GENERIC NAME: sucralfate BRAND NAME: Carafate

DRUG CLASS AND MECHANISM: Sucralfate is a unique oral drug. Chemically, it is a complex of the disaccharide sugar, sucrose, combined with sulfate and aluminum. It is minimally absorbed into the body, and its actions are entirely on the lining of the stomach and duodenum. Although its mechanism is not entirely understood, the following actions are thought to be important for its beneficial effects: 1. sucralfate binds to the surface of ulcers (attaching to exposed proteins) and coats the ulcer, thus protecting the ulcer surface to some extent from further injury by acid and pepsin; 2. sucralfate directly inhibits pepsin (an enzyme that breaks apart proteins) in the presence of stomach acid; 3. sucralfate binds bile salts coming from the liver via the bile thus protecting the stomach lining from injury caused by the bile acids; 4. sucralfate may increase prostaglandin production, and prostaglandins are known to protect the lining of the stomach. Sucralfate was approved by the FDA in 1981. PRESCRIPTION: yes GENERIC AVAILABLE: yes PREPARATIONS: Oblong tablets (pink): 1 gram; pink- colored suspension (1 gram per 2 teaspoonsful). STORAGE: Tablets and suspension should be kept at room temperature, between 15 and 30C (59-86F). The suspension should not be frozen and should be shaken prior to each use. PRESCRIBED FOR: Sucralfate is used for the treatment of peptic ulcer disease and to prevent recurrent ulcers after healing of the ulcer has been achieved. It also has been used to relieve or prevent the ulcers caused bynonsteroidal anti-inflammatory drugs (NSAIDs) but is less effective thanmisoprostol (Cytotec). Sucralfate also is used in the treatment of patients with gastroesophageal reflux disease (GERD) who are prone to get ulcers in the esophagus, and to prevent ulcers associated with high degrees of physical stress (e.g. extensive burns, surgery, and overwhelming infection.) among hospitalized patients. DOSING: Sucralfate generally is given four times daily for treating ulcerations and twice daily for preventing ulcers. It is recommended that it be taken on an empty stomach, at least one hour prior to meals, for best coating of the ulcers. DRUG INTERACTIONS: Sucralfate reduces the absorption of many drugs when taken at the same time as the other drugs. These drugs include:cimetidine (Tagamet), digoxin (Lanoxin), ketoconazole (Nizoral), levothyroxine (Synthroid), phenytoin (Dilantin), quinidine (Quinidex, Quinaglute), ranitidine (Zantac), tetracycline, theophylline (Theo-Dur, Uniphyl, others), and all of the fluoroquinolone antibiotics, includingciprofloxacin (Cipro), norfloxacin (Noroxin), ofloxacin (Floxin),

and lomefloxacin (Maxaquin). All of these medications should be taken at least two hours prior to the sucralfate. It is possible, if not likely, that many other drugs will interact similarly with sucralfate. Therefore, it probably is prudent to take all medications at least 2 hours prior to sucralfate. PREGNANCY: Sucralfate itself is not teratogenic in animals, even in doses considerably higher than those used in humans. Although some animal data demonstrate concern for the effects of aluminum during pregnancy, all human data show no ill-effect on the fetus. Sucralfate is considered safe during pregnancy. NURSING MOTHERS: Minimal if any sucralfate penetrates into breast milk because so little is absorbed from the gastrointestinal tract. Although there is no data, sucralfate is considered safe in nursing mothers. SIDE EFFECTS: Sucralfate is well tolerated. Constipation is the most frequent side effect and occurs in 1 of every 50 patients who take sucralfate

Sucralfate Side Effects

Brand Names: Carafate Please note - some side effects for Sucralfate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
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Side Effects of Sucralfate - for the Consumer Sucralfate

All medicines may cause side effects, but many people have no, or minor, side effects.Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sucralfate: Constipation; dizziness; lightheadedness. Seek medical attention right away if any of these SEVERE side effects occur when using Sucralfate: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Sucralfate Suspension
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sucralfate Suspension: Constipation; dizziness; feeling of a whirling motion. Seek medical attention right away if any of these SEVERE side effects occur when using Sucralfate Suspension: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); symptoms of high blood sugar (eg, confusion; increased thirst, hunger, or urination; severe drowsiness; unusual weakness). This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
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Sucralfate Side Effects - for the Professional Sucralfate

Adverse reactions to Sucralfate in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with Sucralfate tablets, adverse effects were reported in 129 (4.7%). Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system:
Gastrointestinal

diarrhea, nausea, vomiting, gastric discomfort, indigestion, flatulence, dry mouth

Dermatological

pruritus, rash
Nervous System

dizziness, insomnia, sleepiness, vertigo

Other

back pain, headache Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving Sucralfate tablets. Similar events were reported with Sucralfate suspension. However, a causal relationship has not been established. Bezoars have been reported in patients treated with Sucralfate. The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings. Inadvertent injection of insoluble Sucralfate and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate is not intended for intravenous administration. Brand Names: Carafate Generic Name: sucralfate (oral) (Pronunciation: soo KRAL fate)
y y y y y y y y y y What is sucralfate (Carafate)? What are the possible side effects of sucralfate (Carafate)? What is the most important information I should know about sucralfate (Carafate)? What should I discuss with my healthcare provider before taking sucralfate (Carafate)? How should I take sucralfate (Carafate)? What happens if I miss a dose (Carafate)? What happens if I overdose (Carafate)? What should I avoid while taking sucralfate (Carafate)? What other drugs will affect sucralfate (Carafate)? Where can I get more information?

What is sucralfate (Carafate)?

Sucralfate is an anti-ulcer medication. Sucralfate is not greatly absorbed into the body through the digestive tract. It works mainly in the lining of the stomach by adhering to ulcer sites and protecting them from acids, enzymes, and bile salts. Sucralfate is used to treat an active duodenal ulcer. Sucralfate can heal an active ulcer, but it will not prevent future ulcers from occurring. Sucralfate may also be used for other purposes not listed in this medication guide.

Carafate 1 gram

oblong, pink, imprinted with CARAFATE, 17 12

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What are the possible side effects of sucralfate (Carafate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Less serious side effects may include: y y y y y y y y nausea, vomiting,indigestion; stomach pain; constipation,diarrhea; mild itching or skin rash; sleep problems (insomnia); dizziness, drowsiness, spinning sensation; headache; or back pain. This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about sucralfate (Carafate)?
Before taking sucralfate, tell your doctor if you have kidney disease (or if you are on dialysis). You may need a dose adjustment or special tests to safely take sucralfate. Take sucralfate on an empty stomach, at least 1 hour before or 2 hours after a meal. Take sucralfate for the full prescribed length of time. Your symptoms may improve before the ulcer is completely cleared. Avoid taking any other medications at the same time you take sucralfate. It is best not to take other medicines within 2 hours before or after taking sucralfate.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for sucralfate to work in your stomach. If your doctor does recommend using an antacid, avoid taking it within 30 minutes before or after taking sucralfate.

What should I discuss with my healthcare provider before taking sucralfate (Carafate)?
Before taking sucralfate, tell your doctor if you have kidney disease (or if you are on dialysis). You may need a dose adjustment or special tests to safely take sucralfate. FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether sucralfate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take sucralfate (Carafate)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Take sucralfate with a full glass of water. 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. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Take this medication for the full prescribed length of time. Your symptoms may improve before the ulcer is completely cleared. Store sucralfate at room temperature away from moisture and heat.

What happens if I miss a dose (Carafate)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Carafate)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of sucralfate is not likely to produce life-threatening symptoms.

What should I avoid while taking sucralfate (Carafate)?

Avoid taking any other medications at the same time you take sucralfate. It is best not to take other medicines within 2 hours before or after taking sucralfate. Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for sucralfate to work in your stomach. If your doctor does recommend using an antacid, avoid taking it within 30 minutes before or after taking sucralfate.

What other drugs will affect sucralfate (Carafate)?

Taking sucralfate can make it harder for your body to absorb many other medications, especially: y y y y y y y y y y cimetidine (Tagamet); digoxin (digitalis, Lanoxin); levothyroxine (Synthroid); phenytoin (Dilantin); quinidine (Quinaglute, Quinidex, Quin-Release); ranitidine (Zantac); tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); theophylline (Elixophyllin, Respbid, Slo-Bid, Theo-Dur, and others); a blood thinner such as warfarin (Coumadin); or certain antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), lomefloxacin (Maxaquin), ketoconazole (Nizoral), and others.