Level-K 150 gm/sachet

Level-K 150 gm/sachet | INDICATIONS AND USES

Sodium Polystyrene Sulfonate is indicated for the treatment of hyperkalemia. Hyperkalemia is mainly caused by Acute or Chronic Kidney Disease. Other causes may include Liver failure, Adrenal insufciency, Use of certain drugs like ARB, ACE inhibitors, Beta blockers or Excessive use of Potassium supplements.

Level-K 150 gm/sachet | PHARMACOLOGY

Sodium Polystyrene Sulfonate is a cation exchange resin. It releases sodium ions in the stomach in exchange for hydrogen ions. When the resin reaches the large intestine the hydrogen ions are exchanged for free potassium ions; the resin is then eliminated in the feces. The net effect is lowering the amount of potassium available for absorption into the blood and increasing the amount that is excreted via the feces. The effect is a reduction of potassium levels in the body.

Level-K 150 gm/sachet | DOSAGE

Adults (including the elderly)-

Oral Dose: The average daily oral dose for adult is 15 gm to 60 gm (1 Sachet 1-4 times daily).
Rectal dose: In patients who are unable to intake this medicine orally, rectal administration is possible (as enema). 30 gm to 50 gm of resin is given once or twice daily (at intervals of 6 hours). Each dose is administered as a warm emulsion (at body temperature) in 150 ml to 200 ml of aqueous vehicle (such as plain water, 10% dextrose in water or equal parts of water and 2% Methylcellulose suspension). The emulsion should be agitated gently during administration. The enema should be retained for as long as possible and should be followed by a cleansing enema.

Children-

Oral dose: In smaller children and infants correspondingly lower doses should be employed. An appropriate initial dose is 1 gm/kg body weight daily in divided doses in acute hyperkalemia. For maintenance therapy, dosage may be reduced to 0.5 gm/kg body weight daily.
Rectal dose: When refused by mouth, the resin may be given rectally using a dose at least as much as that which would have been given orally. The resin should be suspended in a proportional amount of 10% Dextrose in water. Following retention of the enema, the colon should be irrigated to ensure adequate removal of the resin.

Neonates-

Rectal dose: Since it is advised that the oral route should not be employed, only rectal administration should be considered. With rectal administration, the minimum effective dosage within the range of 0.5 to 1 gm/kg of resin should be employed. The resultant suspension should be diluted as for adults. Following administration of the resin, the colon should be adequately irrigated to ensure recovery of the resin.

Level-K 150 gm/sachet | DRUG INTERACTIONS

Sodium Polystyrene Sulfonate may cause drug interactions with Antacids, Non absorbable cation-donating antacids and laxatives, Digitalis, Sorbitol, Lithium, Thyroxine.

Level-K 150 gm/sachet | SIDE EFFECTS

The drug may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, and significant sodium retention, and their related clinical manifestations, may occur. Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction. Rare instances of colonic necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with such resin has been reported.

Level-K 150 gm/sachet | USE DURING PREGNANCY AND LACTATION

Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Polystyrene Sulfonate. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Level-K 150 gm/sachet | PRECAUTIONS & WARNINGS

Caution is advised when this product is administered to patients who cannot tolerate even a small increase in sodium loads (i.e., severe congestive heart failure, severe hypertension, or marked edema). In such instances compensatory restriction of sodium intake from other sources may be indicated. In the event of clinically signifcant constipation, treatment with this drug should be discontinued until normal bowel motion is resumed. Magnesium-containing laxatives or sorbitol should not be used.

Level-K 150 gm/sachet | USE IN SPECIAL POPULATIONS

Use in Children: The effectiveness in pediatric patients has not been established. In neonates, it should not be given by the oral route. Due to the risk of digestive hemorrhage or colonic necrosis, particular care should be observed in premature infants or low birth weight infants.

Level-K 150 gm/sachet | THERAPEUTIC CLASS

Calcium Regulator

Level-K 150 gm/sachet | STORAGE CONDITIONS

Store below 30°C. Keep out of the reach of children. Suspension of this drug should be freshly prepared and not to be stored beyond 24 hours.