Carafate

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What Are the Typical Dosages for Sucralfate?

The recommended dose of sucralfate for treating active ulcers is 1 gram, four times a day for four to eight weeks. The recommended dose for preventing ulcers from recurring is 1 gram, twice a day.

This drug is given on an empty stomach, at least one hour before a meal.

What Happens if I Take too Much Sucralfate and Overdose?

If you suspect an overdose, you should contact a poison control center or emergency room immediately. You can get in touch with a poison control center at (800) 222-1222.

What Happens if I Miss a Dose of Sucralfate or Don't Take It as Prescribed?

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 return to your regular dosing schedule. Do not double up on doses.

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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)

Carafate 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.

Serious side effects have been reported with Carafate including the following:

• Aluminum toxicity. Too much aluminum can build up in your body if you take Carafate with antacids that contain aluminum (see the "Carafate Interactions" section for examples). This can occur especially in those with reduced kidney function.

Do not take Carafate if you are allergic to Carafate or to any of its ingredients.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Carafate falls into category B. There are no well-done studies that have been done in humans with Carafate . But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Sucralfate can make it harder for your body to absorb other medications you take by mouth. Avoid taking any other medications within 2 hours before or after you take sucralfate.

Other drugs may interact with sucralfate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Duodenal Ulcer

Short-term (up to 8 weeks) treatment of active duodenal ulcer.a b c

Maintenance of healing and reduction in recurrence of duodenal ulcer.a c

Conventional antiulcer therapy, including sucralfate therapy, is associated with a high rate of ulcer recurrence (e.g., 60–100% per year) in patients with initial or recurrent duodenal ulcer and documented Helicobacter pylori infection.100 132 136 140 144 146 154 All such patients should receive anti-infective therapy for treatment of the infection;128 132 144 145 146 choice of a particular regimen should be based on current data on optimal therapy.128 132 140 145 165 166

Efficacy of short-term sucralfate similar to that of cimetidine in adults with duodenal ulcer.a

Gastric Ulcer

Short-term treatment of gastric ulcer†.a

Conventional antiulcer therapy, including sucralfate therapy, is associated with a high rate of ulcer recurrence (e.g., 60–100% per year) in patients with initial or recurrent gastric ulcer and documented H. pylori infection.100 132 136 140 144 146 154 All such patients should receive anti-infective therapy for treatment of the infection;128 132 144 145 146 choice of a particular regimen should be based on current data on optimal therapy.128 132 140 145 165 166

Chemotherapy-induced Mucositis

Has been used as an oral suspension† for prevention and treatment of chemotherapy-induced mucositis†.100 101 102 103 104 108 Results have been conflicting;101 additional study necessary.100 104 106 107

Contraindications

• Manufacturer states that there are no known contraindications to use of sucralfate.b c

Warnings/Precautions

General Precautions

Although sucralfate may result in complete ulcer healing, it does not alter the post-healing frequency or severity of duodenal ulceration; duodenal ulcer is a chronic, recurrent disease.a b c

Do not administer IV; may cause fatal complications, including pulmonary and cerebral emboli.a b c

Formation of bezoars reported, primarily in patients with underlying predisposing medical conditions (e.g., delayed gastric emptying) or those receiving concomitant enteral tube feedings.a b c

Specific Populations

Category B.b c

Not known whether sucralfate is distributed into milk.a b c Caution if used in nursing women.a b c

Safety and efficacy not established.a b c

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.b

Substantially eliminated by kidneys; assess renal function periodically since geriatric patients are more likely to have decreased renal function.b

Use with caution in patients with chronic renal failure or those undergoing dialysis; possible impaired excretion of absorbed aluminum.109 a b c

Possible aluminum accumulation and toxicity (e.g., aluminum osteodystrophy, osteomalacia, encephalopathy) in patients with renal impairment.a b c

Common Adverse Effects

Constipation.a b c

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

This section provides information on the proper use of a number of products that contain sucralfate. It may not be specific to Carafate. Please read with care.

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):
  • 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

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.

Carafate Oral Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.

Carafate Oral Suspension for oral administration contains 1 g of sucralfate per 10 mL.

Carafate Oral Suspension also contains: colloidal silicon dioxide NF, FD&C Red #40, flavor, glycerin USP, methylcellulose USP, methylparaben NF, microcrystalline cellulose NF, purified water USP, simethicone USP, and sorbitol solution USP. Therapeutic category: antiulcer.

Carafate (sucralfate) Oral Suspension 1 g/10 mL is a pink suspension supplied in bottles of 420 mL (NDC 58914-170-14).

Store at controlled room temperature 20-25°C (68-77°F)[see USP].

Rx Only

Prescribing Information rev. - August 2017

Distributed by:

Allergan USA, Inc.

Irvine, CA 92612

Carafate® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate.

® 2017 Allergan. All rights reserved.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.