HomeNDC LookupIngredientsCholestyramine › 00245-0036-42
Prevalite cholestyramine 4 g/5.5g Powder, For Suspension, 42 packets — NDC 00245-0036-42 package photo

Prevalite cholestyramine 4 g/5.5g Powder, For Suspension, 42 packets

by Upsher-Smith Laboratories, LLC · 42 PACKET in 1 CARTON (0245-0036-42) / 5.5 g in 1 PACKET (0245-0036-89)
NDC 00245-0036-42
🏷️ FDA NDC (as labeled) 0245-0036-42 billing pads the labeler segment with a zero
This package
Contains42 packets Cost per ea$0.8034 NADAC Per package$33.74 / 42 packets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.3300/unit · Part D plans $1.24/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) 0245-0036-42
Product NDC 0245-0036
11-digit billing NDC 00245003642
NCPDP billing unit EA — each (per item)
RxCUI 848951, 1801279
UNII 4B33BGI082
Application # ANDA073263
SPL Set ID dd434ef8-8af3-434c-a0a0-9a0b18459ba0
Established class (EPC) Bile Acid Sequestrant
Mechanism of action Bile-acid Binding Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1996-02-01
Marketing end 2027-10-31
Route ORAL
Dosage form POWDER, FOR SUSPENSION
Substance CHOLESTYRAMINE
GPI-14 39100010102905
GPI class Prevalite
GCN Seq No 086952
GCN 56757
HICL code 006437
Ingredient (HICL) Cholestyramine
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D7
Therapeutic class — intermediate (HIC2) Act Primarily On Liver/Biliary Tract
HIC3 code D7L
Therapeutic class — specific (HIC3) Bile Salt Sequestrants
AHFS code 24:06.04.00
AHFS class Bile Acid Sequestrants
FDB label name PREVALITE PACKET
FDB brand name Prevalite
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0245-0036-42 — a 4-4-2 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 labeler segment → 00245-0036-42. 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.

🏷️ RxNorm drug class

This medicine belongs to the Bile Acid Sequestrant class.

Pharmacologic class Bile Acid Sequestrant
Drug family (ATC) Bile acid sequestrants
How it works Bile-acid Binding Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerUpsher-Smith Laboratories, LLC
Application holderAIPING PHARMACEUTICAL INC
FDA applicationANDA073263 (ANDA)
Labeler code00245
First marketedFeb 1996
Product typeHuman Prescription Drug
Portfolio227 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 PREVALITE PACKET Ingredient Cholestyramine
📖 What it is MedlinePlus · NLM

Cholestyramine is used to decrease the amount of cholesterol (a fat-like substance that can build up and clog blood vessels causing heart attacks or strokes or other health problems). Cholestyramine is in a class of medications called bile acid sequestrant. It works by binding bile acids in your intestines to form a product that is removed from the body.

Read the full MedlinePlus article ↗
12
Nutrient depletion considerations

Cholestyramine may be associated with lower levels of 12 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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

FlavorOrange
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.

  • UNII Z0H242BBR1
    Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 817L1N4CKP
    Malic acid is a naturally occurring organic acid found in fruits. It works as a buffer and flavor agent to maintain the medicine's pH balance and add tartness to the product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 26CD3J2R0C
    Propylene glycol alginate is a thickening agent made from seaweed extract. It stabilizes and thickens liquid medicines, helping them achieve the right consistency and preventing ingredients from separating.

5 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 eaPer package
Retail pharmacies payNADAC · weekly $0.803 $33.74 / 42 packets
Medicaid paysCMS SDUD · 12 mo $0.3300 $13.86 / 42 packets
Medicare drug plans payPart D · Q2 2026 $1.24 $52.25 / 42 packets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $1.296 $0.796
▼ Down 28% over the last 24 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
Cholestyramine Light 4 g/5.7g 24658-0271-97 PURACAP 239.4 g $0.114 AB Availability likely save 86%
Cholestyramine Light 4 g/5.7g 42806-0271-97 EPIC 239.6 g $0.114 AB Availability likely save 86%
Cholestyramine for Oral Suspension 4 g/5.7g 62135-0937-54 Chartwell 239.4 g $0.114 AB Availability likely save 86%
Cholestyramine 4 g/4.8g 68094-0906-10 Precision 201.6 g $0.145 AB Availability likely save 82%
Cholestyramine 4 g/5.5g 68382-0529-42 Zydus 231 g $0.162 AB Availability likely save 80%
Prevalite 4 g/5.5gthis 00245-0036-42 Upsher-Smith 42 packets $0.803 AB Availability likely
Cholestyramine Light 4 g/5.7g 24658-0270-95 PURACAP 60 pouches $0.803 AB Availability likely
Cholestyramine Light 4 g/5.7g 42806-0270-95 EPIC 60 pouches $0.803 AB Availability likely
Cholestyramine 4 g/5g 49884-0466-65 Par 60 packets $0.803 AB Availability likely
Cholestyramine 4 g/5.7g 33342-0319-70 Macleods 60 pouches FDA listed
Cholestyramine Light 4 g/5.7g 42806-0269-98 EPIC 5.7 g AB FDA listed
Questran 4 g/5g 49884-0937-67 Par 210 g AB Discontinued
Cholestyramine Light 4 g/4.8g 51224-0009-10 TAGI 201.6 g AB FDA listed
Cholestyramine 4 g/5g 63629-2162-01 Bryant 210 g AB FDA listed
Choleystyramine Light 4 g/5.718g 63629-9466-01 Bryant 60 pouches AB FDA listed
Choleystyramine Light 4 g/5.718g 67877-0422-24 Ascend 240.156 g AB FDA listed
Cholestyramine 4 g/5.5g 70771-1070-01 Zydus 231 g AB FDA listed
Cholestyramine 4 g/5g 72162-1505-02 Bryant 210 g AB 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

🏛️
1996
On the market since
Feb 1996
📍
2026
Currently FDA-listed
30 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 00245-0036-42, 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
35
Units reimbursed last 4 qtrs
7.7K
Gross reimbursed last 4 qtrs
$2.5K
Avg / prescription
$72.67
Avg / unit
$0.3300
Latest quarter Q4 2025
0Rx
Medicaid pays / ea
$0.3300
gross reimbursed
vs
NADAC / ea
$0.8034
acquisition cost
=
Spread
−$0.4734
-59% vs cost
What Medicaid paid per ea (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
37% FFS 63% MCO
Fee-for-service · 13 Rx Managed care · 22 Rx
State Medicaid map
Alaska: 612 units · 83.5 per 100k residents 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: no data reported MI New York: no data reported 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: no data reported IL Indiana: 7,095 units · 103 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported 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: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported 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
83.5103
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 Indiana 103 /100k
2 Alaska 83.5 /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.
60 packets00245-0036-60 1,025 Rx · $68,454
231 gs00245-0036-23 779 Rx · $41,985
Drug total (last 4 qtrs): 1,839 Rx · 426,393 units · $112,982 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 Prevalite — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Prevalite. 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
$178.9K
Claims incl. refills
2.2K
Beneficiaries
1.7K
Spend / beneficiary
$107.94
Spend / claim
$80.46
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 Prevalite (this brand).

Top reported reactions

Diarrhoea1,272
Fatigue710
Nausea618
Arthralgia519
Headache456
Weight Decreased431
Abdominal Pain397

Age at onset

Neonate18
Infant12
Child9
Adolescent11
Adult763
Elderly792

Reporter sex

9,082 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization2,848
Life-threatening292
Disabling146
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 845 360
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
00245-0036-23 231 g in 1 CAN (0245-0036-23) $0.1621 / g $37.45 1996-02-01 Active
00245-0036-42 You're viewing this 42 PACKET in 1 CARTON (0245-0036-42) / 5.5 g in 1 PACKET (0245-0036-89) $0.8034 / ea $33.74 1996-02-01 Active
00245-0036-60 60 PACKET in 1 CARTON (0245-0036-60) / 5.5 g in 1 PACKET (0245-0036-89) $0.8034 / ea $48.21 1996-02-01 Active

This pack accounts for about 1.9% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00245-0036-42?
NDC 00245-0036-42 contains 42 packets — 42 packet in 1 carton / 5.5 g in 1 packet.
What is the difference between NDC 00245-0036-42 and NDC 00245-0036-60?
Both are Prevalite cholestyramine 4 g/5.5g Powder, For Suspension — the drug itself is identical. NDC 00245-0036-42 is the 42 packets package, while NDC 00245-0036-60 is the 60 packets package.
What NDC number is used to bill for this package of Prevalite cholestyramine 4 g/5.5g Powder, For Suspension?
Bill NDC 00245-0036-42 — the 11-digit billing format is 00245003642. 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 ~3 min read

INDICATIONS AND USAGE 1) Prevalite ® (cholestyramine for oral suspension, USP) powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Prevalite ® (cholestyramine for oral suspension, USP) powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern.

Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight.

Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total Cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation: LDL-C = Total Cholesterol - [(TG/5) + HDL-C] For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation.

In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response.

A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered.

Since the goal of treatment is to lower LDL-C, the NCEP 4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year.

The NCEP treatment guidelines are summarized below. LDL-Cholesterol mg/dL (mmol/L) Definite Atherosclerotic Disease Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease) Two or More Other Risk Factors Other risk factors for coronary heart disease (CHD) include: age (males ≥45 years; females: ≥55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (<0.91 mmol/L); and diabetes mellitus.

Subtract one risk factor if HDL-C is ≥60 mg/dL (≥1.6 mmol/L). Initiation Level Goal No No ≥190 (≥4.9) <160 (<4.1) No Yes ≥160 (≥4.1) <130 (<3.4) Yes Yes or No ≥130 (≥3.4) ≤100 (≤2.6) Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression 2,3 and increase the rate of regression 3 of coronary atherosclerosis. 2) Prevalite ® (cholestyramine for oral suspension, USP) powder is indicated for the relief of pruritus associated with partial biliary obstruction.

Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION The recommended starting adult dose for Prevalite ® (cholestyramine for oral suspension, USP) powder is one packet or one level scoopful (5.5 grams of Prevalite ® [cholestyramine for oral suspension, USP] powder contain 4 grams of anhydrous cholestyramine resin) once or twice a day. The recommended maintenance dose for Prevalite ® (cholestyramine for oral suspension, USP) powder is 2 to 4 packets or scoopfuls daily (8 to 16 grams anhydrous cholestyramine resin) divided into two doses. It is recommended that increases in dose be gradual with periodic assessment of lipid/lipoprotein levels at intervals of not less than 4 weeks.

The maximum recommended daily dose is six packets or scoopfuls of Prevalite ® (cholestyramine for oral suspension, USP) powder (24 grams of anhydrous cholestyramine resin). The suggested time of administration is at mealtime but may be modified to avoid interference with absorption of other medications. Although the recommended dosing schedule is twice daily, Prevalite ® (cholestyramine for oral suspension, USP) powder may be administered in 1 to 6 doses per day.

Prevalite ® (cholestyramine for oral suspension, USP) powder should not be taken in its dry form. Always mix the dry powder with water or other fluids before ingesting. See Preparation Instructions .

Concomitant Therapy Preliminary evidence suggests that the lipid-lowering effects of cholestyramine on total and LDL-cholesterol are enhanced when combined with a HMG-CoA reductase inhibitor, e.g., pravastatin, lovastatin, simvastatin and fluvastatin. Additive effects on LDL-cholesterol are also seen with combined nicotinic acid/cholestyramine therapy. See PRECAUTIONS, Drug Interactions for recommendations on administering concomitant therapy.

Preparation The color of Prevalite ® (cholestyramine for oral suspension, USP) powder may vary somewhat from batch to batch but this variation does not affect the performance of the product. Place the contents of one single-dose packet or one level scoopful of Prevalite ® (cholestyramine for oral suspension, USP) powder in a glass or cup. Add at least 2 to 3 ounces of water or the beverage of your choice.

Stir to a uniform consistency. Prevalite ® (cholestyramine for oral suspension, USP) powder may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.

Contraindications 33 words

CONTRAINDICATIONS Prevalite ® powder is contraindicated in patients with complete biliary obstruction where bile is not secreted into the intestine and in those individuals who have shown hypersensitivity to any of its components.

⚠️ Warnings 12 words

WARNING PHENYLKETONURICS: PREVALITE ® CONTAINS 14.1 mg PHENYLALANINE PER

5.5GRAM DOSE.

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS The most common adverse reaction is constipation. When used as a cholesterol-lowering agent, predisposing factors for most complaints of constipation are high dose and increased age (more than 60 years old). Most instances of constipation are mild, transient and controlled with conventional therapy.

Some patients require a temporary decrease in dosage or discontinuation of therapy. Less Frequent Adverse Reactions: Abdominal discomfort and/or pain, flatulence, nausea, vomiting, diarrhea, eructation, anorexia, steatorrhea, bleeding tendencies due to hypoprothrombinemia (Vitamin K deficiency) as well as Vitamin A (one case of night blindness reported) and D deficiencies, hyperchloremic acidosis in children, osteoporosis, rash and irritation of the skin, tongue and perianal area. Rare reports of intestinal obstruction, including two deaths, have been reported in pediatric patients.

Occasional calcified material has been observed in the biliary tree, including calcification of the gallbladder, in patients to whom cholestyramine resin has been given. However, this may be a manifestation of the liver disease and not drug related. One patient experienced biliary colic on each of three occasions on which he took a cholestyramine for oral suspension product.

One patient diagnosed as acute abdominal symptom complex was found to have a "pasty mass" in the transverse colon on x-ray. Other events (not necessarily drug related) reported in patients taking cholestyramine resin include: Gastrointestinal: GI-rectal bleeding, black stools, hemorrhoidal bleeding, bleeding from known duodenal ulcer, dysphagia, hiccups, ulcer attack, sour taste, pancreatitis, rectal pain, diverticulitis. Laboratory Test Changes: Liver function abnormalities.

Hematologic : Prolonged prothrombin time, ecchymosis, anemia. Hypersensitivity : Urticaria, asthma, wheezing, shortness of breath. Musculoskeletal: Backache, muscle and joint pains, arthritis.

Neurologic: Headache, anxiety, vertigo, dizziness, fatigue, tinnitus, syncope, drowsiness, femoral nerve pain, paresthesia. Eye: Uveitis. Renal: Hematuria, dysuria, burnt odor to urine, diuresis.

Miscellaneous: Weight loss, weight gain, increased libido, swollen glands, edema, dental bleeding, dental caries, erosion of tooth enamel, tooth discoloration.

🔄 Drug Interactions 200 words

Drug Interactions Cholestyramine resin may delay or reduce the absorption of concomitant oral medication such as phenylbutazone, warfarin, thiazide diuretics (acidic) or propranolol (basic), as well as tetracycline, penicillin G, phenobarbital, thyroid and thyroxine preparations, estrogens and progestins and digitalis. Interference with the absorption of oral phosphate supplements has been observed with another positively-charged bile acid sequestrant. Cholestyramine resin may interfere with the pharmacokinetics of drugs that undergo enterohepatic circulation.

The discontinuance of cholestyramine resin could pose a hazard to health if a potentially toxic drug such as digitalis has been titrated to a maintenance level while the patient was taking cholestyramine resin. Because cholestyramine binds bile acids, cholestyramine resin may interfere with normal fat digestion and absorption and thus may prevent absorption of fat soluble vitamins such as A, D, E and K. When cholestyramine resin is given for long periods of time, concomitant supplementation with water-miscible (or parenteral) forms of fat-soluble vitamins should be considered.

SINCE CHOLESTYRAMINE RESIN MAY BIND OTHER DRUGS GIVEN CONCURRENTLY, IT IS RECOMMENDED THAT PATIENTS TAKE OTHER DRUGS AT LEAST 1 HOUR BEFORE OR 4 TO 6 HOURS AFTER CHOLESTYRAMINE RESIN (OR AT AS GREAT AN INTERVAL AS POSSIBLE) TO AVOID IMPEDING THEIR ABSORPTION.

🤰 Pregnancy 74 words

Pregnancy There are no adequate and well controlled studies in pregnant women. The use of cholestyramine in pregnancy or lactation or by women of childbearing age requires that the potential benefits of drug therapy be weighted against the possible hazards to the mother and child. Cholestyramine is not absorbed systemically, however, it is known to interfere with absorption of fat-soluble vitamins; accordingly, regular prenatal supplementation may not be adequate (see PRECAUTIONS, Drug Interactions ).

🧒 Pediatric Use 91 words

Pediatric Use Although an optimal dosage schedule has not been established, standard texts (6,7) list a usual pediatric dose of 240 mg/kg/day of anhydrous cholestyramine resin in two to three divided doses, normally not to exceed 8 g/day with dose titration based on response and tolerance. In calculating pediatric dosages, 80 mg of anhydrous cholestyramine resin are contained in 110 mg of Prevalite ® . The effects of long-term drug administration, as well as its effect in maintaining lowered cholesterol levels in pediatric patients, are unknown.

Also see ADVERSE REACTIONS .

🆘 Overdosage 67 words

OVERDOSAGE Overdosage of cholestyramine resin has been reported in a patient taking 150% of the maximum recommended daily dosage for a period of several weeks. No ill effects were reported. Should an overdosage occur, the chief potential harm would be obstruction of the gastrointestinal tract. The location of such potential obstruction, the degree of obstruction, and the presence or absence of normal gut motility would determine treatment.

🧬 Clinical Pharmacology 182 words

CLINICAL PHARMACOLOGY Cholesterol is probably the sole precursor of bile acids. During normal digestion, bile acids are secreted into the intestines. A major portion of the bile acids is absorbed from the intestinal tract and returned to the liver via the enterohepatic circulation.

Only very small amounts of bile acids are found in normal serum. Cholestyramine resin adsorbs and combines with the bile acids in the intestine to form an insoluble complex which is excreted in the feces. This results in a partial removal of bile acids from the enterohepatic circulation by preventing their absorption.

The increased fecal loss of bile acids due to cholestyramine resin administration leads to an increased oxidation of cholesterol to bile acids, a decrease in beta lipoprotein or low density lipoprotein plasma levels and a decrease in serum cholesterol levels. Although in man, cholestyramine resin produces an increase in hepatic synthesis of cholesterol, plasma cholesterol levels fall. In patients with partial biliary obstruction, the reduction of serum bile acid levels by cholestyramine resin reduces excess bile acids deposited in the dermal tissue with resultant decrease in pruritus.

📦 How Supplied / Storage and Handling 89 words

HOW SUPPLIED Prevalite ® (cholestyramine for oral suspension, USP) powder is available in cartons of forty-two and sixty single-dose packets and in cans containing 231 grams. 5.5 grams of Prevalite ® (cholestyramine for oral suspension, USP) powder contain 4 grams of anhydrous cholestyramine resin. NDC 0245-0036-42 Cartons of 42, 5.5 g packets NDC 0245-0036-60 Cartons of 60, 5.5 g packets NDC 0245-0036-23 Cans, 231 g (42 doses) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

📦 Storage and Handling 22 words

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

📋 Description 108 words

DESCRIPTION Prevalite ® (cholestyramine for oral suspension, USP) powder, the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in Prevalite ® (cholestyramine for oral suspension, USP) is not absorbed from the digestive tract.

5.5grams of Prevalite ® (cholestyramine for oral suspension, USP) contain 4 grams of anhydrous cholestyramine resin. It is represented by the following structural formula: Prevalite ® (cholestyramine for oral suspension, USP) powder contains the following inactive ingredients: aspartame, FD&C Yellow No. 6, malic acid, polysorbate 80, propylene glycol alginate, and orange flavor.

Chemical Structure

💬 Information for Patients 84 words

Information for Patients Inform your physician if you are pregnant or plan to become pregnant or are breast-feeding. Drink plenty of fluids and mix each 5.5 gram dose of Prevalite ® (cholestyramine for oral suspension, USP) powder in at least 2 to 3 ounces of fluid before taking. Sipping or holding the resin suspension in the mouth for prolonged periods may lead to changes in the surface of the teeth resulting in discoloration, erosion of enamel or decay; good oral hygiene should be maintained.

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.