HomeNDC LookupIngredientsCholestyramine Light › 42806-0270-95
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CHOLESTYRAMINE LIGHT 4 g/5.7g Powder, For Suspension, 60 pouches

by EPIC PHARMA, LLC · 60 POUCH in 1 CARTON (42806-270-95) / 5.7 g in 1 POUCH (42806-270-98)
NDC 42806-0270-95
🏷️ FDA NDC (as labeled) 42806-270-95 billing pads the product segment with a zero
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) 42806-270-95
Product NDC 42806-270
11-digit billing NDC 42806027095
NCPDP billing unit EA — each (per item)
RxCUI 1801279
UNII 4B33BGI082
Application # ANDA074558
SPL Set ID 3899f0e0-988b-45dc-8ebd-a04330e75ee3
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 2021-12-15
Route ORAL
Dosage form POWDER, FOR SUSPENSION
Substance CHOLESTYRAMINE
GPI-14 39100010103005
GPI class Cholestyramine Light
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 CHOLESTYRAMINE LIGHT PACKET
FDB brand name Cholestyramine Light
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 42806-270-95 — 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 → 42806-0270-95. 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

LabelerEPIC PHARMA, LLC
Application holderEPIC PHARMA LLC
FDA applicationANDA074558 (ANDA)
Labeler code42806
First marketedDec 2021
Product typeHuman Prescription Drug
Portfolio171 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 CHOLESTYRAMINE LIGHT PACKET Ingredient Cholestyramine
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 Yellow
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 3VRD35U26C
    A natural extract from licorice root, ammonium glycyrrhizate is used as a flavoring agent and sweetener in medicines. It may also help soothe irritated tissues in the mouth or throat.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 6YSS42VSEV
    Fructose is a natural sugar derived from fruits and plants. It's used in medicines as a sweetener and filler to improve taste and add bulk to tablets or syrups.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 5EVU04N5QU
    A natural or synthetic colorant that gives the medicine an orange hue. It helps identify the medication and may improve appearance.
  • UNII 89NA02M4RX
    Pectin is a natural fiber extracted from fruit and plants. It's used in medicines as a thickener, binder, and gelling agent to create the right texture and help the product hold together.
  • 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.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

13 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 $48.20 / 60 pouches
Medicaid paysCMS SDUD · 12 mo $0.5005 $30.03 / 60 pouches
Medicare drug plans payPart D · Q2 2026 $1.24 $74.48 / 60 pouches
NADAC price history (per ea) — tap or hover for the price & month
Mar 2022 Sep 2022 Jan 2026 Aug 2026 $1.296 $0.796
▼ Down 34% over the last 21 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%
Prevalite 4 g/5.5g 00245-0036-23 Upsher-Smith 231 g $0.162 AB Availability likely save 80%
Cholestyramine 4 g/5.5g 68382-0529-42 Zydus 231 g $0.162 AB Availability likely save 80%
Cholestyramine Light 4 g/5.7g 24658-0270-95 PURACAP 60 pouches $0.803 AB Availability likely
Cholestyramine Light 4 g/5.7gthis 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

🏛️
2021
On the market since
Dec 2021
📍
2026
Currently FDA-listed
5 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 42806-0270-95, 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 – Q1 2026 · 5 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
8.2K
Units reimbursed last 4 qtrs
887.7K
Gross reimbursed last 4 qtrs
$444.3K
Avg / prescription
$54.51
Avg / unit
$0.5005
Latest quarter Q1 2026
2KRx
Medicaid pays / ea
$0.5005
gross reimbursed
vs
NADAC / ea
$0.8034
acquisition cost
=
Spread
−$0.3029
-38% 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
34% FFS 66% MCO
Fee-for-service · 2,802 Rx Managed care · 5,348 Rx
State Medicaid map
Alaska: 740 units · 101 per 100k residents AK Maine: no data reported ME Washington: 17,475 units · 224 per 100k residents WA Idaho: 5,106 units · 260 per 100k residents ID Montana: 3,101 units · 274 per 100k residents MT North Dakota: no data reported ND Minnesota: 8,096 units · 141 per 100k residents MN Wisconsin: 13,017 units · 220 per 100k residents WI Michigan: 23,269 units · 232 per 100k residents MI New York: 25,338 units · 129 per 100k residents NY Vermont: no data reported VT New Hampshire: 600 units · 42.8 per 100k residents NH Oregon: 43,200 units · 1,021 per 100k residents OR Nevada: 1,527 units · 47.8 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 4,934 units · 154 per 100k residents IA Illinois: 33,858 units · 270 per 100k residents IL Indiana: no data reported IN Ohio: 15,303 units · 130 per 100k residents OH Pennsylvania: 13,676 units · 106 per 100k residents PA New Jersey: 10,384 units · 112 per 100k residents NJ Massachusetts: 1,018 units · 14.5 per 100k residents MA California: 105,279 units · 270 per 100k residents CA Utah: 3,880 units · 114 per 100k residents UT Colorado: 34,562 units · 588 per 100k residents CO Nebraska: 993 units · 50.2 per 100k residents NE Missouri: 17,073 units · 276 per 100k residents MO Kentucky: 71,986 units · 1,590 per 100k residents KY West Virginia: 49,885 units · 2,818 per 100k residents WV Virginia: 9,953 units · 114 per 100k residents VA Maryland: 7,622 units · 123 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 13,210 units · 178 per 100k residents AZ New Mexico: 5,704 units · 270 per 100k residents NM Kansas: 2,459 units · 83.6 per 100k residents KS Arkansas: 3,952 units · 129 per 100k residents AR Tennessee: 9,003 units · 126 per 100k residents TN North Carolina: 16,613 units · 153 per 100k residents NC South Carolina: 2,296 units · 42.7 per 100k residents SC Delaware: 14,592 units · 1,415 per 100k residents DE Oklahoma: 31,578 units · 779 per 100k residents OK Louisiana: 11,742 units · 257 per 100k residents LA Mississippi: 8,807 units · 300 per 100k residents MS Alabama: 24,926 units · 488 per 100k residents AL Georgia: 5,001 units · 45.3 per 100k residents GA D.C.: no data reported DC Hawaii: 3,295 units · 230 per 100k residents HI Texas: 96,122 units · 315 per 100k residents TX Florida: 95,960 units · 424 per 100k residents FL
Units reimbursed · per 100k residents
14.52,818
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 West Virginia 2,818 /100k
2 Kentucky 1,590 /100k
3 Delaware 1,415 /100k
4 Oregon 1,021 /100k
5 Oklahoma 779 /100k
6 Colorado 588 /100k
7 Alabama 488 /100k
8 Florida 424 /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.

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

Medicare Part D (outpatient prescription) spending for Cholestyramine Light — 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 Cholestyramine Light. 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
$3.32M
Claims incl. refills
47.1K
Beneficiaries
32.8K
Spend / beneficiary
$101.13
Spend / claim
$70.40
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 Cholestyramine light — the ingredient across all brands.

Top reported reactions

Diarrhoea51
Fatigue19
Nausea17
Vomiting14
Asthenia12
Headache12
Arthralgia11

Age at onset

Adult20
Elderly33

Reporter sex

279 reports
Male · 38%
Female · 62%

Serious outcomes

Hospitalization70
Death13
Disabling2
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 39 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
42806-0270-95 You're viewing this 60 POUCH in 1 CARTON (42806-270-95) / 5.7 g in 1 POUCH (42806-270-98) 2021-12-15 Active

📄 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) Cholestyramine for Oral Suspension, USP Light 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. Cholestyramine for Oral Suspension, USP Light 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 NCEP4 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. Definite Atherosclerotic Disease * Two or More Other Risk Factors † LDL-Cholesterol mg/dL (mmol/L) Initiation Level Goal No No ≥ 190 (≥4.9) ≥ 60 (4.1) No Yes ≥ 160 (≥4.1) ≥ 130 (3.4) Yes Yes or No ≥ 130 (≥3.4) ≥ 100 (‑2.6) * Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). † 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). 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) Cholestyramine for Oral Suspension, USP Light 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 Cholestyramine for Oral Suspension, USP Light powder is one pouch or one level scoopful (5.7 grams of Cholestyramine for Oral Suspension, USP Light powder contains 4 grams of anhydrous cholestyramine resin) once or twice a day. The recommended maintenance dose for Cholestyramine for Oral Suspension, USP Light powder is 2 to 4 pouches 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 6 pouches or scoopfuls of Cholestyramine for Oral Suspension, USP Light 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, Cholestyramine for Oral Suspension, USP Light powder may be administered in 1 to 6 doses per day.

Cholestyramine for Oral Suspension, USP Light 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 the PRECAUTIONS, Drug Interactions for recommendations on administering concomitant therapy.

Preparation The color of Cholestyramine for Oral Suspension, USP Light 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 pouch or one level scoopful of Cholestyramine for Oral Suspension, USP Light 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. Cholestyramine for Oral Suspension, USP Light powder may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.

Contraindications 37 words

CONTRAINDICATIONS Cholestyramine for Oral Suspension, USP Light 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 17 words

WARNINGS PHENYLKETONURICS: CHOLESTYRAMINE FOR ORAL SUSPENSION, USP LIGHT POWDER CONTAINS 22.4 mg PHENYLALANINE PER

5.7GRAM 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.

🔄 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 positivelycharged 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 77 words

Pregnancy Pregnancy Category C 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 95 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, 70.2 mg of anhydrous cholestyramine resin are contained in 100 mg of Cholestyramine for Oral Suspension USP Light. 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 ~3 min read

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.

Clinical Studies In a large, placebo-controlled, multi-clinic study, LRC-CPPT 1 , hypercholesterolemic subjects treated with cholestyramine resin had mean reductions in total and low-density lipoprotein cholesterol (LDL-C) which exceeded those for diet and placebo treatment by 7.2% and 10.4%, respectively. Over the seven-year study period the cholestyramine resin group experienced a 19% reduction (relative to the incidence in the placebo group) in the combined rate of coronary heart disease death plus non-fatal myocardial infarction (cumulative incidences of 7% cholestyramine resin and 8.6% placebo).

The subjects included in the study were men aged 35 to 59 with serum cholesterol levels above 265 mg/dL and no previous history of heart disease. It is not clear to what extent these findings can be extrapolated to females and other segments of the hypercholesterolemic population. (See also PRECAUTIONS, Carcinogenesis, Mutagenesis, Impairment of Fertility .) Two controlled clinical trials have examined the effects of cholestyramine monotherapy upon coronary atherosclerotic lesions using coronary arteriography.

In the NHLBI Type II Coronary Intervention Trial 2 , 116 patients (80% male) with coronary artery disease (CAD) documented by arteriography were randomized to cholestyramine resin or placebo for five years of treatment. Final study arteriography revealed progression of coronary artery disease in 49% of placebo patients compared to 32% of the cholestyramine resin group (p<0.05). In the St.

Thomas Atherosclerosis Regression Study (STARS) 3 , 90 hypercholesterolemic men with CAD were randomized to three blinded treatments: usual care, lipid-lowering diet and lipid-lowering diet plus cholestyramine resin. After 36 months, follow-up coronary arteriography revealed progression of disease in 46% of usual care patients, 15% of patients on lipid-lowering diet and 12% of those receiving diet plus cholestyramine resin (p<0.02). The mean absolute width of coronary segments decreased in the usual care group, increased slightly (0.003 mm) in the diet group and increased by 0.103 mm in the diet plus cholestyramine group (p<0.05).

Thus in these randomized controlled clinical trials using coronary arteriography, cholestyramine resin monotherapy has been demonstrated to slow progression 2,3 and promote regression 3 of atherosclerotic lesions in the coronary arteries of patients with coronary artery disease. The effect of intensive lipid-lowering therapy on coronary atherosclerosis has been assessed by arteriography in hyperlipidemic patients. In these randomized, controlled clinical trials, patients were treated for two to four years by either conventional measures (diet, placebo or in some cases low dose resin), or intensive combination therapy using diet plus colestipo…

📦 How Supplied / Storage and Handling 97 words

HOW SUPPLIED Cholestyramine for Oral Suspension, USP Light powder orange flavor is available in cartons of sixty 5.7 gram pouches and in cans containing 239.4 grams. Each 5.7 gram dose of Cholestyramine for Oral Suspension, USP Light powder contains 4 grams of anhydrous cholestyramine resin. NDC # 42806-270-95 Carton of 60 pouches NDC # 42806-271-97 Can, 239.4 g (containing a scoop that is not interchangeable with scoops from other products) Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Always replace plastic lid after using. KEEP OUT OF THE REACH OF CHILDREN.

📋 Description 115 words

DESCRIPTION Cholestyramine for Oral Suspension, USP Light 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. Cholestyramine resin is not absorbed from the digestive tract.

Each 5.7 grams of Cholestyramine for Oral Suspension, USP Light powder contain 4 grams of cholestyramine resin. It is represented by the following structural formula: Representation of structure of main polymeric groups Inactive Ingredients: aspartame, citric acid anhydrous, colloidal silicon dioxide, fructose, mannitol, mono ammonium glycyrrhizinate, pectin, propylene glycol alginate, sorbitol, xanthan gum, natural and artificial orange flavor, D&C yellow No. 10 aluminum lake and FD&C yellow No.

6 aluminum lake. structure-formula.jpg

💬 Information for Patients 83 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 5.7 gram dose of Cholestyramine for Oral Suspension USP Light 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.