Drugs Details

Drugs Info of Carafate
Drugs Details
  • Drugs Type  : FDA
  • Date : 6th Jan 2015 02:44 am
  • Brand Name : Carafate
  • Generic Name : sucralfate (oral) (Pronunciation: soo KRAL fate)
Descriptions

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

 

CARAFATE® (sucralfate) Structural Formula Illustration

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

CARAFATE 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.

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; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • nausea, vomiting, upset stomach;
  • 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. Call your doctor for medical advice about side...

Read All Potential Side Effects and See Pictures of Carafate Suspension »

What are the precautions when taking sucralfate (Carafate Suspension)?

Before taking sucralfate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, stomach/intestine problems (e.g., delayed gastric emptying), tube feeding.

Kidney function declines as you grow older. This medication contains aluminum, which is normally removed by your kidneys. Therefore, elderly people may be at greater risk for developing high aluminum levels while using this drug with other products that contain aluminum (e.g., antacids).

If you are pregnant, tell your...

Read All Potential Precautions of Carafate Suspension »

This monograph has been modified to include the generic and brand name in many instances.

Indications

CARAFATE (sucralfate) Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.

Dosage Administration

Active Duodenal Ulcer

The recommended adult oral dosage for duodenal ulcer is 1 g (10 mL/2 teaspoons) four times per day. CARAFATE should be administered on an empty stomach. Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate.

While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by X-ray or endoscopic examination.

Elderly

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 PRECAUTIONS Geriatric Use).

Call your doctor for medical advice about side effects. You may report side effects to Aptalis Pharma US, Inc. at 1-800-472-2634 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

How Supplied

CARAFATE (sucralfate) Suspension 1 g/10 mL is a pink suspension supplied in bottles of 14 fl oz (NDC 58914-170-14).

SHAKE WELL BEFORE USING. AVOID FREEZING.

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

Aptalis Pharma US, Inc. 100 Somerset Corporate Boulevard, Bridgewater, NJ 08807 USA. Prescribing Information rev. March 2013

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2,700 patients treated with sucralfate, 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, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting

Dermatological: pruritus, rash

Nervous System: dizziness, insomnia, sleepiness, vertigo

Other: back pain, headache

Post-marketing cases of hypersensitivity have been reported with the use of sucralfate suspension, including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria.

Cases of bronchospasm, laryngeal edema and respiratory tract edema have been reported with an unknown oral formulation of sucralfate.

Cases of hyperglycemia have been reported with sucralfate.

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.

Read the Carafate Suspension (sucralfate) Side Effects Center for a complete guide to possible side effects

Learn More »

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 cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Due to CARAFATE`s potential to alter the absorption of some drugs, CARAFATE should be administered separately from other drugs when alterations in bioavailability are felt to be critical. In these cases, patients should be monitored appropriately.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

No information provided.

Precautions

The physician should read the “PRECAUTIONS” section when considering the use of Carafate 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.

Episodes of hyperglycemia have been reported in diabetic patients. Close monitoring of glycemia in diabetic patients treated with sucralfate suspension is recommended. Adjustment of the anti-diabetic treatment dose during the use of sucralfate suspension might be necessary.

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.

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 CARAFATE Suspension 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.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.

ContrainDications

Carafate is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Sucralfate is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine.

Although the mechanism of sucralfate's ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action. The following observations also appear pertinent:

  1. Studies in human subjects and with animal models of ulcer disease have shown that sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site.
  2. In vitro, a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions.
  3. In human subjects, sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.

In vitro, sucralfate adsorbs bile salts.

These observations suggest that sucralfate's antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts. There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1g dose of sucralfate.

Clinical Trials

In a multicenter, double-blind, placebo-controlled study of CARAFATE Suspension, a dosage regimen of 1 g (10 mL) four times daily was demonstrated to be superior to placebo in ulcer healing.

Results from Clinical Trials Healing Rates for Acute Duodenal Ulcer

Treatment n Week 2 Healing Rates Week 4 Healing Rates Week 8 Healing Rates
CARAFATE Suspension 145 23 (16%)* 66 (46%)† 95 (66%)‡
Placebo 147 10 (7%) 39 (27%) 58 (39%)
*P=0.016
†P=0.001
‡P=0.0001

Equivalence of sucralfate suspension to sucralfate tablets has not been demonstrated.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

SUCRALFATE SUSPENSION - ORAL

 

(sue-KRAL-fate)

 

COMMON BRAND NAME(S): Carafate

 

USES: This medication is used to treat ulcers in the intestines. Sucralfate forms a coating over ulcers, protecting the area from further injury. This helps ulcers heal more quickly.

 

HOW TO USE: Shake the bottle well before each dose. Take this medicine by mouth, usually 2 teaspoonfuls 4 times daily, on an empty stomach at least 1 hour before a meal, or as directed by your doctor.

The dosage is based on your medical condition and response to therapy.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. It is important to continue taking this medication even if you do not feel ulcer pain. Do not stop taking this medication without consulting your doctor. It may take 4 to 8 weeks for your ulcer to heal completely.

Some medications may not work as well if you take them at the same time as sucralfate. They may need to be taken at a different time of the day than the time you take sucralfate. Ask your doctor or pharmacist for help making a dosing schedule that will work with all your medications.

Antacids can be used with this medicine, but they should be taken at least 30 minutes before or after sucralfate.

Inform your doctor if your condition persists or worsens after you have been taking sucralfate for 4 weeks.

Consumer Overview Side Effect

SIDE EFFECTS: Constipation, dry mouth, upset stomach, gas, and nausea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if these unlikely but serious side effects occur: an unusual/persistent feeling of fullness in the stomach, nausea/vomiting/stomach pain especially after meals.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Carafate Suspension (sucralfate) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking sucralfate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, stomach/intestine problems (e.g., delayed gastric emptying), tube feeding.

Kidney function declines as you grow older. This medication contains aluminum, which is normally removed by your kidneys. Therefore, elderly people may be at greater risk for developing high aluminum levels while using this drug with other products that contain aluminum (e.g., antacids).

If you are pregnant, tell your doctor before using sucralfate.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antacids that contain aluminum, certain antibiotics (e.g., quinolones such as ciprofloxacin/levofloxacin/ofloxacin, tetracyclines), cimetidine, digoxin, ketoconazole, penicillamine, phenytoin, quinidine, ranitidine, theophylline, thyroid medications (e.g., levothyroxine, liothyronine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Your doctor may recommend some lifestyle changes such as stress-reducing programs, diet changes and exercise to assist in treatment and prevention of ulcers. This medicine should not be injected into your veins. Do not share this medication with others.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Carafate

Generic Name: sucralfate (oral) (Pronunciation: soo KRAL fate)

  • What is sucralfate (Carafate Suspension)?
  • What are the possible side effects of sucralfate (Carafate Suspension)?
  • What is the most important information I should know about sucralfate (Carafate Suspension)?
  • What should I discuss with my healthcare provider before taking sucralfate (Carafate Suspension)?
  • How should I take sucralfate (Carafate Suspension)?
  • What happens if I miss a dose (Carafate Suspension)?
  • What happens if I overdose (Carafate Suspension)?
  • What should I avoid while taking sucralfate (Carafate Suspension)?
  • What other drugs will affect sucralfate (Carafate Suspension)?
  • Where can I get more information?

What is sucralfate (Carafate Suspension)?

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 purposes not listed in this medication guide.

Carafate 1 gram

oblong, pink, imprinted with CARAFATE, 17 12

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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • nausea, vomiting, upset stomach;
  • 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Carafate Suspension (sucralfate) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about sucralfate (Carafate Suspension)?

Before taking sucralfate, tell your doctor if you have diabetes, kidney disease, or if you are on dialysis.

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

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

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

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids 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.

Side Effects Centers
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Patient Detailed How Take

What should I discuss with my healthcare provider before taking sucralfate (Carafate Suspension)?

To make sure you can safely take sucralfate, tell your doctor if you have any of these other conditions:

  • diabetes;
  • kidney disease; or
  • if you are on dialysis.

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 Suspension)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Take this medicine 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.

Side Effects Centers
  • Carafate
  • Carafate Suspension

Patient Detailed Avoid Taking

What happens if I miss a dose (Carafate Suspension)?

Take the missed dose as soon as you remember, but avoid taking any other medications within 2 hours after you take sucralfate. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Carafate Suspension)?

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

What should I avoid while taking sucralfate (Carafate Suspension)?

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

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids 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 Suspension)?

Sucralfate can make it harder for your body to absorb other medications you take by mouth. Tell your doctor if you are taking:

  • cimetidine (Tagamet);
  • digoxin (digitalis, Lanoxin);
  • levothyroxine (Synthroid);
  • phenytoin (Dilantin);
  • quinidine (Quin-G);
  • ranitidine (Zantac);
  • tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);
  • theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl, and others);
  • a blood thinner such as warfarin (Coumadin, Jantoven); or
  • certain antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), lomefloxacin (Maxaquin), ketoconazole (Nizoral), and others.

This list is not complete and other drugs may interact with sucralfate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about sucralfate.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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