Sucralfate

Do Other Drugs Affect the Way Sucralfate Works?

Sucralfate can bind to drugs in the stomach and reduce their absorption, so some medicines should be taken at least two hours prior to sucralfate. Sucralfate may reduce the absorption of:

• Cimetidine (Tagamet)
• Digoxin (Lanoxin)
• Ketoconazole (Nizoral)
• Levothyroxine (Synthroid)
• Phenytoin (Dilantin)
• Quinidine (Quinidex, Quinaglute)
• Ranitidine (Zantac)
• Tetracycline
• Theophylline (Theo-Dur, Uniphyl, others)
• Fluoroquinolone antibiotics, including ciprofloxacin (Cipro), norfloxacin (Noroxin), ofloxacin (Floxin) and lomefloxacin (Maxaquin)
• Warfarin (Coumadin)
• Other medications to lower stomach acid such as omeprazole (Prilosec), pantoprazole (Protonix), lansoprazole (Prevacid), and dexlansoprazole (Dexilant)

It is possible that many other drugs will interact with sucralfate, so you should tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs or supplements you are taking.

Should I Avoid Any Food, Drink or Activity While Taking Sucralfate?

Tobacco may block the beneficial effects of sucralfate, so you should not smoke or chew tobacco when taking this drug.

Sucralfate is a prescription medication used for short-term treatment of ulcers. Sucralfate belongs to a group of drugs called anti-ulcer agent, which work by sticking to the ulcer and protecting it against acid and enzymes so that the ulcer can heal.

This medication comes in tablet and oral (by mouth) suspension forms and is taken 2 or 4 times a day on an empty stomach.

Common side effects of sucralfate include constipation, upset stomach, and indigestion.

Sucralfate is a prescription medication used for the treatment of active duodenal ulcers for up to 8 weeks. Duodenal ulcers are ulcers located in the first section of the small intestine.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take sucralfate on an empty stomach, at least 1 hour before or 2 hours after a meal.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Use this medication for the full prescribed length of time. Your symptoms may improve before the ulcer is completely healed.

Store at room temperature away from moisture and heat.

Effects on GI Absorption of Drugs

May bind to a number of drugs in the GI tract, reducing extent of absorption.a b c Instruct patients to administer other drugs at least 2 hours before sucralfate and monitor patients appropriately if alteration in bioavailability of the other drug(s) is critical.a b c

Specific Drugs

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Sucralfate is used to treat and prevent duodenal ulcers. sucralfate may also be used for other conditions as determined by your doctor.

Sucralfate works by forming a ``barrier'' or ``coating'' over the ulcer. This protects the ulcer from the acid of the stomach, allowing it to heal. Sucralfate contains an aluminum salt.

sucralfate is available only with your doctor's prescription.

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.

Special Populations: Chronic Renal Failure and Dialysis Patients

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 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 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 Sucralfate to alter the absorption of some drugs, Sucralfate should be administered separately from other drugs when alterations in bioavailability are felt to be critical.  In these cases, patients should be monitored appropriately.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

Pregnancy

Teratogenic effects. Pregnancy Category B.

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.

Nursing Mothers

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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of 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.

Sucralfate 1-g tablets are supplied in bottles of 90, 100, 360 and 500. Light blue, scored, oblong tablets are engraved WATSON 780 on one side and are blank with bisect on the other.

Rx Only

Prescribing Information rev. March 2017

Distributed by:
Allergan USA, Inc.
Irvine, CA 92612

© 2017 Allergan. All rights reserved.

• Carafate

Treatment of duodenal ulcer: Oral:

Initial treatment: 1 g 4 times daily on an empty stomach for 4-8 weeks

Maintenance/prophylaxis of duodenal ulcer: 1 g twice daily

Refer to adult dosing.

Take with water on an empty stomach.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience constipation. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Applies to sucralfate: compounding powder, oral suspension, oral tablet

General

The most commonly reported side effect was constipation.[Ref]

Gastrointestinal

Common (1% to 10%): Constipation
Uncommon (0.1% to 1%): Dry mouth, nausea
Rare (0.01% to 0.1%): Bezoar formation
Frequency not reported: Diarrhea, vomiting, gastric discomfort, indigestion, flatulence
Postmarketing reports: Lip swelling, mouth edema[Ref]

Bezoars were reported in patients with enteral feedings, delayed gastric emptying, and/or low birthweight neonates.[Ref]

Nervous system

Encephalopathy occurred in patients with chronic renal impairment and/or on long-term treatment.

Cerebral emboli occurred in patients receiving IV administration.[Ref]

Common (1% to 10%): Headache
Frequency not reported: Dizziness, drowsiness/sleepiness, vertigo, encephalopathy
Postmarketing reports: Cerebral emboli[Ref]

Dermatologic

Uncommon (0.1% to 1%): Urticaria
Rare (0.01% to 0.1%): Rash
Frequency not reported: Pruritus[Ref]

Musculoskeletal

Osteodystrophy and osteomalacia occurred in patients with chronic renal impairment and/or on long-term treatment.[Ref]

Frequency not reported: Back pain, osteodystrophy, osteomalacia[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reaction, hypersensitivity reactions[Ref]

Respiratory

Pulmonary edema occurred after IV administration.[Ref]

Frequency not reported: Dyspnea
Postmarketing reports: Bronchospasm, laryngeal edema, pharyngeal edema, respiratory tract edema, pulmonary emboli[Ref]

Other

Frequency not reported: Thirst
Postmarketing reports: Face edema[Ref]

Hematologic

Anemia occurred in patients with chronic renal impairment and/or on long-term treatment.[Ref]

Frequency not reported: Anemia[Ref]

Psychiatric

Frequency not reported: Insomnia[Ref]

Metabolic

Frequency not reported: Hyperglycemia[Ref]

Cardiovascular

Frequency not reported: Edema[Ref]

Some side effects of sucralfate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

• The usual dosage for ulcer treatment is four times daily on an empty stomach (at least an hour before food and at bedtime). Take as directed by your doctor. Continue for the duration recommended or until x-ray or endoscopic exam confirms ulcer healing.
• You may also take antacids while using sucralfate; however, do not take antacids within a half-hour of a dose of sucralfate.