Sodium Polystyrene Sulfonate 1 g/g
Sodium Polystyrene Sulfonate · POWDER · KVK-Tech, Inc.
Sodium Polystyrene Sulfonate is a powder containing sodium polystyrene sulfonate at 1 g/g, taken oral. Manufactured by KVK-Tech, Inc..
Key Facts
- Brand Name
- Sodium Polystyrene Sulfonate
- Generic Name
- Sodium Polystyrene Sulfonate
- NDC Code (Product)
10702-036- Manufacturer
- KVK-Tech, Inc.
- Strength
- 1 g/g
- Dosage Form
- POWDER
- Route
- ORAL, RECTAL
- Marketing Status
- Application #
- ANDA040905
- Drug Class
- Potassium Binder [EPC]
- Marketing Start
- 07/25/2012
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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) ] Sodium polystyrene sulfonate for suspension is a potassium binder indicated for the treatment of hyperkalemia ( 1 ). Limitation of Use : Sodium polystyrene sulfonate for suspension should not be used an emergency treatment for life threatening hyperkalemia because of its delayed onset of action ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 ( 2.1 ). Rectal : The average adult dose is 30 g to 50 g every six hours ( 2.1 ). 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 sm…
Contraindications
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 Hypersensitivity to polystyrene sulfonate resins ( 4 ) Obstructive bowel disease ( 4 ) Neonates with reduced gut motility ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Take other orally administered drugs at least 3 hours before or 3 hours after sodium polystyrene sulfonate ( 7.1 ). Cation-Donating Antacids: may reduce the resin’s potassium exchange capability and increase risk of systemic alkalosis ( 7.2 ). Sorbitol: Concomitant use may contribute to the risk of intestinal necrosis and is not recommended ( 7.3 ). 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 …
Adverse Reactions
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 Adverse reactions reported include: anorexia, constipation, diarrhea, fecal impaction, gastrointestinal concretions (bezoars), ischemic colitis, nausea, vomiting ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Sunrise Pharmaceutical Inc. at 1-732-382-6085 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Frequently Asked Questions
What is Sodium Polystyrene Sulfonate used for?
Sodium Polystyrene Sulfonate contains Sodium Polystyrene Sulfonate. It is a powder taken oral. Consult your doctor for specific uses.
Is Sodium Polystyrene Sulfonate a controlled substance?
Sodium Polystyrene Sulfonate is not classified as a controlled substance by the DEA.
What is the generic name for Sodium Polystyrene Sulfonate?
The generic name for Sodium Polystyrene Sulfonate is Sodium Polystyrene Sulfonate. There are 5 other brand versions of Sodium Polystyrene Sulfonate.
What is the NDC code for Sodium Polystyrene Sulfonate 1 g/g?
The NDC (National Drug Code) for Sodium Polystyrene Sulfonate 1 g/g is 10702-036, listed by KVK-Tech, Inc..