SODIUM POLYSTYRENE SULFONATE 4.1 meq/g Powder, For Suspension, 15 g — NDC 11534-0166-16 package photo

SODIUM POLYSTYRENE SULFONATE 4.1 meq/g Powder, For Suspension, 15 g

by SUNRISE PHARMACEUTICAL, INC. · 15 g in 1 BOTTLE (11534-166-16)
NDC 11534-0166-16
🏷️ FDA NDC (as labeled) 11534-166-16 billing pads the product segment with a zero
This package
Contains15 g Cost per g$0.4713 NADAC Per package$7.07 / 15 g Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.2811/unit · Part D plans $0.1789/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) 11534-166-16
Product NDC 11534-166
11-digit billing NDC 11534016616
NCPDP billing unit GM — per gram (weight)
RxCUI 2101899
UNII 1699G8679Z
UPC 0311534166446
Application # ANDA204071
SPL Set ID c73b9661-2378-4336-8be0-098e7c1ae522
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 2017-01-24
Route ORAL, RECTAL
Dosage form POWDER, FOR SUSPENSION
Substance SODIUM POLYSTYRENE SULFONATE
GPI-14 99450010002900
GPI class Sodium Polystyrene Sulfonate
GCN Seq No 001194
GCN 02890
HICL code 013209
Ingredient (HICL) Sodium Polystyrene Sulfonate
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 SODIUM POLYSTYRENE SULF POWDER
FDB brand name Sodium Polystyrene Sulfonate
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 11534-166-16 — 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 → 11534-0166-16. 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

LabelerSUNRISE PHARMACEUTICAL, INC.
Application holderNUVO PHAMACEUTICALS INC
FDA applicationANDA204071 (ANDA)
Labeler code11534
First marketedJan 2017
Product typeHuman Prescription Drug
Portfolio26 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 SODIUM POLYSTYRENE SULF POWDER Ingredient Sodium Polystyrene Sulfonate
📗 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
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.

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 gPer package
Retail pharmacies payNADAC · weekly $0.471 $7.07 / 15 g
Medicaid paysCMS SDUD · 12 mo $0.2811 $4.22 / 15 g
Medicare drug plans payPart D · Q2 2026 $0.1789 $2.68 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Aug 2021 Sep 2022 Feb 2026 Aug 2026 $0.770 $0.311
▼ Down 11% over the last 17 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 1 g/g 46287-0012-16 CMP 454 g $0.095 AA Availability likely save 80%
Sodium Polystyrene Sulfonate 4.1 meq/g 24658-0760-16 PuraCap 453.6 g $0.153 AA Availability likely save 68%
Sodium Polystyrene Sulfonate 1 g/g 10702-0036-15 KVK-Tech, 15 g $0.471 AA Availability likely
Sodium Polystyrene Sulfonate 4.1 meq/gthis 11534-0166-16 SUNRISE 15 g $0.471 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 17856-0024-01 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

🏛️
2017
On the market since
Jan 2017
📍
2026
Currently FDA-listed
9 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 11534-0166-16, 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
1.6K
Units reimbursed last 4 qtrs
146.4K
Gross reimbursed last 4 qtrs
$41.2K
Avg / prescription
$25.72
Avg / unit
$0.2811
Latest quarter Q4 2025
409Rx
Medicaid pays / g
$0.2811
gross reimbursed
vs
NADAC / g
$0.4713
acquisition cost
=
Spread
−$0.1902
-40% vs cost
What Medicaid paid per g (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
51% FFS 49% MCO
Fee-for-service · 812 Rx Managed care · 788 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 2,025 units · 20.2 per 100k residents MI New York: 15,450 units · 78.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 22,080 units · 176 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 885 units · 6.8 per 100k residents PA New Jersey: 16,716 units · 180 per 100k residents NJ Massachusetts: 2,835 units · 40.5 per 100k residents MA California: 66,815 units · 171 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 9,870 units · 113 per 100k residents VA Maryland: 6,394 units · 103 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 765 units · 10.3 per 100k residents AZ New Mexico: no data reported NM Kansas: 1,695 units · 57.7 per 100k residents KS Arkansas: no data reported AR Tennessee: 870 units · 12.2 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
6.8180
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 New Jersey 180 /100k
2 Illinois 176 /100k
3 California 171 /100k
4 Virginia 113 /100k
5 Maryland 103 /100k
6 New York 78.9 /100k
7 Kansas 57.7 /100k
8 Massachusetts 40.5 /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.
454 gs11534-0166-44 2,166 Rx · $169,254
15 gs this page11534-0166-16 1,600 Rx · $41,159
15 gs11534-0166-15 316 Rx · $13,812
Drug total (last 4 qtrs): 4,082 Rx · 1,235,981 units · $224,225 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
11534-0166-15 15 g in 1 BOTTLE (11534-166-15) $0.5292 / g $7.94 2017-01-24 Active
11534-0166-16 You're viewing this 15 g in 1 BOTTLE (11534-166-16) $0.4713 / g $7.07 2017-01-24 Active
11534-0166-44 454 g in 1 JAR (11534-166-44) $0.0949 / g $43.10 2017-01-24 Active

Per g, this pack runs about 397% above the cheapest pack (454 g, $0.0949 vs $0.4713 NADAC).

This pack accounts for about 39% of this product's recent Medicaid fills; most go to the 454 gs pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 11534-0166-16?
NDC 11534-0166-16 contains 15 g — 15 g in 1 bottle.
What is the difference between NDC 11534-0166-16 and NDC 11534-0166-15?
Both are SODIUM POLYSTYRENE SULFONATE 4.1 meq/g Powder, For Suspension — the drug itself is identical. NDC 11534-0166-16 is the 15 g package, while NDC 11534-0166-15 is the 15 g package. Per-g NADAC also differs: $0.4713 here vs $0.5292 for the 15 g pack.
What NDC number is used to bill for this package of SODIUM POLYSTYRENE SULFONATE 4.1 meq/g Powder, For Suspension?
Bill NDC 11534-0166-16 — the 11-digit billing format is 11534016616. 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 96 words

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 and Administration ~2 min read

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 ).

2.1General 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) ]

2.2Recommended 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 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 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.

💊 Dosage Forms and Strengths 45 words

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. Sodium polystyrene sulfonate for suspension is available as a golden brown, finely ground powder ( 3 )

Contraindications 48 words

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 )

⚠️ 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 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 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.

5.3Fluid 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.

5.4Risk 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 with the patient in an upright position.

5.5Binding 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) ].

🤒 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. 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 .

🔄 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 ( 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 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.

7.2Cation-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.

7.3Sorbitol 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 158 words

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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.

8.2Lactation Risk Summary Sodium polystyrene sulfonate 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 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) ].

🆘 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 212 words

12 CLINICAL PHARMACOLOGY

12.1Mechanism 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.

12.2Pharmacodynamics The effective lowering of serum potassium with sodium polystyrene sulfonate 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 is not absorbed systemically. Drug Interactions In vitro binding studies showed that sodium polystyrene sulfonate bound significantly to the following tested drugs – warfarin, metoprolol, phenytoin, furosemide, amlodipine and amoxicillin.

📦 How Supplied / Storage and Handling 62 words

16 HOW SUPPLIED/STORAGE AND HANDLING Sodium polystyrene sulfonate for suspension is available as a golden brown, finely ground powder in jars of 1 pound (454 g), NDC 11534-166-44, in bottles of 15 g, NDC 11534-166-16 and 10 in 1 carton pack of 15 g per bottle, NDC 11534-166-15 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]

📋 Description 100 words

11 DESCRIPTION Sodium polystyrene sulfonate is a benzene, diethenyl- polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula: n The 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. image description

💬 Information for Patients 63 words

17 PATIENT COUNSELING INFORMATION Drug Interactions Advise 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 Only Manufactured & Distributed by: Sunrise Pharmaceutical, Inc. Rahway, NJ 07065 Revised August 2022 5368/00

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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