Sodium Polystyrene Sulfonate 15 g/60mL Suspension, 473 mL — NDC 46287-0006-01 package photo

Sodium Polystyrene Sulfonate 15 g/60mL Suspension, 473 mL

by CMP Pharma, Inc. · 473 mL in 1 BOTTLE (46287-006-01)
NDC 46287-0006-01
🏷️ FDA NDC (as labeled) 46287-006-01 billing pads the product segment with a zero
This package
Contains473 mL Cost per mL$0.4366 NADAC Per package$206.51 / 473 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.4026/unit · Part D plans $0.3875/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 46287-006-01
Product NDC 46287-006
11-digit billing NDC 46287000601
NCPDP billing unit ML — per mL (volume)
RxCUI 313072
UNII 1699G8679Z
UPC 0346287006015
Application # ANDA087859
SPL Set ID 12d48dcf-07bd-4b06-bd6c-7543f1be8357
Established class (EPC) Potassium Binder
Mechanism of action Potassium Ion Exchange Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1982-12-08
Route ORAL, RECTAL
Dosage form SUSPENSION
Substance SODIUM POLYSTYRENE SULFONATE
GPI-14 99450010001840
GPI class SPS
GCN Seq No 076420
GCN 41955
HICL code 043638
Ingredient (HICL) Sodium Polystyrene Sulfon/Sorb
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1A
Therapeutic class — specific (HIC3) Electrolyte Depleters
AHFS code 40:18.18.00
AHFS class Potassium-Removing Agents
FDB label name SPS 15 GM/60 ML SUSPENSION
FDB brand name Sps
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 46287-006-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 46287-0006-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerCMP Pharma, Inc.
Application holderCMP PHARMA INC
FDA applicationANDA087859 (ANDA)
Labeler code46287
First marketedDec 1982
Product typeHuman Prescription Drug
Portfolio11 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name SPS 15 GM/60 ML SUSPENSION Ingredient Sodium Polystyrene Sulfon/Sorb
📖 What it is MedlinePlus · NLM

Sodium polystyrene sulfonate is used to treat hyperkalemia (increased amounts of potassium in the body). Sodium polystyrene sulfonate is in a class of medications called potassium-removing agents. It works by removing excess potassium from the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Think of it as a tiny sponge that travels through your intestines. It grabs onto extra potassium in your gut and carries it out of your body in your stool — it never actually enter...
  • What exactly is sodium polystyrene sulfonate doing in my body?
  • It can take anywhere from several hours to a few days to meaningfully lower your potassium levels — so it's definitely not a quick fix. If your potassium is dangerously high right...
  • How long does it take to work, and do I need to take it long-term?
📖 Read our full Sodium Polystyrene Sulfonate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Brown
FlavorCherry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 0.18 mL / 60 mL UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • 21.5 mL / 60 mL UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.437 $206.51 / 473 ml
Medicaid paysCMS SDUD · 12 mo $0.4026 $190.43 / 473 ml
Medicare drug plans payPart D · Q2 2026 $0.3875 $183.29 / 473 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.438 $0.282
▲ Up 50% over the last 23 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Polystyrene Sulfonate 15 g/60mLthis 46287-0006-01 CMP 473 ml $0.437 AA Availability likely
Sodium Polystyrene Sulfonate 15 g/60mL 35573-0108-14 Burel 10 bottles AA FDA listed
Sodium Polystyrene Sulfonate 15 g/60mL 55154-7353-02 Cardinal 2 bottles AA FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1982
On the market since
Dec 1982
📍
2026
Currently FDA-listed
44 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 46287-0006-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5.5K
Units reimbursed last 4 qtrs
2.7M
Gross reimbursed last 4 qtrs
$1.09M
Avg / prescription
$197.21
Avg / unit
$0.4026
Latest quarter Q4 2025
1.2KRx
Medicaid pays / mL
$0.4026
gross reimbursed
vs
NADAC / mL
$0.4366
acquisition cost
=
Spread
−$0.0340
-8% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
53% FFS 47% MCO
Fee-for-service · 2,929 Rx Managed care · 2,605 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 37,979 units · 486 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 4,931 units · 86.0 per 100k residents MN Wisconsin: 89,111 units · 1,508 per 100k residents WI Michigan: 39,760 units · 396 per 100k residents MI New York: 330,854 units · 1,691 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 3,686 units · 115 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 163,609 units · 1,304 per 100k residents IL Indiana: 15,485 units · 226 per 100k residents IN Ohio: no data reported OH Pennsylvania: 65,730 units · 507 per 100k residents PA New Jersey: 171,321 units · 1,844 per 100k residents NJ Massachusetts: 22,831 units · 326 per 100k residents MA California: 545,852 units · 1,401 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 77,983 units · 1,259 per 100k residents MO Kentucky: 51,218 units · 1,132 per 100k residents KY West Virginia: no data reported WV Virginia: 76,132 units · 873 per 100k residents VA Maryland: 105,077 units · 1,700 per 100k residents MD Connecticut: 5,961 units · 165 per 100k residents CT Rhode Island: no data reported RI Arizona: 72,330 units · 973 per 100k residents AZ New Mexico: 11,311 units · 535 per 100k residents NM Kansas: no data reported KS Arkansas: 34,779 units · 1,134 per 100k residents AR Tennessee: 73,941 units · 1,038 per 100k residents TN North Carolina: 111,936 units · 1,033 per 100k residents NC South Carolina: 5,736 units · 107 per 100k residents SC Delaware: no data reported DE Oklahoma: 22,651 units · 559 per 100k residents OK Louisiana: 66,366 units · 1,451 per 100k residents LA Mississippi: 78,968 units · 2,686 per 100k residents MS Alabama: 10,182 units · 199 per 100k residents AL Georgia: 78,922 units · 716 per 100k residents GA D.C.: no data reported DC Hawaii: 22,877 units · 1,594 per 100k residents HI Texas: 144,763 units · 475 per 100k residents TX Florida: 168,719 units · 746 per 100k residents FL
Units reimbursed · per 100k residents
86.02,686
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Mississippi 2,686 /100k
2 New Jersey 1,844 /100k
3 Maryland 1,700 /100k
4 New York 1,691 /100k
5 Hawaii 1,594 /100k
6 Wisconsin 1,508 /100k
7 Louisiana 1,451 /100k
8 California 1,401 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
473 ml this page46287-0006-01 5,534 Rx · $1,091,386
10 bottles46287-0006-60 3,995 Rx · $285,070
12 ml46287-0006-04 25 Rx · $9,914
Drug total (last 4 qtrs): 9,554 Rx · 3,469,981 units · $1,386,370 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sodium Polystyrene Sulfonate — the program that covers self-administered drugs. 6 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sodium Polystyrene Sulfonate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$858.1K
Claims incl. refills
13.3K
Beneficiaries
10.4K
Spend / beneficiary
$82.68
Spend / claim
$64.41
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Sodium Polystyrene Sulfonate — the ingredient across all brands.

Top reported reactions

Hyperkalaemia110
Diarrhoea108
Acute Kidney Injury100
Constipation97
Renal Failure95
Chronic Kidney Disease91
Death82

Age at onset

Neonate13
Infant1
Child6
Adolescent2
Adult95
Elderly85

Reporter sex

1,584 reports
Male · 58%
Female · 42%
Unknown · 0%

Serious outcomes

Hospitalization748
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 130 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
46287-0006-01 You're viewing this 473 mL in 1 BOTTLE (46287-006-01) $0.4366 / mL $206.51 1982-12-08 Active
46287-0006-04 120 mL in 1 BOTTLE (46287-006-04) 1987-07-16 Active
46287-0006-60 10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-006-60) / 60 mL in 1 BOTTLE, UNIT-DOSE $0.3851 / mL $231.07 1985-12-12 Active

Per mL, this pack runs about 13% above the cheapest pack (NDC 46287-0006-60, $0.3851 vs $0.4366 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 58% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 46287-0006-01?
NDC 46287-0006-01 contains 473 mL — 473 ml in 1 bottle.
What is the difference between NDC 46287-0006-01 and NDC 46287-0006-04?
Both are Sodium Polystyrene Sulfonate 15 g/60mL Suspension — the drug itself is identical. NDC 46287-0006-01 is the 473 mL package, while NDC 46287-0006-04 is the 120 ml package.
What NDC number is used to bill for this package of Sodium Polystyrene Sulfonate 15 g/60mL Suspension?
Bill NDC 46287-0006-01 — the 11-digit billing format is 46287000601. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 13 words

INDICATION AND USAGE SPS ® Suspension is indicated for the treatment of hyperkalemia.

⏱️ Dosage and Administration ~2 min read

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 35 words

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 ).

⚠️ Warnings ~2 min read

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…

🤒 Adverse Reactions 162 words

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 ~1 min read

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.

🤰 Pregnancy 52 words

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 70 words

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 89 words

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.

🧬 Clinical Pharmacology 92 words

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.

📦 How Supplied / Storage and Handling 94 words

HOW SUPPLIED SPS ® Suspension is a light brown, cherry-flavored suspension supplied in pint (473 mL) bottles (NDC 46287-006-01), 120 mL bottles (NDC 46287-006-04), and 60 mL unit dose bottles, 10 bottles per carton (NDC 46287-006-60). 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 Revised August 2021 3081 R0821

📋 Description 151 words

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.