary management alone has failed.

4.2. Posology and Method of Administration

As for any hypoglycemic agent, dosage must be adapted for each individual case.

Short-term administration of glipizide may be sufficient during periods of transient loss of control in patients usually controlled well on diet.

In general, glipizide should be given approximately 30 minutes before a meal to achieve the greatest reduction in postprandial hyperglycemia.

Initial Dose

The recommended starting dose is 5 mg/day, given before breakfast or the mid-day meal. Elderly patients and other patients at risk for hypoglycemia may be started on 2.5 mg (See Use in Elderly and High-Risk Patients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Titration

Dosage adjustments should ordinarily be in increments of 2.5 mg or 5 mg, as determined by blood glucose response. At least several days should elapse between titration steps.

Maintenance

Some patients may be effectively controlled on a once-a-day regimen. The maximum recommended single dose is 15 mg. If this is not sufficient, splitting the daily dosage may prove effective. Total daily dosage above 15 mg should ordinarily be divided. The maximum recommended daily dosage is 20 mg.

Use in Children

Safety and effectiveness in children have not been established.

Use in Elderly and High-Risk Patients

To decrease the risk of hypoglycemia in patients at risk including elderly, debilitated, and malnourished patients or patients with irregular caloric intake and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (See Initial Dose and section 4.4. Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients Receiving Insulin

As with other sulfonylurea-class hypoglycemics, many stable type 2 diabetic patients receiving insulin may be transferred safely to treatment with glipizide. When transferring patients from insulin to glipizide, the following general guidelines should be considered:

For patients whose daily insulin requirement is 20 units or less, insulin may be discontinued and glipizide therapy may begin at usual dosages. Several days should elapse between titration steps.

For patients whose daily insulin requirement is greater than 20 units, the insulin dose should be reduced by 50% and glipizide therapy may begin at usual dosages. Subsequent reductions in insulin dosage should depend on individual patient response. Several days should elapse between titration steps.

During the insulin withdrawal period, the patient should self-monitor glucose levels. Patients should be instructed to contact the prescriber immediately if these tests are abnormal. In some cases, especially when the patient has been receiving greater than 40 units of insulin daily, it may be advisable to consider hospitalization during the transition period.

Patients Receiving Other Oral Hypoglycemic Agents

As with other sulfonylurea-class hypoglycemics, no transition period is necessary when transferring patients to glipizide. Patients should be observed carefully (1–2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to glipizide due to potential overlapping of drug effect.

Combination Use

When adding other blood-glucose-lowering agents to glipizide for combination therapy, the agent should be initiated at the lowest recommended dose, and patients should be observed carefully for hypoglycemia. Refer to the product information supplied with the oral agent for additional information.

When adding glipizide to other blood-glucose-lowering agents, glipizide can be initiated at 5 mg. Those patients who may be more sensitive to hypoglycemic drugs may be started at a lower dose. Titration should be based on clinical judgment.

4.3. Contraindications

Glipizide is contraindicated in patients with:

1. Hypersensitivity to glipizide or any excipients in the tablets

2. Type 1 diabetes mellitus, diabetic ketoacidosis, diabetic coma

3. Severe renal, hepatic or thyroid impairment; co-existent renal and hepatic disease

4. Pregnancy and lactation