What is Carafate and how is it used. What are the available formulations of Carafate. How does Carafate work to treat gastrointestinal conditions. What are the recommended dosages for Carafate. Are generic versions of Carafate available in the market. What are the potential side effects and precautions associated with Carafate use.

Understanding Carafate: An Overview of the Medication

Carafate, known generically as sucralfate, is a medication primarily used to treat and prevent ulcers in the gastrointestinal tract. This pharmaceutical agent has been approved by the U.S. Food and Drug Administration (FDA) and is available in various formulations. Let’s delve deeper into the specifics of this medication to understand its uses, dosages, and availability.

What is Carafate?

Carafate is a brand name for sucralfate, a medication that belongs to the class of drugs known as miscellaneous GI agents. It works by forming a protective coating over ulcers and other damaged areas in the digestive tract, promoting healing and preventing further damage.

FDA-Approved Formulations

The FDA has approved Carafate in two primary formulations:

• Oral suspension: 1GM/10ML strength, approved on December 16, 1993
• Oral tablet: 1GM strength, approved prior to January 1, 1982

Both formulations are manufactured by ABBVIE and are designated as the Reference Listed Drug (RLD) with an AB rating, indicating their bioequivalence to generic versions.

Generic Availability of Carafate

Generic versions of Carafate have been approved by the FDA, offering patients more affordable alternatives to the brand-name medication. These generic formulations are available in both oral suspension and tablet forms.

Generic Oral Suspension (1GM/10ML)

Several manufacturers have received FDA approval for generic sucralfate oral suspension:

• AMNEAL: Approved on December 2, 2019
• MYLAN: Approved on September 12, 2022
• VISTAPHARM: Approved on March 15, 2022

Generic Oral Tablets (1GM)

Generic sucralfate tablets are also available from multiple manufacturers:

• AMNEAL PHARMS: Approved on April 15, 2022
• NOSTRUM LABS INC: Approved on June 8, 1998
• TEVA: Approved on March 29, 1996
• ZYDUS LIFESCIENCES: Approved on May 3, 2023

All these generic versions have an AB rating, indicating their bioequivalence to the brand-name Carafate.

Carafate Dosage and Administration

The dosage of Carafate can vary depending on the specific condition being treated and the individual patient’s needs. However, general guidelines for dosage are as follows:

Oral Suspension

The typical dosage for the oral suspension is 1 gram (10 mL) taken four times daily, usually on an empty stomach. For optimal effectiveness, it’s often recommended to take the medication at bedtime and before meals.

Oral Tablets

The usual dosage for tablets is one 1-gram tablet taken four times daily. As with the suspension, it’s generally advised to take the tablets on an empty stomach, particularly before meals and at bedtime.

Is it necessary to adjust Carafate dosage for specific populations? In some cases, dosage adjustments may be necessary for patients with renal impairment or the elderly. It’s crucial to consult with a healthcare provider for personalized dosing instructions.

Mechanism of Action: How Carafate Works

Carafate’s effectiveness in treating and preventing ulcers lies in its unique mechanism of action. The medication works by creating a protective barrier over damaged areas in the gastrointestinal tract.

Protective Coating Formation

When Carafate comes into contact with stomach acid, it forms a paste-like substance. This paste adheres to ulcers and other damaged areas in the stomach and small intestine, creating a protective barrier. This barrier helps to:

• Shield the damaged tissue from further irritation by stomach acid and digestive enzymes
• Promote healing of the ulcerated or damaged areas
• Prevent further damage to the gastrointestinal lining

Interaction with Pepsin

Carafate also has the ability to bind to pepsin, an enzyme in the stomach that can contribute to ulcer formation. By binding to pepsin, Carafate helps to reduce its damaging effects on the stomach lining.

Does Carafate affect the production of stomach acid? Unlike some other medications used to treat ulcers, Carafate does not reduce or neutralize stomach acid. Its protective action is primarily physical rather than chemical.

Indications and Uses of Carafate

Carafate is primarily used in the treatment and prevention of various gastrointestinal conditions. Its approved uses include:

Treatment of Active Duodenal Ulcers

Carafate is effective in promoting the healing of active duodenal ulcers. The protective coating it forms over the ulcer helps to shield it from further damage and allows the body’s natural healing processes to take place.

Maintenance Therapy for Duodenal Ulcers

After the initial healing of duodenal ulcers, Carafate may be prescribed as a maintenance therapy to prevent recurrence. This long-term use helps to protect the previously ulcerated area from new damage.

Gastroesophageal Reflux Disease (GERD)

While not its primary indication, Carafate is sometimes used off-label in the management of GERD. It can help protect the esophagus from damage caused by stomach acid reflux.

Stress Ulcer Prophylaxis

In certain high-risk situations, such as in critically ill patients, Carafate may be used to prevent the formation of stress ulcers.

Can Carafate be used for other gastrointestinal conditions? While these are the primary indications, healthcare providers may sometimes prescribe Carafate for other gastrointestinal conditions where a protective coating on the mucosa would be beneficial. Always consult with a healthcare professional for appropriate use.

Potential Side Effects and Precautions

While Carafate is generally well-tolerated, like all medications, it can cause side effects in some individuals. Understanding these potential effects and necessary precautions is crucial for safe and effective use.

Common Side Effects

The most commonly reported side effects of Carafate include:

• Constipation
• Dry mouth
• Nausea
• Stomach discomfort
• Gas or bloating
• Headache

These side effects are usually mild and often resolve on their own as the body adjusts to the medication. However, if they persist or worsen, it’s important to consult a healthcare provider.

Rare but Serious Side Effects

While less common, some individuals may experience more serious side effects, including:

• Allergic reactions (rash, itching, swelling, severe dizziness, difficulty breathing)
• Bezoar formation (a solid mass of indigestible material in the digestive tract)
• Aluminum toxicity (in patients with impaired renal function)

If any of these serious side effects occur, immediate medical attention should be sought.

Precautions and Contraindications

Several precautions should be considered when using Carafate:

1. Renal Impairment: Patients with kidney problems may be at increased risk of aluminum accumulation and should use Carafate with caution.
2. Pregnancy and Breastfeeding: The safety of Carafate during pregnancy and breastfeeding has not been fully established. Consult a healthcare provider before use.
3. Drug Interactions: Carafate can interfere with the absorption of other medications. It’s generally recommended to take other oral medications at least 2 hours before or after Carafate.
4. Difficulty Swallowing: The tablet form of Carafate should be used with caution in patients with difficulty swallowing, as it can potentially cause choking.

Should patients with a history of bezoars avoid Carafate? Patients with a history of bezoars or those at risk of developing them (such as those with delayed gastric emptying) should use Carafate with caution and under close medical supervision.

Drug Interactions and Considerations

Carafate’s mechanism of action, which involves forming a protective coating in the gastrointestinal tract, can potentially interact with the absorption of other medications. Understanding these interactions is crucial for ensuring the effectiveness of both Carafate and other concurrent treatments.

Common Drug Interactions

Carafate may interact with several types of medications, including:

• Antibiotics (e.g., tetracyclines, fluoroquinolones)
• Thyroid hormones (e.g., levothyroxine)
• Antacids
• Blood thinners (e.g., warfarin)
• Certain heart medications (e.g., digoxin)
• Phenytoin (an anti-seizure medication)

These interactions typically involve decreased absorption of the other medication due to Carafate’s coating effect in the gastrointestinal tract.

Timing of Medication Administration

To minimize the risk of drug interactions, it’s generally recommended to:

1. Take other oral medications at least 2 hours before Carafate
2. Or, take other oral medications at least 2 hours after Carafate

This timing allows for the absorption of other medications before Carafate forms its protective coating in the gastrointestinal tract.

Specific Considerations

Certain medications require special consideration:

• Antacids: If antacids are needed, they should be taken at least 30 minutes before or after Carafate.
• Proton Pump Inhibitors (PPIs): While not typically interacting directly, the timing of PPI administration may need to be adjusted in relation to Carafate for optimal effectiveness of both medications.
• Enteric-coated medications: These may be particularly affected by Carafate’s coating action and may require careful timing or dosage adjustments.

How can patients ensure they’re taking their medications correctly with Carafate? It’s crucial for patients to inform their healthcare provider about all medications they’re taking, including over-the-counter drugs and supplements. The healthcare provider can then provide specific instructions on timing and potential dosage adjustments to ensure all medications are effective.

Long-term Use and Monitoring

While Carafate is generally considered safe for both short-term and long-term use, ongoing monitoring is important to ensure its continued effectiveness and to watch for any potential long-term effects.

Duration of Treatment

The duration of Carafate treatment can vary depending on the condition being treated:

• For active duodenal ulcers: Treatment typically lasts 4-8 weeks
• For maintenance therapy to prevent ulcer recurrence: Long-term use may be recommended, often for several months or even years
• For GERD or other off-label uses: Duration can vary widely based on individual patient needs and response to treatment

Monitoring During Long-term Use

For patients on long-term Carafate therapy, regular monitoring may include:

1. Periodic endoscopic examinations to assess healing and prevent complications
2. Blood tests to monitor for potential aluminum accumulation, especially in patients with impaired renal function
3. Assessment of symptom relief and overall gastrointestinal health
4. Monitoring for potential nutritional deficiencies, as Carafate may affect the absorption of certain nutrients

Discontinuation Considerations

When discontinuing Carafate, especially after long-term use, it’s important to:

• Follow healthcare provider instructions for tapering off the medication if necessary
• Be aware of potential symptom recurrence and report any concerning symptoms promptly
• Consider follow-up endoscopy to ensure continued healing or maintenance of gastrointestinal health

Is it safe to stop Carafate abruptly? While Carafate is not known to cause withdrawal symptoms, abrupt discontinuation could potentially lead to a recurrence of the original symptoms. It’s best to consult with a healthcare provider before stopping or changing the dosage of Carafate.

Generic Carafate Availability – Drugs.com

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Last updated on Jun 7, 2023.

Carafate is a brand name of sucralfate, approved by the FDA in the following formulation(s):

CARAFATE (sucralfate – suspension;oral)

• Manufacturer: ABBVIE
  Approval date: December 16, 1993
  Strength(s): 1GM/10ML ^[RLD][AB]

CARAFATE (sucralfate – tablet;oral)

• Manufacturer: ABBVIE
  Approved Prior to Jan 1, 1982
  Strength(s): 1GM ^[RLD][AB]

Has a generic version of Carafate been approved?

Yes. The following products are equivalent to Carafate:

sucralfate suspension;oral

• Manufacturer: AMNEAL
  Approval date: December 2, 2019
  Strength(s): 1GM/10ML ^[AB]
• Manufacturer: MYLAN
  Approval date: September 12, 2022
  Strength(s): 1GM/10ML ^[AB]
• Manufacturer: VISTAPHARM
  Approval date: March 15, 2022
  Strength(s): 1GM/10ML ^[AB]

sucralfate tablet;oral

• Manufacturer: AMNEAL PHARMS
  Approval date: April 15, 2022
  Strength(s): 1GM ^[AB]
• Manufacturer: NOSTRUM LABS INC
  Approval date: June 8, 1998
  Strength(s): 1GM ^[AB]
• Manufacturer: TEVA
  Approval date: March 29, 1996
  Strength(s): 1GM ^[AB]
• Manufacturer: ZYDUS LIFESCIENCES
  Approval date: May 3, 2023
  Strength(s): 1GM ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Carafate. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

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Patient resources

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• Carafate (Sucralfate Tablets)

Professional resources

• Prescribing Information

Related treatment guides

• GERD
• Duodenal Ulcer
• Hyperphosphatemia of Renal Failure
• Duodenal Ulcer Prophylaxis

Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U. S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AB	Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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:

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 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.

*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

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58914-170 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUCRALFATE (SUCRALFATE) SUCRALFATE 1 g in 10 mL

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE FD&C RED NO. 40 0.004 mg in 10 mL GLYCERIN 87.92 mg in 10 mL METHYLCELLULOSE, UNSPECIFIED METHYLPARABEN 1.78 mg in 10 mL MICROCRYSTALLINE CELLULOSE WATER 618.006 mg in 10 mL SORBITOL SOLUTION 177.62 mg in 10 mL

Product Characteristics Color pink Score Shape Size Flavor CHERRY (Maraschino Cherry Artificial Flavor #2359) Imprint Code Contains

Packaging # Item Code Package Description 1 NDC:58914-170-14 414 mL in 1 BOTTLE 2 NDC:58914-170-60 6 CUP, UNIT-DOSE in 1 BOX 2 295. 7 mL in 1 CUP, UNIT-DOSE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019183 12/16/1993

Allergan, Inc.

Frequently asked questions

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More about Carafate (sucralfate)

• Check interactions
• Compare alternatives
• Pricing & coupons
• Reviews (68)
• Drug images
• Side effects
• Dosage information
• During pregnancy
• Generic availability
• Support group
• Drug class: miscellaneous GI agents
• Breastfeeding
• En español

Patient resources

• Drug Information
• Carafate (Sucralfate Oral Suspension)
• Carafate (Sucralfate Tablets)

Professional resources

• Prescribing Information
• Sucralfate (AHFS Monograph)

Related treatment guides

• GERD
• Duodenal Ulcer
• Hyperphosphatemia of Renal Failure
• Duodenal Ulcer Prophylaxis

Medical Disclaimer

💊 LEVOFORD solution for infusions 100 ml 5mg/ml N1 Before use, read the instructions for use or seek advice from specialists.

Dosage form of release: solution for infusion. Primary packaging: 100 ml plastic bottle. Secondary packaging: A vial enclosed with instructions for medical use in a cardboard box.
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LEVOFLOXACIN eye drops 5 ml 0.5 Peptazol 15mg0232
What are the possible side effects of peptazole 15 mg?

Clinical

Worldwide, more than 10,000 patients have been treated with peptazole 15 mg in phase 2 or phase 3 clinical trials involving various doses and durations of treatment. Overall, treatment with Peptazole 15 mg was well tolerated in both short and long term studies.

Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in clinical trials of a medicinal product cannot be directly compared with the frequency in clinical trials of another medicinal product and may not reflect rates observed in clinical practice.

The following adverse reactions were reported by the attending physician to have a possible or probable relationship with the drug in 1% or more of patients receiving Peptazole 15 mg, and occurred with a greater frequency in patients receiving Peptazole 15 mg than in patients receiving placebo in table. 1.

Headache was also observed at an incidence greater than 1% but was more common with placebo. The incidence of diarrhea was similar in patients treated with placebo and in patients treated with 15 mg and 30 mg peptazole 15 mg, but higher in patients treated with 60 mg peptazole 15 mg (2.9%, 1.4%, 4.2% and 7.4% respectively).

The most common treatment-related adverse event during maintenance therapy was diarrhea.

In a risk reduction study of peptazole 15 mg for NSAID-associated gastric ulcers, the incidence of diarrhea in patients treated with peptazole 15 mg, misoprostol, and placebo was 5%, 22%, and 3%, respectively.

Another study for the same indication, where patients received either a COX-2 inhibitor or peptazole 15 mg and naproxen, demonstrated that the safety profile was similar to the previous study. Additional reactions from this study, not previously observed in other clinical trials with Peptazole 15 mg, included contusion, duodenitis, epigastric discomfort, esophageal upset, fatigue, hunger, oral hernia, hoarseness, impaired gastric emptying, metaplasia, and renal failure.

Additional side effects occurring in less than 1% of patients or subjects treated with peptazole 15 mg in home trials are shown below: in the chest (not otherwise specified), chills, swelling, fever, influenza syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck stiffness, pain, pelvic pain

Cardiovascular system – angina, arrhythmia, bradycardia, cerebrovascular accident / cerebral infarction, hypertension / hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation

Digestive system – abnormal stool, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, belching, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundicoid polyps, gastritis , gastroenteritis, gastrointestinal anomaly, gastrointestinal disorders, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea, vomiting and diarrhea, gastrointestinal moniliasis , rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis

Endocrine system – diabetes mellitus, goiter, hypothyroidism

Hemic and lymphatic system – anemia, hemolysis, lymphadenopathy

Metabolic and nutritional disorders – beriberi, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss 9000 3

Musculoskeletal system – arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia gravis, ptosis, synovitis

Nervous system – abnormal dreams, agitation, amnesia, restlessness, apathy, confusion, convulsions , dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, exacerbation of hostility, hyperkinesia, hypertension, hypoesthesia, insomnia, decrease / increase in libido, nervousness, paresthesia, sleep disturbance, drowsiness, drowsiness

Respiratory system – asthma, bronchitis, increased cough, dyspnea, epistaxis, hemoptysis, laryngeal neoplasms, pulmonary fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorders, upper respiratory tract inflammation/infection, rhinitis, sinusitis, stridor

Skin and adnexa – acne, alopecia, contact dermatitis, dry skin, fixed rash, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin cancer, skin disease, sweating, urticaria

Special Senses – abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eye, ear/eye disorder, eye pain, glaucoma, otitis media, paromia, photophobia, retinal degeneration/disorder, loss of taste, taste perversion, tinnitus, visual field defect

Urogenital system – abnormal menstruation, breast enlargement, chest pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, renal calculus, kidney pain, leukorrhea, menorrhagia, menstrual disturbance cycle, penile disorder, polyuria, testicular disorder, urinary pain, urinary tract retention, urinary urgency, vaginitis.

Post-marketing experience

Additional side effects have been reported since Peptazole 15 mg delayed-release capsules and Peptazole 15 mg delayed-release tablets were marketed. Most of these cases are related to a foreign source, and the association with peptazole 15 mg delayed-release capsules and peptazole 15 mg delayed-release tablets has not been established. Because these reactions have been reported voluntarily from a population of unknown size, frequency estimates cannot be made. These events are listed below by the COSTART body system.

Body as a whole – anaphylactic/anaphylactoid reactions; Digestive system – hepatotoxicity, pancreatitis, vomiting; Hemic and lymphatic system – agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura; Musculoskeletal system – bone fracture, myositis; Skin and appendages – severe dermatological reactions including erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis (some fatal) Special Senses – impaired speech; Urogenital system – interstitial nephritis, urinary retention.

Combination therapy with amoxicillin and clarithromycin

In clinical trials using combination therapy with peptazole 15 mg plus amoxicillin and clarithromycin and peptazole 15 mg plus amoxicillin, no adverse reactions associated with these drug combinations were observed. Adverse reactions that have occurred have been limited to those previously reported with Peptazole 15 mg, amoxicillin or clarithromycin.

Triple therapy: peptazole 15 mg / amoxicillin / clarithromycin

The most common adverse reactions in patients treated with triple therapy for 14 days were diarrhea (7%), headache (6%) and taste perversion (5%). There were no statistically significant differences in reported adverse reactions between 10- and 14-day triple therapy regimens. No treatment-related adverse reactions were observed with significantly higher rates of triple therapy than with any dual therapy regimen.

Dual therapy: peptazole 15 mg / amoxicillin

The most common adverse reactions in patients treated with peptazole 15 mg three times a day plus amoxicillin three times a day in dual therapy were diarrhea (8%) and headache (7%). No treatment-related adverse reactions were observed at significantly higher rates with Peptazole 15 mg three times a day plus amoxicillin three times a day dual therapy than with Peptazole 15 mg alone.

For information on adverse reactions with amoxicillin or clarithromycin, see Full Prescribing Information sections.

Laboratory values ​​

The following changes in laboratory parameters in patients treated with Peptazol 15 mg have been reported as adverse reactions:

Liver dysfunction, increased SGOT (AST) increased SGPT (ALT) increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, blood potassium increased, blood urea increased, crystal urine present, eosinophilia, hemoglobin decreased, hyperlipemia, increased/decreased electrolytes, increased/lowered cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, elevated gastrin, and positive fecal occult blood. Urine abnormalities such as albuminuria, glycosuria and hematuria have also been reported.