Nhà máy Stada
Stada
stada
stada
Antidiabetic Agents

Staclazide 30 MR

 

Pack size:

Box of 3 blisters x 10 tablets.


Composition:

Each modified-release tablet contains gliclazide 30 mg.

 

Shelf-life:

 36 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

  • Diabetics non-insulin-dependent (type 2) whose plasma glucose levels cannot be controlled by diet alone. 
     
  • Taken orally in a single intake at breakfast time, the tablet should be swallowed whole.
     
  • One tablet of 30 mg modified-release tablet is comparable to 1 tablet of 80 mg tablet. The initial dose is 30 mg daily (1 tablet). 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 (2 tablets), 90 mg (3 tablets), 120 mg (4 tablets) daily, 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).
    Gliclazide can be given in combination with metformin, α - glucosidase inhibitors (e.g. acarbose) or insulin. Concomitant insulin therapy can be initiated under close physician.
  • Special populations
    Elderly: Staclazide 30 MR tablets 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 is used.
    Paediatric population:
    The safety and efficacy of Staclazide 30 MR in children and adolescents have not been established. No data are available.


Or as prescribed by physicians.

 

  • Hypersensitivity to gliclazide or 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 ketoacidosis 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.
  • Gliclazide should not be in pregnant women. When pregnancy is detected, immediately notify a physician to switch to insulin.
  • Gliclazide is contraindicated in breastfeeding mothers.
  • 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

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



Visitors Counter

Online
24
Total