Carafate 1mg: Carafate Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing
Carafate Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing
Uses
This medication is used to treat and prevent 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 Carafate oral
Take this medicine by mouth on an empty stomach (at least 1 hour before a meal) as directed by your doctor, usually 2 to 4 times daily. The dosage is based on your medical condition and response to treatment.
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. Keep 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 lasts or gets worse after you have been taking sucralfate for 4 weeks.
Side Effects
Constipation, dry mouth, upset stomach, gas, and nausea may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.
Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: an unusual feeling of fullness in the stomach that doesn’t go away, nausea/vomiting/stomach pain especially after meals, difficulty swallowing.
A very serious allergic reaction to this drug is rare.
However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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, swallowing problems (such as difficulty swallowing, history of aspiration), stomach/intestine problems (such as delayed gastric emptying), tube feeding, use of a breathing tube (tracheotomy).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be at greater risk for developing high aluminum levels while using this drug with other products that contain aluminum (such as antacids).
If you are pregnant, tell your doctor before using sucralfate.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Interactions
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Some products that may interact with this drug include: antacids that contain aluminum, certain antibiotics (for example, quinolones such as ciprofloxacin/levofloxacin/ofloxacin, tetracyclines), digoxin, ketoconazole, levoketoconazole, penicillamine, phenytoin, quinidine, thyroid medications (such as levothyroxine, liothyronine).
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Overdose
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Your doctor may recommend some lifestyle changes such as stress-reducing programs, diet changes and exercise to assist in treatment and prevention of ulcers.
Do not share this medication with others.
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. Take your next dose at the regular time. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.
Images
Carafate 1 gram tablet
Color: light pinkShape: oblongImprint: CARAFATE 17 12
This medicine is a light pink, oblong, scored, tablet imprinted with “CARAFATE” and “17 12”.
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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals.
The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Carafate: Package Insert – Drugs.com
Package insert / product label
Generic name: sucralfate
Dosage form: oral suspension
Drug class: Miscellaneous GI agents
Medically reviewed by Drugs.com. Last updated on Jan 1, 2023.
On This Page
- Description
- Clinical Pharmacology
- Clinical Studies
- Indications and Usage
- Contraindications
- Warnings
- Precautions
- Drug Interactions
- Adverse Reactions/Side Effects
- Overdosage
- Dosage and Administration
- How Supplied/Storage and Handling
Carafate Description
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 emulsion USP, and sorbitol solution USP. Therapeutic category: antiulcer.
Carafate – Clinical Pharmacology
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:
- 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.
- In vitro, a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions.
- 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 1 g dose of sucralfate.
Clinical Trials
In a multicenter, double-blind, placebo-controlled study of Carafate Oral Suspension, a dosage regimen of 1 gram (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 Oral 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 oral suspension to sucralfate tablets has not been demonstrated.
Indications and Usage for Carafate
Carafate (sucralfate) Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
Contraindications
Carafate Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.
Warnings
Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of Carafate Oral Suspension. Administer Carafate Oral Suspension only by the oral route. Do not administer intravenously.
Precautions
The physician should read the “PRECAUTIONS” section when considering the use of Carafate Oral Suspension 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 Carafate Oral Suspension is recommended. Adjustment of the anti-diabetic treatment dose during the use of Carafate Oral 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.
Drug 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 Oral Suspension’s potential to alter the absorption of some drugs, Carafate Oral Suspension should be administered separately from other drugs when alterations in bioavailability are felt to be critical. In these cases, patients should be monitored appropriately.
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
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 Oral 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.
ADVERSE REACTIONS
Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 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 oral 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.
Overdosage
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.
DOSAGE AND ADMINISTRATION
Active Duodenal Ulcer: The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL) four times per day. Carafate Oral Suspension 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 Carafate Oral Suspension.
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 Allergan USA, Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.
fda.gov/medwatch.
HOW SUPPLIED
Carafate (sucralfate) Oral Suspension 1 g/10 mL is a pink suspension supplied in bottles of 420 mL (NDC 58914-170-14).
SHAKE WELL BEFORE USING. AVOID FREEZING.
Store at controlled room temperature 20-25°C (68-77°F) [see USP].
Rx Only
Prescribing Information rev. Jan 2023
Distributed by:
Allergan USA, Inc.
Madison, NJ 07940
Carafate® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate.
® 2023 Allergan. All rights reserved.
Allergan® and its design are trademarks of Allergan, Inc.
v2.0USPI0170
PRINCIPAL DISPLAY PANEL
NDC 58914-170-14
Carafate
(sucralfate)
Oral
Suspension
1g/ 10mL
| Carafate sucralfate suspension | ||||||||||||||||||||
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40
7 mL in 1 CUP, UNIT-DOSE| Labeler – Allergan, Inc. (144796497) |
Allergan, Inc.
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Sucralfate – description of the substance, pharmacology, use, contraindications, formula
Contents
Structural formula
Russian name
English title
Latin name
chemical name
Gross formula
Pharmacological group of the substance Sucralfate
Nosological classification
CAS code
pharmachologic effect
Characteristic
Pharmacology
Application of the substance Sucralfate
Contraindications
Use during pregnancy and lactation
Side effects of sucralfate
Interaction
Dosage and administration
Precautionary measures
Trade names with the active substance Sucralfate
Structural formula
Russian name
Sucralfate
English name
Sucralfate
Latin name
Sucralfatum ( born 90 060 Sucralfati)
Chemical name
beta-D-Fructofuranosyl-alpha-D-glucopyranoside octakis (hydrosulfate) aluminum complex
Gross formula
C 12 HmAl 16 OnS 8
Pharmacological group of substance Sucralfate
Gastroprotectors
Nosological classification
ICD-10 code list
CAS code
54182-58-0
Pharmacological action
Pharmacological action –
absorbent , antacid , gastroprotective , enveloping , antiulcer .
Feature
White hygroscopic amorphous powder. Easily soluble in dilute acids, practically insoluble in water.
Pharmacology
In the acidic environment of the stomach (at pH below 4) decomposes into aluminum and sucrose sulfate; the former denatures mucus proteins, and the latter combines with them, fixes on the necrotic masses of the ulcerative lesion, forms a protective film, which is a barrier to the action of pepsin, hydrochloric acid and bile. Adsorbs bile acids, waste products of the microflora of the gastrointestinal tract, reduces the local inflammatory process.
The gel firmly covers the ulcerative surface in the stomach and duodenum for 6 hours. It interacts slightly with the normal mucous membrane.
Up to 5% of the disaccharide component and less than 0.02% of aluminum are absorbed in the gastrointestinal tract. It is excreted mainly with faeces, a small amount of sulfate disaccharide (entering the systemic circulation) is excreted by the kidneys.
Application of the substance Sucralfate
Gastric and duodenal ulcer (prevention and treatment), damage to the gastrointestinal mucosa due to stress or NSAIDs (prevention and treatment), hyperacid gastritis, gastroesophageal reflux disease, hyperphosphatemia in patients with uremia who are on hemodialysis.
Contraindications
Hypersensitivity, dysphagia or obstruction of the gastrointestinal tract, bleeding from the gastrointestinal tract, severe renal failure, children under 4 years of age.
Use during pregnancy and lactation
Use with caution during pregnancy and lactation.
FDA fetal category B.
Side effects of Sucralfate
Dyspepsia, constipation or diarrhea, pain (abdominal, back, headache), dizziness, drowsiness, dry mouth, nausea, skin rash and itching, urticaria.
Interaction
Reduces the absorption of fluoroquinolones (including moxifloxacin, ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), tetracyclines, theophylline, phenytoin.
Increases (mutually) the toxicity of drugs containing aluminum (especially in patients with renal insufficiency). The activity of sucralfate is reduced by antacids, blockers of histamine H 2 receptors.
Dosage and administration
Inside, 30-60 minutes before meals and at night; adults – 0.5-1 g 4 times a day (before breakfast, lunch, dinner and at night) or 1 g in the morning and evening; the maximum daily dose is 8–12 g; course of treatment – 4-6 weeks, if necessary – up to 12 weeks.
Children – 0.5 g 4 times a day.
Precautions
Serum aluminum and phosphate levels should be monitored in patients with renal insufficiency – drowsiness and seizures may indicate aluminum toxicity. When combined, antacids should be administered 30 minutes before or 30 minutes after sucralfate. Administration via a nasogastric tube may result in the formation of a bezoar with other drugs or parenteral nutrition solutions (due to the ability to bind protein).
Trade names with the active substance Sucralfate
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powder substance
Dosage
No dosage
Manufacturer
Zhejiang Haisen Pharmaceutical Co.
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Can a dog take famotidine long-term?
In conclusion, these results suggest that famotidine loses its effectiveness as an acid suppressant over time when administered twice daily to dogs. Therefore, caution is advised in recommending long-term oral administration of famotidine to dogs.
Pepsid® is a short acting medicine that lasts up to 24 hours. In dogs with kidney or liver disease, the duration may be longer.
Although this drug is not approved by the FDA for use in animals, it is commonly used off label in dogs. Famotidine for dogs is generally safe and it is very rare for dogs to experience any side effects.
Famotidine oral tablet is used for the long-term treatment of Zollinger-Ellison syndrome and the maintenance of ulcer healing. Famotidine oral tablet is used for the short-term treatment of gastroesophageal reflux disease (GERD) and duodenal and stomach ulcers.
Do not use famotidine in pets that are allergic to it. Use with caution in geriatric pets with liver, kidney or heart disease. Be careful with pregnant or lactating animals.
Pepcid dosage for dogs: For both dogs and cats, the dose is one 10-milligram tablet for a 20-pound dog every 12-24 hours, says Dr. Klein. It is best to give this medicine one hour before meals.
It was concluded that 7-year treatment of dogs with omeprazole at a dose resulting in clinically significant plasma concentrations did not cause any adverse effects in any of the animals.
Consult your veterinarian if you have any concerns before or after your procedure about vomiting or acid reflux in your dog. Allergen irritation: If your dog is allergic to something in the food, it can cause acid reflux.
Common dog allergens include gluten, soy, and GMOs.
Chicken and rice are the main ingredients in many dog foods, and these bland foods are good for indigestion in dogs. In addition, this simple dish is easy to prepare. All you need is skinless and boneless chicken breasts and rice.
Supportive and symptomatic treatment often includes stomach medications. Famotidine, omeprazole, and sucralfate (or carafate) help reduce acidity and soothe irritation in the stomach.
Famotidine Deficiency Linked to Heartburn Drug Recalls and COVID-19 Research.
PPIs are effective and some, such as lansoprazole (Prevacid) and omeprazole (Prilosec), are readily available without a prescription. Others, such as pantoprazole (Protonix), are often prescribed for long-term use.
Therefore, the safest medicine for acid reflux is the one that works best for you with the fewest side effects. Compared with famotidine, omeprazole may have an increased risk of side effects such as osteoporosis, especially with long-term use.