Sucralfate 1gm/10ml Suspension
It is used to treat GI (gastrointestinal) ulcers.
Drug Class
Antiulcer agent
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 over ulcers in your stomach or intestines. This coating acts like a bandage, shielding the ulcer from stomach acid and helping 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.
Before using the liquid form, shake the bottle well to ensure the ingredients are mixed properly.
Measure liquid doses accurately using the measuring device provided with the medication. If one is not included, ask your pharmacist for a suitable measuring device.
Avoid taking antacids within 30 minutes before or after taking your medication, as this can interfere with its absorption.
Try to take other medications at least 2 hours apart from this one, as it may affect the absorption of other drugs.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better.
Important Administration Instructions
Take your medication by mouth only. Injecting this medication can lead to 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.
Do not freeze your medication.
Keep all medications in a safe and secure location, out of the reach of children and pets.
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 to make up for a missed dose.
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.
Before using the liquid form, shake the bottle well to ensure the ingredients are mixed properly.
Measure liquid doses accurately using the measuring device provided with the medication. If one is not included, ask your pharmacist for a suitable measuring device.
Avoid taking antacids within 30 minutes before or after taking your medication, as this can interfere with its absorption.
Try to take other medications at least 2 hours apart from this one, as it may affect the absorption of other drugs.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better.
Important Administration Instructions
Take your medication by mouth only. Injecting this medication can lead to 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.
Do not freeze your medication.
Keep all medications in a safe and secure location, out of the reach of children and pets.
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 to make up for a missed dose.
Lifestyle & Tips
- Take sucralfate on an empty stomach, typically one hour before meals and at bedtime, for best results.
- Do not take antacids, H2-blockers (like Pepcid, Zantac), or proton pump inhibitors (like Prilosec, Nexium) within 30 minutes before or after taking sucralfate, as they can interfere with its action.
- Separate sucralfate from other medications (especially antibiotics like ciprofloxacin, phenytoin, digoxin, warfarin, and thyroid hormones) by at least 2 hours before or 6 hours after sucralfate, as it can reduce their absorption.
- Maintain adequate fluid intake to help prevent constipation, a common side effect.
- Avoid alcohol, caffeine, and spicy foods if they worsen your ulcer symptoms.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1 gram (10 ml) orally four times daily (one hour before meals and at bedtime) for active duodenal ulcers; 1 gram (10 ml) orally twice daily for maintenance therapy.
Dose Range:
1 - 4 mg
Condition-Specific Dosing:
activeDuodenalUlcer:
1 gram (10 ml) four times daily (one hour before meals and at bedtime) for 4-8 weeks.
maintenanceTherapy:
1 gram (10 ml) twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (off-label use for GERD or stress ulcer prophylaxis: 40-80 mg/kg/day divided every 6 hours, max 1 gram/dose)
Adolescent:
Not established (off-label use for GERD or stress ulcer prophylaxis: 40-80 mg/kg/day divided every 6 hours, max 1 gram/dose)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, but use with caution due to aluminum content.
Moderate:
Use with caution; consider aluminum accumulation, especially with long-term use. Monitor for signs of aluminum toxicity.
Severe:
Use with caution; consider aluminum accumulation, especially with long-term use. Monitor for signs of aluminum toxicity.
Dialysis:
Use with caution; aluminum accumulation is a risk. Avoid prolonged use.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Pharmacology
Mechanism of Action
Sucralfate is an aluminum salt of sucrose octasulfate. In an acidic environment (pH < 4), it forms a viscous, paste-like substance that selectively binds to proteins in the ulcer crater, forming a protective barrier over the ulcer site. This barrier protects the ulcer from further damage by acid, pepsin, and bile salts, allowing it to heal. It also stimulates prostaglandin synthesis and epidermal growth factor production, contributing to mucosal defense and repair.
Pharmacokinetics
Absorption:
Bioavailability:
<5%
Tmax:
Not applicable (local action)
FoodEffect:
Food can reduce binding to ulcer site; should be taken on an empty stomach.
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Feces (unchanged)
Unchanged:
>95%
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (for binding to ulcer site)
PeakEffect:
Not applicable (local action)
DurationOfAction:
Up to 6 hours (duration of protective barrier)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Breath that smells like fruit
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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
* Constipation
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is available to provide medical advice about side effects, so don't hesitate to contact them.
Although rare, some people may experience severe and potentially life-threatening side effects while 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Breath that smells like fruit
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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
* Constipation
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is available to provide medical advice about side effects, so don't hesitate to contact them.
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)
- 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 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 is crucial to avoid 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 vital to verify that it is safe to take this medication 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 is crucial to avoid 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 vital to verify that it is safe to take this medication 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 drug 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 have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels while taking this drug.
If you are pregnant, planning to become pregnant, or 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 drug 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 have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels while taking this drug.
If you are pregnant, planning to become pregnant, or 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:
- Minimal systemic toxicity is expected due to poor absorption.
- Large doses may cause severe constipation.
What to Do:
Contact a poison control center (1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive.
Drug Interactions
Moderate Interactions
- Antacids (e.g., aluminum hydroxide, magnesium hydroxide): May reduce sucralfate's effectiveness by raising gastric pH, preventing its activation. Separate administration by at least 30 minutes.
- H2-receptor antagonists (e.g., cimetidine, ranitidine, famotidine): May reduce sucralfate's effectiveness by raising gastric pH. Separate administration by at least 30 minutes.
- Proton pump inhibitors (e.g., omeprazole, lansoprazole, pantoprazole): May reduce sucralfate's effectiveness by raising gastric pH. Separate administration by at least 30 minutes.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Sucralfate can chelate these antibiotics, reducing their absorption. Administer fluoroquinolones at least 2 hours before or 6 hours after sucralfate.
- Phenytoin: Sucralfate can reduce phenytoin absorption. Administer phenytoin at least 2 hours before or 6 hours after sucralfate.
- Digoxin: Sucralfate can reduce digoxin absorption. Administer digoxin at least 2 hours before or 6 hours after sucralfate.
- Warfarin: Sucralfate can reduce warfarin absorption. Administer warfarin at least 2 hours before or 6 hours after sucralfate.
- Thyroid hormones (e.g., levothyroxine): Sucralfate can reduce absorption. Administer thyroid hormones at least 4 hours before or after sucralfate.
Monitoring
Baseline Monitoring
Renal function (BUN, creatinine)
Rationale: Sucralfate contains aluminum, which can accumulate in patients with impaired renal function, potentially leading to aluminum toxicity.
Timing: Prior to initiating long-term therapy, especially in patients with pre-existing renal impairment.
Routine Monitoring
Symptom improvement (e.g., reduction in ulcer pain)
Frequency: Daily/Weekly
Target: Reduction or resolution of symptoms
Action Threshold: Lack of symptom improvement after 2-4 weeks may indicate need for re-evaluation or alternative therapy.
Bowel habits (for constipation)
Frequency: Daily
Target: Regular bowel movements
Action Threshold: Significant constipation may require dose adjustment, increased fluid intake, or laxatives.
Signs of aluminum toxicity (in renal impairment)
Frequency: Periodically (e.g., monthly to quarterly)
Target: Absence of symptoms (e.g., bone pain, muscle weakness, encephalopathy)
Action Threshold: Presence of symptoms or elevated serum aluminum levels (if measured) warrants discontinuation or dose reduction.
Symptom Monitoring
- Constipation
- Nausea
- Dry mouth
- Dizziness
- Headache
- Indigestion
- Back pain
- Sleepiness
- Rash
- Itching
Special Patient Groups
Pregnancy
Sucralfate is classified as Pregnancy Category B. Animal reproduction studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. It is generally considered safe for use during pregnancy when clearly needed due to minimal systemic absorption.
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 to have a low risk during breastfeeding (Lactation Risk Category L2). Due to minimal systemic absorption, it is unlikely to be excreted in breast milk in clinically significant amounts. It is generally considered compatible with breastfeeding.
Infant Risk:
Low risk
Pediatric Use
Safety and efficacy have not been established in pediatric patients. However, it is used off-label for conditions like GERD, stress ulcer prophylaxis, and esophagitis in children. Dosing is typically weight-based, and caution is advised, especially regarding aluminum accumulation in very young children or those with renal impairment.
Geriatric Use
No specific dose adjustment is required based on age alone. However, elderly patients are more likely to have decreased renal function, which increases the risk of aluminum accumulation and toxicity. Use with caution in elderly patients with impaired renal function, and monitor for signs of aluminum toxicity.
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, H2RAs, and PPIs.
- The most common side effect is constipation, which can often be managed with increased fluid intake and dietary fiber.
- Due to its binding properties, sucralfate can significantly reduce the absorption of many other medications. Strict adherence to separation times is crucial.
- While generally safe due to minimal absorption, long-term use, especially in patients with renal impairment, carries a risk of aluminum accumulation and toxicity (e.g., osteomalacia, encephalopathy).
- Sucralfate suspension should be shaken well before use.
Alternative Therapies
- Proton Pump Inhibitors (PPIs) (e.g., omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole)
- H2-receptor antagonists (H2RAs) (e.g., famotidine, cimetidine, ranitidine)
- Antacids (e.g., aluminum hydroxide, magnesium hydroxide, calcium carbonate)
- Bismuth subsalicylate (for H. pylori eradication or dyspepsia)
Cost & Coverage
Average Cost:
$30 - $100 per 420ml bottle (1gm/10ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.