Sodium Polystyrene Sulfonate (KVK-Tech, Inc.): FDA Package Insert (2024)

SODIUM POLYSTYRENE SULFONATE- sodium polystyrene sulfonate powder
KVK-Tech, Inc.

1 INDICATIONS AND USAGE

Sodium polystyrene sulfonate is indicated for the treatment of hyperkalemia.

Limitation of Use:
Sodium polystyrene sulfonate 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 DOSAGE AND ADMINISTRATION

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)].

2.2 Recommended Dosage

The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.

Oral
The 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.

Rectal
The 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 Suspension
Suspend 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)].

Enema
After 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, USP is a cream to light 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 resins
• Obstructive bowel disease
• Neonates with reduced gut motility

5 WARNINGS AND PRECAUTIONS

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 DRUG INTERACTIONS

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 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

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

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

https://medlibrary.org/lib/rx/meds/sodium-polystyrene-sulfonate-18/

Sodium Polystyrene Sulfonate (KVK-Tech, Inc.): FDA Package Insert (2024)

FAQs

Is Kayexalate discontinued? ›

Similar to Lokelma, Kayexalate was a brand-name drug prescribed for hyperkalemia (high potassium levels). Note that Kayexalate has been discontinued and is no longer available in the United States. However, Kayexalate's active drug (sodium polystyrene sulfonate) is still available as a generic version.

What is a sodium polystyrene sulfonate enema used for? ›

Uses. This medication is used to treat a high level of potassium in your blood. Too much potassium in your blood can sometimes cause heart rhythm problems. Sodium polystyrene sulfonate works by helping your body get rid of extra potassium.

What is the drug sodium polystyrene sulfonate used for? ›

Sodium polystyrene sulfonate is used to treat high levels of potassium in the blood, also called hyperkalemia. This medicine is available only with your doctor's prescription.

Can you buy Kayexalate over the counter? ›

SPS (generic for Kayexelate)

SPS is available under the brand name Kayexalate. It can only be supplied via a prescription from a licensed health care provider.

What happened with Kayexalate? ›

The Kayexalate brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.

What is the new version of Kayexalate? ›

Sodium Zirconium Cyclosilicate (SZC) is an oral potassium binder, essentially an upgrade of sodium polystyrene sulfonate (Kayexalate). Unlike sodium polystyrene sulfonate, SZC doesn't appear to cause bowel necrosis. SZC is studied predominantly for subacute to chronic reduction in potassium.

What foods should I avoid while taking sodium polystyrene sulfonate? ›

Sodium Polystyrene Sulfonate Food

Foods high in potassium such as orange juice and other fruit juices may reduce the effectiveness of sodium polystyrene sulfonate in treating your condition. Do not mix sodium polystyrene sulfonate in fruit juice or drink fruit juice with it.

How long do you hold a sodium phosphate enema? ›

Hold the enema contents in place until you feel a strong urge to have a bowel movement. This will usually take 1 to 5 minutes, and you should not hold the enema solution for more than 10 minutes.

What is the best fluid to use for enema? ›

Sodium phosphate enemas are the most common and fastest-acting type. A sodium phosphate enema is a mix of water and salt (saline). These enemas pull water from your colon and into your stool, so it's easier to pass. Glycerin enemas also pull water into your colon to soften stools.

How long does it take for sodium polystyrene sulfonate to work? ›

Sodium polystyrene sulfonate starts working over a period of several hours and therefore should not be used to treat life-threatening episodes of acute hyperkalemia. Sodium polystyrene sulfonate was initially approved by the US FDA in 1958.

Which drug should not be given with sodium polystyrene sulfonate? ›

Before taking or receiving sodium polystyrene sulfonate,

Be sure to mention any of the following: antacids, antibiotics taken by mouth; anticoagulants such as warfarin (Coumadin, Jantoven); digoxin (Lanoxin); laxatives; lithium (Lithobid); or thyroxine.

What are the side effects of sodium polystyrene sulfonate Kayexalate? ›

Loss of appetite, nausea, vomiting, or constipation may occur. Diarrhea may occur less often. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

How expensive is Kayexalate? ›

Oral And Rectal Powder
QuantityPer unitPrice
453.6 grams$1.77$803.90

What to avoid while taking Kayexalate? ›

Magnesium-containing laxatives or sorbitol should not be used (see PRECAUTIONS, Drug Interactions). Antacids: The simultaneous oral administration of KAYEXALATE with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability.

How fast does Kayexalate work? ›

The onset of action for Kayexalate is reportedly 1-2 hours. Chatmain et. al demonstrated that 10 hours after administration 15 g of Kayexalate potassium level was reduced by 0.82 meq/L whereas 60 g reduced it by 1.4 meq/L2.

What can I use instead of Kayexalate? ›

Kayexalate Alternatives Compared
Kayexalate (sodium polystyrene sulfonate)Calcium gluconateSodium bicarbonate
Brand Names
Other sodium polystyrene sulfonate brands include: Kalexate, KionexCal-G, Cal-GLU, KalcinateBell/ans, Neut
41 more rows

Is lokelma better than Kayexalate? ›

In the first 24 hours, the percentage of patients that obtained a serum potassium within normal limits (K less than or equal to 5.0 mEq/L) with Lokelma was 67.5% (n=27) compared to 82.5% (n=33) in the Kayexalate group.

Is patiromer better than Kayexalate? ›

Kayexalate also reduced the calcium concentration by as much as 40%, while Patiromer increased the calcium concentration by equivalent amount. Both Kayexalate and Patiromer decreased the magnesium concentration with the decrease being more pronounced with Kayexalate.

Why not use Kayexalate? ›

Cases of intestinal necrosis, some fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with KAYEXALATE use.

Top Articles
Latest Posts
Recommended Articles
Article information

Author: Jonah Leffler

Last Updated:

Views: 6075

Rating: 4.4 / 5 (65 voted)

Reviews: 88% of readers found this page helpful

Author information

Name: Jonah Leffler

Birthday: 1997-10-27

Address: 8987 Kieth Ports, Luettgenland, CT 54657-9808

Phone: +2611128251586

Job: Mining Supervisor

Hobby: Worldbuilding, Electronics, Amateur radio, Skiing, Cycling, Jogging, Taxidermy

Introduction: My name is Jonah Leffler, I am a determined, faithful, outstanding, inexpensive, cheerful, determined, smiling person who loves writing and wants to share my knowledge and understanding with you.