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APO-GLICLAZIDE is a brand name for Gliclazide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-GLICLAZIDE (gliclazide tablets) is indicated for: • Control of hyperglycemia in gliclazide responsive diabetes mellitus of stable, mild, non- ketosis prone, maturity onset or adult type which cannot be controlled by proper dietary management and exercise, or when insulin therapy is not appropriate. 1.1 Pediatrics…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics). 2 CONTRAINDICATIONS APO-GLICLAZIDE is contraindicated: • in patients who are hypersensitive or allergic to gliclazide, other sulfonylureas, sulfonamides, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
). Discontinue treatment if cholestatic jaundice appears. Therefore, APO-GLICLAZIDE is contraindicated in patients with severe hepatic impairment (see 2 CONTRAINDICATIONS). Monitoring and Laboratory Tests Measurement of glycated hemoglobin levels (or fasting venous plasma glucose) is recommended in assessing blood glucose control.
Blood glucose self-monitoring is also recommended. Blood glucose control in a patient receiving APO-GLICLAZIDE treatment may be affected by fever, infection, surgical intervention or when used concomitantly with St. John's Wort (Hypericum perforatum) preparations.
Close monitoring is required in these patients. In some cases, it may be necessary to administer insulin. Hepatic function should be assessed before initiating therapy and the liver function should be assessed periodically in patients with mild to moderately impaired hepatic function.
In patients with mild to moderately impaired renal function, renal function should be assessed periodically. Blood glucose and glycated hemoglobin levels should be regularly monitored in all patients. Elderly patients (malnourished, with impaired hepatic, renal, or adrenal function) will require periodic monitoring and special care.
Peri-Operative Considerations In patients stabilized on gliclazide therapy, loss of blood sugar control may occur in cases of acute intercurrent disease or in stressful situations such as trauma or surgery. Under these conditions, discontinuation of APO-GLICLAZIDE and administration of insulin should be considered.
Renal The metabolism and excretion of sulfonylureas including APO-GLICLAZIDE may be slowed in patients with impaired renal function. If hypoglycemia should occur in such patients, it may be APO-GLICLAZIDE (Gliclazide Tablets) Page 11 of 38 prolonged and appropriate management should be instituted.
). • in patients with severe renal impairment (see 7 WARNINGS AND PRECAUTIONS). 4 Drug-Drug Interactions). 2 Breast- feeding). 1 Dosing Considerations Determination of the proper dosage for APO-GLICLAZIDE for each patient should be made on the basis of frequent determinations of blood glucose during dose titration and throughout maintenance.
Patients with renal or hepatic impairment may require dosage reduction (see 7 WARNINGS AND PRECAUTIONS). Use in patients with severe renal or hepatic impairment is contraindicated (see 2 CONTRAINDICATIONS). In patients where on initial trial the maximal recommended dose fails to lower blood glucose adequately, the drug should be discontinued.
During the course of therapy, a loss of effectiveness may occur. In general, the dosage will depend on the severity of the glycemia with ongoing adjustments should be made in order to obtain the optimal response at the lowest dosage.
It is advisable to ascertain the contribution of the drug in control of the blood glucose by discontinuing the medication semi-annually or at least annually with careful monitoring of the patient. If the need for the drug is not evident, the drug should not be resumed.
In some diabetic subjects, short-term administration periods of the drug may be sufficient during periods of transient loss of blood sugar controls.
Patients receiving insulin:
Maturity onset diabetics with no ketoacidosis or history of metabolic decompensation and whose insulin requirements are less than 40 units per day may be considered for gliclazide tablets therapy after cessation of insulin. If a change from insulin to APO-GLICLAZIDE is contemplated in such a patient, discontinue insulin for a period of 2 or 3 days to determine whether any therapy other than dietary regulation and exercise is needed.
APO-GLICLAZIDE is contraindicated: • in patients who are hypersensitive or allergic to gliclazide, other sulfonylureas, sulfonamides, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • in patients with unstable and/or insulin-dependent (Type 1) diabetes mellitus, particularly juvenile diabetes, diabetic ketoacidosis, diabetic pre-coma and coma.
• during stress conditions such as serious infection, trauma or surgery. • in patients with severe hepatic impairment (see 7 WARNINGS AND PRECAUTIONS). • in patients with severe renal impairment (see 7 WARNINGS AND PRECAUTIONS). 4 Drug-Drug Interactions).
2 Breast- feeding). APO-GLICLAZIDE (Gliclazide Tablets) Page 5 of 38
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Therefore, APO-GLICLAZIDE is contraindicated in patients with severe renal impairment (see 2 CONTRAINDICATIONS). Sensitivity/Resistance Due to the presence of lactose in APO-GLICLAZIDE, patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption or the Lapp lactose deficiency should not take.
5 Post-Market Adverse Reactions). 5 Post-Market Adverse Reactions). In reported cases, patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the gliclazide tablets. Tell patients to report development of blisters or erosions while receiving APO-GLICLAZIDE.
If bullous pemphigoid is suspected, APO-GLICLAZIDE should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment. 1 Pregnant Women APO-GLICLAZIDE is contraindicated in pregnancy.
It is recommended that insulin be used during pregnancy in diabetic women (see 2 CONTRAINDICATIONS). Uncontrolled diabetes (gestational or not) is associated with a higher incidence of congenital abnormalities and perinatal mortality.
Blood glucose control should be optimal around the time of conception to reduce the risk of congenital malformations. 2 Breast-feeding APO-GLICLAZIDE is contraindicated in breast-feeding mothers because the product may potentially cause hypoglycemia in nursing infants (see 2 CONTRAINDICATIONS).
Some sulfonylurea drugs are excreted in human milk although it is not known whether APO- GLICLAZIDE is one of them. 3 Pediatrics Safety and effectiveness of APO-GLICLAZIDE in pediatrics (<18 years of age) have not been established; therefore, Health Canada has not authorized an indication for pediatric use.
4 Geriatrics Efficacy and tolerance of APO-GLICLAZIDE, prescribed using the same therapeutic regimen in subjects over 65 years, has been confirmed in clinical trials, however greater sensitivity of some older individuals cannot be ruled out.
Severe hypoglycemia can be induced by all sulfonylurea drugs. Elderly subjects are particularly susceptible. 2% of patients. The most frequent adverse drug reactions are hypoglycemia and gastrointestinal disturbances (including abdominal pain, nausea, vomiting, dyspepsia, diarrhea, constipation).
Serious adverse drug reactions that resulted in hospitalization during clinical trials were malaise, acute renal failure, and thrombophlebitis. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
3 Less Common Clinical Trial Adverse Reactions Blood and lymphatic system disorders: leukopenia, erythrocytopenia agranulocytosis, thrombocytopenia, hemolytic anemia, pancytopenia and allergic vasculitis. Cardiovascular disorders: angina pectoris, arteritis, cardiac failure, cerebrovascular disorder, coronary artery disorder, epistaxis, hypertension, hypotension, myocardial infarction, oedema legs, palpitation, tachycardia, thrombophlebitis, vein disorder.
Ear/Nose/Throat disorders: hearing decreased, tinnitus. Endocrine disorders: […]
During this insulin-free interval, test the patient's urine at least 3 times daily for glucose and ketone bodies and monitor the results carefully. The appearance of significant ketonuria accompanied by glucosuria within 12 to 24 hours after the withdrawal of insulin, strongly suggests that the patient is ketosis prone, and precludes the change from insulin to sulfonylurea therapy.
2 Recommended Dose and Dosage Adjustment • The recommended daily dosage of APO-GLICLAZIDE is 80 to 320 mg (1 to 4 tablets). The total daily dose should not exceed 320 mg. • The recommended starting dose of APO-GLICLAZIDE is 2 tablets per day (160 mg) taken as one tablet twice a day with meals.
• Pediatrics (<18 years of age): The safety and effectiveness of APO-GLICLAZIDE have not been studied in patients under 18 years of age. APO-GLICLAZIDE is not indicated for pediatric use. 4 Geriatrics). 4 Administration This treatment should only be prescribed if the patient is likely to have a regular food intake (including breakfast).
It is important to have a regular carbohydrate intake due to the increased risk of hypoglycemia if a meal is taken late, if an inadequate amount of food is consumed or if the food is low in carbohydrate. Doses up to 160 mg daily may be taken in a single dose but preferably at the same time each morning.
Doses in excess of 160 mg should be taken in divided doses in the morning and evening with meals. APO-GLICLAZIDE tablets must not be chewed or crushed. 5 Missed Dose If a dose is forgotten, the patient should be advised to skip the missed dose and take his or her usual dose at the regular time the next day.
The dose taken on the next day should not be increased to account for the missed dose. 5 OVERDOSAGE Symptoms Overdosage with sulfonylureas may result in hypoglycemia but it should be noted that the dosage which causes such hypoglycemia varies widely and may be within the accepted therapeutic range in sensitive individuals.
The manifestations of hypoglycemia include sweating, flushing or pallor, numbness, chilliness, hunger, trembling, headache, dizziness, increased pulse rate, palpitations, increased blood pressure and apprehensiveness in mild cases.
In more severe cases, coma appears. However, symptoms of hypoglycemia are not necessarily as typical as those described above and sulfonylureas may cause insidious development of symptoms mimicking cerebrovascular insufficiency. Treatment of overdosage Discontinue medication and treat hypoglycemia by giving dextrose promptly and in sufficient quantity.
Some sulfonylurea-induced hypoglycemias may be refractory to treatment and susceptible to relapse especially in elderly or malnourished patients. Continuous dextrose infusions for hours or days have been necessary. Strict monitoring should be continued until the doctor is sure that the patient is out of danger.
APO-GLICLAZIDE (Gliclazide Tablets) Page 7 of 38 Severe hypoglycemic reactions, with coma, convulsions or other neurological disorders are possible and must be treated as a medical emergency, requiring immediate hospitalization. V. injection of 50 mL of concentrated glucose solution (20 to 30%).
This should be followed by continuous infusion of a more dilute glucose solution (10%) at a rate that will maintain blood glucose levels above 1 g/L. Patients should be monitored closely and, depending on the patient's condition after this time, the doctor will decide if further monitoring is necessary.
Dialysis is of no benefit to patients due to the strong binding of gliclazide to proteins. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or […]