Carafate 1gm Tablets
It is used to treat GI (gastrointestinal) ulcers.
Drug Class
Antiulcer agent
Pharmacologic Class
Cytoprotective agent
Pregnancy Category
Category B
FDA Approved
Oct 1981
DEA Schedule
Not Controlled
Overview
What is this medicine?
Sucralfate is a medication that helps heal ulcers in your stomach and intestines. It works by forming a protective coating over the ulcer, like a bandage, which shields it from stomach acid and helps it heal.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication on an empty stomach, as food may affect its absorption.
It's also important to avoid taking antacids within 30 minutes before or after taking your medication, as they may interfere with its effectiveness. Try to space out your other medications by at least 2 hours from the time you take this medication, as it may interact with other drugs and prevent them from being absorbed properly.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's essential to take your medication by mouth only, as injecting it can cause severe and potentially life-threatening side effects.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe and secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication, or look into local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses, as this can increase the risk of side effects.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication on an empty stomach, as food may affect its absorption.
It's also important to avoid taking antacids within 30 minutes before or after taking your medication, as they may interfere with its effectiveness. Try to space out your other medications by at least 2 hours from the time you take this medication, as it may interact with other drugs and prevent them from being absorbed properly.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's essential to take your medication by mouth only, as injecting it can cause severe and potentially life-threatening side effects.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe and secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication, or look into local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses, as this can increase the risk of side effects.
Lifestyle & Tips
- Take this medication on an empty stomach, usually 1 hour before meals and at bedtime.
- Do not take antacids within 30 minutes of taking sucralfate, as they can interfere with its action.
- Separate sucralfate from other medications (especially antibiotics, digoxin, phenytoin, warfarin, and thyroid hormones) by at least 2 hours before or 6 hours after to prevent reduced absorption of the other drugs.
- If you are taking the liquid suspension, shake it well before each use.
- Drink plenty of fluids and eat fiber-rich foods to help prevent constipation, a common side effect.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1 gram four times daily (QID)
Dose Range:
1 - 4 mg
Condition-Specific Dosing:
duodenalUlcerTreatment:
1 gram QID, 1 hour before meals and at bedtime, for 4-8 weeks.
duodenalUlcerMaintenance:
1 gram twice daily (BID).
Pediatric Dosing
Neonatal:
Not established (off-label use: 250-500 mg/dose every 6-8 hours)
Infant:
Not established (off-label use: 250-500 mg/dose every 6-8 hours)
Child:
Not established (off-label use: 40-80 mg/kg/day divided QID, max 1g/dose)
Adolescent:
Not established (off-label use: 40-80 mg/kg/day divided QID, max 1g/dose)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, but use with caution due to aluminum content.
Moderate:
Use with caution; consider reduced frequency or dose, monitor for aluminum toxicity.
Severe:
Use with extreme caution or avoid; significant risk of aluminum accumulation and toxicity (e.g., osteodystrophy, encephalopathy). Monitor serum aluminum and phosphate.
Dialysis:
Avoid or use with extreme caution; sucralfate is not dialyzable, and aluminum accumulation is a significant risk. Monitor serum aluminum and phosphate.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Pharmacology
Mechanism of Action
Sucralfate is a basic aluminum salt of sucrose octasulfate. In an acidic environment (pH < 4), it forms a viscous, sticky gel that adheres selectively to ulcerated and eroded areas of the gastrointestinal mucosa. It forms a protective barrier that shields the ulcer from acid, pepsin, and bile salts. It also inhibits pepsin activity, absorbs bile salts, and may stimulate prostaglandin synthesis and epidermal growth factor production, contributing to mucosal defense and healing.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (as disaccharide), <0.005% (as aluminum)
Tmax:
Not applicable (local action)
FoodEffect:
Food can reduce binding to ulcer sites; should be taken on an empty stomach.
Distribution:
Vd:
Not applicable (local action)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Fecal (unchanged drug); small absorbed portion excreted renally.
Unchanged:
>95% (feces)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (local protective effect)
PeakEffect:
Local action, sustained for up to 6 hours.
DurationOfAction:
Up to 6 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience:
- Constipation
or if any other side effects bother you or do not go away.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor if you experience:
- Constipation
or if any other side effects bother you or do not go away.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe constipation
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Unusual weakness or tiredness (especially in patients with kidney problems, could indicate aluminum toxicity)
- Muscle weakness or bone pain (in patients with kidney problems)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including any symptoms that occurred.
This medication may interact with other medications or health conditions. To ensure safe use, provide your doctor and pharmacist with a comprehensive list of all your current medications, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
Also, inform them about any existing health problems. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including any symptoms that occurred.
This medication may interact with other medications or health conditions. To ensure safe use, provide your doctor and pharmacist with a comprehensive list of all your current medications, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
Also, inform them about any existing health problems. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
This medication may increase aluminum levels in the body, which can lead to aluminum toxicity, particularly in individuals with kidney problems. Before starting any new medication, carefully review the label to check for aluminum content. If the medication contains aluminum or you are unsure, consult your doctor.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
This medication may increase aluminum levels in the body, which can lead to aluminum toxicity, particularly in individuals with kidney problems. Before starting any new medication, carefully review the label to check for aluminum content. If the medication contains aluminum or you are unsure, consult your doctor.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms reported for acute overdose due to minimal systemic absorption.
- In patients with impaired renal function, chronic high doses could lead to aluminum toxicity symptoms (e.g., encephalopathy, osteomalacia, anemia).
What to Do:
Contact a poison control center (1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive. In cases of suspected aluminum toxicity, chelation therapy may be considered.
Drug Interactions
Moderate Interactions
- Antacids (e.g., aluminum hydroxide, magnesium hydroxide): Concurrent use can reduce the binding efficacy of sucralfate by raising gastric pH. Administer antacids at least 30 minutes before or after sucralfate.
- H2-receptor antagonists (e.g., cimetidine, ranitidine, famotidine): Can reduce the binding efficacy of sucralfate by raising gastric pH. Administer H2RAs at least 30 minutes before or after sucralfate.
- Proton pump inhibitors (e.g., omeprazole, lansoprazole, pantoprazole): Can reduce the binding efficacy of sucralfate by raising gastric pH. Administer PPIs at least 30 minutes before or after sucralfate.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Sucralfate can chelate these antibiotics, significantly reducing their absorption. Administer fluoroquinolones at least 2 hours before or 6 hours after sucralfate.
- Tetracyclines (e.g., doxycycline, minocycline): Sucralfate can chelate these antibiotics, reducing their absorption. Administer tetracyclines at least 2 hours before or 6 hours after sucralfate.
- Phenytoin: Sucralfate can reduce phenytoin absorption. Administer phenytoin at least 2 hours before or after sucralfate.
- Digoxin: Sucralfate can reduce digoxin absorption. Administer digoxin at least 2 hours before or after sucralfate.
- Warfarin: Sucralfate can reduce warfarin absorption, potentially decreasing its anticoagulant effect. Monitor INR closely. Administer warfarin at least 2 hours before or after sucralfate.
- Ketoconazole: Sucralfate can reduce ketoconazole absorption (requires acidic environment). Administer ketoconazole at least 2 hours before or after sucralfate.
- Theophylline: Sucralfate can reduce theophylline absorption. Administer theophylline at least 2 hours before or after sucralfate.
- Thyroid hormones (e.g., levothyroxine): Sucralfate can reduce thyroid hormone absorption. Administer thyroid hormones at least 4 hours before or after sucralfate.
Monitoring
Routine Monitoring
Symptom relief (e.g., abdominal pain, heartburn)
Frequency: Throughout treatment
Target: Reduction or resolution of symptoms
Action Threshold: Lack of improvement or worsening symptoms may indicate need for further evaluation or alternative therapy.
Bowel habits (for constipation)
Frequency: Daily
Target: Normal bowel movements
Action Threshold: Significant constipation may require dose adjustment or laxative use.
Symptom Monitoring
- Abdominal pain
- Heartburn
- Nausea
- Constipation
- Dry mouth
- Dizziness
- Back pain
- Headache
Special Patient Groups
Pregnancy
Sucralfate is Pregnancy Category B. Animal reproduction studies have shown no evidence of fetal harm. Due to minimal systemic absorption, the risk to the fetus is considered low.
Trimester-Specific Risks:
First Trimester:
Low risk, minimal systemic absorption.
Second Trimester:
Low risk, minimal systemic absorption.
Third Trimester:
Low risk, minimal systemic absorption.
Lactation
Sucralfate is considered L3 (moderately safe) for use during lactation. Due to minimal systemic absorption by the mother, it is unlikely to be excreted in breast milk in clinically significant amounts or cause adverse effects in the infant.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Safety and efficacy have not been fully established in pediatric patients. However, sucralfate is commonly used off-label in children for various gastrointestinal conditions (e.g., stress ulcer prophylaxis, esophagitis). Dosing is typically weight-based. Caution is advised, especially in very young children or those with renal impairment, due to potential for aluminum accumulation.
Geriatric Use
No specific dose adjustment is generally required based on age alone. However, geriatric patients are more likely to have age-related decline in renal function. Use with caution in elderly patients with impaired renal function due to the aluminum content and potential for aluminum accumulation and toxicity. Monitor renal function and consider lower doses or alternative therapies if renal impairment is present.
Clinical Information
Clinical Pearls
- Sucralfate requires an acidic environment (pH < 4) to activate and form its protective barrier. Therefore, it should be taken on an empty stomach and separated from antacids, H2-receptor antagonists, and proton pump inhibitors.
- It is crucial to separate sucralfate administration from other medications (especially those listed in interactions) by at least 2 hours before or 6 hours after to prevent reduced absorption of the other drugs.
- Constipation is the most common side effect; advise patients to maintain adequate fluid intake and dietary fiber.
- Sucralfate does not neutralize stomach acid directly but forms a physical barrier, making it a cytoprotective agent rather than an acid suppressor.
- While effective for ulcer healing, its complex dosing schedule and interaction profile can affect patient adherence.
Alternative Therapies
- Proton Pump Inhibitors (PPIs) (e.g., omeprazole, esomeprazole, lansoprazole)
- H2-receptor antagonists (H2RAs) (e.g., famotidine, ranitidine, cimetidine)
- Antacids (e.g., aluminum hydroxide, magnesium hydroxide, calcium carbonate)
- Bismuth subsalicylate (for H. pylori eradication or dyspepsia)
Cost & Coverage
Average Cost:
$15 - $50 per 30 tablets (generic 1g)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.