Carafate Sucralfate 1 g Tablet, 100-count — NDC 58914-171-10 (Billing 58914-0171-10)
This is a package of 100 tablets of Carafate Sucralfate 1 g Tablet from Allergan, Inc., marketed since Oct 1981 and currently FDA-listed; retail pharmacies pay about $4.73 per tablet (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 58914-171-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 58914 labeler · 171 product · 10 package
- Package marketed since
- Oct 30, 1981
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 100 EA per package
- Barcode (UPC-A, from the NDC)
- 3 5891417110 2
- Medicaid fills, this package
- 12,369 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 002766
- GCN: 08200
- GPI-14 (Medi-Span): 49300010000305
- HICL (First Databank): 001186
- AHFS class code: 56:28.32.00
- RxCUI (RxNorm): 208097
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Aluminum Complex class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗- It treats an active duodenal ulcer, which is a sore in the first part of your small intestine. Treatment usually lasts up to 8 weeks. The tablets can also be used at a lower dose t...
- Take it by mouth on an empty stomach, as your prescriber directs. For an active ulcer, the label describes four doses a day. Keep going for the full course even if you feel better,...
- Yes, for pain relief if your doctor allows. Just keep them at least 30 minutes before or after your sucralfate dose.
- Constipation is the most common one, though most people have no trouble. Some get nausea, diarrhea, dry mouth, dizziness or a rash. Call your doctor if something bothers you or doe...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Sucralfate — tap one for details:
Sucralfate may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $4.731 | $473.08 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $4.68 | $468.31 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $4.87 | $487.29 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 58914-0171-10 You're viewing this Main listing | 100 TABLET in 1 BOTTLE | 1981-10-30 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sucralfate 1 g 00093-2210-01 | Teva | 100 tablets | $0.173 | AB | Availability likely | save 96% |
| Sucralfate 1 g 51079-0753-20 | Mylan | 100 tablets | $0.173 | AB | Availability likely | save 96% |
| Sucralfate 1 g 59762-0401-01 | Mylan | 100 tablets | $0.173 | AB | Availability likely | save 96% |
| Sucralfate 1 g 60219-1656-01 | Amneal | 100 tablets | $0.173 | AB | Availability likely | save 96% |
| Sucralfate 1 g 62135-0436-90 | Chartwell | 90 tablets | $0.173 | AB | Availability likely | save 96% |
| Sucralfate 1 g 69238-1656-01 | Amneal | 100 tablets | $0.173 | AB | Availability likely | save 96% |
| Sucralfate 1 g 72578-0081-01 | Viona | 100 tablets | $0.173 | AB | Availability likely | save 96% |
| Sucralfate 1 g 60687-0695-01 | American | 100 tablets | $0.179 | AB | Discontinued | save 96% |
| Carafate 1 gthis 58914-0171-10 | Allergan, | 100 tablets | $4.731 | AB | Availability likely | — |
| Sucralfate 1 g 00615-4517-30 | NCS | 30 tablets | — | AB | Discontinued | — |
| Sucralfate 1 g 00615-8653-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 42291-0936-90 | AvKARE | 90 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 48433-0091-20 | Safecor | 100 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 50090-5287-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 50090-6455-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 51407-0881-90 | Golden | 90 tablets | — | AB | Discontinued | — |
| Sucralfate 1 g 51655-0031-52 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 51655-0475-52 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 55154-4379-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 63629-1307-00 | Bryant | 28 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 63629-9152-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 63629-9153-01 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 67046-1469-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 67296-2147-04 | Redpharm | 40 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 68071-1749-01 | NuCare | 100 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 68071-3478-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 68071-3812-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 68788-8316-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 68788-8779-03 | Preferred | 30 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 68788-8946-01 | Preferred | 100 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 70771-1833-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 71335-2114-00 | Bryant | 28 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 71335-2461-00 | Bryant | 28 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 71335-2637-00 | Bryant | 28 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 71610-0017-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 71610-0541-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 72162-2264-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 72189-0234-20 | DIRECT | 20 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 72189-0429-20 | Direct_Rx | 20 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 80425-0091-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 80425-0188-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 80425-0213-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 80425-0377-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 82804-0063-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 82804-0102-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 87063-0176-01 | ASCLEMED | 100 tablets | — | AB | FDA listed | — |
| Sucralfate 1 g 55154-0281-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 6, 2026
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.
🧪 Avoiding an ingredient? See Sucralfate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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115 mg
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.
-
1.25 mg
UNII 2S42T2808B
A synthetic red dye used as a colorant to give the medicine its red color. It helps make pills or liquids visually distinct and easier to identify.
-
0.16 mg
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
-
12 mg
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
76.59 mg
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient 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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Allergan, Inc. labeler code 58914
- Carafate Sucralfate 1 g/10mL Suspension NDC 58914-170-14
- sucralfate 1 g Tablet NDC 58914-172-00
- Rectiv nitroglycerin 4 mg/g Ointment NDC 58914-301-80
- Canasa Mesalamine 1000 mg Suppository NDC 58914-501-33
- Urso 250 Ursodiol 250 mg Tablet, Film Coated NDC 58914-785-10
- Urso Forte Ursodiol 500 mg Tablet, Film Coated NDC 58914-790-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDI C A T I O N S A ND U S A G E CARAFATE ® (sucralfate) is indicated in: Short-term treatment (up to 8 weeks) of active duodenal ulcer. 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. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
⏱️ Dosage and Administration ▾
D O S A G E A N D A D M INI S T R A T I O N A cti v e D u oden a l Ulc e r : The recommended adult oral dosage for duodenal ulcer is 1 g four times per day 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. 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.
M ain t enance T he r ap y : The recommended adult oral dosage is 1 g twice a day. 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 AbbVie, Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
⛔ Contraindications ▾
C O N T R A INDI C A T I O NS Carafate is contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.
🤒 Adverse Reactions ▾
A D VE R S E R E A C T I O NS Adverse reactions to sucralfate in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate tablets, 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: G a s t r oin t e s t inal: diarrhea, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth De r ma t olo g i c a l: pruritus, rash Ne r v ous S y s t em: dizziness, insomnia, sleepiness, vertigo Ot he r : back pain, headache P os t- ma r k e t in g : cases of hypersensitivity have been reported with the use of sucralfate tablets, including dyspnea, lip swelling, pruritus, rash, and urticaria. Cases of anaphylactic reactions, bronchospasm, laryngeal edema, edema of the mouth, Pharyngeal edema, respiratory tract edema and swelling of the face have been reported with an unknown oral formulation of 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. Inadvertent injection of insoluble sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli.
Sucralfate is n ot intended for intravenous administration.
🔄 Drug Interactions ▾
Drug In t e r a c t io n s 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 case studies to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Because of the potential of CARAFATE to alter the absorption of some drugs, CARAFATE 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 ▾
Pr eg n an c y T e r at o genic e ff e c t s 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 ▾
P edia t r ic U se Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
G e r iatr i c U s e Clinical studies of CARAFATE (sucralfate) Tablets 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 ▾
O VE RD OS A G E Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral toxicity 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 ▾
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 ▾
H O W S U P P LI E D CARAFATE (sucralfate) 1 g tablets are supplied in bottles of 100 (NDC 58914-171-10). Light pink, scored, oblong tablets are embossed with CARAFATE on one side and 1712 on the other. Storage Store at Controlled room temperature 59-86°F (15-30°C).
Rx Only Prescribing Information rev. May 2024 Distributed by: AbbVie, Inc. North Chicago, IL 60064 © 2024 AbbVie.
All rights reserved. CARAFATE and its design are trademarks of Aptalis Pharma Canada ULC, an AbbVie company.
📦 Storage and Handling ▾
Storage Store at Controlled room temperature 59-86°F (15-30°C). Rx Only Prescribing Information rev. May 2024 Distributed by: AbbVie, Inc. North Chicago, IL 60064 © 2024 AbbVie. All rights reserved. CARAFATE and its design are trademarks of Aptalis Pharma Canada ULC, an AbbVie company.
📋 Description ▾
D E S CRI P T I O N CARAFATE Tablets contain sucralfate and sucralfate is an α-D-glucopyranoside, β-D- fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Tablets for oral administration contain 1 g of sucralfate. Also contain: D & C Red #30 Lake, FD&C Blue #1 Lake, magnesium stearate, microcrystalline cellulose, and starch.
Therapeutic category: antiulcer. CARAFATE Tablets contain sucralfate and sucralfate is an α-D-glucopyranoside, β-D- fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
⚠️ Precautions ▾
P R E C A U T I O NS The physician should read the “ PRECAUTIONS ” section when considering the use of this drug in pregnant or pediatric patients, or patients of childbearing potential. Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with sucralfate can result in complete healing of the ulcer, a successful course of treatment with sucralfate should not be expected to alter the post healing frequency or severity of duodenal ulceration.
Isolated reports of sucralfate tablet aspiration with accompanying respiratory complications have been received. Therefore, sucralfate tablets should be used with caution by patients who have known conditions that may impair swallowing, such as recent or prolonged intubation, tracheostomy, prior history of aspiration, dysphagia, or any other conditions that may alter gag and cough reflexes, or diminish oropharyngeal coordination or motility. S pe c i al P opulati o ns: C h r onic Renal Failu r e a nd Di a l y s i s P atien t s When sucralfate is administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract.
Concomitant use of sucralfate with other products that contain aluminum, such as aluminum-containing antacids, may increase the total body burden of aluminum. Patients with normal renal function receiving the recommended doses of sucralfate and aluminum-containing products adequately excrete aluminum in the urine. Patients with chronic renal failure or those receiving dialysis have impaired excretion of absorbed aluminum.
In addition, aluminum does not cross dialysis membranes because it is bound to albumin and transferrin plasma proteins. Aluminum accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal impairment. Sucralfate should be used with caution in patients with chronic renal failure.
Drug In t e r a c t io n s 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 case studies to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Because of the potential of CARAFATE to alter the absorption of some drugs, CARAFATE should be administered separately from other drugs when alterations in bioavailability are felt to be critical.
In these cases, patients should be monitored appropriately. Ca r cin o g enes i s, M u t agene s is, Im p a i r me n t of Ferti li t y Chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1 g/kg (12 times the human dose). There was no evidence of drug-related tumorigenicity.
A reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of fertility impairment. Mutagenicity studies were not conducted. Pr eg n an c y T e r at o genic e ff e c t s 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 shou… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
N u r sing M o t he r s It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sucralfate is administered to a nursing woman.
🔬 Clinical Studies ▾
CLINICAL TRIALS Acute Duodenal Ulcer Over 600 patients have participated in well-controlled clinical trials worldwide. Multicenter trials conducted in the United States, both of them placebo-controlled studies with endoscopic evaluation at 2 and 4 weeks, showed: STUDY 1 T r e a t me n t G r oups Ulc e r H e al i ng/ No. P at i en t s 2 w k 4 w k ( O v e r al l ) Sucralfate Placebo 37/105 (35.2%) 26/106 (24.5%) 82/109 (75.2%) 68/107 (63.6%) STUDY 2 T r e a t me n t G r oups Ulc e r H e aling/ No.
P at i en t s 2 w k 4 w k ( O v e r al l ) Sucralfate Placebo 8/24 (33%) 4/31 (13%) 22/24 (92%) 18/31 (58%) The sucralfate-placebo differences were statistically significant in both studies at 4 weeks but not at 2 weeks. The poorer result in the first study may have occurred because sucralfate was given 2 hours after meals and at bedtime rather than 1 hour before meals and at bedtime, the regimen used in international studies and in the second United States study. In addition, in the first study liquid antacid was utilized as needed, whereas in the second study antacid tablets were used.
M ain t enance T he r apy A f t er H e al i ng of Duoden a l U l c e r Two double-blind randomized placebo-controlled U.S. multicenter trials have demonstrated that sucralfate (1 g bid) is effective as maintenance therapy following healing of duodenal ulcers. In one study, endoscopies were performed monthly for 4 months. Of the 254 patients who enrolled, 239 were analyzed in the intention-to-treat life table analysis presented below.
D u odenal U l c e r Rec u rr e n ce Rate ( % ) Months of Therapy Drug n 1 2 3 4 CARAFATE Placebo 122 117 20* 33 30* 46 38† 55 42† 63 * P <0.05,† P <0.01 In this study, prn antacids were not permitted. In the other study, scheduled endoscopies were performed at 6 and 12 months, but for-cause endoscopies were permitted as symptoms dictated. Median symptom scores between the sucralfate and placebo groups were not significantly different.
A life table intention-to-treat analysis for the 94 patients enrolled in the trial had the following results: D u odenal U l c e r Rec u rr e n ce Rate ( % ) Drug n 6 months 12 months CARAFATE Placebo 48 46 19* 54 27* 65 * P <0.002 In this study, prn antacids were permitted. Data from placebo-controlled studies longer than 1 year are not available.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Ca r cin o g enes i s, M u t agene s is, Im p a i r me n t of Ferti li t y Chronic oral toxicity studies of 24 months’ duration were conducted in mice and rats at doses up to 1 g/kg (12 times the human dose). There was no evidence of drug-related tumorigenicity. A reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of fertility impairment. Mutagenicity studies were not conducted.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 58914-171-10 Carafate ® (sucralfate) Tablets 1 gram 100 Tablets abbvie PRINCIPAL DISPLAY PANEL NDC 58914-171-10 Carafate® (sucralfate) Tablets 1 gram 100 Tablets abbvie