Sucralfate 1gm Tablets
It is used to treat GI (gastrointestinal) ulcers.
Drug Class
Antiulcer agent; Gastric mucosal protectant
Pharmacologic Class
Mucosal protective agent
Pregnancy Category
Category B
FDA Approved
Oct 1981
DEA Schedule
Not Controlled
Overview
What is this medicine?
Sucralfate is a medication that works by forming a protective coating, like a bandage, over ulcers or sores in your stomach or intestines. This coating shields the ulcer from stomach acid, pepsin, and bile, allowing it to 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. Additionally, do not take antacids within 30 minutes before or after taking your medication, as they may interact with it. Try to space out your other medications by at least 2 hours, as this medication can affect the absorption of other drugs.
It is essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. 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 drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and return to your regular 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. Additionally, do not take antacids within 30 minutes before or after taking your medication, as they may interact with it. Try to space out your other medications by at least 2 hours, as this medication can affect the absorption of other drugs.
It is essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. 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 drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and return to your regular 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 sucralfate on an empty stomach, typically 1 hour before meals and at bedtime, for optimal effectiveness.
- It is crucial to separate sucralfate from other medications (especially antacids, antibiotics, thyroid hormones, digoxin, phenytoin) by at least 2 hours to prevent interactions and ensure proper absorption of other drugs.
- Do not crush or chew the tablet; swallow it whole with water. If you have difficulty swallowing, the tablet can be dispersed in a small amount of water.
- Complete the full course of treatment as prescribed by your doctor, even if your symptoms improve, to ensure complete ulcer healing.
- Maintain adequate fluid intake to help prevent constipation, a common side effect.
- Avoid alcohol, caffeine, and spicy foods if they tend to worsen your gastrointestinal symptoms.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1 gram four times daily (one hour before meals and at bedtime)
Dose Range:
1 - 4 mg
Condition-Specific Dosing:
Duodenal Ulcer (Acute):
1 gram four times daily for 4-8 weeks.
Duodenal Ulcer (Maintenance):
1 gram twice daily.
Gastric Ulcer (Off-label):
1 gram four times daily.
GERD (Off-label):
1 gram four times daily.
Stress Ulcer Prophylaxis (Off-label):
1 gram four to six times daily.
Pediatric Dosing
Neonatal:
Not established (used off-label: e.g., 250 mg/dose every 6-8 hours)
Infant:
Not established (used off-label: e.g., 250-500 mg/dose every 6-8 hours)
Child:
Not established (used off-label: e.g., 0.5-1 gram four times daily or 40-80 mg/kg/day divided QID)
Adolescent:
Not established (used off-label: e.g., 0.5-1 gram four times daily)
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for signs of aluminum toxicity with prolonged use.
Moderate:
Use with caution; monitor for signs of aluminum toxicity with prolonged use.
Severe:
Use with extreme caution or avoid prolonged use due to risk of aluminum accumulation and toxicity (osteodystrophy, encephalopathy). Monitor serum aluminum levels.
Dialysis:
Avoid prolonged use. If used, monitor serum aluminum levels closely and consider alternative agents.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Sucralfate is an aluminum salt of sucrose octasulfate. In an acidic environment (pH < 4), it forms a viscous, sticky gel that adheres selectively to ulcerated or eroded areas of the gastrointestinal mucosa. This protective barrier shields the ulcer from acid, pepsin, and bile salts, allowing the ulcer to heal. It also stimulates prostaglandin synthesis, bicarbonate secretion, and epidermal growth factor production, contributing to mucosal defense and repair.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (sucrose octasulfate), <0.02% (aluminum)
Tmax:
Not applicable (local action)
FoodEffect:
Food can interfere with binding; should be taken on an empty stomach.
Distribution:
Vd:
Not applicable (local action)
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable
ExcretionRoute:
Fecal (unchanged); absorbed aluminum is renally excreted.
Unchanged:
>95% (feces)
Pharmacodynamics
OnsetOfAction:
Immediate (local coating)
PeakEffect:
Sustained local coating
DurationOfAction:
6-8 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for advice:
Constipation
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for advice:
Constipation
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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:
- Worsening or persistent abdominal pain
- Persistent nausea or vomiting
- Black, tarry stools or blood in vomit (signs of gastrointestinal bleeding)
- Severe or persistent constipation
- Signs of aluminum toxicity (rare, primarily in kidney disease): bone pain, muscle weakness, confusion, seizures
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current 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 the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current 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 you find aluminum in the ingredients or are unsure, consult your doctor for guidance.
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 you find aluminum in the ingredients or are unsure, consult your doctor for guidance.
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:
- Constipation
- Abdominal pain
- Nausea
- Vomiting
- In rare cases, particularly with chronic overdose in patients with renal impairment, symptoms of aluminum toxicity (e.g., osteodystrophy, encephalopathy, muscle weakness, seizures) may occur.
- Bezoar formation (a mass of undigested material) has been reported with sucralfate overdose, especially in patients with altered GI motility.
What to Do:
Call 1-800-222-1222 (Poison Control). Treatment is primarily supportive. Gastric lavage may be considered if ingestion was recent. For aluminum toxicity, deferoxamine may be used to chelate aluminum.
Drug Interactions
Major Interactions
- Antacids (separate administration by at least 30 minutes)
- H2-receptor antagonists (e.g., cimetidine, famotidine; separate by at least 30 min before or 2 hours after)
- Proton Pump Inhibitors (e.g., omeprazole, lansoprazole; separate by at least 30 min before or 2 hours after)
- Fluoroquinolone antibiotics (e.g., ciprofloxacin, levofloxacin; separate by at least 2 hours, preferably 4-6 hours)
- Tetracycline antibiotics (e.g., doxycycline, minocycline; separate by at least 2 hours)
- Digoxin (separate by at least 2 hours)
- Phenytoin (separate by at least 2 hours)
- Warfarin (monitor INR, separate by at least 2 hours)
- Levothyroxine (separate by at least 4 hours)
Moderate Interactions
- Aluminum-containing products (increased risk of aluminum toxicity in renal impairment)
- Fat-soluble vitamins (potential for reduced absorption, separate administration)
Monitoring
Baseline Monitoring
Renal function (BUN, creatinine, GFR)
Rationale: To assess the risk of aluminum accumulation, especially with prolonged use or in patients with pre-existing renal impairment.
Timing: Before initiating therapy, particularly in patients with known or suspected renal impairment.
Routine Monitoring
Symptom improvement (e.g., reduction in abdominal pain, heartburn)
Frequency: Daily
Target: Resolution or significant reduction of symptoms
Action Threshold: Persistent or worsening symptoms may indicate treatment failure or require further diagnostic evaluation.
Serum aluminum levels
Frequency: Periodically, as clinically indicated (e.g., every 1-3 months for patients with renal impairment on prolonged therapy)
Target: < 60 mcg/L (toxicity risk increases above this)
Action Threshold: Elevated levels may necessitate discontinuation of sucralfate or dose reduction, and consideration of deferoxamine therapy.
Bowel habits (for constipation)
Frequency: Daily
Target: Regular bowel movements
Action Threshold: Severe or persistent constipation may require laxatives or discontinuation.
Symptom Monitoring
- Abdominal pain (worsening or persistent)
- Nausea
- Vomiting
- Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground emesis)
- Severe constipation
- Signs of aluminum toxicity (in renal impairment): bone pain, muscle weakness, confusion, seizures (rare)
Special Patient Groups
Pregnancy
Category B. Animal reproduction studies have not demonstrated a risk to the fetus, and there are no adequate and well-controlled studies in pregnant women. Due to minimal systemic absorption, the risk to the fetus is considered low. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
L2 (Safer). Minimal systemic absorption of sucralfate means negligible amounts are expected to be excreted into breast milk. Considered compatible with breastfeeding.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Not FDA approved for pediatric use, but commonly used off-label for peptic ulcer disease, GERD, or stress ulcer prophylaxis. Dosing must be individualized based on weight and condition. Caution is advised with prolonged use due to the potential for aluminum accumulation and toxicity, especially in very young children or those with renal impairment.
Geriatric Use
Use with caution, particularly in elderly patients with impaired renal function, due to the increased risk of aluminum accumulation and toxicity. Lower doses or shorter durations of therapy may be considered. Monitor for constipation, which can be more prevalent in this population.
Clinical Information
Clinical Pearls
- Sucralfate works best when taken on an empty stomach, 1 hour before meals and at bedtime, as its activation and binding are pH-dependent.
- It is critical to separate sucralfate administration from other medications (especially antacids, H2 blockers, PPIs, certain antibiotics like fluoroquinolones and tetracyclines, digoxin, phenytoin, and levothyroxine) by at least 2 hours to prevent binding and reduced absorption of other drugs.
- Constipation is a common side effect; advise patients to maintain adequate fluid intake and consider fiber supplements if needed.
- While effective for ulcer healing, sucralfate does not alter gastric acid secretion.
- The tablet can be dissolved in a small amount of water (e.g., 10-15 mL) for patients who have difficulty swallowing pills, forming a suspension that can be swallowed.
Alternative Therapies
- Proton Pump Inhibitors (PPIs) (e.g., omeprazole, esomeprazole, lansoprazole)
- H2-receptor antagonists (H2RAs) (e.g., famotidine)
- Antacids (e.g., aluminum hydroxide/magnesium hydroxide)
- Bismuth subsalicylate (for H. pylori eradication or dyspepsia)
Cost & Coverage
Average Cost:
$20 - $60 per 30 tablets (1gm)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Preferred Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure 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.