DELA

DELA

Commercial Name

DELA ®

Generic Name

Gliclazide BP

Composition

DELA® (Gliclazide) is a white, circular, flat, four scored, compressed tablet containing 80 mg Gliclazide BP.

Description

DELA® (Gliclazide) is a second generation oral hypoglycaemic sulfonylurea which stimulates the release of insulin from pancreatic β-cells by facilitating Ca+2 transport across the β-cells membranes and decrease hepatic glucose output.

Indication

DELA® (Gliclazide) is indicated for the treatment of maturity onset diabetes mellitus (NIDDM) of patients who require oral anti diabetic treatment.

Dosage & Administration

Oral Route
Duration of action is 12 hours or more.
Adult: The usual initial dose is 40 to 80 mg daily, gradually increased, if necessary upto 320 mg daily until adequate control is achieved. A single dose should not exceed 160 mg. when higher doses are required it should be taken twice daily and according to the main meals of the day.
Elderly: Plasma clearance of Gliclazide is not altered in the elderly and steady state plasma levels are similar to those in adults under 65 years Clinical experience in the elderly shows that it is effective and well tolerated.
Children: DELA® (Gliclazide) as with other sulfonylureas is not indicated for the treatment of juvenile onset diabetes mellitus.

Contraindication

DELA® (Gliclazide) should not be used in :
– Juvenile onset diabetes
– Diabetes complicated by ketosis and acidosis
– Pregnancy
– Diabetics undergoing surgery, after severe trauma or during infections
– Patients known to have hypersensitivity to other sulfonylureas and related drugs
– Diabetic pre-coma and coma
– Severe renal or hepatic insufficiency
– Combination with miconazole tablets.

Precaution

Care should be exercised in patients with hepatic and/or renal impairment and a small starting dose should be used with careful patient monitoring. In long term clinical trials patients with renal insufficiency have been treated satisfactorily using follow the physician’s dietary recommendations.

Pregnancy and Lactation

Pregnancy: DELA® (Gliclazide) should not be used in pregnancy.
Nursing Mothers: No study has reported its presence in human breast milk.

Side Effect

Hypoglycaemia may occur in concurrent conditions such as hepatic & renal diseases, alcohol intoxication and adrenal & pituitary insufficiency.
Mild gasto-intestinal disturbances including nausea, dyspepsia, diarrhea and constipation have been reported but these type of adverse reaction can be avoided if DELA® (Gliclazide) is taken during a meal. Allergic dermatological reactions including rash, pruritus erythema, bullous eruption have been reported during treatment with the drug but are not known to be directly attributable to it. More serious reactions like leucopenia, thrombocytopenia, agranulocytosis, pancytopenia, haemolytic anaemia, cholestatic jaundice and GI haemorrhage which have been reported with other sulphonylureas, have not been reported with DELA® (Gliclazide). Nor has hyponatraemia been noted with this particular sulfonylurea.

Drug Interaction

The hypoglycaemic effect of DELA® (Gliclazide) may be potentiated by NSAID (in particular aspirin), phenylbutazone, sulphonamides, coumarin derivatives. MAOIs, β adrenergic blockers, tetracyclines, chlorapmphenicol, clofibrate cimetidine and miconazole tablets. Ingestion of alcohol may also increase the hypoglycaemic effect of DELA® (Gliclazide).

Overdose

Accidental or deliberate over dosage leads essentially to signs of hypoglycaemia. The treatment is gastric lavage and correction of the hypoglycaemia. In severe cases, if there is clouding of consciousness, 10% or 30% hypertonic glucose solution must be administered intravenously without delay and the patient removed to hospital urgently.

Storage

Below 300C

Pack Size

Tablet: Box containing 10×5’s DELA® (Gliclazide) tablet in blister pack.

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