Zepranil®
Glibenclamide Tablets BP 5mg
For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only.
COMPOSITION
Each uncoated tablet contains:
Glibenclamide BP 5mg
Excipients Q. S.
PHARMACOLOGICAL ACTION
ZEPRANIL is an oral sulphonylurea antidiabetic preparation with a hypoglycaemic effect.
INDICATIONS
ZEPRANIL is indicated as an adjunct to diet to lower the blood glucose level in patients with non-insulin dependent (type 2) diabetes mellitus whose hyperglycaemia cannot be controlled by diet alone.
CONTRA-INDICATIONS
Hypersensitivity to sulphonylureas; Diabetes mellitus in patients with a history of metabolic decompensation e.g. acidosis, diabetic precoma and coma; Diabetes mellitus complicated by fever, trauma or gangrene and in patients with impaired renal or hepatic function or serious impairment of thyroid or adrenal function; Insulin-dependent diabetes mellitus; Diabetes mellitus in young people; Pregnancy and lactation. Women who plan to become pregnant should consult their doctor. Hypersensitivity to glibenclamide.
WARNING
The administration of oral hypoglycaemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin, although controversy exists concerning interpretation of these findings.
DOSAGE AND DIRECTIONS FOR USE
The dosage of ZEPRANIL used for treatment of new patients is determined by results of medical and laboratory examinations. In general the initial dose is half a tablet (=2.5 mg ZEPRANIL) daily The daily dose can then be raised gradually in steps of half a tablet, but only after repeating medical examination. Raising the dose beyond 15 mg daily does not usually produce any increased response. When changing over from another oral antidiabetic preparation, with a similar mode of action, the dosage of ZEPRANIL is determined by the amount of the previously administered dose and the medical examination. It may be considered that the effect of 1 g talbutamide or glycodiazine, 0.5 g carbutamide or 250 mg chlorpropamide corresponds roughly to that of 5 mg ZEPRANIL (1 tablet). In combination therapy with a biguanide, there may be a greater risk of cardiovascular mortality than with the use of glibenclamide alone.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects include skin rashes, photosensitivity, diarrhoea, nausea, vomiting, epigastric pain, feeling of gastric fullness, dizziness, headache, weakness, fever; hypoglycaemic reactions and paraesthesia. Eosinophilia, cholestasis, hepatitis, jaundice, blood disorders including leucopenia, thrombocytopenia, aplastic anaemia, pancytopenia, haemolytic anaemia and agranulocytosis may occur. The incidence of hypoglycaemia can be reduced if ZEPRANIL is taken with or immediately after a meal. Transient visual disturbances may occur at the commencement of treatment. Intolerance to alcohol may occur. Adjustment of dosage of ZEPRANIL may be required in patients suffering from recurrent infections, trauma, shock or after anaesthesia. When molar surgery is to be performed, ZEPRANIL should be substituted with insulin therapy.
Interactions
The hypoglycaemic effects may be enhanced by: chloromphenical, clofibrate, halofenate, cyclophosohamide, dicoumarol, monoamine oxidase inhibitors, salicylates, phenylbutazone, propranolol and other beta-adrenergic blocking agents, sulphonamides, anabolic steroids, bezafibrate, biguanides, fenfluramine, fenyremidol, miconazole, parenteral pentoxifylline in high doses, phosphamides, ACE-inhibitors, fluoxetine, guanethidine, probenecid, reserpine, sulphinpyrazone, tritoqualine and tetracyclines. The hypoglycaemic effect may be diminished by adrenaline, oestrogens, corticosteroids or diuretics, abuse of laxatives, high doses of nicotinates, phenothiazines, acetazolamide, clonidine, diazoxide, glucagon, phenytoin, saluretics, sympathomimetics and thyroid hormones. Prapranolol may inhibit normal physiological response to hypoglycaemia and mask the symptoms of hypoglycaemia. Under treatment with beta-blockers as also with clonidine, guanethidine or reserpine, the perception of the warning symptoms of a hypoglycaemic attack may be impaired. In rare instances, undesired potentiation or attenuation of the blood-sugar-lowering effect of ZEPRANIL have been observed during concomitant medication with H2-receptor antagonists.
Alcohol
If the drug is taken at the same time as alcohol, there may be either a potentiation or an attenuation of the hypoglycaemic effect.
Special Precautions
The treatment of diabetes with ZEPRANIL requires regular follow-up checks. Until optimal control has been achieved, or when changing from one antidiabetic preparation to another, or if the tablets have not been taken regularly, alertness and reaction time may be altered to such an extent that the patient cannot safely cope with road traffic or operate machinery. Strict adherence to the diet and regularity in taking the tablets are essential to maintain physical efficiency and to prevent the blood sugar from rising too high (hyperglycaemia) or failing too low (hypoglycaemia). The signs of such undesirable changes in the blood sugar level are:
Hyperglycaemia
Severe thirst, dryness of mouth, frequent micturition, dry skin.
Hypoglycaemia
Intense hunger, sweating, tremor, restlessness, irritability, depression of mood, headaches and disturbed sleep. Artificial sweeteners are of no use for this purpose. Any hypoglycaemic reactions should be reported as soon as possible to the doctor; who will then check whether the dose of ZEPRANIL requires correction. If simple measures fail to relieve a hypoglycaemic attack promptly, a doctor should be called immediately. Should other illnesses arise during the treatment with ZEPRANIL, the doctor in charge should be consulted without delay.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Hypoglycaemic symptoms, e.g. excessive perspiration, light-headedness, etc., can be treated by giving the patient glucose orally or intravenously. Further treatment is symptomatic and supportive.
IDENTIFICATION
Almost white, biplane, oblong tablets, 10 mm by 5 mm in dimension. Each side with a scoreline and engraved the letters LDL on one side of the scoreline and company logo on the other side.
PRESENTATION
10 X 10 Blister
STORAGE INSTRUCTIONS
Store in a cool dry place away from light.
Manufactured by
BAROQUE PHARAMACEUTICALS PVT. LTD.
192/2 & 3, Sokhada-380 620 (Kkhambhat)
Product License Holder
TICOS LIFESCIENCES LIMITED
1103/A, Synergy Tower,
Corporate Road, Prahladnagar,
Ahmedabad-380 015 INDIA
Marketed by
KUKA CONSUMER HEALTHCARE LIMITED
7/9, Sawyer Crescent, Phase 1,
Gbagada Estate, Lagos, NIGERIA
