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SANDOZ 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: Sandoz Gliclazide MR (gliclazide modified-release tablets 30 and 60 mg) 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…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics). 2 CONTRAINDICATIONS Sandoz 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
1 Adverse Reaction Overview Gliclazide modified-release tablets 30 mg have been evaluated for safety in controlled clinical trials in 955 patients, of which 728 were treated in long-term studies for up to 10 months, in comparison with gliclazide 80 mg tablets.
The most frequent adverse drug reactions are hypoglycaemia 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. Product Monograph – Sandoz Gliclazide MR (Gliclazide) Page 15 of 50 Hypoglycemia (see 8 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism) Severe hypoglycemia which mimics acute CNS disorders may occur.
Hepatic and/or renal impairment, malnutrition, debility, advanced age, alcoholism, adrenal or pituitary insufficiency may be predisposing factors. 1%). 8). 1). Other adverse events Adverse events reported during controlled clinical trials with gliclazide 30 mg modified- release tablets were those expected in the population of interest, a population whose underlying disease is recognized atheromatous risk factor.
0% of diabetic patients in long-term controlled studies, whatever their relationship to treatment, are listed by body system in Table 2. The most frequent adverse events were unspecific of the disease as respiratory infections or back pain.
, Hepatic/Biliary/Pancreatic). • In the presence of severe renal impairment (see 7 WARNINGS AND PRECAUTIONS, Renal). 4 Drug-Drug Interactions). 2 Breast- Product Monograph – Sandoz Gliclazide MR (Gliclazide) Page 5 of 50 feeding). 1 Dosing Considerations Determination of the proper dosage for Sandoz 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 Sandoz Gliclazide MR 60 mg, or 1 to 4 tablets of Sandoz Gliclazide MR 30 mg). e. one half tablet of Sandoz Gliclazide MR 60 mg or one tablet of Sandoz 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 Sandoz Gliclazide MR 60 mg tablet is equivalent to two Sandoz Gliclazide MR 30 mg tablets.
The breakability of the Sandoz Gliclazide 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 Sandoz Gliclazide MR 60 mg or one tablet of Sandoz Gliclazide MR 30 mg corresponds to one immediate-release tablet of gliclazide 80 mg.
- Sandoz Gliclazide MR can replace an antidiabetic treatment without any transitional Product Monograph - Sandoz Gliclazide MR (Gliclazide) Page 6 of 50 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.
Sandoz 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- Product Monograph – Sandoz Gliclazide MR (Gliclazide) Page 5 of 50 feeding).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Table 2 – Adverse events reported in ≥1% of type 2 diabetic patients in long-term controlled studies with gliclazide 30 mg modified-release tablets vs. 7 Product Monograph - Sandoz Gliclazide MR (Gliclazide) Page 16 of 50 Table 2 – Adverse events reported in ≥1% of type 2 diabetic patients in long-term controlled studies with gliclazide 30 mg modified-release tablets vs.
1 Product Monograph – Sandoz Gliclazide MR (Gliclazide) Page 17 of 50 Table 2 – Adverse events reported in ≥1% of type 2 diabetic patients in long-term controlled studies with gliclazide 30 mg modified-release tablets vs. 4 Analysis of adverse events in sub-populations led to similar pattern as in the whole population and showed that sex, age and renal insufficiency had no significant influence on the safety profile of 30 mg.
3 Less Common Clinical Trial Adverse Reactions Adverse events other than those already specifically mentioned in this product monograph and that have been reported with gliclazide 30 mg modified-release tablets during long-term studies in more than one patient and/or that have been previously reported with gliclazide 80 mg tablets or with other sulfonylurea drugs include the following (drug relationship has not been proved for all cases): Cardiovascular disorders: arteritis, cardiac failure, cerebrovascular disorder, coronary artery disorder, epistaxis, hypotension, myocardial infarction, palpitation, tachycardia, thrombophlebitis, vein disorder.
Ear/Nose/Throat disorders: hearing decreased, tinnitus. Endocrine disorders: hypothyroidism. A decrease in the uptake of radioactive iodine by the thyroid gland has been reported with other sulfonylurea drugs. This has not been shown with gliclazide 80 mg tablets during a study involving 15 patients.
Gastrointestinal […]
Pediatrics (< 18 years of age) Safety and effectiveness of Sandoz Gliclazide MR 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 Sandoz Gliclazide MR 30 mg with dosage adjustments being made cautiously. Hepatic or Renal Impairment Patients with renal or hepatic impairment should be started with Sandoz Gliclazide MR 30 mg with dosage adjustments being made cautiously (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism).
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 Sandoz Gliclazide MR therapy after cessation of insulin.
If a change from insulin to Sandoz 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 Product Monograph – Sandoz Gliclazide MR (Gliclazide) Page 7 of 50 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.
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