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Sodium Polystyrene Sulfonate (Sodium Polystyrene Sulfonate)

Trade Name : Sodium Polystyrene Sulfonate

West-Ward Pharmaceuticals Corp.

SUSPENSION

Strength 15 g/60mL

SODIUM POLYSTYRENE SULFONATE

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sodium Polystyrene Sulfonate (Sodium Polystyrene Sulfonate) which is also known as Sodium Polystyrene Sulfonate and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 15 g/60mL per ml. Read more

Sodium Polystyrene Sulfonate (Sodium Polystyrene Sulfonate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Sodium Polystyrene Sulfonate Suspension USP can be administered orally or in an enema. It is a cherry-flavored suspension containing 15 grams of cation-exchange resin (Sodium Polystyrene Sulfonate USP). In addition sodium polystyrene sulfonate suspension contains the following inactive ingredients: citric acid (anhydrous), artificial flavor (wild-cherry), magnesium aluminum silicate, methylparaben, propylene glycol, propylparaben, purified water and sucralose.
  • Sodium polystyrene sulfonate is a benzene, diethenyl-, polymer with ethenylbenzene, sulfonated, sodium salt and has the following structural formula:
  • The sodium content of the suspension is 1575 mg (68.5 mEq) per 60 mL which is equivalent to 1500 mg on the anhydrous basis. It is an amber, smooth suspension with an exchange capacity of approximately 3.1 mEq ( approximately 1 mEq) of potassium per 4 mL (1 gram) of suspension. It can be administered orally or in an enema.
  • As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. For the most part, this action occurs in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable. It commonly approximates the order of 33%, but the range is so large that definitive indices of electrolyte balance must be clearly monitored.
  • Metabolic data are unavailable.
  • Sodium polystyrene sulfonate is indicated for the treatment of hyperkalemia.
  • Sodium polystyrene sulfonate is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, oral or rectal administration in neonates (see ).
  • No data
  • Caution is advised when sodium polystyrene sulfonate 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.
  • Precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.
  • In the event of clinically significant constipation, treatment with sodium polystyrene sulfonate should be discontinued until normal bowel motion is resumed (see ).
  • Sodium polystyrene sulfonate may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, hypomagnesemia and significant sodium retention, and their related clinical manifestations, may occur (see ). Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction (see ). Rare instances of intestinal necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with sodium polystyrene sulfonate, has been reported.
  • The following events have been reported from worldwide post marketing experience:
  • Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia. Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including: irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, which may progress to frank paralysis and/or apnea. Tetany may occur. Electrocardiographic changes may be consistent with hypokalemia or hypercalcemia; cardiac arrhythmias may occur. Appropriate measures should be taken to correct serum electrolytes (potassium, calcium, magnesium), and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.
  • The average daily adult dose is 15 g (60 mL) to 60 g (240 mL) of suspension. This is best provided by administering 15 g (60 mL) of sodium polystyrene sulfonate suspension one to four times daily. Each 60 mL of sodium polystyrene sulfonate suspension contains 1575 mg (68.5 mEq) per 60 mL which is equivalent to 1500 mg on the anhydrous basis of sodium. Since the efficiency of sodium-potassium exchange resins is approximately 33%, about one-third of the resinu2019s actual sodium content is being delivered to the body.
  • In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation.
  • Sodium polystyrene sulfonate suspension may be introduced into the stomach through a plastic tube and, if desired, given with a diet appropriate for a patient in renal failure.
  • Sodium polystyrene sulfonate suspension may also be given, although with less effective results, as an enema consisting (for adults) of 30 g (120 mL) to 50 g (200 mL) every six hours. The enema should be retained as long as possible and followed by a cleansing enema.
  • After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped in place. The suspension is introduced at body temperature by gravity. The suspension is flushed with 50 or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. The suspension is kept in the sigmoid colon for several hours, if possible. n
  • The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.
  • Sodium polystyrene sulfonate suspension should not be heated for to do so may alter the exchange properties of the resin.
  • Sodium Polystyrene Sulfonate Suspension USP
  • 15 g per 60 mL is supplied as a (wild-cherry flavored) amber smooth suspension.
  • NDC 0054-0379-51: Unit dose bottles filled to deliver 60 mL
  • NDC 0054-0379-50: Unit of use enema bottles filled to contain 120 mL (for use in delivering the suspension rectally through appropriate tubing)
  • NDC 0054-0379-55: Unit of use enema bottles filled to contain 200 mL (for use in delivering the suspension rectally through appropriate tubing)
  • NDC 0054-0379-63: Bottles of 500 mL
  • Dispense in a tight, child-resistant container as defined in the USP/NF. If repackaging into other containers, store in refrigerator and use within 14 days of packaging.
  • SHAKE WELL BEFORE USING.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10007838/03
  • Revised May 2016
  • No data

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