GLYCHEK

GLICLAZIDE TABLETS BP

Glychek contains gliclazide, an oral hypoglycemic agent belonging to the sunfonylurea group whith is used widely for the treatment of type-2 diabetes mellitus.






COMPOSITION  :

GLYCHEK 40                                           GLYCHEK 80
Each uncoated tablet contains :                    Each uncoated tablet contains :  
Gliclazide    BP    40mg                              Gliclazide    BP    80mg
                                                                  Colour    :   ponceau     4R

DESCRIPTION :

Glicazide  acts the chemical name [1-(3-azabicyclo-[3,3,0]-oct-3-yl)-3-ptolylsulfonylurea. It has the chemicals formula  C15 H21 N3 O3 S and a molecular weght of 323.4.

PHARMACOLOGY :

gliclazide acts chiefky by stimulating the release of insulin from the B cell of the pancreas. in patients with type-2 diabete, it improves the defective insulin secretion and thus ensures glycaemic control. it also helps to decrease the peripheral insulin resistance to some extent. There is evidence that Cliclazide may help to improve the defective haemobiological activity in patients with  type-2 diabetes as seen by a decrease in platelet hyperadhesiveness and hyperaggregation, an increase in fibrinolytic activity and decrease in levels of free radicals.

PHARMACOKINETICS :

Gliclazide is really absorbed from the gastrointestinal tract. After oral administration the peak plasma  concentrations are achieved in about 2-8  hours. Glclazide is extensively bound to plasma proteins, the plasma protein binding being 92%. Gliclazide is xtensively metabolize in the liver, but the metabolites have no hypoglycemic activity. The metabolites and a small amount of the unchanged drug are excreted in the urine. The half-life of gliclazied is about 10-12 hours.

INDICATIONS :

Glychek 40 / 80 is indicated for the treament of type -2 diabetes mellitus in association with dietary measures and with physical exercise, when these measures alone are not sufficient to normalize the bolld glucose levels.

DOSAGE & ADMINISTRATION :

The usual initial dose of gliclazide is 40-80 mg daily, gradually increased if necessary to 320 mg daily. The doses may be given once daily or in 2 divided doses. Doses more than 160 mg daily should be given in 2 divided doses. The doses are administered half an hour before meals.

CONTRAINDICATIONS :

Glychek 40 / 80 is contraindicated in the following situations :
•    Type -1 diabetes mellitus
•    Hypersensitivity to sunfonylureas
•    Severe hepatic ans renal failure
•    Pregnancy and location
•    Patients with ketoacidosis
•    Patients undergoing surgery, after severe trauma or during severe infections.

DRUG INTERACITONS :

An increased hypoglycemic effect can occur on co-administration of sunfonylureas, including gliclazide, with the following drugs :
Salicylates, sulfonamides, alcohol, betablockers, azole antifungals like fluconazole, ketoconazole and miconazole, ACE inhibitors, MAO inhibitors, tricyclic anti-depressants, chloramphenicol, tetracyclines, thyroid hormones, cimetidine, ranitidine, clofibrate, allopurinol and oral anti coagulants. Care should be taken when gliclazide is administered with there drugs. A diminished hypoglycemic effect, possibly requiring an increase in gliclazide dose may occur with drugs like danazol, chlorpomazine, glucocorticoids, oral contracepives, rifamycins, thiazide diuretics and epinephrine.

USE IN SPECIAL POPULATION :

•    Pregnancy : Gliclazide is contraindicated in pregnancy.

•    Nursing Mother :  Gliclazide is contraindicated in a mother who is breast feeding her baby.
•    Pediatric use : As most patients in paediatric segment with diabetes mellitus have type-1 diabetes, Gliclazide is not indicated in such patients.
•    Geriatric  use : As elderly individuals are prone to some degree of renal failure, Gliclazide should be used with caution.
•    Use in Helpatic & Renal Impairment :  gliclazide should be used with caution in patientd with mild to moderate hepatic or renal impairments and should be avoided in patients with severe hapatic and renal impairments.

ADVERSE REACTIONS :  

The following adverse reactions may occur with sulfonylureas, including gliclazide: hypoglycemia, gastrointestinal  distubances like nausea, vomiting, anoreia, diarrhoea  and a metallic taste, dermatological side efffects like skin rashes, pruitus and photosensitivity have been reported. Rarely hypersensitivity reactions like raised liver enzymes and cholestatic jaundice, leukopenia, thrombocytopenia, aplastic anaemia, erythema multiforme or exfoliative dermatitis may occur.

WARNINGS & PRECAUTIONS :

All sulfonylureas including gliclazide, can cause episodes of hypoglycemia. Hypoglycemia may present with sweating, intense hunger, trembing , pallor, visual to disturbances, feeling of malasia and abnormal beheviour. If untreated it can lead to drowsiness, convulsions or coma, hypoglycemic coma can be fatal. Hance all patients given sulfonylureas must be taught to recognisse the symptoms of hypoglycemia and if it occurs be told to take either sugar or sugar containing food immedately and inform he doctor. Hypoglycemia can occur becouse of irrigular meal times, missed meals, chenges in dite, prolonged or strenous execise, by intale of alcohol or other hypoglycemic drugs. The patient should be warrned about the dangers of hypoglycemia whilst driving or  operating machinery. Patients who develop frequent episodes of hypoglycemia should not drive or operate machinery.