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 name | Content of Potassium L-aspartate | Description of the product |
|---|---|---|
| ASPAR®-K tablet | 300 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:
- 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. - 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. - 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.
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).
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
- CONTRAINDICATION:
- Patient with Addison's disease untreated
- Patient with hyperkalemia
- Patients with hypersensitivity to the drug component
- 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. - ADVERSE REACTION:
- Digestive system : Anorexia and gastric disturbances have been encountered.
- Heart : Precordial heavy feeling has been noted
- 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.
- INTERACTION:
Since the following drugs may cause hyperkalemia, concurrent use with them should be exercised with much care.
- Antialdosterone preparation
- Triamterene
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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