In the U.S.—

In Canada—

• Antiulcer agent
• Gastric mucosa protectant

Sucralfate (soo-KRAL-fate ) is used to treat and prevent duodenal ulcers. This medicine 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.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Oral suspension (U.S. and Canada)
• Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sucralfate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to sucralfate. Also, tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in humans. However, sucralfate has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—Sucralfate has not been shown to cause problems in nursing babies.

Children—This medicine has been tested in a limited number of children. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of sucralfate in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking sucralfate, it is especially important that your health care professional know if you are taking the following:

• Ciprofloxacin or
• Digoxin or
• Norfloxacin or
• Ofloxacin or
• Phenytoin or
• Theophylline—Sucralfate may prevent these medicines from working properly

• Gastrointestinal tract obstruction disease—Sucralfate may bind with other foods and drugs and cause obstruction of the gastrointestinal tract

• Kidney failure—Use may lead to a toxic increase of aluminum blood levels

Sucralfate is best taken with water on an empty stomach 1 hour before meals and at bedtime, unless otherwise directed by your doctor.

Take this medicine for the full time of treatment, even if you begin to feel better. Also, it is important that you keep your doctor's appointments for check-ups so that your doctor will be better able to tell you when to stop taking this medicine.

Dosing—

The dose of sucralfate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of sucralfate. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets or teaspoonfuls of suspension that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking sucralfate.

• For oral dosage form (suspension):
  • To treat duodenal ulcers:
    • Adults and teenagers—One gram four times a day, one hour before each meal and at bedtime. Some people may take two grams two times a day, when they wake up and at bedtime on an empty stomach.
    • Children—Dose must be determined by your doctor.
• For oral dosage form (tablets):
  • To treat duodenal ulcers:
    • Adults and teenagers—One gram four times a day, one hour before each meal and at bedtime.
    • Children—Dose must be determined by your doctor.
  • To prevent duodenal ulcers:
    • Adults and teenagers—One gram two times a day on an empty stomach.
    • Children—Dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Antacids may be taken with sucralfate to help relieve any stomach pain, unless your doctor has told you not to use them. However, antacids should not be taken within 30 minutes before or after sucralfate. Taking these medicines too close together may keep sucralfate from working properly.

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.

Check with your doctor immediately if any of the following side effects occur:

• Signs of aluminum toxicity
  • Drowsiness;  convulsions (seizures) 
  
  

Check with your doctor as soon as possible if any of the following side effects continue or are bothersome:

• More common
  • Constipation 
  
  

• Less common or rare
  • Backache;  diarrhea;  dizziness or lightheadedness;  dryness of mouth;  indigestion;  nausea;  skin rash, hives, or itching;  stomach cramps or pain  
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, sucralfate is used in certain patients with the following medical conditions:

• Gastric ulcers
• Gastroesophageal reflux disease (a condition in which stomach acid washes back into the esophagus)
• Stomach or intestinal ulcers resulting from stress or trauma damage or from damage caused by medication used to treat rheumatoid arthritis

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.