Glubitor/Glubitor-OD

Glubitor/Glubitor-OD

gliclazide

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Gliclazide
Indications/Uses
Type 2 DM uncontrolled by diet & exercise.
Dosage/Direction for Use
Glubitor tab/Glubitor-OD MR & PR tab 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. Patient at risk of hypoglycemia Use a min daily starting dose of 30 mg. Glubitor-OD MR tab 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.
Administration
Should be taken with food: Swallow whole. Glubitor-OD Do not chew/crush.
Contraindications
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. Lactation. Glubitor-OD MR tab Unstable or brittle diabetes. Stress conditions eg, serious infection, trauma or surgery. Pregnancy.
Special Precautions
Malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary changes; alcohol intake; imbalance between physical exercise & carbohydrate intake; renal & severe hepatic insufficiency; gliclazide overdose, certain endocrine disorders (ie, thyroid disorders, hypopituitarism & adrenal insufficiency) may increase risk of hypoglycemia. Poor blood glucose control. Dysglycemia. Hemolytic anemia in patients w/ G6PD-deficiency. May affect ability to drive & use of machines. Childn. Elderly. Glubitor tab/Glubitor-OD PR tab Avoid use during pregnancy. Glubitor-OD MR tab 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. Not recommended in insulin-treated patients. Glubitor-OD PR tab Contains lactose; not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
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, DRESS. Glubitor-OD MR tab 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, increased saliva, toothache, & tooth disorder. Cholestasis, jaundice, abnormal liver function, hepatitis which 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, congenital hernia, 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, allergy, 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). Increased hypoglycemic reaction (by inhibiting compensatory reactions): alcohol. Other antidiabetic agents (insulins, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 receptor agonists); β-blockers (eg, propranolol), fluconazole, ACE inhibitors (captopril, enalapril), H2-receptor antagonists (eg, cimetidine), 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; due to 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 & other anticoagulants. Glubitor-OD MR tab Tuberculostatics, clofibrate, coumarin derivatives, salicylates, probenecid, tetracyclines, chloramphenicol, azole antifungal agents (eg, ketoconazole, itraconazole), disopyramide. May result to lower gliclazide plasma conc w/ inducers of hepatic enzymes eg, rifampicin, barbiturates, thyroid hormones & phenytoin. Drugs that induce hyperglycemia (pharmacologic doses): Diuretics (thiazides, furosemide), corticosteroids, 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.
Presentation/Packing
Form
Glubitor-OD MR tab 30 mg
Packing/Price
60's (P551/box)
Form
Glubitor-OD PR tab 60 mg
Packing/Price
60's (P1,100/box)
Form
Glubitor tab 80 mg
Packing/Price
60's (P529/pack)
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