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Antidiabetic Agents

Pranstad 1


Pack size:

Box of 3 blisters x 10 tablets.
 

Composition:

Each tablet contains repaglinide 1.0 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

  • Monotherapy as an adjunct to diet and exercise for the management of type 2 (noninsulin-dependent) diabetes mellitus (NIDDM) in patients whose hyperglycemia cannot be controlled by diet, an exercise alone.
  • In combination with metformin in patients who do not achieve adequate glycemic control with diet, exercise, and monotherapy with metformin, a sulfonylurea, repaglinide, or a thiazolidinedione antidiabetic agent.
     
  • Administered orally, given within 15 minutes of each meal but may be given as early as 30 minutes prior to each meal up to immediately preceding each meal.
     
  • Starting dose
    For patients not previously treated or whose HbA1C is < 8%: The starting dose should be 0.5 mg with each meal preprandial.
    For patients previously treated with blood glucose-lowering drugs and whose HbA1C is ≥ 8%: The initial dose is 1 or 2 mg with each meal preprandial.
  • Dose adjustment
    Dosing adjustments should be determined by blood glucose response, usually fasting blood glucose.
    The preprandial dose should be doubled up to 4 mg with each meal until satisfactory blood glucose response is achieved. At least one week should elapse to assess response after each dose adjustment.
    The recommended dose range is 0.5 mg to 4 mg. Pranstad 1 may be dosed preprandially 2, 3, or 4 times a day in response to changes in the patient's meal pattern. The maximum recommended daily dose is 16 mg.
  • Patients receiving other oral hypoglycemic agents
    Patients can be transferred directly from other oral hypoglycaemic agents to repaglinide. The recommended maximum starting dose of patients transferred to repaglinide is 1 mg given before main meals.
  • Combination with metformin
    Dosage of each drug should be adjusted to obtain adequate glycemic control, using the minimum effective dosage of each drug.
  • Specific patient groups
    Patients with severe renal impairment (e.g., creatinine clearance of 20 - 40 ml/ minute) should initiate therapy with a repaglinide dose of 0.5 mg, with subsequent careful dosage titration.
    No clinical studies have been performed in children and adolescents < 18 years of age or in patients > 75 years of age. Therefore, treatment is not recommended in these patient groups.
     

Or as prescribed by physicians.

 

  • Patients with known hypersensitivity to the drug.
  • Patients with type 1 diabetes.
  • Patients with diabetes complicated by acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma; insulin should be used to treat these conditions.
     

Common

  • Hypoglycemia.
  • Upper respiratory tract infection, sinusitis, rhinitis, bronchitis.
  • Nausea, diarrhoea.
  • Arthralgia, back pain.
  • Headache.

Uncommon

  • Constipation, vomiting, dyspepsia.
  • Paresthesia, chest pain, urinary tract infection, allergy.

     

  • Repaglinide is not indicated for use in combination with NPH-insulin.
  • All oral blood glucose-lowering drugs including repaglinide are capable of producing hypoglycemia.
  • Hepatic insufficiency may cause elevated repaglinide blood levels and may diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycemia.
  • Elderly, debilitated, or malnourished patients and those with adrenal, pituitary, hepatic, or severe renal insufficiency may be particularly susceptible to the hypoglycemic action of glucose lowering drugs.
  • Hypoglycemia may be difficult to recognize in the elderly and in people taking beta-adrenergic blocking drugs. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used.
  • When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of glycemic control may occur. At such times, repaglinide may be necessary to discontinue and administer insulin.
  • Pregnancy:The safety of repaglinide in pregnant women has not been established, and the drug should be used during pregnancy only when clearly needed.
  • Since abnormal maternal blood glucose concentrations during pregnancy may be associated with a higher incidence of congenital abnormalities, most experts recommend that insulin be used during pregnancy to maintain optimum control of blood glucose concentration.
  • Lactation: Because of the potential for repaglinide to cause hypoglycemia and resultant skeletal changes in nursing infants may exist, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. If repaglinide is discontinued and diet therapy alone does not provide adequate glycemic control, insulin therapy should be instituted.
  • Effects on ability to drive and use machines: Patients should be advised to take precautions to avoid hypoglycemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycemia or have frequent episodes of hypoglycemia. The advisability of driving should be considered in these circumstances.

     

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



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