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Sucralfate

Carafate

An oral ulcer-surface protectant with product-specific duodenal-ulcer indications and important binding interactions.

Therapeutic class
Local gastrointestinal protectant
Selected brand
Carafate
Reference focus
U.S. 1 g tablets and 1 g / 10 mL oral suspension
Essential safety

Oral only; review renal function and medicine spacing.

Never inject sucralfate. Aluminum accumulation can harm patients with chronic renal failure or dialysis. Binding may reduce other medicines’ absorption; a universal two-hour rule is not supported.

Warnings and precautions
01

Indications

The selected products treat active duodenal ulcer; maintenance labeling differs.

Labeled uses

Both products have short-term active duodenal-ulcer treatment labeling, up to eight weeks. Tablets also have maintenance treatment after healing at a reduced dose. The suspension label does not establish that maintenance regimen or equivalence to tablets.

Scope

This profile does not supply an H. pylori eradication, gastric-ulcer, reflux, stress-ulcer prevention or compounded/tube regimen. Sucralfate treats the ulcer surface; it does not by itself establish elimination of an underlying cause or prevention of recurrence.

02

Dosage and administration

Adult treatment is taken on an empty stomach.

Adult selected regimens

Product / purposeRegimen and limit
Tablets: active duodenal ulcer1 g orally four times daily on an empty stomach; continue 4–8 weeks unless healing is demonstrated by x-ray or endoscopy
Suspension: active duodenal ulcer1 g (10 mL) orally four times daily on an empty stomach; same 4–8 week healing-directed course
Tablets: maintenance after healing1 g orally twice daily; do not extrapolate this indication to suspension

Administration and spacing

Shake suspension well before measuring. The selected concentration is 1 g / 10 mL. Antacids may be used for pain as prescribed, but not within thirty minutes before or after sucralfate. Resolve other medicines’ timing individually; the studied two-hour-before result is not an instruction for every drug.

Dose limitations

Pediatric safety and effectiveness are unestablished. No numeric renal or hepatic adjustment schedule is supplied; renal aluminum risk can make simple dose extrapolation unsafe. Elderly dose selection should be cautious. No independently verified missed-dose, crushing or enteral-tube protocol is supplied.

03

Safety

Renal aluminum risk, aspiration and bezoars matter despite low absorption.

Warnings and precautions

Inappropriate IV administration has caused fatal pulmonary and cerebral emboli; suspension is explicitly oral only. Chronic renal failure and dialysis impair aluminum removal: accumulation can cause bone disease and encephalopathy. Additional aluminum antacids increase burden. Bezoars have occurred, especially with delayed gastric emptying or enteral feeding. Tablets have aspiration/respiratory complications in swallowing impairment or compromised airway reflexes. Suspension has reports of hyperglycemia in diabetes; monitor glucose and review treatment adjustment.

Contraindications

Known hypersensitivity to sucralfate or product ingredients is contraindicated. Renal failure is a labeled caution requiring careful selection, rather than an invented universal creatinine-clearance contraindication.

Boxed warning status

Neither selected Carafate label has a boxed warning. The absence of a box does not reduce the seriousness of inappropriate injection, allergy or renal aluminum toxicity.

Adverse reactions

Constipation is the most frequent reported trial complaint. Other reported effects include nausea, diarrhea, vomiting, dyspepsia, dry mouth, dizziness, headache and rash. Postmarketing reports include airway/facial swelling, bronchospasm and anaphylactic reactions; formulation attribution is not always known. Bezoars and aspiration are clinically important complications.

04

Drug interactions

Local binding can reduce clinically important drug absorption.

Binding interactions

Reported affected medicines include digoxin, fluoroquinolones, levothyroxine, phenytoin, tetracyclines, ketoconazole, quinidine, theophylline and selected H2 blockers. These are label examples, including legacy products; not all require identical spacing. Administering selected studied medicines two hours before sucralfate eliminated those studied interactions, but this was not demonstrated universally.

Warfarin and aluminum

Subtherapeutic prothrombin-time case reports with warfarin contrast with two studies showing no effect; monitor anticoagulation where clinically appropriate without predicting a guaranteed INR direction. Aluminum-containing antacids add to renal aluminum burden; preserve the separate thirty-minute antacid administration restriction.

05

Use in specific populations

Human pregnancy, milk and pediatric evidence are limited.

Pregnancy and lactation

There are no adequate controlled pregnancy studies; animal findings do not establish human safety. Use in pregnancy only when clearly needed under clinical review. Excretion in human milk is unknown and the labels advise caution during breastfeeding.

Children and older adults

Safety and effectiveness in pediatric patients have not been established. Older-adult clinical information is limited; consider concurrent diseases, medicines and reduced renal function when selecting treatment and monitoring.

Renal and hepatic considerations

Use cautiously in chronic renal failure or dialysis because absorbed aluminum cannot be adequately cleared. Protein-bound aluminum does not cross dialysis membranes; dialysis is not a reason to dismiss accumulation. The labels provide no numeric hepatic adjustment or validated renal dose table.

06

Clinical pharmacology

Sucralfate forms a local protective complex at the ulcer surface.

Mechanism

An ulcer-adherent complex with proteinaceous exudate provides a barrier to acid, pepsin and bile salts. The exact healing mechanism is not fully defined; the effect is predominantly local.

Disposition

Gastrointestinal absorption is minimal. Absorbed sulfated disaccharide is principally excreted in urine; some aluminum is absorbed, explaining renal toxicity concerns. The suspension label specifically states that clinical equivalence to tablets has not been demonstrated.

07

Monitoring and counseling

Monitor healing, tolerability and medicines with critical bioavailability.

Monitoring and counseling

Review ulcer response and the planned course, constipation, swallowing ability, renal function and aluminum exposures. In diabetes using suspension, monitor glucose. Review the whole medicine schedule with a pharmacist, especially thyroid replacement, seizure medicines, antibiotics or anticoagulation. Shake and measure suspension accurately; never inject.

Overdose and urgent symptoms

Seek medical or Poison Control advice for excessive dosing or concerning symptoms. Human overdose experience is limited and the labels provide no specific treatment recommendation; animal tolerance is not a safe human threshold. Report severe abdominal symptoms, airway swelling or breathing difficulty urgently.

08

Product identification

Identify the actual product before applying its directions.

Representative products

Tablet
AbbVie Carafate 1 g
Tablet appearance
Light pink, scored, oblong; CARAFATE / 1712
Tablet package
Bottle 100 · NDC 58914-171-10
Suspension
Pink 1 g / 10 mL; bottle 420 mL · NDC 58914-170-14

Dosage forms and strengths

Selected tablets contain 1 g sucralfate; selected oral suspension contains 1 g per 10 mL. Check all inactive ingredients for allergy. No compounded concentration, opened-tablet stability or enteral-tube recipe is verified here.

Storage and handling

Tablets: controlled room temperature 15–30°C. Suspension: 20–25°C; avoid freezing and shake well before use. Follow the actual dispensed container and expiry; do not infer a universal post-opening or compounded beyond-use date.

09

References

Original sources for the clinical and product information.

  1. DailyMed / AbbVieCarafate tablets · Full prescribing information

    Current SPL version 17, effective 2024-05-21.

  2. DailyMed / AbbVieCarafate oral suspension · Full prescribing information

    Current SPL version 20, effective 2023-06-08.

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