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sucralfate (Carafate)

 

Classes: Gastrointestinal Agents, Other

Dosing and uses of Carafate (sucralfate)

 

Adult dosage forms and strengths

tablet

  • 1g

oral suspension

  • 1000mg/10mL

 

Duodenal Ulcer

1 g PO q6hr initially; maintenance: 1 g PO q12hr

Take on empty stomach 1 hour before or 2 hours after meals

 

Stress Ulcer (Off-label)

Prophylaxis

1 g PO q6hr for 4-8 weeks

Take on empty stomach 1 hour before or 2 hours after meals

 

Epidermolysis Bullosa (Orphan)

Treatment of oral ulcerations and dysphagia in patients with epidermolysis bullosa

Orphan indication sponsor

  • Darby Pharmaceuticals, Inc, 100 Banks Ave, Rockville Centre, NY 11570

 

Oral Complications After Bone Marrow Transplantation (Orphan)

Treatment of oral complications of chemotherapy in bone marrow transplant recipients

Orphan indication sponsor

  • Darby Pharmaceuticals, Inc, 100 Banks Ave, Rockville Centre, NY 11570

 

Dosing Modifications

Renal failure: Use with caution; aluminum salt may accumulate

 

Pediatric dosage forms and strengths

 

Active Duodenal Ulcer (Off-label)

40-80 mg/kg/day PO divided q6hr

 

Stomatitis (Off-label)

500-1000 mg PO q6hr; 1g/10mL suspension q6hr; swish and spit or swish and swallow the suspension

 

Gastric Ulcer (Off-label)

40-80 mg/kg/day PO divided q6hr or 0.5-1 g PO q6hr

 

Carafate (sucralfate) adverse (side) effects

1-10%

Constipation (2%)

 

<1%

Diarrhea

Dizziness

Dry mouth

Flatulence

Headache

Indigestion

Insomnia

Nausea

Vertigo

Vomiting

 

Frequency not defined

Bezoars formation

Gastrointestinal discomfort

 

Postmarketing Reports

Hypersensitivity reactions

Hyperglycemia

 

Warnings

Contraindications

Documented hypersensitivity

 

Cautions

Not expected to alter posthealing frequency of recurrence or severity of duodenal ulceration; acts locally at the ulcer

Do not take antacids within 30 minutes of sucralfate dose

Aluminum absorption is increased;, use with caution in patients with chronic renal failure or udnergoing dialysis

Potential significant drug interactions possible; consult drug interaction database

Use tablet with caution in patients with conditions that may impair swallowing, or with altered gag/cough reflex

Hyperglycemia has been reported when drug is used in patients with diabetes

Sucralfate may alter absorption of some drugs; take other medications 2 hours before taking sucralfate

 

Pregnancy and lactation

Pregnancy category: B

Lactation: Probably safe because drug is minimally absorbed; unknown whether drug is excreted in breast milk

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Carafate (sucralfate)

Mechanism of action

Forms ulcer-adherent complex; protects ulcer from acid, pepsin, and bile salts, thus allowing it to heaL

 

Absorption

Bioavailability: 5% (sucralfate is considered nonsystemic); sucrose octasulfate, 5%; aluminum, 0.005%

Onset: 1-2 hr

Duration: Up to 6 hr

 

Metabolism

Not metabolized

 

Elimination

Dialyzable: Yes

Excretion: Primarily urine (as unchanged drug)