Repaglinide® Tablet is used to lower blood sugar levels in adults with type 2 diabetes mellitus. It is usually prescribed along with other diabetes medicines to achieve adequate blood sugar control. It also prevents serious complications of diabetes like kidney damage and blindness.

Repaglinide® Tablet is normally prescribed when diet and exercise alone or other medicines have not been enough to control your blood sugar level. It works best when taken before meals. The dose will depend on your condition, and blood sugar levels, but you should take it as advised by your doctor.

Take Repaglinide® Tablet regularly, at the same time each day, to get the most benefit and you should not stop unless your doctor recommends it. It is controlling your blood sugar levels and helping to prevent serious complications in the future. It is important to stay on the diet and exercise program recommended by your doctor while taking this medicine. Your lifestyle plays a big part in controlling diabetes.

The most common side effect of taking this medicine is hypoglycemia (low blood sugar levels). You can carry sugar or glucose candy to control low blood sugar levels. Other common side effects that may be seen while taking this medicine include abdominal pain and diarrhea. Contact your doctor if the side effects worry you or if they do not go away.

Before taking this medicine, let your doctor know if you have ever had kidney disease, heart or pancreas problems, or if you drink a lot of alcohol. Pregnant or breastfeeding women should also consult their doctor before taking it. Some other medicines you are taking may interfere with it so make sure your doctor knows about all the other medicines you are taking. Limit your alcohol intake while taking this medicine because it can increase your risk of developing low blood sugar levels. You may need regular tests such as kidney function and blood glucose levels to check that the medicine is working properly.

Composition

Each tablet contains: Repaglinide 0.5, 1, or 2 mg.

Indications

• Oral antidiabetic agent In patients with type 2 diabetes mellitus, as an adjunct to diet and exercise where hyperglycemia cannot be controlled satisfactorily by diet and exercise alone.
• In combination therapy with metformin to lower blood glucose in patients whose hyperglycemia cannot be controlled by exercise, diet and either agent alone.

Dosage and Administration

• Repaglinide® tablets are taken immediately to 30 minutes before each meal. Starting dose is 0.5 mg, for patients not previously treated or whose glycosylated hemoglobin is below 8%. or 1 – 2 mg for patients previously treated with glucose-lowering drugs and whose glycosylated hemoglobin is 8% or more The dose may be adjusted, at intervals of 1 – 2 weeks, up to a maximum of 4 mg before meals.
• Recommended dosage range is 0.5 mg to 4 mg taken with meals.
• Repaglinide® may be dosed preprandially 2, 3, or 4 times a day, depending on patient’s meal pattern.
• The maximum recommended daily dose is 16 mg.

Drug Interactions

• Repaglinide® metabolism may be inhibited by cytochrome P-450 enzyme system 3A4 inhibitors such as: Ketoconazole, miconazole, erythromycin, and clarithromycin. Monitor blood glucose and adjust Repaglinide® dose as needed.
• Drugs that indue the cytochrome P-450 enzyme system 3A4 such as troglitazone, rifampin. barbiturates, and carbamazepine, may increase Repaglinide® metabolism. Monitor blood glucose and adjust Repaglinide® dose as needed.
• The action of Repaglinide® may be potentiated by certain drugs including beta blockers, chloramphenicol, coumarins, MAO Inhibitors, NSAIDs, salicylates. probenecid, and sulfonamides. Observe for hypoglycemia and loss of glycemic control.
• Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control, such as calcium channel blockers, conicosteroids, estrogens, isoniazid, nicotinic acid, oral contraceptives, phenothiazines, phenytoin, syrnpathomimetics, thiazides and other diuretics. and thyroid products. Monitor glucose level.
• The use of Repaglinide® with gemfibrozil causes reduction in Repaglinide® clearance, and severe hypoglycemia: the combination is contraindicated.

Precautions

• All oral blood glucose-lowering medications may cause hypoglycemia.
• Repaglinide® should be taken with caution in Patients with hepatic insufficiency in whom reduced metabolism could increase blood Repaglinide® levels and cause hypoglycemia.
• Elderly, debilitated or malnourished patients, because they are more susceptible to hypoglycemia.
• Patients with renal function impairment or renal failure requiring hemodialysis.
• Patients with adrenal or pituitary insufficiency.
• Patients should be instructed to skip a dose if they skip a meal and to add a dose if they add an extra meal.
• Because of the potential for hypoglycemia, the ability to drive or operate machinery may be impaired.
• Pregnancy and lactation
• Repaglinide® is contraindicated in pregnancy and lactation.

Contraindications

• Hypersensitivity to the product.
• Patients with type 1 diabetes mellitus.
• Diabetic ketoacidosis, with or without coma.

Side effects

These may include gastrointestinal disorders such as abdominal pain, diarrhea, constipation, nausea, and vomiting; hypoglycemia (usually mild); hypersensitivity rashes and urticana; elevated liver enzyme values, headache, and upper respiratory tract infection.

Properties

Repaglinide® is a meglitinide antidiabetic used in the management of type 2 diabetes mellitus. It has a chemical structure different from that of the sulfonylureas, but it has a similar mode of action.

It lowers blood glucose levels by stimulating the release of insulin from beta cells in the pancreas. This action is dependent on functioning beta cells in the pancreas.

Pharmacokinetics

Repaglinide® is rapidly and completely absorbed From the gastrointestinal tract following oral administration; peak plasma concentrations are achieved within 1 hour after dosing. Absolute bioavailability is about 60%.

Repaglinide® is highly bound to plasma proteins (> 98%). The elimination half-life is about 1 hour. It is metabolized in the liver to inactive metabolites. About 90% are excreted in feces and 8% in urine.

Storage and package

• Store at temperature not exceeding 30° C.
• How supplied: Blisters of 10 tablets each.

Marketing Authorization Holder and Manufacturer : EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO. (E. I. P. I. CO. )-10th OF RAMADAN CITY, AREA B1 P.O.BOX 149 TENTH, EGYPT.

Repaglinide® – Information Leaflet

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