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Antidiabetic Agents

Pranstad 1

Packaging:

Blister of 10 tablets. Box of 3 blisters

Blister of 10 tablets. Box of 6 blisters

Composition:

Each tablet contains:

Repaglinide                      1.0 mg

Excipients q.s                  1 tablet

Shelf – Life:  

36 months from the date of manufacturing.

  • Indications
  • Contraindications
  • Adverse reactions
  • Dosage and administration

  • Pranstad 1 is used as 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.
  • Pranstad 1 also may be used 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.

  • 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.

Pregnancy and Lactation:   

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.

Common

  • Metabolism: Hypoglycemia.
  • Respiratory: Upper respiratory tract infection, sinusitis, rhinitis, bronchitis.
  • Gastrointestinal: Nausea, diarrhoea.
  • Musculoskeletal: Arthralgia, back pain.
  • Nervous system: Headache.

Uncommon

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

  • Pranstad 1 is 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 HbA1Cis < 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 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.

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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