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Antidiabetic Agents

Staclazide 60 MR

 

Pack size:

Box of 6 blisters x 10 tablets.


Composition:

Each modified-release tablet contains gliclazide 60 mg.

 

Shelf-life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.  
  • Staclazide MR is taken orally in a single intake at breakfast time. It is recommended to swallow whole without chewing or breaking the tablet before use. 
    The daily dose may vary from 1 tablet of Staclazide 30 MR to 2 tablets of Staclazide 60 MR per day, i.e. from 30 to 120 mg.
    If a dose is forgotten, there must be no increase in the dose taken the next day.
    As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbA1c).
Initial dose:
  • The recommended starting dose is 30 mg daily (1 tablet of Staclazide 30 MR).
  • If blood glucose is effectively controlled, this dose may be used for maintenance treatment.
  • If blood glucose is not adequately controlled, the dose may be increased to 60 mg daily (2 tablets of Staclazide 30 MR or 1 tablet of Staclazide 60 MR), 90 mg daily (3 tablets of Staclazide 30 MR) or 120 mg daily (4 tablets of Staclazide 30 MR or 2 tablets of Staclazide 60 MR), in successive steps. The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment.
  • The maximum recommended daily dose is 120 mg (4 tablets of Staclazide 30 MR or 2 tablets of Staclazide 60 MR).
Switching from gliclazide 80 mg tablets to Staclazide 30 MR modified-release tablets:
  • 1 tablet of gliclazide 80 mg is comparable to 1 tablet of Staclazide 30 MR. Consequently the switch can be performed provided a careful blood monitoring.
Switching from another oral antidiabetic agent to Staclazide MR:
  • Staclazide MR modified-release tablets can be used to replace other oral antidiabetic agents.
  • The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to Staclazide MR modified-release tablets.
  • A transitional period is not generally necessary. A starting dose of 30 mg (1 tablet of Staclazide 30 MR) should be used and this should be adjusted to suit the patient's blood glucose response, as described above.
  • When switching from a hypoglycaemic sulfonylurea with a prolonged half-life, a treatment free period of a few days may be necessary to avoid an additive effect of the two products, which might cause hypoglycaemia. The procedure described for initiating treatment should also be used when switching to treatment with Staclazide MR modified-release tablets, i.e. a starting dose of 30 mg/day (1 tablet of Staclazide 30 MR), followed by a stepwise increase in dose, depending on the metabolic response.
Combination treatment with other antidiabetic agents:
  • Staclazide MR modified-release tablets can be given in combination with biguanides, alpha glucosidase inhibitors or insulin. 
  • In patients not adequately controlled with Staclazide MR modified-release tablets, concomitant insulin therapy can be initiated under close medical supervision.
Special populations:
  • Elderly: Staclazide MR should be prescribed using the same dosing regimen recommended for patients under 65 years of age.
    Patients with renal impairment: In patients with mild to moderate renal insufficiency the same dosing regimen can be used as in patients with normal renal function with careful patient monitoring. These data have been confirmed in clinical trials.
    Patients at risk of hypoglycaemia: Undernourished or malnourished,severe or poorly compensated endocrine disorders (hypopituitarism, hypothyroidism, adrenocorticotrophic insufficiency), withdrawal of prolonged and/or high dose corticosteroid therapy, severe vascular disease (severe coronary heart disease, severe carotid impairment, diffuse vascular disease); 
    It is recommended that the minimum daily starting dose of 30 mg (1 tablet of Staclazide 30 MR) is used.
  • Paediatric population: The safety and efficacy of Staclazide MR in children and adolescents have not been established. No data are available. 

Or as precribed by physicians.

 

  • Known hypersensitivity to any ingredient of the drug.
  • Type 1 diabetes.
  • Diabetic pre-coma and coma, diabetic keto-acidosis.
  • Severe infections or trauma, or major surgery.
  • Severe renal or hepatic insufficiency.
  • Treatment with miconazole. 
  • Lactation.

     

Common
  • Hypoglycaemia.
  • Headache.
  • Disturbances, nausea.
  • Rashes.
Uncommon
  • Generally reversible, thrombocytopenia, agranulocytosis, leukopenia, anemia.
  • Mucocutaneous reaction.
Rare
  • Clouding of consciousness, sweating.
  • Increased heart rate.
  • Pallor.
  • Vomiting, hunger pangs.

     

  • Sulfonylurea should not be used in type 1 diabetes mellitus. Use in type 2 diabetes mellitus is contra-indicated in patients with keto-acidosis and in those with severe infection, trauma, or other severe conditions where the sulfonylurea is unlikely to control the hyperglycaemia. 
  • When a sulfonylurea needs to be used in patients at increased risk of hypoglycaemia, a short-acting drug such as gliclazide may be preferred; gliclazide  being principally inactivated in the liver, are perhaps particularly suitable in renal impairment, although careful monitoring of blood-glucose concentration is essential.
  • Sulfonylureas should be used with caution in patients with G6PD deficiency because of risk of haemolytic anaemia.
  • Pregnancy: 
    There is no or limited amount of data from the use of gliclazide in pregnant women, even though there are few data with other sulfonylureas.
    In animal studies, gliclazide is not teratogenic. 
    As a precautionary measure, it is preferable to avoid the use of gliclazide during pregnancy.
    Control of diabetes should be obtained before the time of conception to reduce the risk of congenital abnormalities linked to uncontrolled diabetes. 
    Oral hypoglycaemic agents are not suitable, insulin is the drug of first choice for treatment of diabetes during pregnancy. It is recommended that oral hypoglycaemic therapy is changed to insulin before a pregnancy is attempted, or as soon as pregnancy is discovered.
  • Lactation: It is unknown whether gliclazide or its metabolites are excreted in human milk. Given the risk of neonatal hypoglycaemia, the product is therefore contra-indicated in breast-feeding mothers. A risk to the newborns/infants cannot be excluded.
  • Patients should be warned of the dangers of hypoglycaemic attacks while driving, and should be counselled in appropriate management of the situation (stopping driving as soon as it is safe to do so, taking carbohydrate immediately, and quitting the driving seat and removing the ignition key from the car) should such an event occur. Patients who have lost hypoglycaemic awareness, or have frequent hypoglycaemic episodes, should not drive. 

     

Contact us

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Email : stada@stada.com.vn
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