Sodium Polystyrene Sulfonate


Belcher Pharmaceuticals, Llc
Human Prescription Drug
NDC 62250-660
Sodium Polystyrene Sulfonate is a human prescription drug labeled by 'Belcher Pharmaceuticals, Llc'. National Drug Code (NDC) number for Sodium Polystyrene Sulfonate is 62250-660. This drug is available in dosage form of Powder, For Suspension. The names of the active, medicinal ingredients in Sodium Polystyrene Sulfonate drug includes Sodium Polystyrene Sulfonate - 4.1 meq/g . The currest status of Sodium Polystyrene Sulfonate drug is Active.

Drug Information:

Drug NDC: 62250-660
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: Belcher Pharmaceuticals, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Powder, For 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 - 4.1 meq/g
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: 15 Mar, 2016
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: ANDA205727
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:Belcher Pharmaceuticals, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:2101899
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.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0362250660237
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
62250-660-23454 g in 1 BOTTLE (62250-660-23)15 Mar, 2016N/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 sodium cation cream to light brown fine powder

Drug Interactions:

Drug interactions antacids the simultaneous oral administration of sodium polystyrene sulfonate for suspension with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability. non-absorbable 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 for suspension. one case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate for suspension with magnesium hydroxide as a laxative. intestinal obstruction due to concretions of aluminum hydroxide when used in combination with sodium polystyrene sulfonate for suspension has been reported. digitalis the toxic effects of digitalis on the hea
rt, 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 for suspension has been implicated in cases of intestinal necrosis, which may be fatal. therefore, concomitant administration is not recommended. (see warnings .) lithium sodium polystyrene sulfonate for suspension may decrease absorption of lithium. thyroxine sodium polystyrene sulfonate for suspension may decrease absorption of thyroxine. carcinogenesis, mutagenesis, impairment of fertility studies have not been performed. pregnancy category c animal reproduction studies have not been conducted with sodium polystyrene sulfonate for suspension. it is also not known whether sodium polystyrene sulfonate for suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium polystyrene sulfonate for suspension should be given to a pregnant woman only if clearly needed. nursing mothers 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 sodium polystyrene sulfonate for suspension is administered to a nursing woman. pediatric use the effectiveness of sodium polystyrene sulfonate for suspension in pediatric patients has not been established. in neonates, sodium polystyrene sulfonate for suspension should not be given by the oral route. in both children and neonates particular care should be observed with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin. due to the risk of digestive hemorrhage or intestinal necrosis, particular care should be observed in premature infants or low birth weight infants.

Indications and Usage:

Indications and usage sodium polystyrene sulfonate for 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 for suspension 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 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 effective lowering of serum potassium with sodium polystyrene sulfonate for suspension 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 therapy with sodium polystyrene sulfonate for suspension. 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 for suspension 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 for suspension 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 for suspension 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 for suspension. one case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate for suspension with magnesium hydroxide as laxative. (see precautions, drug interactions .)

Dosage and Administration:

Dosage and administration suspension of this drug should be freshly prepared and not stored beyond 24 hours. the average daily adult dose of the resin is 15 g to 60 g. this is best provided by administering 15 g (approximately 4 level teaspoons) of sodium polystyrene sulfonate for suspension one to four times daily. one gram of sodium polystyrene sulfonate for suspension contains 4.1 meq of sodium; one level teaspoon contains approximately 3.5 g of sodium polystyrene sulfonate for suspension and 15 meq of sodium. (a heaping teaspoon may contain as much as 10 g to 12 g of sodium polystyrene sulfonate for suspension.) since the in vivo efficiency of sodium-potassium exchange resins is approximately 33 percent, 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. each dose should be given as a suspe
nsion in a small quantity of water or, for greater palatability, in syrup. the amount of fluid usually ranges from 20 ml to 100 ml, depending on the dose, or may be simply determined by allowing 3 ml to 4 ml per gram of resin. healthcare professionals should follow full aspiration precautions when administering this product, such as placing and maintaining the patient in an upright position while the resin is being administered. the resin may be introduced into the stomach through a plastic tube and, if desired, mixed with a diet appropriate for a patient in renal failure. the resin may also be given, although with less effective results, in an enema consisting (for adults) of 30 g to 50 g every six hours. each dose is administered as a warm emulsion (at body temperature) in 100 ml of aqueous vehicle. the emulsion should be agitated gently during administration. 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 resin is then suspended in the appropriate amount of aqueous vehicle at body temperature and introduced by gravity, while the particles are kept in suspension by stirring. the suspension is flushed with 50 ml 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. a somewhat thicker suspension may be used, but care should be taken that no paste is formed, because the latter has a greatly reduced exchange surface and will be particularly ineffective if deposited in the rectal ampulla. the suspension is kept in the sigmoid colon for several hours, if possible. then, the colon is irrigated with nonsodium containing solution 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. while the use of sorbitol is not recommended, particular attention should be paid to this cleansing enema if sorbitol has been used. the intensity and duration of therapy depend upon the severity and resistance of hyperkalemia. sodium polystyrene sulfonate for suspension should not be heated for to do so may alter the exchange properties of the resin.

Contraindications:

Contraindications sodium polystyrene sulfonate for suspension is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, neonates with reduced gut motility (postoperatively or drug induced) and oral administration in neonates (see precautions ).

Adverse Reactions:

Adverse reactions sodium polystyrene sulfonate for 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 for suspension 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 broncho-pneumonia associated with inhalation of particles of polystyrene sulfonate.

Drug Interactions:

Drug interactions antacids the simultaneous oral administration of sodium polystyrene sulfonate for suspension with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability. non-absorbable 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 for suspension. one case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate for suspension with magnesium hydroxide as a laxative. intestinal obstruction due to concretions of aluminum hydroxide when used in combination with sodium polystyrene sulfonate for suspension has been reported. digitalis the toxic effects of digitalis on the hea
rt, 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 for suspension has been implicated in cases of intestinal necrosis, which may be fatal. therefore, concomitant administration is not recommended. (see warnings .) lithium sodium polystyrene sulfonate for suspension may decrease absorption of lithium. thyroxine sodium polystyrene sulfonate for suspension may decrease absorption of thyroxine. carcinogenesis, mutagenesis, impairment of fertility studies have not been performed. pregnancy category c animal reproduction studies have not been conducted with sodium polystyrene sulfonate for suspension. it is also not known whether sodium polystyrene sulfonate for suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium polystyrene sulfonate for suspension should be given to a pregnant woman only if clearly needed. nursing mothers 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 sodium polystyrene sulfonate for suspension is administered to a nursing woman. pediatric use the effectiveness of sodium polystyrene sulfonate for suspension in pediatric patients has not been established. in neonates, sodium polystyrene sulfonate for suspension should not be given by the oral route. in both children and neonates particular care should be observed with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin. due to the risk of digestive hemorrhage or intestinal necrosis, particular care should be observed in premature infants or low birth weight infants.

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:

Sodium polystyrene sulfonate, usp is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula: the drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, usp a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 meq (in vivo approximately 1 meq) of potassium per gram. the sodium content is approximately 100 mg (4.1 meq) per gram of the drug. it can be administered orally or in an enema. 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 percent but the range is so large that definitive indices of electrolyte balance must be clearly monitored. metabolic data are unavailable.

How Supplied:

How supplied sodium polystyrene sulfonate for suspension is available as a cream to light brown, finely ground powder in bottles of 1 pound (454 g), ndc 62250-660-23. store at 20° to 25° c (68° to 77° f) with excursions permitted between 15° to 30° c (59° – 86° f) [see usp controlled room temperature]. call your doctor for medical advice about side effects. you may report side effects to belcher pharmaceuticals, llc at 1-727-471-0850 or fda at 1-800-fda-1088 or www.fda.gov/medwatch. rx only manufactured by belcher pharmaceuticals, llc largo, fl 33777 usa revised december 2015 l49i d-1512

Package Label Principal Display Panel:

Principal display panel - 454 g bottle sodium polystyrene sulfonate for suspension read package insert. average adult dose: 15 g (approximately 4 level teaspoons) one to four time daily in water. see complete prescribing information. the effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. sodium content approximately 60 meq per 15 g. suspension should be freshly prepared and not stored beyond 24 hours. dispense in tight, light- resistant containers as defined in the official compendia. store at 20° to 25° c (68° to 77° f) with excursions permitted between 15° to 30° c (59° – 86° f) [see usp controlled room temperature]. rx only manufactured by belcher pharmaceuticals, llc largo, fl 33777 usa revised december 2015 l49i d-1512 label


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