HomeNDC LookupIngredientsCholestyramine › 68382-0528-42
CHOLESTYRAMINE 4 g/9g Powder, For Suspension, 378 g — NDC 68382-0528-42 package photo

CHOLESTYRAMINE 4 g/9g Powder, For Suspension, 378 g

by Zydus Pharmaceuticals (USA) Inc. · 378 g in 1 CAN (68382-528-42)
NDC 68382-0528-42
🏷️ FDA NDC (as labeled) 68382-528-42 billing pads the product segment with a zero
This package
Contains378 g Cost per g$0.0946 NADAC Per package$35.76 / 378 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1068/unit · Part D plans $1.23/unit — full pricing hub ↓
Also comes in: 60 pouches 68382-0528-60
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) 68382-528-42
Product NDC 68382-528
11-digit billing NDC 68382052842
NCPDP billing unit GM — per gram (weight)
RxCUI 848943
UNII 4B33BGI082
Application # ANDA202901
SPL Set ID acc48703-c15b-4275-aa75-749f1c07dcbb
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 2018-08-01
Route ORAL
Dosage form POWDER, FOR SUSPENSION
Substance CHOLESTYRAMINE
GPI-14 39100010002905
GPI class Cholestyramine
GCN Seq No 048571
GCN 14295
HICL code 004851
Ingredient (HICL) Cholestyramine (With Sugar)
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 POWDER
FDB brand name Cholestyramine
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 68382-528-42 — 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 → 68382-0528-42. 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

LabelerZydus Pharmaceuticals (USA) Inc.
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA202901 (ANDA)
Labeler code68382
First marketedAug 2018
Product typeHuman Prescription Drug
Portfolio173 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 POWDER Ingredient Cholestyramine (With Sugar)
📖 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

FlavorVanilla
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 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 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 5EVU04N5QU
    A natural or synthetic colorant that gives the medicine an orange hue. It helps identify the medication and may improve appearance.
  • 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 C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII Q74T35078H
    Vanilla is a flavoring ingredient extracted from vanilla orchid beans. It's added to medicines to improve taste and make them more pleasant to take, especially for children or patients who need liquid formulations.
  • 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.095 $35.76 / 378 g
Medicaid paysCMS SDUD · 12 mo $0.1068 $40.37 / 378 g
Medicare drug plans payPart D · Q2 2026 $1.23 $464.60 / 378 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jun 2022 Jan 2024 Aug 2026 $0.162 $0.092
▼ Down 38% 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 powder for suspension 4 g/8.78g 67877-0298-37 Ascend 368.76 g $0.088 AB Availability likely save 7%
Cholestyramine 4 g/9g 42806-0267-97 EPIC 378 g $0.095 AB Availability likely
Cholestyramine for Oral Suspension 4 g/9g 62135-0008-56 Chartwell 378 g $0.095 AB Availability likely
Cholestyramine 4 g/9gthis 68382-0528-42 Zydus 378 g $0.095 AB Availability likely
Cholestyramine 4 g/9g 24658-0266-95 PURACAP 60 pouches $0.772 AB Availability likely +717%
Cholestyramine 4 g/9g 27241-0134-36 Ajanta 60 packets $0.772 AB Availability likely +717%
Cholestyramine 4 g/9g 33342-0293-70 Macleods 60 pouches $0.772 AB Availability likely +717%
Cholestyramine 4 g/9g 42571-0508-29 Micro 60 pouches $0.772 AB Availability likely +717%
Cholestyramine 4 g/9g 42806-0266-95 EPIC 60 pouches $0.772 AB Availability likely +717%
Cholestyramine 4 g/9g 49884-0465-65 Par 60 packets $0.772 AB Availability likely +717%
Cholestyramine 4 g/9g 42806-0265-98 EPIC 9 g AB FDA listed
Questran 4 g/9g 49884-0936-65 Par 60 packets AB Discontinued
Cholestyramine 4 g/8.3g 51224-0011-10 TAGI 348.6 g AB FDA listed
Cholestyramine 4 g/9g 63629-2164-01 Bryant 378 g AB FDA listed
cholestyramine powder for suspension 4 g/8.78g 63629-9196-01 Bryant 368.76 g AB FDA listed
Cholestyramine 4 g/9g 68094-0806-10 Precision 348.6 g AB FDA listed
Cholestyramine 4 g/9g 70771-1105-01 Zydus 378 g AB FDA listed
cholestyramine powder for suspension 4 g/8.78g 71335-2902-01 Bryant 368.76 g AB FDA listed
Cholestyramine 4 g/9g 72162-1504-02 Bryant 378 g AB FDA listed
cholestyramine powder for suspension 4 g/8.78g 72162-1834-02 Bryant 368.76 g AB FDA listed
Cholestyramine 4 g/9g 11788-0150-17 AiPing 378 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

🏛️
2018
On the market since
Aug 2018
📍
2026
Currently FDA-listed
8 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 68382-0528-42, 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
2.7K
Units reimbursed last 4 qtrs
1.1M
Gross reimbursed last 4 qtrs
$115.9K
Avg / prescription
$42.23
Avg / unit
$0.1068
Latest quarter Q4 2025
615Rx
Medicaid pays / g
$0.1068
gross reimbursed
vs
NADAC / g
$0.0946
acquisition cost
=
Spread
+$0.0122
+13% 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
44% FFS 56% MCO
Fee-for-service · 1,201 Rx Managed care · 1,543 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 28,728 units · 368 per 100k residents WA Idaho: 23,589 units · 1,201 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 5,292 units · 92.2 per 100k residents MN Wisconsin: 36,318 units · 615 per 100k residents WI Michigan: 26,460 units · 264 per 100k residents MI New York: 27,594 units · 141 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 23,814 units · 563 per 100k residents OR Nevada: 9,450 units · 296 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 41,958 units · 1,308 per 100k residents IA Illinois: 77,162 units · 615 per 100k residents IL Indiana: 87,696 units · 1,278 per 100k residents IN Ohio: 34,776 units · 295 per 100k residents OH Pennsylvania: 38,934 units · 300 per 100k residents PA New Jersey: 5,670 units · 61.0 per 100k residents NJ Massachusetts: no data reported MA California: 180,655 units · 464 per 100k residents CA Utah: 23,058 units · 675 per 100k residents UT Colorado: 30,231 units · 514 per 100k residents CO Nebraska: no data reported NE Missouri: 75,600 units · 1,220 per 100k residents MO Kentucky: 17,137 units · 379 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 17,010 units · 275 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 47,250 units · 636 per 100k residents AZ New Mexico: 22,725 units · 1,075 per 100k residents NM Kansas: no data reported KS Arkansas: 23,436 units · 764 per 100k residents AR Tennessee: 74,817 units · 1,050 per 100k residents TN North Carolina: 19,200 units · 177 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 18,900 units · 466 per 100k residents OK Louisiana: 29,106 units · 636 per 100k residents LA Mississippi: no data reported MS Alabama: 4,536 units · 88.8 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 33,642 units · 149 per 100k residents FL
Units reimbursed · per 100k residents
61.01,308
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 Iowa 1,308 /100k
2 Indiana 1,278 /100k
3 Missouri 1,220 /100k
4 Idaho 1,201 /100k
5 New Mexico 1,075 /100k
6 Tennessee 1,050 /100k
7 Arkansas 764 /100k
8 Utah 675 /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.
378 gs this page68382-0528-42 2,744 Rx · $115,866
60 pouches68382-0528-60 1,068 Rx · $65,053
Drug total (last 4 qtrs): 3,812 Rx · 1,284,589 units · $180,918 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 Cholestyramine — the program that covers self-administered drugs. 8 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. 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
$9.46M
Claims incl. refills
129.1K
Beneficiaries
89.3K
Spend / beneficiary
$105.94
Spend / claim
$73.22
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 — the ingredient across all brands.

Top reported reactions

Diarrhoea1,323
Fatigue728
Nausea635
Arthralgia530
Headache467
Weight Decreased435
Abdominal Pain404

Age at onset

Neonate18
Infant12
Child9
Adolescent11
Adult782
Elderly825

Reporter sex

9,356 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization2,913
Death582
Life-threatening293
Disabling148
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 798 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
68382-0528-42 You're viewing this 378 g in 1 CAN (68382-528-42) $0.0946 / g $35.76 2018-08-01 Active
68382-0528-60 60 POUCH in 1 CARTON (68382-528-60) / 9 g in 1 POUCH $0.7724 / ea $46.34 2018-08-01 Active

In Medicaid, this is the most-dispensed pack of this product — about 72% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 68382-0528-42?
NDC 68382-0528-42 contains 378 g — 378 g in 1 can.
What NDC number is used to bill for this package of CHOLESTYRAMINE 4 g/9g Powder, For Suspension?
Bill NDC 68382-0528-42 — the 11-digit billing format is 68382052842. 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) Cholestyramine for oral suspension 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 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 for oral suspension 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 for oral suspension 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 for oral suspension therapy. The therapy should be continued to sustain cholesterol reduction.

If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine for oral suspension or adding other lipid-lowering agents in combination with cholestyramine for oral suspension 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. * 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). LDL-Cholesterol mg/dL (mmol/ L) Definite Atherosclerotic Disease* Two or More Other Risk Factors** 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 for oral suspension 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 is indicated for the relief of pruritus associated with partial biliary obstruction.

Cholestyramine for oral suspension 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…

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION The recommended starting adult dose for cholestyramine for oral suspension is one pouch or one level scoopful once or twice a day. The recommended maintenance dose for cholestyramine for oral suspension is 2 to 4 pouches or scoopfuls daily (8 to 16 grams anhydrous cholestyramine resin) divided into two doses. Four grams of anhydrous cholestyramine resin is contained in each measured dose of cholestyramine for oral suspension as follows: Cholestyramine for oral suspension 9 grams 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 pouches or scoopfuls of cholestyramine for oral suspension (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 may be administered in 1 to 6 doses per day.

Cholestyramine for oral suspension should not be taken in its dry form. Always mix cholestyramine for oral suspension with water or other fluids before ingesting. See Preparation Instructions.

Concomitant Therapy Preliminary evidence suggests that the lipid-lowering effects of cholestyramine for oral suspension 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 for oral suspension therapy. See the Drug Interactions subsection of the PRECAUTIONS section for recommendations on administering concomitant therapy.

PREPARATION The color of cholestyramine for oral suspension 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 in a glass or cup. Add an amount of water or other noncarbonated beverage of your choice depending on the product being used: Product Formula Amount of Water or other Non-Carbonated Liquid Cholestyramine for oral suspension 2 to 6 ounces per dose Stir to a uniform consistency and drink.

Cholestyramine for oral suspension may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.

Contraindications 34 words

CONTRAINDICATIONS Cholestyramine for oral suspension 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.

🤒 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, and 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 for oral suspension 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 cholestyramine for oral suspension.

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 for oral suspension 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.

🆘 Overdosage 69 words

OVERDOSAGE Overdosage with cholestyramine for oral suspension 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

ACTIONS/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 for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension. 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 for oral suspension (p < 0.02). The mean absolute width of coronary segments decreased in the usual care group, increased slightly (0.003mm) in the diet group and increased by 0.103mm in the diet plus cholestyramine for oral suspension group (p < 0.05).

Thus in these randomized controlled clinical trials using coronary arteriography, cholestyramine for oral suspension 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 th…

📦 How Supplied / Storage and Handling 103 words

HOW SUPPLIED Cholestyramine for Oral Suspension, USP is available in cans containing 378 grams and in cartons of sixty 9 gram pouches. Four grams of anhydrous cholestyramine resin are contained in 9 grams of cholestyramine for oral suspension, USP. The 378 grams can includes a 14 cc scoop.

The scoop is not interchangeable with scoops from other products. NDC 68382-528-42 Can, 378 grams NDC 68382-528-60 Carton of 60, 9 grams pouches Storage Store between 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

📦 Storage and Handling 32 words

Storage Store between 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

📋 Description 119 words

DESCRIPTION Cholestyramine for oral suspension USP, 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 cholestyramine for oral suspension, USP is not absorbed from the digestive tract.

Four grams of anhydrous cholestyramine resin is contained in 9 grams of cholestyramine for oral suspension, USP. It is represented by the following structural formula: Cholestyramine for oral suspension, USP contains the following inactive ingredients: citric acid, d & c yellow # 10 aluminum lake, flavor (natural and artificial orange, natural and artificial vanilla), fd & c yellow # 6 aluminum lake, propylene glycol alginate, sucrose and xanthan gum. Formula

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