Wednesday, September 2, 2009

Aspar-K Tablet

ASPAR®-K
POTASSIUM ASPARTATE PREPARATION
Reg. No. DKL7625202517A1

COMPOSITION & DESCRIPTION
  • Generic name : Potassium L-aspartate
  • White crystalline powder: odorless
  • Freely soluble in water and practically insoluble in ethanol or acetone.
Product's nameContent of Potassium L-aspartateDescription of the product
ASPAR®-K tablet300 mg per tablet (K : 1,8 mEq)White film-coated tablet

ACTIONS
PHARMACOLOGICAL ACTIONS:
A potassium ion, one of the main electrolytes in the cell, has actions such as to induce the membrane potential, to maintain the osmotic presssure and to control the acid-base equilibrium. When the red blood cell is employed as a sample to examine the transport of potassium into the tissues, Potassium L-aspartate proves a better intake by the tissue than potassium chloride.

ABSORPTION AND EXCRETION:
When the amount of Potassium L-aspartate equivalent to 20 mEq/kg/day of potassium was administered for 32 days to rats fed on food lacking potassium for 24 days, the mean amount of potassium excreted in the feces was 26,1 µEq/head/day. Namely, the absorption rate of potassium from the intestines was not less than 99,5 % because the mean administration amount of potassium was 5497 µEq/head/day.

TOXICOLOGY AND TERATOLOGY:
  1. Acute toxicity:
    The LD50 of Potassium L-aspartate in male rats is not less than 10,000 mg/kg, 4,061 mg/kg, 1,500 mg/kg and 667 mg/kg by oral, subcutaneous, intraperitoneal and intravenous routes respectively.
  2. Chronic toxicity:
    After administration of 4 g/kg/day of ASPAR@-K in oral route and 1 g/kg/day in intraperitoneal route to male and female rats for 3 months, no significant difference was observed in general condition urinary findings hemafological findings and pathohistological findings between administration group and control group.
  3. Teratology:
    Fetal toxicity in mice and rats was evaluated in accordance with the Measurements for Safety of Drugs by the Japanese Ministry of Health & Welfare, and no significant difference was observed between administration and control group.
INDICATIONS
Potassium supplement in the following diseases and symptoms accompanied with abnormal balance of electrolytes:
  • Cardiac diseases
  • Liver diseases
  • Periodic tetraplegia due to hypokalemia
  • Hypokalemia due to prolonged administration of anti-hypertensive diuretics, adrenal cortical steroids digitalis and insulin.
  • Other disorders of potassium metabolism (pre- and post-operative course, diarrhea, vomiting).
ADMINISTRATION AND DOSAGE
Take 1 to 3 tablets three times per day.
The dose may be increased according to the severity of symptoms and condition of patients.

CAUTIONS ON USE
  1. CONTRAINDICATION:
    • Patient with Addison's disease untreated
    • Patient with hyperkalemia
    • Patients with hypersensitivity to the drug component
  2. USES WITH CAUTION:
    On administration to those patients with advanced hypofunctioned or damage kidneys including those suspected of such disorders, whose serum and urinary electrolytes should be carefully examined.
  3. ADVERSE REACTION:
    • Digestive system : Anorexia and gastric disturbances have been encountered.
    • Heart : Precordial heavy feeling has been noted
  4. IT IS ADVISABLE NOT TO ADMINISTER THE DRUG to premature infants, newborns and infants because the drug is reported to cause at 250 mg/kg or more as aspartic acid some histopathological change in the nucleus arciformis of the hypothalamus in mice and rats at the age of 3 weeks or below.
  5. INTERACTION:
    Since the following drugs may cause hyperkalemia, concurrent use with them should be exercised with much care.
  • Antialdosterone preparation
  • Triamterene
CAUTION ON HANDLING
Store in a tight and light-resistant container at below 30°C.

PRESENTATION
Box of 10 aluminum strips of 10 tablets

Manufactured by
PT. TANABE INDONESIA
Bandung, Indonesia

Under license from
TANABE SEIYAKU CO., LTD.
Osaka, Japan

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