Sodium Polystyrene Sulfonate


Cardinal Health 107, Llc
Human Prescription Drug
NDC 55154-7353
Sodium Polystyrene Sulfonate is a human prescription drug labeled by 'Cardinal Health 107, Llc'. National Drug Code (NDC) number for Sodium Polystyrene Sulfonate is 55154-7353. This drug is available in dosage form of Suspension. The names of the active, medicinal ingredients in Sodium Polystyrene Sulfonate drug includes Sodium Polystyrene Sulfonate - 15 g/60mL . The currest status of Sodium Polystyrene Sulfonate drug is Active.

Drug Information:

Drug NDC: 55154-7353
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Sodium Polystyrene Sulfonate
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Sodium Polystyrene Sulfonate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Cardinal Health 107, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Suspension
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:SODIUM POLYSTYRENE SULFONATE - 15 g/60mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
RECTAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 01 Jan, 1983
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 22 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA087859
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Cardinal Health 107, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:313072
1799654
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
UPC:0055154735322
UPC stands for Universal Product Code.
NUI:N0000178378
N0000175357
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:1699G8679Z
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:Potassium Ion Exchange Activity [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:Potassium Binder [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
55154-7353-22 BOTTLE, UNIT-DOSE in 1 BAG (55154-7353-2) / 60 mL in 1 BOTTLE, UNIT-DOSE01 Jan, 1983N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Sodium polystyrene sulfonate sodium polystyrene sulfonate sodium polystyrene sulfonate polystyrene sulfonic acid sorbitol alcohol water propylene glycol magnesium aluminum silicate saccharin sodium methylparaben propylparaben light

Drug Interactions:

Drug interactions general interactions no formal drug interaction studies have been conducted in humans. sodium polystyrene sulfonate suspension has the potential to bind other drugs. in in-vitro binding studies, sodium polystyrene sulfonate was shown to significantly bind the oral medications (n=6) that were tested. decreased absorption of lithium and thyroxine have also been reported with co-administration of sodium polystyrene sulfonate. binding of sodium polystyrene sulfonate suspension to other oral medications could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time sodium polystyrene sulfonate suspension is administered. 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. monitor for clinical response and/or blood levels where possible. antacids the simultaneous oral administration of sodium polystyrene sulfonate
with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability. nonabsorbable cation-donating antacids and laxatives systemic alkalosis has been reported after cation exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. magnesium hydroxide should not be administered with sodium polystyrene sulfonate. one case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative. intestinal obstruction due to concretions of aluminum hydroxide when used in combination with sodium polystyrene sulfonate has been reported. digitalis the toxic effects of digitalis on the heart, especially various ventricular arrhythmias and a-v nodal dissociation, are likely to be exaggerated by hypokalemia, even in the face of serum digoxin concentrations in the "normal range" (see warnings ). sorbitol concomitant use of sorbitol with sodium polystyrene sulfonate has been implicated in cases of intestinal necrosis, which may be fatal (see warnings ). lithium sps ® suspension may decrease absorption of lithium. thyroxine sps ® suspension may decrease absorption of thyroxine.

Indications and Usage:

Indication and usage sps ® suspension is indicated for the treatment of hyperkalemia.

Warnings:

Warnings intestinal necrosis cases of intestinal necrosis, which may be fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with sodium polystyrene sulfonate use. the majority of these cases reported the concomitant use of sorbitol. risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiency and failure. concomitant administration of additional sorbitol is not recommended (see precautions, drug interactions ). • use only in patients who have normal bowel function. avoid use in patients who have not had a bowel movement post-surgery. • avoid use in patients who are at risk for developing constipation or impaction (including those with history of impaction, chronic constipation, inflammatory bowel disease, ischemic colitis, vascular intestinal atherosclerosis, previous bowel
resection, or bowel obstruction). • discontinue use in patients who develop constipation. alternative therapy in severe hyperkalemia since the effective lowering of serum potassium with sodium polystyrene sulfonate may take hours to days, treatment with this drug alone may be insufficient to rapidly correct severe hyperkalemia associated with states of rapid tissue breakdown (e.g., burns and renal failure) or hyperkalemia so marked as to constitute a medical emergency. therefore, other definitive measures, including dialysis, should always be considered and may be imperative. hypokalemia serious potassium deficiency can occur from sodium polystyrene sulfonate therapy. the effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with sodium polystyrene sulfonate should be discontinued must be determined individually for each patient. important aids in making this determination are the patient's clinical condition and electrocardiogram. early clinical signs of severe hypokalemia include a pattern of irritable confusion and delayed thought processes. electrocardiographically, severe hypokalemia is often associated with a lengthened q-t interval, widening, flattening, or inversion of the t wave, and prominent u waves. also, cardiac arrhythmias may occur, such as premature atrial, nodal, and ventricular contractions, and supraventricular and ventricular tachycardias. the toxic effects of digitalis are likely to be exaggerated. marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis. electrolyte disturbances like all cation-exchange resins, sodium polystyrene sulfonate is not totally selective (for potassium) in its actions, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. accordingly, patients receiving sodium polystyrene sulfonate should be monitored for all applicable electrolyte disturbances. systemic alkalosis systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. magnesium hydroxide should not be administered with sodium polystyrene sulfonate. one case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative (see precautions, drug interactions ). risk of aspiration cases of acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles has been reported. patients with impaired gag reflex, altered level of consciousness, or patients prone to regurgitation may be at increased risk. administer sodium polystyrene sulfonate suspension with the patient in an upright position. binding to other orally administered medications sodium polystyrene sulfonate suspension may bind orally administered medications, which could decrease their gastrointestinal absorption and lead to reduced efficacy. administer other oral medications at least 3 hours before or 3 hours after sodium polystyrene sulfonate suspension. patients with gastroparesis may require a 6 hour separation (see dosage and administration and precautions, drug interactions ).

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.

Contraindications:

Contraindications sps ® suspension 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 precautions ).

Adverse Reactions:

Adverse reactions sps ® suspension 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 warnings ). occasionally diarrhea develops. large doses in elderly individuals may cause fecal impaction (see precautions ). 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: • fecal impaction following rectal administration, particularly in children; • gastrointestinal concretions (bezoars) following oral administration; • ischemic colitis, gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation; and
• rare cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of polystyrene sulfonate (see warnings ). to report suspected adverse reactions, contact cmp pharma, inc., toll free at 1-844-321-1443 or the fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Drug Interactions:

Drug interactions general interactions no formal drug interaction studies have been conducted in humans. sodium polystyrene sulfonate suspension has the potential to bind other drugs. in in-vitro binding studies, sodium polystyrene sulfonate was shown to significantly bind the oral medications (n=6) that were tested. decreased absorption of lithium and thyroxine have also been reported with co-administration of sodium polystyrene sulfonate. binding of sodium polystyrene sulfonate suspension to other oral medications could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time sodium polystyrene sulfonate suspension is administered. 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. monitor for clinical response and/or blood levels where possible. antacids the simultaneous oral administration of sodium polystyrene sulfonate
with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability. nonabsorbable cation-donating antacids and laxatives systemic alkalosis has been reported after cation exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. magnesium hydroxide should not be administered with sodium polystyrene sulfonate. one case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative. intestinal obstruction due to concretions of aluminum hydroxide when used in combination with sodium polystyrene sulfonate has been reported. digitalis the toxic effects of digitalis on the heart, especially various ventricular arrhythmias and a-v nodal dissociation, are likely to be exaggerated by hypokalemia, even in the face of serum digoxin concentrations in the "normal range" (see warnings ). sorbitol concomitant use of sorbitol with sodium polystyrene sulfonate has been implicated in cases of intestinal necrosis, which may be fatal (see warnings ). lithium sps ® suspension may decrease absorption of lithium. thyroxine sps ® suspension may decrease absorption of thyroxine.

Use in Pregnancy:

Pregnancy category c animal reproduction studies have not been conducted with sodium polystyrene sulfonate. it is also not known whether sodium polystyrene sulfonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium polystyrene sulfonate should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Pediatric use the effectiveness of sps ® suspension in pediatric patients has not been established. the use of sps ® suspension is contraindicated in neonates and especially in premature infants. in children and neonates, particular care should be observed with rectal administration, as excessive dosage could result in impaction of the resin. precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.

Overdosage:

Overdosage 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 hypocalcemia; 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.

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

Clinical Pharmacology:

Clinical pharmacology 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.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility studies have not been performed.

How Supplied:

How supplied sps ® suspension is a light brown, cherry-flavored suspension supplied: overbagged with 2 x 60 ml unit dose bottles, ndc 55154-7353-2. 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 distributed by: cardinal health dublin, oh 43017 l45323471020 revised august 2021 3081 r0821

Package Label Principal Display Panel:

Package/label display panel sps® suspension sodium polystyrene sulfonate suspension, usp 15 g/ 60 ml 2 x 60 ml bottles bag label


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