How does Carafate work to treat and prevent ulcers. What are the common side effects of Carafate. How should Carafate be taken for maximum effectiveness. What precautions should be considered when using Carafate. What potential drug interactions exist with Carafate.

Understanding Carafate: A Powerful Ulcer Treatment

Carafate, also known by its generic name sucralfate, is a medication primarily used to treat and prevent ulcers in the intestines. This powerful drug works by forming a protective coating over ulcers, shielding the affected area from further damage and promoting faster healing. Its unique mechanism of action makes it an essential tool in managing gastrointestinal health.

Are you curious about how Carafate achieves its therapeutic effects? The medication adheres to the ulcer site, creating a barrier that protects the damaged tissue from stomach acid and other irritants. This protective layer allows the body’s natural healing processes to work more effectively, leading to quicker recovery and relief from ulcer-related symptoms.

Proper Usage and Dosage Guidelines for Carafate

To maximize the benefits of Carafate, it’s crucial to follow the prescribed dosage and administration guidelines. The medication is typically taken orally on an empty stomach, at least one hour before meals. The usual dosage ranges from 2 to 4 times daily, but your doctor will determine the most appropriate regimen based on your specific medical condition and response to treatment.

Why is it important to take Carafate on an empty stomach? Taking the medication without food allows it to adhere more effectively to the ulcer site, enhancing its protective properties. Consistency is key when using Carafate, so try to take it at the same times each day to maintain a steady level of protection.

Duration of Treatment and Expectations

Patients should be prepared for a treatment course lasting 4 to 8 weeks for complete ulcer healing. It’s essential to continue taking Carafate as prescribed, even if ulcer pain subsides. Discontinuing the medication prematurely may hinder the healing process and increase the risk of ulcer recurrence.

Is it normal to experience immediate relief from ulcer symptoms when taking Carafate? While some patients may notice improvements relatively quickly, it’s important to understand that the full healing process can take several weeks. Patience and adherence to the prescribed regimen are crucial for achieving optimal results.

Navigating Potential Side Effects of Carafate

Like all medications, Carafate can cause side effects in some patients. Common side effects include constipation, dry mouth, upset stomach, gas, and nausea. These effects are generally mild and often resolve on their own as the body adjusts to the medication.

• Constipation
• Dry mouth
• Upset stomach
• Gas
• Nausea

When should you be concerned about side effects from Carafate? If any of these effects persist or worsen, it’s important to consult your doctor or pharmacist promptly. They can provide guidance on managing side effects or adjust your treatment plan if necessary.

Recognizing Serious Side Effects

While rare, some patients may experience more serious side effects that require immediate medical attention. These can include:

• Unusual feeling of fullness in the stomach that doesn’t subside
• Persistent nausea, vomiting, or stomach pain, especially after meals
• Difficulty swallowing

How can you differentiate between normal side effects and those requiring medical intervention? Pay close attention to the severity and duration of symptoms. If you experience any of the serious side effects listed above or notice signs of an allergic reaction (such as rash, itching, swelling, severe dizziness, or trouble breathing), seek medical help immediately.

Important Precautions and Considerations for Carafate Use

Before starting Carafate, it’s crucial to inform your healthcare provider about any allergies, medical conditions, or medications you’re currently taking. This information helps ensure the safe and effective use of the medication while minimizing the risk of adverse reactions or interactions.

What specific medical conditions might affect Carafate use? Patients with kidney problems, swallowing difficulties, stomach or intestinal issues (such as delayed gastric emptying), or those using feeding tubes or breathing tubes should discuss these conditions with their doctor before starting Carafate.

Special Considerations for Older Adults

Older adults may be at higher risk of developing elevated aluminum levels when using Carafate in combination with other aluminum-containing products, such as certain antacids. Healthcare providers should carefully monitor these patients and consider alternative treatment options if necessary.

How can older adults minimize the risk of aluminum toxicity while using Carafate? Discuss all medications and supplements with your doctor, including over-the-counter antacids. Your healthcare provider may recommend spacing out the doses of Carafate and aluminum-containing products or suggest alternative treatments to reduce the risk of complications.

Navigating Drug Interactions with Carafate

Carafate can interact with various medications, potentially altering their effectiveness or increasing the risk of side effects. It’s essential to inform your healthcare provider about all the products you use, including prescription drugs, over-the-counter medications, and herbal supplements.

Which medications are most likely to interact with Carafate? Some common interactions include:

• Aluminum-containing antacids
• Certain antibiotics (e.g., quinolones, tetracyclines)
• Digoxin
• Ketoconazole and levoketoconazole
• Penicillamine
• Phenytoin
• Quinidine
• Thyroid medications (e.g., levothyroxine, liothyronine)

How can you manage potential drug interactions while taking Carafate? Your doctor or pharmacist may recommend taking certain medications at different times of the day to avoid interactions with Carafate. For example, some drugs may need to be taken at least 2 hours before or after Carafate to ensure proper absorption.

Antacids and Carafate: Timing Is Key

While antacids can be used in conjunction with Carafate, proper timing is crucial to maintain the effectiveness of both medications. Antacids should be taken at least 30 minutes before or after Carafate to avoid interference with its protective coating properties.

Why is it important to space out antacid and Carafate doses? Antacids can potentially reduce the effectiveness of Carafate by altering the pH of the stomach or interfering with its ability to adhere to the ulcer site. By taking these medications at different times, you can ensure that both drugs work optimally to manage your symptoms and promote healing.

Managing Carafate Treatment: Tips for Success

To get the most benefit from your Carafate treatment, consider the following tips:

1. Adhere to the prescribed dosing schedule
2. Take Carafate on an empty stomach
3. Space out other medications as directed by your healthcare provider
4. Monitor for side effects and report any concerns to your doctor
5. Complete the full course of treatment, even if symptoms improve
6. Attend follow-up appointments to assess your progress

How can you ensure you’re taking Carafate correctly? Consider setting reminders on your phone or using a pill organizer to help you stay on track with your dosing schedule. If you have any questions or concerns about your treatment, don’t hesitate to reach out to your healthcare provider for guidance.

Monitoring Treatment Progress

It’s important to keep your doctor informed about your progress while taking Carafate. If your symptoms persist or worsen after four weeks of treatment, contact your healthcare provider. They may need to reassess your condition and adjust your treatment plan accordingly.

What signs indicate that Carafate is working effectively? While individual experiences may vary, you may notice a gradual reduction in ulcer-related pain and discomfort. However, it’s important to remember that complete healing can take several weeks, even if symptoms improve sooner.

Carafate in Special Populations: Pregnancy and Breastfeeding

If you are pregnant or planning to become pregnant, it’s crucial to discuss Carafate use with your doctor before starting treatment. While limited data is available on the effects of Carafate during pregnancy, your healthcare provider can help weigh the potential risks and benefits based on your individual situation.

Is Carafate safe to use while breastfeeding? The safety of Carafate during breastfeeding has not been definitively established. It’s unknown whether the medication passes into breast milk or if it could potentially affect a nursing infant. Consult your doctor before using Carafate if you are breastfeeding to determine the best course of action for you and your baby.

Alternative Treatment Options

In some cases, your healthcare provider may recommend alternative treatments for ulcers, especially if you’re pregnant or breastfeeding. These may include:

• Proton pump inhibitors (PPIs)
• H2 receptor antagonists
• Antacids
• Dietary and lifestyle modifications

How do these alternatives compare to Carafate in terms of effectiveness and safety? Each treatment option has its own set of benefits and potential risks. Your doctor will consider factors such as the severity of your condition, your overall health, and any other medications you’re taking when recommending the most appropriate treatment approach.

Handling Carafate Overdose: What You Need to Know

While Carafate overdose is rare, it’s important to be aware of the signs and know how to respond in case of accidental overuse. If someone has taken too much Carafate and is experiencing severe symptoms such as difficulty breathing or loss of consciousness, call emergency services immediately.

What should you do if you suspect a Carafate overdose but symptoms are not severe? Contact your local poison control center for guidance. In the United States, you can reach the poison control center at 1-800-222-1222. Canadian residents can contact their provincial poison control center for assistance.

Preventing Accidental Overdose

To minimize the risk of Carafate overdose, follow these precautions:

• Always take Carafate exactly as prescribed by your doctor
• Keep track of your doses using a medication log or app
• Store Carafate out of reach of children and pets
• Never share your medication with others
• Dispose of unused or expired medication properly

How can you safely dispose of unused Carafate? Check with your local pharmacy or healthcare provider for medication take-back programs in your area. If no such programs are available, you can typically dispose of Carafate in household trash after mixing it with an undesirable substance (such as used coffee grounds) and sealing it in a plastic bag.

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 not known 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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Drug Survey

Are you currently using Carafate oral?

This survey is being conducted by the WebMD marketing sciences department.

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.

What is the Difference Between Antacid and Sucralfate

The key difference between antacid and sucralfate is that antacids are useful in neutralizing stomach acidity, whereas sucralfate is useful in treating stomach ulcers.

Antacids and sucralfate are important medications that treat conditions related to the stomach. However, antacids are not useful for serious conditions in the stomach, while sucralfate is useful for severe conditions such as stomach ulcers.

CONTENTS

1. Overview and Key Difference
2. What is Antacid
3. What is Sucralfate
4. Antacid vs Sucralfate in Tabular Form
5. Summary – Antacid vs Sucralfate

What is Antacid?

Antacids are a medication we use to neutralize stomach acidity and relieve heartburns, indigestion, and upset stomach. We take these medicines orally (by mouth) to quickly relieve occasional heartburns and other symptoms of indigestion. Moreover, these drugs cannot kill the bacteria Helicobacter pylori, which can cause stomach ulcers.

When there are excessive amounts of acid in our stomach, it can damage the natural mucous barrier that protects the inner wall of the stomach. Antacids contain alkaline ions, which can neutralize this gastric acid. It reduces the damage to the stomach and relieves pain as well. Some common antacids include Alka-seltzer, Maalox, Mylanta, Rolaids, and Tums.

Figure 01: Calcium Carbonate Tablets as Antacids

Most of the time, this medication is safe for people. But there can be some side effects as well. For example, antacids containing magnesium may cause diarrhoea. Brands containing calcium may cause constipation. Long time use may cause kidney diseases as well. Long-term use of brands with aluminium can cause a person to get osteoporosis as well.

What is Sucralfate?

Sucralfate is a medication useful in treating stomach ulcers, gastroesophageal reflux disease, radiation proctitis, and stomach inflammation. Moreover, it can be used to prevent stress ulcers. The trade name of this drug is Carafate. The routes of administration of sucralfate are oral administration and rectal administration. The bioavailability of this medication is about 3 – 5%. The metabolism of sucralfate occurs in the liver, and the excretion occurs through feces and urine.

Figure 02: The Chemical Structure of Sucralfate

There are some common side effects of sucralfate, which include constipation, bezoar formation, and encephalopathy. Apparently, the use of this drug during pregnancy and breastfeeding is safe. Although the mode of action of this drug is not well-known, it appears to be involved in binding to the ulcer and protecting it from further damage.

In addition to treating stomach ulcers, sucralfate is also useful in treating active duodenal ulcers, gastric ulcers, aphthous ulcers and stomatitis, stress ulcer prophylaxis, proctitis from ulcerative colitis, rectal bleeding, treating anastomotic ulcers after gastric bypass surgery, etc.

What is the Difference Between Antacid and Sucralfate?

Antacids and sucralfate are important medications that treat conditions related to the stomach. The key difference between antacid and sucralfate is that antacids are useful in neutralizing stomach acidity, whereas sucralfate is useful in treating stomach ulcers. Antacids are used to neutralize stomach acidity and to relieve heartburns, indigestion, and upset stomachs, while sucralfate is useful in treating stomach ulcers, gastroesophageal reflux disease, radiation proctitis, and stomach inflammation.

The below infographic presents the differences between antacid and sucralfate in tabular form for side by side comparison.

Summary – Antacid vs Sucralfate

Antacids are a medication we use to neutralize stomach acidity and to relieve heartburns, indigestion, and upset stomach. Sucralfate is a medication useful in treating stomach ulcers, gastroesophageal reflux disease, radiation proctitis, and stomach inflammation. The key difference between antacid and sucralfate is that antacids are useful in neutralizing stomach acidity, whereas sucralfate is useful in treating stomach ulcers.

Reference:

1. “Sucralfate Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing.” WebMD.
2. “Sucralfate: Medlineplus Drug Information.” MedlinePlus, U.S. National Library of Medicine.
3. “Carafate Tablets (Sucralfate): Uses, Dosage, Side Effects, Interactions, Warning.” RxList.

Image Courtesy:

1. “Antacid-L478” By Midnightcomm – Own work (CC BY 2.5) via Commons Wikimedia
2. “Sucralfate” By Edgar181 – Own work (Public Domain) via Commons Wikimedia

Carafata Tablets (Sucralphate): Uses, Dosage, Side Effects, Interactions, Warning

• Generic Name: Sucralfate
• Brand Name: Carafata Tablets

• Product Description
• Indications and Dosage 90 004
• Side effects
• Drug interactions
• Warnings and Precautions
• Overdose and Contraindications
• Clinical Pharmacology
• Medication guide

Product description

What is carafat and how is it used?

Karafate is a prescription medicine used to treat the symptoms of duodenal ulcers. Carafat can be used alone or with other medications.

Carafat belongs to a class of drugs called Gastrointestinal Agents, Other.

It is not known if Carafat is safe and effective in children.

What are the possible side effects of Carafat?

Karafate can cause serious side effects, including:

• hives
• difficulty breathing,
• swelling of the face, lips, tongue, or throat

Get medical help right away if you have any of these above symptoms.

The most common side effects of Carafate include:

• constipation,
• diarrhea,
• nausea,
• vomiting,
• upset stomach,
• itching,
• rash,
• dizziness,
• drowsiness,

9 0009 sleep problems (insomnia),

• headache and
• back pain

Tell your doctor if you have any side effects that bother you or that don’t go away.

These are not all possible side effects of Carafate. For more information, contact your doctor or pharmacist.

Ask your doctor about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

DESCRIPTION

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

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Carafate oral suspension contains 1 g of sucralfate per 10 ml. CARAFAT Oral Suspension also contains: Colloidal Silica 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.

Indications and dosage

INDICATIONS

CARAFAT (sucralfate) oral suspension is indicated for the short-term (up to 8 weeks) treatment of active duodenal ulcers.

DOSAGE AND ADMINISTRATION

Active duodenal ulcer

The recommended oral dose for adults with duodenal ulcer is 1 gram (10 ml) four times a day. CARAFAT oral suspension should be administered on an empty stomach.

Antacids may be given to relieve pain if necessary, but should not be taken within half an hour before or after CARAFAT oral suspension.

Although healing with sucralfate may occur within the first week or two, treatment should be continued for 4-8 weeks if healing is not demonstrated by x-ray or endoscopy.

Elderly

In general, dose selection for the elderly patient should be cautious, usually starting at the lower end of the dosing range, reflecting a greater incidence of decreased hepatic, renal, or cardiac function, as well as concomitant disease or other drug therapy (see PRECAUTIONS Geriatric use ).

Ask your doctor about side effects. You can report side effects to Allergan USA, Inc. call 1-800-678-1605 or the 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 420 ml vials ( NDC 58914-170-14).

Can I take Flonaz with Zyrtec?

SHAKE WELL BEFORE USE. AVOID FREEZING.

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

Distributed by: Allergan USA, Inc. Irvine, CA 92612 Revised: July 2017

Side effects

SIDE EFFECTS

Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely resulted in discontinuation of the drug. In studies involving more than 2700 patients treated with sucralfate, side effects were reported in 129(4.7%).

Constipation was the most common complaint (2%). Other side effects reported in less than 0.5% of patients are listed below by body system:

Gastrointestinal tract: diarrhea, dry mouth, flatulence, stomach discomfort, indigestion, nausea, vomiting

Dermatological: pruritus, rash

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Nervous system: dizziness, insomnia, drowsiness, dizziness

Other: back pain, headache

Post-marketing Cases of hypersensitivity have been reported with sucralfate oral suspension, including anaphylactic reactions, dyspnea, swelling of the lips, swelling of the mouth, swelling of the throat, pruritus, rash, swelling of the face and hives. Cases of bronchospasm, laryngeal edema, and airway edema have been reported with the unknown oral drug sucralfate.

Cases of hyperglycemia have been reported with sucralfate. Bezoars have been reported in patients treated with sucralfate. Most patients had comorbidities that may predispose to bezoar formation (eg, delayed gastric emptying) or received concomitant enteral tube feeding.

Drug interactions

DRUG INTERACTIONS

Some studies have shown that the simultaneous administration of sucralfate to healthy volunteers reduces the rate of absorption (bioavailability) of the following single doses: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline and theophylline. Subtherapeutic prothrombin time with concurrent warfarin and sucralfate therapy has been described in spontaneous and published case reports. However, two clinical studies demonstrated no change in either serum warfarin concentration or prothrombin time when sucralfate was added to chronic warfarin therapy. The mechanism of these interactions appears to be non-systemic and presumably results from the binding of sucralfate to the co-agent in the gastrointestinal tract. In all cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing of the concomitant medication 2 hours before sucralfate eliminated the interaction. Because of the ability of CARAFAT oral suspension to alter the absorption of some drugs, CARAFAT oral suspension should be administered separately from other drugs when changes in bioavailability appear to be critical. In these cases, patients should be under appropriate supervision.

Warnings and Precautions

WARNINGS

Inappropriate intravenous administration of CARAFAT oral suspension has resulted in fatal complications, including pulmonary and cerebral emboli. Administer CARAFAT oral suspension by mouth only. Do not administer intravenously.

PRECAUTIONS

The physician should read “ PRECAUTIONS ” when considering the use of CARAFAT oral suspension in pregnant or pediatric patients or patients of childbearing potential.

Duodenal ulcer is a chronic relapsing disease. Although short-term treatment with sucralfate may result in complete healing of the ulcer, a successful course of treatment with sucralfate should not be expected to change the incidence or severity of duodenal ulcer after healing.

Episodes of hyperglycemia have been reported in patients with diabetes mellitus. Careful monitoring of glycemia is recommended in diabetic patients taking CARAFAT oral suspension. It may be necessary to adjust the dose of antidiabetic treatment while using CARAFAT oral suspension.

Special populations: patients with chronic renal failure and dialysis

When sucralfate is taken orally, a small amount of aluminum is absorbed from the gastrointestinal tract. Concomitant use of sucralfate with other aluminum-containing products, such as aluminum-containing antacids, may increase the overall body burden of aluminum. Patients with normal renal function receiving recommended doses of sucralfate and aluminum-containing products adequately excrete aluminum in the urine. In patients with chronic renal failure or those receiving dialysis, there is a violation of the excretion of absorbed aluminum. In addition, aluminum does not cross dialysis membranes because it is bound to albumin and plasma proteins transferrin. Aluminum accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been described in patients with renal insufficiency. Sucralfate should be used with caution in patients with chronic renal failure.

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Carcinogenesis, Mutagenesis, Impairment of Fertility

Chronic oral toxicity studies lasting 24 months were performed in mice and rats at doses up to 1 g/kg (12 times the human dose).

No evidence of drug related carcinogenicity. A reproduction study in rats at doses 38 times the human dose showed no evidence of impaired fertility. Mutagenicity studies have not been conducted.

Pregnancy

Teratogenic effects

Pregnancy category B.

Teratogenicity studies have been conducted in mice, rats and rabbits at 50 times the human dose and found no evidence of harm to the fetus due to sucra alpha. However, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should only be used during pregnancy if absolutely necessary.

Nursing mothers

It is not known if this drug is excreted in breast milk. Because many drugs are excreted in breast milk, caution should be exercised when administering sucralfate to a nursing woman.

Pediatric use

Safety and efficacy in pediatric patients have not been established.

Geriatric Use

Clinical studies of CARAFAT oral suspension did not include sufficient numbers of subjects aged 65 years and older to determine if they respond differently than younger subjects. Other reported clinical experience has found no difference in response between older and younger patients. In general, dose selection for the elderly patient should be cautious, usually starting at the lower end of the dosing range, reflecting a greater incidence of decreased hepatic, renal, or cardiac function, as well as concomitant disease or other drug therapy (see DOSAGE AND ADMINISTRATION ). This drug is known to be largely excreted by the kidneys and the risk of toxic reactions to this drug may be higher in patients with impaired renal function (see PRECAUTIONS Special Populations : Patients with Chronic Renal Insufficiency and Dialysis ) . Because older patients are more likely to have decreased renal function, care should be taken in dose selection and it may be beneficial to monitor renal function.

Overdose and contraindications

OVERDOSAGE

Due to limited experience in people with sucralfate overdose, specific treatment recommendations cannot be made. However, acute oral animal studies using doses up to 12 g/kg body weight have failed to find a lethal dose. Sucralfate is only minimally absorbed from the gastrointestinal tract. Therefore, the risks associated with acute overdose should be minimal. In rare reports describing sucralfate overdose, most patients remained asymptomatic. The few reports that reported adverse events included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.

CONTRAINDICATIONS

CARAFAT oral suspension is contraindicated in patients with known hypersensitivity reactions to the active substance or any of the excipients.

Clinical pharmacology

CLINICAL PHARMACOLOGY

Sucralfate is only minimally absorbed from the gastrointestinal tract. Small amounts of absorbed sulfated disaccharide are excreted primarily in the urine. Although the mechanism of sucralfate’s ability to accelerate the healing of duodenal ulcers has yet to be fully determined, it is known that it exerts its action through local rather than systemic action. The following observations also seem relevant:

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

Sucralfate adsorbs bile salts in vitro.

These observations suggest that the anti-ulcer activity of sucralfate results from the formation of an ulcer-adherent complex that coats the ulcer site and protects it from further attack by acid, pepsin, and bile salts. For 1 g of sucralfate, there are approximately 14 to 16 meq of acid-neutralizing capacity.

Clinical trials

In a multicentre, double-blind, placebo-controlled study of CARAFAT oral suspension, a dosing regimen of 1 gram (10 ml) four times a day was shown to be superior to placebo in healing ulcers.

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Results of clinical trials. Acute duodenal ulcer healing rates

90 097 CARAFAT Oral suspension 9028 8 * P = 0.016 † P=0.001‡ P = 0.0001

Results of clinical trials. Acute duodenal ulcer healing rates
Care	n	Healing rate at week 2	Healing rate at week 4	Healing rate at week 8
145	23 (16%) *	66 (46%) and dagger;	95 (66%) and dagger;
Placebo	147	10 (7%)	39 (27%)	58 (39%)

The equivalence of sucralfate oral suspension to sucralfate tablets has not been demonstrated.

Medication guide

PATIENT INFORMATION

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

Sucralfate – description of the substance, pharmacology, use, contraindications, formula

Contents

• Structural formula

• Russian name

• English name

• 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 Sucralfati)

Chemical name

beta-D-Fructofuranosyl-alpha-D-glucopyranoside aluminum octakis(hydrosulfate) complex

General formula

C ₁₂ HmAl 9 0414 16 OnS ₈

Pharmacological group of the substance Sucralfate

Gastroprotectors

Nosological classification

ICD-10 code list

• K21 Gastroesophageal reflux

• K25 Gastric ulcer

• K26 Duodenal ulcer

• K27 Peptic ulcer, unspecified

• K29 Gastritis and duodenitis

• K29. 6.1* Hyperacid gastritis

• R12 Heartburn

• T39 Non-opioid analgesic, antipyretic and antirheumatic poisoning

• Z49.1 Extracorporeal dialysis

CAS code

54182-58-0

Pharmacological action

Pharmacological action –

adsorbent , antacid , gastroprotective , coating , antiulcer .

Characteristic

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.

Use of the substance Sucralfate

Peptic ulcer of the stomach and duodenum (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 the substance 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).