Sucralfate 1gm/10ml U/d Suspension
It is used to treat GI (gastrointestinal) ulcers.
Drug Class
Antiulcer agent
Pharmacologic Class
Gastrointestinal protectant
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 or the first part of your small intestine (duodenum). It works by forming a protective coating over the ulcer, like a bandage, which shields it from stomach acid and helps it heal. It's not absorbed much into your body, so it mostly works where it's needed.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication on an empty stomach.
Before using the liquid form, shake the bottle well to mix the contents.
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.
Try to space out your other medications by at least 2 hours, as this medication can interfere with the absorption of other drugs.
Continue taking your medication as instructed by your doctor or healthcare provider, even if you start feeling well.
Take your medication by mouth only. Injecting this medication can cause severe and potentially life-threatening side effects.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, away from the bathroom.
Do not freeze your medication.
Keep all medications in a secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
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 ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication on an empty stomach.
Before using the liquid form, shake the bottle well to mix the contents.
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.
Try to space out your other medications by at least 2 hours, as this medication can interfere with the absorption of other drugs.
Continue taking your medication as instructed by your doctor or healthcare provider, even if you start feeling well.
Take your medication by mouth only. Injecting this medication can cause severe and potentially life-threatening side effects.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, away from the bathroom.
Do not freeze your medication.
Keep all medications in a secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
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 this medication on an empty stomach, at least 1 hour before meals and at bedtime.
- Do not take antacids within 30 minutes before or after taking sucralfate, as they can interfere with its action.
- If you are taking other medications, especially antibiotics (like ciprofloxacin, levofloxacin, tetracycline), phenytoin, digoxin, or thyroid hormones, take them at least 2 hours before or after sucralfate to ensure they are properly absorbed.
- Maintain good hydration to help prevent constipation, a common side effect.
- Avoid alcohol and smoking, as they can irritate the stomach lining and hinder ulcer healing.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1 gram (10 mL) four times daily (QID) on an empty stomach, 1 hour before meals and at bedtime, or 2 grams (20 mL) twice daily (BID) on an empty stomach, 1 hour before breakfast and at bedtime.
Dose Range:
1 - 4 mg
Condition-Specific Dosing:
duodenalUlcerTreatment:
1 gram QID or 2 grams BID for 4-8 weeks, or until healing is confirmed.
duodenalUlcerMaintenance:
1 gram BID.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Limited data, typically 40-80 mg/kg/day divided QID, max 1 gram QID.
Adolescent:
Same as adult dosing for duodenal ulcer treatment.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, but use with caution due to aluminum content.
Moderate:
Use with caution; consider lower doses or shorter duration due to risk of aluminum accumulation.
Severe:
Avoid or use with extreme caution due to significant risk of aluminum accumulation and toxicity (e.g., osteodystrophy, encephalopathy).
Dialysis:
Avoid or use with extreme caution. Sucralfate is not dialyzable. Aluminum accumulation is a significant concern.
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. It forms a viscous, adhesive paste that selectively binds to proteins in the ulcer crater, such as albumin and fibrinogen. This creates a protective barrier over the ulcer, shielding it from acid, pepsin, and bile salts. It also stimulates prostaglandin synthesis, bicarbonate secretion, and epidermal growth factor production, contributing to mucosal defense and healing.
Pharmacokinetics
Absorption:
Bioavailability:
<5%
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Food significantly reduces its effectiveness by interfering with its binding to the ulcer site. Must 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:
Primarily fecal (unchanged drug)
Unchanged:
>95%
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (for protective barrier formation)
PeakEffect:
Not applicable (local action)
DurationOfAction:
Approximately 6 hours (due to binding to ulcer site)
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
+ 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. 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 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.
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
+ 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. 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 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 or persistent constipation
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Signs of aluminum toxicity (in patients with kidney problems): bone pain, muscle weakness, confusion, seizures (rare but serious)
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 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 safely with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 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 safely with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 check the label 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 are breast-feeding, inform 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 check the label 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 are breast-feeding, inform 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 of acute overdose have been reported due to minimal systemic absorption. However, large doses may exacerbate common side effects like constipation.
What to Do:
In case of suspected overdose, contact a poison control center or emergency medical services immediately. For the U.S., call 1-800-222-1222. Treatment is generally supportive and symptomatic.
Drug Interactions
Moderate Interactions
- Antacids (aluminum-containing): Increased risk of aluminum toxicity, especially in renal impairment.
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin): Decreased absorption of fluoroquinolones. Separate administration by at least 2 hours.
- Tetracyclines: Decreased absorption of tetracyclines. Separate administration by at least 2 hours.
- Phenytoin: Decreased absorption of phenytoin. Separate administration by at least 2 hours.
- Digoxin: Decreased absorption of digoxin. Separate administration by at least 2 hours.
- Warfarin: Potential for decreased absorption of warfarin (monitor INR).
- Thyroid hormones (e.g., levothyroxine): Decreased absorption of thyroid hormones. Separate administration by at least 4 hours.
- H2-receptor antagonists (e.g., cimetidine, ranitidine): May reduce the binding of sucralfate to the ulcer site if given concurrently (due to pH elevation). Administer sucralfate 30 minutes before H2RAs.
- Proton pump inhibitors (PPIs) (e.g., omeprazole, pantoprazole): May reduce the binding of sucralfate to the ulcer site if given concurrently (due to pH elevation). Administer sucralfate 30 minutes before PPIs.
Monitoring
Baseline Monitoring
Renal function (BUN, creatinine)
Rationale: To assess baseline kidney function, especially important in patients at risk for aluminum accumulation.
Timing: Before initiating therapy, particularly for long-term use or in patients with pre-existing renal impairment.
Routine Monitoring
Symptoms of ulcer (e.g., pain, dyspepsia)
Frequency: Regularly throughout treatment
Target: Resolution or improvement of symptoms
Action Threshold: Persistent or worsening symptoms may indicate treatment failure or need for further investigation.
Bowel habits (constipation)
Frequency: Daily/weekly
Target: Normal bowel movements
Action Threshold: Severe or persistent constipation may require dose adjustment or laxative use.
Serum aluminum levels (in renal impairment or long-term use)
Frequency: Periodically, as clinically indicated
Target: <60 mcg/L (toxic levels typically >100 mcg/L)
Action Threshold: Elevated levels warrant discontinuation or dose reduction and investigation for aluminum toxicity.
Symptom Monitoring
- Abdominal pain
- Dyspepsia
- Nausea
- Constipation
- Dry mouth
- Dizziness
- Back pain
- Headache
- Insomnia
- Pruritus
- Rash
Special Patient Groups
Pregnancy
Sucralfate is classified as 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. It is generally considered safe for use during pregnancy when clearly needed, due to its 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 L3 (Moderately Safe) according to LactMed. It is minimally absorbed systemically, and therefore, very little, if any, is expected to be excreted into breast milk. No adverse effects have been reported in breastfed infants. It is generally considered compatible with breastfeeding.
Infant Risk:
Low risk
Pediatric Use
Safety and efficacy have not been fully established in pediatric patients. Use in children is off-label and typically reserved for specific conditions like stress ulcer prophylaxis or refractory GERD, with dosing based on weight and clinical judgment. 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 for elderly patients. However, elderly patients may be more susceptible to constipation and may have age-related decline in renal function, increasing the risk of aluminum accumulation. Monitor renal function and bowel habits closely.
Clinical Information
Clinical Pearls
- Sucralfate works best when taken on an empty stomach, 1 hour before meals and at bedtime, to allow it to bind effectively to the ulcer site.
- Crucial to separate administration of sucralfate from other medications (especially fluoroquinolones, tetracyclines, phenytoin, digoxin, levothyroxine) by at least 2 hours to prevent reduced absorption of the other drugs.
- Avoid concurrent use with antacids, or separate by at least 30 minutes, as antacids can interfere with sucralfate's binding.
- Constipation is the most common side effect; advise patients to increase fluid and fiber intake.
- While effective for ulcer healing, sucralfate does not neutralize acid or reduce acid secretion directly.
- Caution is paramount in patients with renal impairment due to the aluminum content, which can lead to aluminum toxicity (e.g., osteodystrophy, encephalopathy) with prolonged use or high doses.
Alternative Therapies
- Proton Pump Inhibitors (PPIs) (e.g., omeprazole, pantoprazole, esomeprazole): More potent acid suppression, widely used for ulcer healing and GERD.
- H2-receptor antagonists (H2RAs) (e.g., famotidine, ranitidine): Reduce acid secretion, also used for ulcer healing and GERD.
- Antacids: Provide symptomatic relief but do not promote healing as effectively.
- Bismuth subsalicylate: Has some mucosal protective and antimicrobial properties, often used in H. pylori eradication regimens.
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200 per 420 mL bottle (1gm/10mL)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 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 this 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.