HomeNDC LookupIngredientsSucralfate Oral › 65162-0062-05
Sucralfate 1 g/10mL Suspension, 420 mL — NDC 65162-0062-05 package photo

Sucralfate 1 g/10mL Suspension, 420 mL

by Amneal Pharmaceuticals LLC · 420 mL in 1 BOTTLE (65162-062-05)
NDC 65162-0062-05
🏷️ FDA NDC (as labeled) 65162-062-05 billing pads the product segment with a zero
This package
Contains420 mL Cost per mL$0.1209 NADAC Per package$50.78 / 420 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.1821/unit · Part D plans $0.2427/unit — full pricing hub ↓
Also comes in: 10 cups 65162-0062-48
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) 65162-062-05
Product NDC 65162-062
11-digit billing NDC 65162006205
NCPDP billing unit ML — per mL (volume)
RxCUI 313123
UNII XX73205DH5
Application # ANDA209356
SPL Set ID 4350b771-76a9-4e00-93f0-a18c71288f83
Established class (EPC) Aluminum Complex
Chemical class Organometallic Compounds
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-12-02
Route ORAL
Dosage form SUSPENSION
Substance SUCRALFATE
GPI-14 49300010001820
GPI class Sucralfate
GCN Seq No 016133
GCN 07651
HICL code 001186
Ingredient (HICL) Sucralfate
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4E
Therapeutic class — specific (HIC3) Anti-Ulcer Preparations
AHFS code 56:28.32.00
AHFS class Protectants
FDB label name SUCRALFATE 1 GM/10 ML SUSP
FDB brand name Sucralfate
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 65162-062-05 — 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 → 65162-0062-05. 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 Aluminum Complex class.

Pharmacologic class Aluminum Complex
Drug family (ATC) Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)
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

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL PHARMACEUTICALS LLC
FDA applicationANDA209356 (ANDA)
Labeler code65162
First marketedDec 2019
Product typeHuman Prescription Drug
Portfolio472 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 SUCRALFATE 1 GM/10 ML SUSP Ingredient Sucralfate
📖 What it is MedlinePlus · NLM

Sucralfate is used to treat and prevent the return of duodenal ulcers (ulcers located in first part of the small intestine). Treatment with other medications, such as antibiotics, may also be necessary to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) Sucralfate is in a class of medications called protectants. It sticks to damaged ulcer tissue and protects against acid and enzymes so healing can occur.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Sucralfate helps heal a duodenal ulcer — that's an ulcer in the first part of your small intestine. It works by coating the ulcer like a protective bandage, shielding it from stoma...
  • What exactly is sucralfate supposed to do for me?
  • Yes, timing really does matter. You should take sucralfate on an empty stomach so it can stick directly to the ulcer lining. Taking it with food can get in the way of that. If you...
  • When should I take sucralfate — does it matter if I take it with food?
📖 Read our full Sucralfate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color pink
FlavorCherry
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.

  • 100 mg / 10 mL UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 88 mg / 10 mL UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • 0.05 mg / 10 mL UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 990 mg / 10 mL UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 25 mg / 10 mL UNII MRJ667KA5E
    Methylcellulose is a plant-derived thickening agent made by chemically modifying cellulose. In medicines, it acts as a binder to hold ingredients together, a thickener to create the right consistency, and sometimes a disintegrant to help the tablet break apart when swallowed.
  • 20 mg / 10 mL UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 20 mg / 10 mL 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.
  • 2000 mg / 10 mL 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.
  • 7011.95 mg / 10 mL UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

9 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 mLPer package
Retail pharmacies payNADAC · weekly $0.121 $50.78 / 420 ml
Medicaid paysCMS SDUD · 12 mo $0.1821 $76.48 / 420 ml
Medicare drug plans payPart D · Q2 2026 $0.2427 $101.93 / 420 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.353 $0.115
▼ Down 66% 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
Sucralfate 1 g/10mL 66689-0305-16 VistaPharm, 1 bottle $0.113 AB Availability likely save 7%
Sucralfate 1 g/10mL 50742-0386-42 Ingenus 420 ml $0.115 AB Discontinued save 5%
sucralfate 1 g/10mL 00378-9205-35 Mylan 420 ml $0.121 AB Availability likely
Sucralfate 1 g/10mL 00713-0791-75 Cosette 420 ml $0.121 AB Availability likely
Sucralfate 1 g/10mL 13668-0754-42 Torrent 420 ml $0.121 AB Availability likely
sucralfate 1 g/10mL 64380-0149-01 Strides 420 ml $0.121 AB Availability likely
Sucralfate 1 g/10mLthis 65162-0062-05 Amneal 420 ml $0.121 AB Availability likely
Sucralfate 1 g/10mL 82182-0106-14 Pacific 420 ml $0.121 Availability likely
Sucralfate 1 g/10mL 52817-0840-16 TruPharma, 473 ml $0.145 AB Availability likely +20%
Carafate 1 g/10mL 58914-0170-14 Allergan, 414 ml $0.609 FDA listed +404%
Sucralfate 1 g/10mL 00121-0974-00 PAI 10 cups AB FDA listed
Sucralfate 1 g/10mL 00904-7470-01 Major 30 cups AB FDA listed
Sucralfate 1 g/10mL 17856-0306-01 ATLANTIC 72 cups AB FDA listed
Sucralfate 1 g/10mL 42291-0781-42 AvKARE 420 ml AB FDA listed
Sucralfate 1 g/10mL 50268-0745-14 AvPAK 40 cups AB FDA listed
Sucralfate 1 g/10mL 54738-0005-42 Richmond 420 ml AB FDA listed
Sucralfate 1 g/10mL 55154-4348-05 Cardinal 5 cups AB FDA listed
Sucralfate 1 g/10mL 55154-5790-05 Cardinal 5 cups AB FDA listed
Sucralfate 1 g/10mL 60687-0738-08 American 10 cups AB FDA listed
Sucralfate 1 g/10mL 68094-0041-61 Precision 10 cups AB FDA listed
Sucralfate oral suspension 1 g/10mL 68462-0827-61 Glenmark 420 ml AB FDA listed
sucralfate 1 g/10mL 72162-2479-02 Bryant 420 ml AB FDA listed
Sucralfate 1 g/10mL 81033-0149-44 Kesin 40 cups 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

🏛️
2019
On the market since
Dec 2019
📍
2026
Currently FDA-listed
7 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 65162-0062-05, 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
42K
Units reimbursed last 4 qtrs
26.6M
Gross reimbursed last 4 qtrs
$4.84M
Avg / prescription
$115.30
Avg / unit
$0.1821
Latest quarter Q4 2025
9.2KRx
Medicaid pays / mL
$0.1821
gross reimbursed
vs
NADAC / mL
$0.1209
acquisition cost
=
Spread
+$0.0612
+51% vs cost
What Medicaid paid per mL (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
46% FFS 54% MCO
Fee-for-service · 19,189 Rx Managed care · 22,804 Rx
State Medicaid map
Alaska: 167,894 units · 22,905 per 100k residents AK Maine: 38,664 units · 2,772 per 100k residents ME Washington: 626,257 units · 8,017 per 100k residents WA Idaho: 168,618 units · 8,585 per 100k residents ID Montana: 38,641 units · 3,414 per 100k residents MT North Dakota: no data reported ND Minnesota: 137,800 units · 2,402 per 100k residents MN Wisconsin: 409,595 units · 6,931 per 100k residents WI Michigan: 17,882 units · 178 per 100k residents MI New York: 1,203,455 units · 6,149 per 100k residents NY Vermont: 18,186 units · 2,811 per 100k residents VT New Hampshire: 121,351 units · 8,656 per 100k residents NH Oregon: 248,915 units · 5,880 per 100k residents OR Nevada: 472,091 units · 14,781 per 100k residents NV Wyoming: no data reported WY South Dakota: 13,221 units · 1,439 per 100k residents SD Iowa: 151,839 units · 4,735 per 100k residents IA Illinois: 586,740 units · 4,676 per 100k residents IL Indiana: 143,218 units · 2,087 per 100k residents IN Ohio: 1,004,664 units · 8,525 per 100k residents OH Pennsylvania: 1,098,430 units · 8,475 per 100k residents PA New Jersey: 75,114 units · 809 per 100k residents NJ Massachusetts: 444,694 units · 6,352 per 100k residents MA California: 7,390,268 units · 18,966 per 100k residents CA Utah: 70,682 units · 2,069 per 100k residents UT Colorado: 549,043 units · 9,341 per 100k residents CO Nebraska: 12,209 units · 617 per 100k residents NE Missouri: 672,382 units · 10,852 per 100k residents MO Kentucky: 657,122 units · 14,519 per 100k residents KY West Virginia: 295,804 units · 16,712 per 100k residents WV Virginia: 528,197 units · 6,060 per 100k residents VA Maryland: 171,467 units · 2,775 per 100k residents MD Connecticut: 326,137 units · 9,017 per 100k residents CT Rhode Island: no data reported RI Arizona: 222,879 units · 2,999 per 100k residents AZ New Mexico: 17,842 units · 844 per 100k residents NM Kansas: 68,816 units · 2,341 per 100k residents KS Arkansas: no data reported AR Tennessee: 107,109 units · 1,503 per 100k residents TN North Carolina: 1,018,753 units · 9,402 per 100k residents NC South Carolina: 238,152 units · 4,432 per 100k residents SC Delaware: 58,901 units · 5,713 per 100k residents DE Oklahoma: 266,843 units · 6,584 per 100k residents OK Louisiana: 961,587 units · 21,023 per 100k residents LA Mississippi: 244,410 units · 8,313 per 100k residents MS Alabama: 125,399 units · 2,455 per 100k residents AL Georgia: 563,336 units · 5,108 per 100k residents GA D.C.: 45,403 units · 6,687 per 100k residents DC Hawaii: no data reported HI Texas: 2,032,918 units · 6,665 per 100k residents TX Florida: 2,472,828 units · 10,937 per 100k residents FL
Units reimbursed · per 100k residents
17822,905
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 Alaska 22,905 /100k
2 Louisiana 21,023 /100k
3 California 18,966 /100k
4 West Virginia 16,712 /100k
5 Nevada 14,781 /100k
6 Kentucky 14,519 /100k
7 Florida 10,937 /100k
8 Missouri 10,852 /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.
42 ml this page65162-0062-05 41,993 Rx · $4,841,621
10 cups65162-0062-48 No Medicaid data
Drug total (last 4 qtrs): 41,993 Rx · 26,587,799 units · $4,841,621 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 Sucralfate — the program that covers self-administered drugs. 19 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 Sucralfate. 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
$26.89M
Claims incl. refills
567.6K
Beneficiaries
356.8K
Spend / beneficiary
$75.38
Spend / claim
$47.38
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 Sucralfate (this brand).

Top reported reactions

Nausea1,438
Diarrhoea1,040
Fatigue1,033
Pain930
Headache912
Vomiting820
Dyspnoea801

Age at onset

Infant6
Child29
Adolescent41
Adult1,326
Elderly1,197

Reporter sex

14,175 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization5,738
Death1,409
Life-threatening526
Disabling305
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,222 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
65162-0062-05 You're viewing this 420 mL in 1 BOTTLE (65162-062-05) $0.1209 / mL $50.76 2019-12-02 Active
65162-0062-48 10 CUP, UNIT-DOSE in 1 TRAY (65162-062-48) / 10 mL in 1 CUP, UNIT-DOSE (65162-062-47) 2019-12-02 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 65162-0062-05?
NDC 65162-0062-05 contains 420 mL — 420 ml in 1 bottle.
What NDC number is used to bill for this package of Sucralfate 1 g/10mL Suspension?
Bill NDC 65162-0062-05 — the 11-digit billing format is 65162006205. 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 20 words

INDICATIONS AND USAGE Sucralfate Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.

⏱️ Dosage and Administration 159 words

DOSAGE AND ADMINISTRATION Active Duodenal Ulcer: The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL) four times per day. Sucralfate Oral Suspension should be administered on an empty stomach. Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after Sucralfate Oral Suspension.

While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. Elderly: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see PRECAUTIONS Geriatric Use ). Call your doctor for medical advice about side effects.

You may report side effects to Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Contraindications 22 words

CONTRAINDICATIONS Sucralfate Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.

⚠️ Warnings 31 words

WARNINGS Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of Sucralfate Oral Suspension. Administer Sucralfate Oral Suspension only by the oral route. Do not administer intravenously.

🤒 Adverse Reactions 180 words

ADVERSE REACTIONS Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate, adverse effects were reported in 129 (4.7%). Constipation was the most frequent complaint (2%).

Other adverse effects reported in less than 0.5% of the patients are listed below by body system: Gastrointestinal: diarrhea, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting Dermatological: pruritus, rash Nervous System: dizziness, insomnia, sleepiness, vertigo Other: back pain, headache Post-marketing cases of hypersensitivity have been reported with the use of Sucralfate Oral Suspension, including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria.

Cases of bronchospasm, laryngeal edema and respiratory tract edema have been reported with an unknown oral formulation of sucralfate. Cases of hyperglycemia have been reported with sucralfate. Bezoars have been reported in patients treated with sucralfate.

The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.

🔄 Drug Interactions 168 words

Drug Interactions Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of sucralfate to chronic warfarin therapy.

The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from sucralfate binding to the concomitant agent in the gastrointestinal tract. In all cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Due to Sucralfate Oral Suspension's potential to alter the absorption of some drugs, Sucralfate Oral Suspension should be administered separately from other drugs when alterations in bioavailability are felt to be critical.

In these cases, patients should be monitored appropriately.

🤰 Pregnancy 68 words

Pregnancy Teratogenic effects Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

🧒 Pediatric Use 12 words

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 156 words

Geriatric Use Clinical studies of Sucralfate Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see DOSAGE AND ADMINISTRATION ).

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function (see PRECAUTIONS Special Populations: Chronic Renal Failure and Dialysis Patients ). Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage 83 words

OVERDOSAGE Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract.

Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.

🧬 Clinical Pharmacology 180 words

CLINICAL PHARMACOLOGY Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine. Although the mechanism of sucralfate’s ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action.

The following observations also appear pertinent: Studies in human subjects and with animal models of ulcer disease have shown that sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site. In vitro , a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions. In human subjects, sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.

In vitro , sucralfate adsorbs bile salts. These observations suggest that sucralfate’s antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts. There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1 g dose of sucralfate.

📦 How Supplied / Storage and Handling 73 words

HOW SUPPLIED Sucralfate Oral Suspension 1 g/10 mL is supplied as a pink colored, cherry flavored suspension available as follows: Bottle of 420 mL NDC 65162-062-05 10 mL unit dose cup NDC 65162-062-47 10 unit dose cups in a tray NDC 65162-062-48 SHAKE WELL BEFORE USING. AVOID FREEZING. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rx Only Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 07-2023-03

📋 Description 62 words

DESCRIPTION Sucralfate Oral Suspension contains sucralfate, USP and sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Sucralfate Oral Suspension for oral administration contains 1 g of sucralfate, USP per 10 mL. Sucralfate Oral Suspension also contains: cherry flavor, colloidal silicon dioxide, FD&C Red #40, glycerin, methylcellulose, methylparaben, microcrystalline cellulose, purified water, simethicone emulsion, and sorbitol solution.

Therapeutic category: antiulcer. Chemical Structure

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