Carafate

Sucralfate 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.

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

This product is available in the following dosage forms:

• Suspension
• Tablet

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 this medicine, the following should be considered:

1. Allergies:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

2. Pediatric Population:

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.

3. Geriatric Population:

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.

4. Pregnancy

All Trimesters: Category B: Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

5. Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

6. Drug Interactions

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ketoconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ciprofloxacin
• Digoxin
• Dolutegravir
• Fleroxacin
• Gemifloxacin
• Grepafloxacin
• Moxifloxacin
• Norfloxacin
• Ofloxacin
• Sparfloxacin
• Trovafloxacin Mesylate
• Warfarin

7. Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

8. Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine 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 using the medicine.

• For oral dosage form (suspension):

o 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):

o 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.

o 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions to take:

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.

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. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.