Drug Catalog - Product Detail
SODIUM POLYSTYRENE SULFONATE SUSPENSION USP SUSP 15G/60ML 473ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 46287-0006-01 | CMP PHARMA | 473 | 15GM/60ML | SUSPENSION |
PACKAGE FILES
Generic Name
SODIUM POLYSTYRENE SULFONATE
Substance Name
SODIUM POLYSTYRENE SULFONATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA087859
Description
DESCRIPTION Sodium Polystyrene Sulfonate Suspension USP (SPS ® Suspension) 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); 21.5 mL of Sorbitol Solution USP (equivalent to approximately 20 grams of Sorbitol) ; 0.18 mL (0.3%) of Alcohol per 60 mL of suspension. Also contains Purified Water USP; Propylene Glycol USP; Magnesium Aluminum Silicate NF; Sodium Saccharin USP; Methylparaben NF; Propylparaben NF; and flavor. 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 1500 mg (65 mEq) per 60 mL. It is a brown, slightly viscous suspension with an in‑vitro exchange capacity of approximately 3.1 mEq ( in-vivo approximately 1 mEq) of potassium per 4 mL (1 gram) of suspension. It can be administered orally or in an enema. Chemical Structure
How Supplied
HOW SUPPLIED SPS ® Suspension is a light brown, cherry-flavored suspension supplied in pint (473 mL) bottles (NDC 46287-006-01), 120 mL bottles (NDC 46287-006-04), and 60 mL unit dose bottles, 10 bottles per carton (NDC 46287-006-60). Dispense in a tight container, as defined in the USP. If repackaging into other containers, store in refrigerator and use within 14 days of packaging. SHAKE WELL BEFORE USING. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. CMP Pharma, Inc. P.O. Box 147 Farmville, North Carolina 27828 Revised August 2021 3081 R0821
Indications & Usage
INDICATION AND USAGE SPS ® Suspension is indicated for the treatment of hyperkalemia.
Dosage and Administration
DOSAGE AND ADMINISTRATION Administer sodium polystyrene sulfonate suspension at least 3 hours before or 3 hours after other oral medications. Patients with gastroparesis may require a 6 hour separation (see WARNINGS and PRECAUTIONS, Drug Interactions ). 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 SPS ® Suspension one to four times daily. Each 60 mL of SPS ® Suspension contains 1500 mg (65 mEq) of sodium. Since the in-vivo efficiency of sodium-potassium exchange resins is approximately 33%, about one-third of the resin's 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. Administer with patient in an upright position (see WARNINGS ). SPS ® 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. SPS ® 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 into 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. Then the colon is irrigated with a sodium-free cleansing enema at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. Particular attention should be paid to this cleansing enema, because sorbitol is present in the vehicle. The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia. SPS ® Suspension should not be heated for to do so may alter the exchange properties of the resin.