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TARO-GLICLAZIDE MR is a brand name for Gliclazide, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ................................................................................ 4 1.1 Pediatrics (< 18 years of age): .............................................................................. 4 1.2 Geriatrics (≥ 65 years of age):…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics). 2 CONTRAINDICATIONS TARO-GLICLAZIDE MR is contraindicated in patients: • With known hypersensitivity or allergy 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
, Hepatic/Biliary/Pancreatic). • In the presence of severe renal impairment (see 7 WARNINGS AND PRECAUTIONS, Renal). 4 Drug-Drug Interactions). 2 Breast-feeding). 1 Dosing Considerations Determination of the proper dosage for TARO-GLICLAZIDE MR for each patient should be made on the basis of frequent determinations of blood glucose during dose titration and throughout maintenance.
, one half tablet to 2 tablets of TARO-GLICLAZIDE MR 60 mg, or 1 to 4 tablets of TARO-GLICLAZIDE 30 mg). e. one half tablet of TARO-GLICLAZIDE MR 60 mg or one tablet of TARO-GLICLAZIDE MR 30 mg, even in elderly patients (over 65 years old).
A single daily dose provides effective blood glucose control. The single daily dose may be between 30 mg and 120 mg. The daily dose should not exceed 120 mg. Dose adjustment should be carried out in steps of 30 mg, according to the blood glucose response.
Each step should last for at least two weeks. 4 Administration It is recommended that the medication be taken at breakfast time. The 30 mg tablets cannot be split in half and should be swallowed whole. The 60 mg tablets can be halved.
Both the 30 mg and 60 mg tablets must not be chewed or crushed. - Previously untreated patients should commence with a dose of 30 mg and will benefit from dose adjustment until the appropriate dose is reached. - One TARO-GLICLAZIDE MR 60 mg tablet is equivalent to two TARO-GLICLAZIDE MR 30 mg tablets.
The breakability of the TARO-GLICLAZIDE MR modified-release 60 mg tablet allows the use of a dose of 30 mg as a half tablet and of 90 mg as one and a half tablets. - Half a tablet of TARO-GLICLAZIDE MR 60 mg or one tablet of TARO-GLICLAZIDE MR 30 mg corresponds to one tablet of gliclazide 80 mg.
- TARO-GLICLAZIDE MR can replace an antidiabetic treatment without any transitional period. chlorpropamide) he/she should be carefully monitored (for 1 to 2 weeks) in order to avoid hypoglycemia due to possible residual effects of the previous therapy.
TARO-GLICLAZIDE MR is contraindicated in patients: • With known hypersensitivity or allergy 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). • 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 the presence of severe hepatic impairment (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). • In the presence of severe renal impairment (see 7 WARNINGS AND PRECAUTIONS, Renal).
4 Drug-Drug Interactions). 2 Breast-feeding).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Gliclazide in Canada.
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Pediatrics (< 18 years of age) Safety and effectiveness of gliclazide modified release tablets in pediatrics have not been established; therefore, Health Canada has not authorized an indication for pediatric use. Geriatrics (≥ 65 years of age) No significant differences in efficacy and tolerance were observed between patients over 65 years of age and younger patients, however greater sensitivity of some older individuals cannot be ruled out.
Patients over 65 years of age should be started with TARO-GLICLAZIDE MR 30 mg with dosage adjustments being made cautiously. Hepatic or Renal Impairment Patients with renal or hepatic impairment should be started with TARO-GLICLAZIDE MR 30 mg with dosage adjustments being made cautiously (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism).
Patients receiving Insulin PrTARO-GLICLAZIDE MR (Gliclazide) Tablets - Product Monograph Page 6 of 44 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 TARO- GLICLAZIDE MR therapy after cessation of insulin.
If a change from insulin to TARO-GLICLAZIDE MR 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. 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.
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.
Severe hypoglycaemic reactions, with coma, convulsions or other neurological disorders are possible and must be treated as a medical emergency, requiring immediate hospitalization. Dialysis is of no benefit to patients due to the strong binding of gliclazide to proteins.
For management of a suspected drug overdose contact your regional Poison Control Center. […]