Carafate 1gm/10ml Suspension
It is used to treat GI (gastrointestinal) ulcers.
Drug Class
Gastrointestinal agent, Antiulcer agent
Pharmacologic Class
Mucosal 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 and protect the lining of your stomach and intestines. It works by forming a protective coating over the ulcer, shielding it from stomach acid and other irritants, allowing it to heal.
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.
Measure liquid doses accurately using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.
Avoid taking antacids within 30 minutes before or after taking your medication.
Try to take other medications at least 2 hours apart from this one, as it may interfere with their absorption.
Continue taking your medication as instructed 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 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.
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.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed one.
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.
Measure liquid doses accurately using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.
Avoid taking antacids within 30 minutes before or after taking your medication.
Try to take other medications at least 2 hours apart from this one, as it may interfere with their absorption.
Continue taking your medication as instructed 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 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.
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.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take this medication on an empty stomach, usually 1 hour before meals and at bedtime.
- Shake the suspension well before each use.
- Do not take antacids within 30 minutes of taking sucralfate.
- Separate sucralfate from other medications (especially certain antibiotics, digoxin, phenytoin, warfarin, and thyroid hormones) by at least 2 hours (or 4 hours for thyroid hormones) to prevent reduced absorption of those medications.
- Continue taking the medication for the full prescribed duration, even if your symptoms improve.
- Avoid alcohol and smoking, as they can irritate the stomach lining and hinder healing.
- Follow any dietary recommendations from your doctor (e.g., avoiding spicy or acidic foods if they worsen symptoms).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1 gram (10 mL) four times daily (q.i.d.) or 2 grams (20 mL) twice daily (b.i.d.)
Condition-Specific Dosing:
Duodenal Ulcer (active):
1 gram (10 mL) q.i.d. (1 hour before meals and at bedtime) for 4-8 weeks, or 2 grams (20 mL) b.i.d. for 4-8 weeks.
Duodenal Ulcer (maintenance):
1 gram (10 mL) b.i.d.
GERD/Esophagitis (off-label):
1 gram (10 mL) q.i.d.
Oral Mucositis (off-label):
5-10 mL swish and spit/swallow q.i.d.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (use is off-label, typically 40-80 mg/kg/day divided q6h for specific conditions like GERD or oral mucositis, max 1g/dose)
Adolescent:
Similar to adult dosing for specific off-label conditions, individualized based on weight and severity.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for signs of aluminum accumulation with long-term use.
Moderate:
Use with caution; monitor for signs of aluminum accumulation and consider serum aluminum levels.
Severe:
Avoid or use with extreme caution due to risk of aluminum accumulation and toxicity.
Dialysis:
Avoid or use with extreme caution due to significant risk of aluminum accumulation and toxicity.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Pharmacology
Mechanism of Action
Sucralfate forms a viscous, adhesive paste that selectively binds to proteins (e.g., albumin, fibrinogen) in the base of ulcers and erosions, creating a protective barrier against acid, pepsin, and bile salts. It also stimulates prostaglandin synthesis and epidermal growth factor, contributing to mucosal defense and repair.
Pharmacokinetics
Absorption:
Bioavailability:
<5%
Tmax:
Not clinically relevant (local action)
FoodEffect:
Food may reduce binding to ulcer site; should be taken on an empty stomach (1 hour before meals).
Distribution:
Vd:
Not clinically relevant (local action)
ProteinBinding:
Not clinically relevant
CnssPenetration:
No
Elimination:
HalfLife:
Not clinically relevant (minimal absorption)
Clearance:
Not clinically relevant
ExcretionRoute:
Primarily excreted unchanged in feces; absorbed aluminum is renally excreted.
Unchanged:
>95% (in feces)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (for protective barrier formation)
PeakEffect:
Not applicable (local protective effect)
DurationOfAction:
Up to 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
+ Trouble 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
+ Passing urine more often
+ Flushing
+ Fast 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 have mild 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 do not go away, contact your doctor:
* Constipation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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 can provide medical advice about side effects and help you manage any concerns.
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
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast 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 have mild 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 do not go away, contact your doctor:
* Constipation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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 can provide medical advice about side effects and help you manage any concerns.
Seek Immediate Medical Attention If You Experience:
- Severe constipation
- Severe stomach pain
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- In patients with kidney problems, watch for signs of aluminum toxicity (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 you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other 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 and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other 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 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 are breast-feeding, 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 are breast-feeding, 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:
- Generally considered to have low acute toxicity due to minimal absorption.
- Large doses may cause severe constipation or abdominal pain.
- In patients with renal impairment, signs of aluminum toxicity may appear (e.g., encephalopathy, osteomalacia).
What to Do:
Call 1-800-222-1222 (Poison Control) or seek emergency medical attention.
Drug Interactions
Major Interactions
- Antacids (separate by at least 30 minutes to avoid reduced sucralfate efficacy)
- H2-receptor antagonists (e.g., famotidine, ranitidine) and Proton Pump Inhibitors (PPIs) (e.g., omeprazole, pantoprazole) (separate administration to avoid reduced sucralfate efficacy by altering gastric pH)
- Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) (reduced absorption; separate by at least 2 hours)
- Tetracyclines (reduced absorption; separate by at least 2 hours)
- Digoxin (reduced absorption; separate by at least 2 hours)
- Phenytoin (reduced absorption; separate by at least 2 hours)
- Warfarin (potential for reduced absorption; separate by at least 2 hours)
- Thyroid hormones (e.g., levothyroxine) (reduced absorption; separate by at least 4 hours)
Moderate Interactions
- Fat-soluble vitamins (potential for reduced absorption)
Monitoring
Baseline Monitoring
Renal function (BUN, serum creatinine, CrCl)
Rationale: To assess baseline kidney function and risk of aluminum accumulation, especially in patients with pre-existing impairment.
Timing: Before initiating therapy, particularly for long-term use or in patients with suspected renal impairment.
Routine Monitoring
Symptoms of ulcer/mucosal irritation (e.g., pain, discomfort)
Frequency: Daily
Target: Resolution or improvement of symptoms
Action Threshold: Worsening symptoms or lack of improvement after 4-8 weeks of therapy.
Serum aluminum levels (in patients with renal impairment or on long-term therapy)
Frequency: Periodically (e.g., monthly to quarterly, as clinically indicated)
Target: <60 mcg/L (or institution-specific target)
Action Threshold: Elevated levels, or development of signs/symptoms of aluminum toxicity (e.g., osteomalacia, encephalopathy).
Symptom Monitoring
- Constipation
- Nausea
- Dry mouth
- Indigestion
- Abdominal discomfort
- Signs of aluminum toxicity (in renal patients: bone pain, muscle weakness, confusion, seizures)
Special Patient Groups
Pregnancy
Generally considered safe due to minimal systemic absorption. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Low risk, minimal systemic exposure.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Considered compatible with breastfeeding due to minimal systemic absorption by the mother and unlikely transfer into breast milk in clinically significant amounts.
Infant Risk:
Low risk.
Pediatric Use
Use is off-label for most indications. Dosing must be individualized and carefully monitored. There is a risk of aluminum accumulation in very young children or those with renal impairment.
Geriatric Use
No specific dose adjustment needed based on age alone. However, elderly patients are more likely to have renal impairment, increasing the risk of aluminum accumulation. Monitor renal function closely.
Clinical Information
Clinical Pearls
- Sucralfate works locally by forming a protective barrier; it does not neutralize stomach acid.
- Crucial to administer on an empty stomach (1 hour before meals) and separate from other medications (at least 2 hours before or after) to ensure optimal efficacy and prevent drug interactions.
- Constipation is a common side effect.
- Contains aluminum; use with caution in patients with renal impairment due to the risk of aluminum accumulation and toxicity.
- Shake the suspension well before each use.
- Often used as a 'slurry' (swish and swallow/spit) for oral mucositis.
Alternative Therapies
- Proton Pump Inhibitors (PPIs): Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole (for acid suppression and ulcer healing).
- H2-receptor antagonists (H2RAs): Famotidine, Ranitidine (for acid suppression).
- Antacids: Aluminum hydroxide, Magnesium hydroxide, Calcium carbonate (for symptomatic relief).
- Bismuth subsalicylate (for protective coating, H. pylori eradication).
Cost & Coverage
Average Cost:
Price range varies widely by pharmacy and dosage form per 420 mL bottle (1gm/10mL)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.