SB-Glic XR 60Tablet (Extended Release)

Generic

Gliclazide

Indications

Patients with maturity-onset diabetes mellitus (NIDDM) who require an oral hypoglycaemic medication should use gliclazide.

Pharmacology

Gliclazide is a sulfonylurea of the second generation with hypoglycemic and possibly hematological effects. It reduces hepatic glucose production while stimulating insulin release from pancreatic -cells by promoting Ca+2 transport across the -cell membranes.

Dosage & Administration

Film-coated tablet: The usual initial dose is 40 to 80 mg daily. The dose can be increased up to 320 mg daily in divided doses when needed. The drug should be taken before meal. For children, Gliclazide is not used because it is contraindicated in juvenile-onset diabetes.

Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.

The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).

If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.

Interaction

Aspirin, NSAIDs, Phenylbutazone, Clofibrate, Sulfonamide, Cimetidine, Imidazole antifungal medications, and Monoamine Oxidase inhibitors may enhance Gliclazide's hypoglycaemic effects. Rifampin, Barbiturates, Phenytoin, Thiazide diuretics, Diazoxide, Glucocorticoids, Estrogens, Sympathomimetic medications, and Alcohol may decrease the hypoglycaemic impact of Gliclazide.

Contraindications

Gliclazide should not be used in the following situations:

• Juvenile-onset (type-1) diabetes
• Diabetes associated with Ketosis
• Diabetic patients undergoing surgery, after severe injury or during infection
• Patients having hypersensitivity for sulfonylurea group of drugs
• Pregnant women and breast-feeding mother
• Hepatic insufficiency

Side Effects

Hypoglycemia can occur in the presence of other diseases such as hepatic and renal dysfunction, starvation, and alcohol abuse. Headaches, gastrointestinal disturbances, nausea, dizziness, and skin responses such as rash, pruritus, and erythema are all possible side effects.

Pregnancy & Lactation

Pregnant women should avoid using gliclazide. It should not be used by a woman who is breastfeeding.

Precautions & Warnings

In individuals with hepatic impairment, gliclazide should be taken with caution. Gliclazide should not be taken if there is clear evidence of liver illness. Because gliclazide is thoroughly metabolized, it can be administered safely in individuals with renal failure. Gliclazide has a lower risk of hypoglycemia than the other sulfonylurea medications.

Therapeutic Class

Sulfonylureas

Storage Conditions

Store below 30°C and away from light in a cool, dry area.

Pharmaceutical Name

Sunman-Birdem Pharma Ltd.