Concise Prescribing Info
Type 2 DM uncontrolled by diet & exercise.
Dosage/Direction for Use
Glubitor Initially 30 mg daily. May be increased to 60, 90 or 120 mg daily in increments of at least 1 mth. Max: 120 mg daily. Glubitor-OD 30-120 mg once daily. Titrate dose at increments of 30 mg at 2-4 wk intervals. Maintenance: 60 mg once daily. Max: 120 mg daily.
Should be taken with food: Glubitor-OD Swallow whole, do not chew/crush.
Hypersensitivity to gliclazide, other sulfonylureas or sulfonamides. Type 1 DM; diabetic pre-coma & coma, diabetic keto-acidosis. Concomitant use w/ miconazole. Severe renal or hepatic insufficiency. Pregnancy & lactation. Glubitor-OD Unstable or brittle diabetes. Stress conditions eg, serious infection, trauma or surgery.
Special Precautions
Malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary changes; alcohol intake; imbalance between physical exercise & carbohydrate intake; renal & hepatic impairment; thyroid disorders, hypopituitarism & adrenal insufficiency may increase risk of hypoglycemia. Poor blood glucose control. Dysglycemia. Hemolytic anemia in patients w/ G6PD-deficiency. Childn. Elderly. Glubitor-OD Development of complications peculiar to DM. Not to be used as substitute for diet. Discontinue use if loss of adequate blood glucose-lowering response is detected. Increased risk of CV mortality. Insulin-treated patients. May affect ability to drive & use of machines.
Adverse Reactions
Hypoglycemia. Signs of adrenergic counter-regulation: Sweating, clammy skin, anxiety, tachycardia, HTN, palpitations, angina pectoris & cardiac arrhythmia. GI disturbances, including abdominal pain, nausea, vomiting, dyspepsia, diarrhea, & constipation. Angioedema, drug rash w/ eosinophilia & systemic symptoms (DRESS). Glubitor-OD Hyperglycemia, lipid metabolism disorder, gout, glycosuria, hypercholesterolemia, hypertriglyceridemia, hyperlipemia & thirst. Heartburn, gastroesophageal reflux, anorexia, gastric irritation, gastritis, gastroenteritis, anal fissure, colitis, duodenal ulcer, epigastric fullness, fecal incontinence, flatulence, metallic taste, GI neoplasm benign, hemorrhoids, melena, dry mouth, saliva increased, toothache & tooth disorder. Cholestasis, jaundice, abnormal liver function, hepatitis w/c may lead to liver failure or hepatic dysfunction, hepatic porphyria reactions, hepatomegaly & increased liver enzyme levels (AST, ALT, alkaline phosphatase). Allergic reactions (eg, pruritus, rash, erythema, urticaria, morbilliform or maculopapular rash, bullous reactions), porphyria cutanea tarda, photosensitivity reactions, fungal dermatitis, dermatitis, skin disorder, eczema, hyperkeratosis, nail disorder, onychomycosis, dry skin & skin ulceration. Hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia, pancytopenia, erythrocytopenia & allergic vasculitis. Arteritis, cardiac failure, cerebrovascular disorder, CAD, epistaxis, hypotension, MI, edema legs, thrombophlebitis & vein disorder. Hypothyroidism. Rhinitis, bronchitis, pharyngitis, upper resp infection, coughing, pneumonia, dyspnea, asthma, tracheitis & sinusitis. Disulfiram-like reactions, confusion, nervousness, dizziness, depression, insomnia & neuralgia. UTI, increased urinary frequency, albuminuria, cystitis, nocturia, polyuria, renal calculus & renal cyst. Back pain, arthralgia, arthrosis, arthropathy, bursitis, hernia congenital, skeletal pain, spine malformation, arthritis, tendinitis & myalgia. Balanoposthitis, benign female breast neoplasm, impotence, mastitis, menstrual disorder, prostatic disorder & vaginitis. Conjunctivitis, visual disturbance/abnormal vision, cataract, conjunctival hemorrhage, diplopia, glaucoma, abnormal lacrimation, retinal disorder, vitreous disorder, xerophthalmia, otitis media, decreased hearing, tinnitus & impaired speech disorder. Headache, asthenia, carpal tunnel syndrome, chest pain, viral infection, infection, fungal infection, leg pain, malaise, pain. Inflicted injury.
Drug Interactions
Increased hypoglycemic effect: Miconazole (systemic route, oromucosal gel); (displaced binding to plasma proteins &/or reduced elimination) phenylbutazone (systemic route); (by inhibiting compensatory reactions) alcohol; tuberculostatics, clofibrate, coumarin derivatives, salicylates, probenecid, tetracyclines, chloramphenicol, azole antifungal agents (eg, ketoconazole, itraconazole), disopyramide, antidiabetic agents (insulins, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 receptor agonists); β-blockers, fluconazole, ACE inhibitors (captopril, enalapril), H2-receptor antagonists, MAOIs, sulfonamides, clarithromycin & NSAIDs. Diabetogenic effect of danazol. Increased blood glucose levels: (reduced insulin release) chlorpromazine (neuroleptic agent; high doses); w/ possible ketosis w/ glucocorticoids (systemic & local route: IA, cutaneous & rectal prep) & tetracosactrin; β2 agonist effects w/ ritodrine, salbutamol, terbutaline (IV). Decreased exposure w/ St. John's wort (Hypericum perforatum). May cause dysglycemia: fluoroquinolones; Potentiation of anticoagulation of warfarin. Glubitor-OD May lower plasma conc w/ inducers of hepatic enzymes eg, rifampicin, barbiturates, thyroid hormones & phenytoin. Drugs that induce hyperglycemia (pharmacologic doses): Diuretics (thiazides, furosemide), OCs (estrogens plus progestogens) & nicotinic acid. May unpredictably potentiate or reduce activity w/ alcohol.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BB09 - gliclazide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Glubitor-OD MR tab 30 mg
60's (P480/box)
Glubitor tab 80 mg
60's (P485/pack)
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