NDC 63629-2390 Sodium Polystyrene Sulfonate

Sodium Polystyrene Sulfonate

NDC Product Code 63629-2390

NDC 63629-2390-1

Package Description: 454 g in 1 JAR

NDC Product Information

Sodium Polystyrene Sulfonate with NDC 63629-2390 is a a human prescription drug product labeled by Bryant Ranch Prepack. The generic name of Sodium Polystyrene Sulfonate is sodium polystyrene sulfonate. The product's dosage form is powder, for suspension and is administered via oral; rectal form.

Labeler Name: Bryant Ranch Prepack

Dosage Form: Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sodium Polystyrene Sulfonate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM POLYSTYRENE SULFONATE 4.1 meq/g

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Rectal - Administration to the rectum.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bryant Ranch Prepack
Labeler Code: 63629
FDA Application Number: ANDA204071 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 01-24-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Sodium Polystyrene Sulfonate Product Label Images

Sodium Polystyrene Sulfonate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

Sodium polystyrene sulfonate for suspension is indicated for the treatment of hyperkalemia.Limitation of Use:Sodium polystyrene sulfonate for suspension should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2)]

2.1 General Information

Administer sodium polystyrene sulfonate 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(5.5) and Drug Interaction(7)]

The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.OralThe average total daily adult dose of sodium polystyrene sulfonate is 15 g to 60 g, administered as a 15-g dose (four level teaspoons), one to four times daily.RectalThe average adult dose is 30 g to 50 g every six hours.

2.3 Preparation And Administration

Prepare suspension fresh and use within 24 hours.Do not heat sodium polystyrene sulfonate as it could alter the exchange properties of the resin.One level teaspoon contains approximately 3.5 g of sodium polystyrene sulfonate and 15 mEq of sodium.Oral SuspensionSuspend each dose in a small quantity of water or syrup, approximately 3 to 4 mL of liquid per gram of resin. Administer with patient in an upright position [see Warnings and Precautions (5.4)].EnemaAfter an initial cleansing enema, insert a soft, large size (French 28) rubber tube into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and tape in place.Administer as a warm (body temperature) emulsion in 100 mL of aqueous vehicle and flush with 50 to 100 ml of fluid. A somewhat thicker suspension may be used, but do not form a paste.Agitate the emulsion gently during administration. The resin should be retained for as long as possible and follow by a cleansing enema with a nonsodium containing solution. Ensure an adequate volume of cleansing solution (up to 2 liters) is utilized.

3 Dosage Forms And Strengths

Sodium polystyrene sulfonate for suspension is a golden brown, finely ground powder and is available in 454 g jars and 15 g bottles.

4 Contraindications

  • Sodium polystyrene sulfonate is contraindicated in patients with the following conditions:Hypersensitivity to polystyrene sulfonate resinsObstructive bowel diseaseNeonates with reduced gut motility

5.1 Intestinal Necrosis

  • Cases of intestinal necrosis, some 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 sorbitol is not recommended.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.

5.2 Electrolyte Disturbances

Monitor serum potassium during therapy because severe hypokalemia may occur.Sodium polystyrene sulfonate is not totally selective for potassium, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Monitor calcium and magnesium in patients receiving sodium polystyrene sulfonate.

5.3 Fluid Overload In Patients Sensitive To High Sodium Intake

Each 15 g dose of sodium polystyrene sulfonate contains 1500 mg (60 mEq) of sodium. Monitor patients who are sensitive to sodium intake (heart failure, hypertension, edema) for signs of fluid overload. Adjustment of other sources of sodium may be required.

5.4 Risk Of Aspiration

Cases of acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles have 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 with the patient in an upright position.

5.5 Binding To Other Orally Administered Medications

Sodium polystyrene sulfonate 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. Patients with gastroparesis may require a 6 hour separation. [see Dosage and Administration (2.1) and Drug Interactions (7)].

6 Adverse Reactions

  • The following adverse reactions are discussed elsewhere in the labeling:Intestinal Necrosis [see Warnings and Precautions (5.1)]Electrolyte Disturbances [see Warnings and Precautions (5.2, 5.3)]Aspiration [see Warnings and Precautions (5.4)]The following adverse reactions have been identified during post-approval use of sodium polystyrene sulfonate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure.Gastrointestinal: anorexia, constipation, diarrhea, fecal impaction, gastrointestinal concretions (bezoars), ischemic colitis, nausea, ulcerations, vomiting, gastric irritation, intestinal obstruction (due to concentration of aluminium hydroxide)Metabolic: systemic alkalosis

7.1 General Interactions

No formal drug interaction studies have been conducted in humans.Sodium polystyrene sulfonate 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 to other oral medications could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time sodium polystyrene sulfonate is administered. Administer sodium polystyrene sulfonate 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.

7.2 Cation-Donating Antacids

The simultaneous oral administration of sodium polystyrene sulfonate with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability and increase the risk of systemic alkalosis.

7.3 Sorbitol

Sorbitol may contribute to the risk of intestinal necrosis [see Warnings and Precautions (5.1)] and concomitant use is not recommended.

8.1 Pregnancy

Risk SummarySodium polystyrene sulfonate is not absorbed systemically following oral or rectal administration and maternal use is not expected to result in fetal risk.

8.2 Lactation

Risk SummarySodium polystyrene sulfonate is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant.

8.4 Pediatric Use

Studies of safety and efficacy have not been conducted in pediatric patients.In pediatric patients, as in adults, sodium polystyrene sulfonate is expected to bind potassium at the practical exchange ratio of 1mEq potassium per 1 gram of resin.In neonates, sodium polystyrene sulfonate should not be given by the oral route. In both children and neonates, excessive dosage or inadequate dilution could result in impaction of the resin. Premature infants or low birth weight infants may have an increased risk for gastrointestinal adverse effects with sodium polystyrene sulfonate use [see Warnings and Precautions (5.4)].

10 Overdosage

Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia. 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.

11 Description

Sodium polystyrene sulfonate is a benzene, diethenyl- polymer, with ethenylbenzene,sulfonated, sodium salt and has the following structural formula:nThe drug is a golden brown finely ground, powdered form of sodium polystyrene sulfonate, 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.One gram of sodium polystyrene sulfonate contains 4.1 mEq of sodium.

12.1 Mechanism Of Action

Sodium polystyrene sulfonate is a non-absorbed, cation exchange polymer that contains a sodium counterion.Sodium polystyrene sulfonate increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels. The practical exchange ratio is 1 mEq K per 1 gram of resin.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. This action occurs primarily 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.

12.2 Pharmacodynamics

The effective lowering of serum potassium with sodium polystyrene sulfonate may take hours to days.

12.3 Pharmacokinetics

The in vivo efficiency of sodium-potassium exchange resins is approximately 33 percent; hence, about one third of the resin's actual sodium content is delivered to the body. Sodium polystyrene sulfonate is not absorbed systemically.Drug InteractionsIn vitro binding studies showed that sodium polystyrene sulfonate bound significantly to the following tested drugs – warfarin, metoprolol, phenytoin, furosemide, amlodipine and amoxicillin.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Studies have not been performed.

16 How Supplied/Storage And Handling

NDC: 63629-2390-1: Sodium polystyrene sulfonate for suspension is available as a golden brown, finely ground powder in jars of 1 pound (454 g)

17 Patient Counseling Information

Drug InteractionsAdvise patients who are taking other oral medication to separate the dosing of sodium polystyrene sulfonate by at least 3 hours (before or after) [see Dosage and Administration (2.1), Warnings and Precautions (5.5), and Drug Interactions (7.1)]Rx OnlyManufactured & Distributed by:Sunrise Pharmaceutical, Inc.Rahway, NJ 07065Revised March 20205082/06

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