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Sodium Polystyrene Sulfonate 4.1 meq/g Powder, For Suspension — NDC 17856-0024-02 package photo

Sodium Polystyrene Sulfonate 4.1 meq/g Powder, For Suspension

by ATLANTIC BIOLOGICALS CORP. · 50 CUP in 1 BOX, UNIT-DOSE (17856-0024-2) / 30 g in 1 CUP (17856-0024-4)
NDC 17856-0024-02
🏷️ FDA NDC (as labeled) 17856-0024-2 billing pads the package segment with a zero
This package
Contains30 g in 1 cup Pack sizes2 compare ↓
Also priced by: Part D plans $0.1789/unit — full pricing hub ↓
Also comes in: 50 cups 17856-0024-01
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 17856-0024-2
Product NDC 17856-0024
11-digit billing NDC 17856002402
RxCUI 2101899
UNII 1699G8679Z
Application # ANDA202333
SPL Set ID 2d95d23e-94c8-4975-99f5-ce746dfbb60e
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 2014-04-14
Route ORAL
Dosage form POWDER, FOR SUSPENSION
Substance SODIUM POLYSTYRENE SULFONATE
TE code (Orange Book) AA · RLD · RS
Why two NDCs? The FDA registers this code as 17856-0024-2 — a 5-4-1 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 package segment → 17856-0024-02. 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

LabelerATLANTIC BIOLOGICALS CORP.
Application holderEPIC PHARMA LLC
FDA applicationANDA202333 (ANDA)
Labeler code17856
First marketedApr 2014
Product typeHuman Prescription Drug
Portfolio106 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

📗 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1789 —
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 1 g/g 46287-0012-16 CMP 454 g $0.095 AA Availability likely —
Sodium Polystyrene Sulfonate 4.1 meq/g 24658-0760-16 PuraCap 453.6 g $0.153 AA Availability likely —
Sodium Polystyrene Sulfonate 1 g/g 10702-0036-15 KVK-Tech, 15 g $0.471 AA Availability likely —
Sodium Polystyrene Sulfonate 4.1 meq/g 42806-0013-94 Epic 15 g $0.471 AA Availability likely —
Sodium Polystyrene Sulfonate 4.1 meq/g 11534-0166-15 SUNRISE 15 g $0.529 — FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/gthis 17856-0024-02 ATLANTIC 50 cups — AA FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/g 62135-0340-11 Chartwell 10 bottles — AA FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/g 63629-2390-01 Bryant 454 g — — FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/g 63629-8849-01 Bryant 15 g — — FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/g 63629-8850-01 Bryant 15 g — — FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/g 71335-2855-01 Bryant 15 g — — FDA listed —
Sodium Polystyrene Sulfonate 4.1 meq/g 72162-1230-02 Bryant 454 g — — 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

🏛️
2014
On the market since
Apr 2014
📍
2026
Currently FDA-listed
12 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.

📊 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 Marketing startStatus
17856-0024-01 50 CUP in 1 BOX, UNIT-DOSE (17856-0024-1) / 15 g in 1 CUP (17856-0024-3) 2023-04-11 Active
17856-0024-02 You're viewing this 50 CUP in 1 BOX, UNIT-DOSE (17856-0024-2) / 30 g in 1 CUP (17856-0024-4) 2023-04-11 Active

Pack size FAQ

What quantity is in NDC 17856-0024-02?
NDC 17856-0024-02 is listed by the FDA — 50 cup in 1 box, unit-dose / 30 g in 1 cup.
What NDC number is used to bill for this package of Sodium Polystyrene Sulfonate 4.1 meq/g Powder, For Suspension?
Bill NDC 17856-0024-02 — the 11-digit billing format is 17856002402. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 17856-0024-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 17856-0024-02, written without dashes as 17856002402. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 17856-0024-02, the first segment (17856) is the labeler code FDA assigned to ATLANTIC BIOLOGICALS CORP.; the middle segment (0024) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by ATLANTIC BIOLOGICALS CORP.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 50 cups (17856-0024-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
ATLANTIC BIOLOGICALS CORP. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 93 words ▾

1 INDICATIONS AND USAGE Sodium Polystyrene Sulfonate Powder, for Suspension is indicated for the treatment of hyperkalemia. Limitation of Use: Sodium Polystyrene Sulfonate Powder, 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 Powder, for Suspension is indicated for the treatment of hyperkalemia (1) .

Limitation of Use: Sodium Polystyrene Sulfonate Powder, for Suspension should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action (1) .

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Oral : The average total daily adult dose of Sodium Polystyrene Sulfonate Powder, for Suspension 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 ).

2.1General Information Administer Sodium Polystyrene Sulfonate Powder, for 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 (5.5) and Drug Interaction (7) ]

2.2Recommended 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 Powder, for Suspension 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.

2.3Preparation and Administration Prepare suspension fresh and use within 24 hours. Do not heat Sodium Polystyrene Sulfonate Powder, for Suspension as it could alter the exchange properties of the resin. One level teaspoon contains approximately 3.5 g of Sodium Polystyrene Sulfonate Powder, for Suspension 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.

💊 Dosage Forms and Strengths 49 words ▾

3 DOSAGE FORMS AND STRENGTHS Sodium Polystyrene Sulfonate Powder, for Suspension is a cream to light brown, finely ground powder and is available in 453.6 g jars and 15 g bottles Sodium Polystyrene Sulfonate Powder, for Suspension is available as a cream to light brown, finely ground powder (3)

⛔ Contraindications 43 words ▾

4 CONTRAINDICATIONS Sodium Polystyrene Sulfonate Powder, for Suspension 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)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS •Intestinal Necrosis: cases of intestinal necrosis and other serious gastrointestinal events have been reported (5.1). •Electrolyte Disturbances: Severe hypokalemia can occur. (5.2). •Fluid overload in patient sensitive to high sodium intake: Monitor patients who are sensitive to sodium intake for signs of fluid overload. (5.3). •Risk of aspiration: Acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles has been reported.

(5.4)

5.1Intestinal 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 Powder, 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. •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.

5.2Electrolyte Disturbances Monitor serum potassium during therapy because severe hypokalemia may occur. Sodium Polystyrene Sulfonate Powder, for Suspension 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 Powder, for Suspension.

5.3Fluid Overload in Patients Sensitive to High Sodium Intake Each 15 g dose of Sodium Polystyrene Sulfonate Powder, for Suspension 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.

5.4Risk 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 Powder, for Suspension with the patient in an upright position.

5.5Binding to Other Orally Administered Medications Sodium Polystyrene Sulfonate Powder, for Suspension 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 Powder, for Suspension. Patients with gastroparesis may require a 6 hour separation. [SEE DOSAGE AND ADMINISTRATION (2.1) and DRUG INTERACTIONS (7)].

🤒 Adverse Reactions 147 words ▾

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 Powder, for Suspension. 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 Epic Pharma, LLC 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Take other orally administered drugs at least 3 hours before or 3 hours after Sodium Polystyrene Sulfonate Powder, for Suspension ( 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 ).

7.1General Interactions No formal drug interaction studies have been conducted in humans. Sodium Polystyrene Sulfonate Powder, for Suspension has the potential to bind other drugs. In in vitro binding studies, Sodium Polystyrene Sulfonate Powder, for Suspension 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 Powder, for Suspension. Binding of Sodium Polystyrene Sulfonate Powder, for Suspension to other oral medications could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time Sodium Polystyrene Sulfonate Powder, for Suspension is administered. Administer Sodium Polystyrene Sulfonate Powder, for 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.

7.2Cation-Donating Antacids The simultaneous oral administration of Sodium Polystyrene Sulfonate Powder, for Suspension with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability and increase the risk of systemic alkalosis

7.3Sorbitol Sorbitol may contribute to the risk of intestinal necrosis [ see Warnings and Precautions (5.1) ] and concomitant use is not recommended.

👥 Use in Specific Populations 176 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Sodium Polystyrene Sulfonate Powder, for Suspension is not absorbed systemically following oral or rectal administration and maternal use is not expected to result in fetal risk.

8.2Labor and Delivery Risk Summary Sodium Polystyrene Sulfonate Powder, for Suspension is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant.

8.4Pediatric Use Studies of safety and efficacy have not been conducted in pediatric patients. In pediatric patients, as in adults, Sodium Polystyrene Sulfonate Powder, for Suspension is expected to bind potassium at the practical exchange ratio of 1mEq potassium per 1 gram of resin. In neonates, Sodium Polystyrene Sulfonate Powder, for Suspension 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 Powder, for Suspension use [ see Warnings and Precautions (5.4) ] .

🤰 Pregnancy 30 words ▾

8.1Pregnancy Risk Summary Sodium Polystyrene Sulfonate Powder, for Suspension is not absorbed systemically following oral or rectal administration and maternal use is not expected to result in fetal risk.

🧒 Pediatric Use 110 words ▾

8.4Pediatric Use Studies of safety and efficacy have not been conducted in pediatric patients. In pediatric patients, as in adults, Sodium Polystyrene Sulfonate Powder, for Suspension is expected to bind potassium at the practical exchange ratio of 1mEq potassium per 1 gram of resin. In neonates, Sodium Polystyrene Sulfonate Powder, for Suspension 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 Powder, for Suspension use [ see Warnings and Precautions (5.4) ] .

🆘 Overdosage 42 words ▾

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.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Sodium Polystyrene Sulfonate Powder, for Suspension is a non-absorbed, cation exchange polymer that contains a sodium counterion. Sodium Polystyrene Sulfonate Powder, for Suspension 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.

12.2Pharmacodynamics The effective lowering of serum potassium with Sodium Polystyrene Sulfonate Powder, for Suspension may take hours to days.

12.3Pharmacokinetics 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 Powder, for Suspension is not absorbed systemically. Drug Interactions In vitro binding studies showed that Sodium Polystyrene Sulfonate Powder, for Suspension bound significantly to the following tested drugs - warfarin, metoprolol, phenytoin, furosemide, amlodipine and amoxicillin.

🧬 Mechanism of Action 136 words ▾

12.1Mechanism of Action Sodium Polystyrene Sulfonate Powder, for Suspension is a non-absorbed, cation exchange polymer that contains a sodium counterion. Sodium Polystyrene Sulfonate Powder, for Suspension 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.

📦 How Supplied / Storage and Handling 52 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Sodium Polystyrene Sulfonate Powder, for Suspension is available as follows: ndc 17856-0024-01 SODIUM POLYSTYRENE SULFONATE PWD 15 GM CUP 50 ct UD ndc 17856-0024-02 SODIUM POLYSTYRENE SULFONATE PWD 30 GM CUP 50 ct UD Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 115 words ▾

11 DESCRIPTION Sodium Polystyrene Sulfonate Powder, for Suspension 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, 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 rectally as an enema. One gram of Sodium Polystyrene Sulfonate Powder, for Suspension contains 4.1 mEq of sodium. L:\Labeling Department\ANDA\Sodium Polystyrene Sulfonate_SZ- Done\Epic\Package Insert\2017.10 RLD update\Platimun\Docs for Submission\SBS\Structure

💬 Information for Patients 58 words ▾

17 PATIENT COUNSELING INFORMATION Drug Interactions Advise patients who are taking other oral medication to separate the dosing of Sodium Polystyrene Sulfonate Powder, for Suspension 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 Only DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP MIAMI FL 33179

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 17856-0008-02 · ATLANTIC 17856-0025-01 · ATLANTIC →
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.