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Sugril

Sugril

glibenclamide

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Glibenclamide
Indications/Uses
NIDDM (type 2) when blood glucose levels is inadequately controlled by diet, physical exercise & wt reduction alone.
Dosage/Direction for Use
Initially 2.5 mg (½ tab)-5 mg (1 tab) once daily. Start w/ the lowest possible dose. If necessary, gradually increase dose eg, in increments of not >½ tab at 1-2 wk intervals. Dose range in patients w/ well controlled diabetes Usual single dose: 2.5 mg (½ tab)-10 mg (2 tab) daily. Max single dose: 10 mg (2 tab). Divide large daily doses into at least 2 separate single doses. Max daily dose: 15 mg (3 tab).
Administration
Should be taken with food: Swallow whole w/ sufficient liqd.
Contraindications
Hypersensitivity to glibenclamide, other sulfonylureas or any sulfonamide derivative. IDDM (type 1). Treatment of diabetic ketoacidosis & precoma or coma. Patients w/ serious renal, hepatic or adrenocortical dysfunction. Patients treated w/ bosentan. Pregnancy & breast-feeding.
Special Precautions
Not to be used in type 1 DM, diabetic ketoacidosis, severe infection & trauma. Discontinue if erythema multiforme, bullous eruptions, exfoliative dermatitis eg, oral cavity, throat, nose, genital & conjunctivitis occur. Hypoglycemia (eg, hunger, palpitation, sweating) & hyperglycemia (increased urinary frequency, intense thirst, dry mouth & skin). Increased CV mortality risk. May deteriorate blood glucose regulation in exceptional stress situations (eg, trauma, surgery, febrile infections). Patients allergic to sulfonamide derivatives. Consider non-sulfonylurea alternative in patients w/ G6PD deficiency. Adhere to correct diet, regular & sufficient physical exercise & body wt reduction. Regularly measure glucose levels in blood & urine; determine HbA1C proportions. Develop awareness of hypoglycemic factors including unwillingness or (more common in older patients) incapacity to cooperate; undernutrition, irregular mealtimes or missed meals; diet alternations or unaccustomed physical exertion; impaired renal function; serious liver dysfunction; glibenclamide overdose; uncompensated endocrine system disorders affecting carbohydrate metabolism or counter-regulation of hypoglycemia (thyroid function & anterior pituitary gland or adrenocortical insufficiency); concurrent administration of certain other medicines. Promptly control hypoglycemia by immediate intake of carbohydrates (eg, sugar lumps, sugar sweetened fruit juice or tea); may advise patients to carry 20 g min glucose at all times. Avoid alcohol. Concomitant use w/ β-blockers, clonidine, reserpine, guanidine or other sympatholytic drugs. Not to be used in patients w/ serious renal & hepatic dysfunction. Avoid during pregnancy. Lactation. Elderly.
Adverse Reactions
Severe & occasionally fatal hypoglycemia. Hypoglycemic symptoms include headache, ravenous, hunger, nausea, vomiting, lassitude, sleepiness, disordered sleep, restlessness, aggressive, impaired conc, alertness & reactions, depression, confusion, speaking difficulty & speech loss, visual disorders, tremor, paresis, sensory disturbances, dizziness, helplessness, delirium, cerebral convulsion, somnolence, loss of self-control & consciousness up to & including coma, shallow respiration & slow heart rate (bradycardia). Signs of adrenergic counter-regulation including sweating, clammy skin, anxiety, rapid heart rate (tachycardia), HTN, palpitations, angina pectoris & cardiac arrhythmias. Wt gain; nausea, abdominal pain, diarrhea; rashes. Erythema multiforme, exfoliative dermatitis.
Drug Interactions
Increased elevated liver enzymes w/ bosentan. Concomitant use w/ CYP2C9 inducers or inhibitors. Potentiated blood-glucose lowering effect w/ insulin & other (oral) antidiabetics, ACE inhibitors, anabolic steroids & male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluoxetine, ifosfamide, MAOIs, miconazole, para-aminosalicylic acid, high dose parental pentoxifylline, phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, sulphonamides, sympatholytic agents (eg, β-blockers & guanethidine), clarithromycin, tetracyclines, tritoqualine, trofosfamide. Raised blood-glucose levels w/ acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine (adrenaline) & other sympathomimetic agents, glucagon, laxatives (after protracted use), high dose nicotinic acid, estrogens & progestogens, phenothiazines, phenytoin, thyroid hormones, rifampicin. May lead to either potentiation or weakening of blood glucose lowering effect w/ H2 antagonists, clonidine & reserpine. Reduced or absent adrenergic counter-regulation to hypoglycemia w/ β-blockers, clonidine, guanethidine, and reserpine. May potentiate or weaken blood glucose-lowering action w/ acute & chronic alcohol; effect of coumarin derivatives. May increase plasma conc & toxicity of cyclosporine. Intervals of at least 4 hr prior to colesevelam.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BB01 - glibenclamide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Presentation/Packing
Form
Sugril tab 5 mg
Packing/Price
10 × 10's
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