Glimyx

Glimyx

gliclazide

Manufacturer:

ACME Lab

Distributor:

Novocore Pharma
Full Prescribing Info
Contents
Gliclazide.
Description
White to off-white colored, oval-shaped tablet with engraved 'ACME' on one face and break line on the other face.
Each modified-release tablet contains: Gliclazide BP 60 mg.
Action
Blood Glucose Lowering Drug (Sulfonylurea).
Pharmacology: Pharmacodynamics: Gliclazide (Glimyx) is a second-generation oral hypoglycemic sulfonylurea that stimulates the release of insulin from functioning pancreatic β-cells. This is mediated by an increase in the intracellular ratio of ATP/ADP, which inhibits K+-ATP channels. In addition, there is evidence that Gliclazide has action on peripheral tissues. This has been shown to enhance glycogen synthesis and inhibit glycogenolysis and gluconeogenesis in the liver. This may also improve peripheral glucose uptake by muscles. It reduces hepatic glucose output while stimulating insulin release from pancreatic cells by promoting Ca+2 transport across the cell membranes.
Pharmacokinetics: Absorption: Gliclazide is completely absorbed. Food intake does not affect the rate or degree of absorption.
Plasma levels increase progressively during the first 6 hours, reaching a plateau that is maintained from the sixth to the twelfth hour after administration. Intra-individual variability is low.
Distribution: Plasma protein binding is approximately 95%. The volume of distribution is around 30 liters. A single daily intake of Glimyx 60 mg maintains effective gliclazide plasma concentrations over 24 hours.
Metabolism: Gliclazide is mainly metabolized in the liver and excreted in the urine: less than 1% of the unchanged form is found in the urine. No active metabolites have been detected in plasma.
Elimination: The elimination half-life of Gliclazide varies between 12 and 20 hours.
Indications/Uses
It is indicated for patients with maturity-onset diabetes mellitus (NIDDM) who require an oral hypoglycemic medication.
Dosage/Direction for Use
The recommended starting dose of Gliclazide is 30 mg, may be increased to 60, 90 or 120 mg daily as a single dose. It is recommended that the drug should be taken at breakfast time. It is preferable to take this drug before breakfast to avoid or minimize the possible onset of digestive disorders.
Gliclazide (Glimyx) is a modified-release tablet and, therefore, should be neither broken nor chewed.
Or as directed by the physician.
Overdosage
An overdose of sulfonylurea may cause hypoglycemia. Moderate symptoms of hypoglycemia, without any loss of consciousness or neurological signs, must be corrected by carbohydrate intake, dose adjustment, and/or diet change. Strict monitoring should be continued until the doctor is sure that the patient is out of danger. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid I.V. injection of 50 mL of concentrated glucose solution (20 to 30%). This should be followed by continuous infusion of a more dilute glucose solution (10%) at a rate that will maintain blood glucose levels above 1 g/L. Dialysis is of no benefit to patients due to the strong binding of Gliclazide to proteins.
The administration of an excessive dose results in hypoglycemia (refer to Precautions), which should be treated immediately by the administration of sugar.
If the patient is unconscious, immediately inform a doctor and call the emergency service.
Contraindications
Gliclazide should not be used under the following conditions: Juvenile-onset (Type-1) diabetes.
Diabetes with Ketosis.
Diabetic individuals having surgery, recovering from a serious accident, or fighting an infection.
Patients who are hypersensitive to the sulfonylurea medication class.
Pregnant ladies and mothers who are breast-feeding.
Hepatic insufficiency is a condition in which the liver is unable to function properly.
Special Precautions
Gliclazide (Glimyx) should be administered with caution in patients with hepatic impairment. It should not be used if there is clear evidence of liver illness. Because gliclazide is thoroughly metabolized, it can be taken safely in patients with renal failure. Gliclazide has a lower risk of hypoglycemia than the other sulfonylurea medications.
Use In Pregnancy & Lactation
Pregnancy: Gliclazide, like other sulfonylureas, is contraindicated for use in pregnant women.
Lactation: It has not yet been established whether Gliclazide is transferred to human milk. However, it should not be used by a mother who is breastfeeding.
Adverse Reactions
Hypoglycemia can occur in the presence of other illnesses such as hepatic and renal dysfunction, starvation, and alcohol consumption. Headaches, gastrointestinal problems, nausea, dizziness, and skin reactions such as rash, pruritus, and erythema are all possible side effects.
Drug Interactions
With Medicine: The hypoglycemic effects of Gliclazide may be increased by Aspirin, NSAIDs, Phenylbutazone, Clofibrate, Sulfonamide, Cimetidine, Imidazole antifungal agents, and Monoamine Oxidase Inhibitors. The hypoglycemic effect of Gliclazide may sometimes be reduced by Rifampin, Barbiturates, Phenytoin, Thiazide diuretics, Diazoxide, Glucocorticoids, Estrogens, Sympathomimetic drugs, and occasionally alcohol.
With food: There are no established drug-food interactions.
Caution For Usage
Special Precautions for Handling and Disposal: No special requirements, but any unused medicine should be disposed of properly. Consult the pharmacist or local waste management center for more details about how to safely discard expired or unused medicines.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BB09 - gliclazide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Presentation/Packing
Form
Glimyx MR tab 60 mg
Packing/Price
30's