Ethamolin 5% Injection, 2ml
It is used to prevent rebleeding from esophageal varices.
Drug Class
Sclerosing Agent
Pharmacologic Class
Sclerosing Agent
Pregnancy Category
Category C
FDA Approved
Mar 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ethamolin is a medicine injected directly into swollen veins in your esophagus (the tube that carries food from your mouth to your stomach), called esophageal varices. It works by causing these veins to scar and close off, which helps to stop or prevent bleeding.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered as an intravenous injection, which means it is given as a shot into a vein.
Storing and Disposing of Your Medication
Since this medication is given in a healthcare setting, you will not need to store it at home. A healthcare professional will administer the injection, and you will not be responsible for storing or disposing of it.
Missing a Dose
If you are concerned about missing a dose, please note that this medication will be administered in a healthcare setting, and the healthcare team will ensure that you receive the correct dose at the scheduled time.
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered as an intravenous injection, which means it is given as a shot into a vein.
Storing and Disposing of Your Medication
Since this medication is given in a healthcare setting, you will not need to store it at home. A healthcare professional will administer the injection, and you will not be responsible for storing or disposing of it.
Missing a Dose
If you are concerned about missing a dose, please note that this medication will be administered in a healthcare setting, and the healthcare team will ensure that you receive the correct dose at the scheduled time.
Lifestyle & Tips
- Follow your doctor's specific instructions regarding diet and activity after the procedure.
- Avoid strenuous activities and heavy lifting for a period as advised by your doctor.
- Report any new or worsening symptoms immediately to your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1.5 to 5 mL per varix, not to exceed 20 mL per treatment session.
Dose Range:
1.5 - 5 mg
Condition-Specific Dosing:
esophagealVarices:
1.5 to 5 mL per varix, not to exceed 20 mL per treatment session. Injected directly into the varix.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment guidelines
Moderate:
No specific adjustment guidelines
Severe:
No specific adjustment guidelines
Dialysis:
No specific adjustment guidelines
Hepatic Impairment:
Mild:
No specific adjustment guidelines
Moderate:
No specific adjustment guidelines
Severe:
No specific adjustment guidelines
Pharmacology
Mechanism of Action
Ethanolamine Oleate acts as a sclerosing agent. When injected into esophageal varices, it causes inflammation of the vascular endothelium and induces a sterile inflammatory reaction, leading to thrombosis and subsequent fibrosis of the varix. This process obliterates the varix, preventing further bleeding.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (local action)
Tmax:
Not applicable (local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not available (primarily local)
ProteinBinding:
Not available
CnssPenetration:
Limited
Elimination:
HalfLife:
Not available (minimal systemic absorption)
Clearance:
Not available
ExcretionRoute:
Not available (minimal systemic absorption)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Immediate local effect (endothelial damage)
PeakEffect:
Local inflammation and thrombosis develop over hours to days, leading to varix obliteration over days to weeks.
DurationOfAction:
Permanent obliteration of the treated varix if successful.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
* Tissue damage at the injection site, characterized by:
+ Redness
+ Burning
+ Pain
+ Swelling
+ Blisters
+ Skin sores
+ Leaking of fluid
If you notice any of these symptoms, inform your nurse immediately.
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 have side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
* Tissue damage at the injection site, characterized by:
+ Redness
+ Burning
+ Pain
+ Swelling
+ Blisters
+ Skin sores
+ Leaking of fluid
If you notice any of these symptoms, inform your nurse immediately.
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 have side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
Seek Immediate Medical Attention If You Experience:
- Severe chest pain or back pain
- Difficulty or pain with swallowing (dysphagia)
- Fever or chills
- Vomiting blood or material that looks like coffee grounds
- Black, tarry stools (melena)
- Shortness of breath or difficulty breathing
- Signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness)
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 identify potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
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. Never start, stop, or adjust the dose of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
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 identify potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
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. Never start, stop, or adjust the dose of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are 65 years of age or older, exercise caution when using this drug, as you may be more susceptible to experiencing side effects. Additionally, if you are pregnant, planning to become pregnant, or are currently breast-feeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Esophageal ulceration or necrosis
- Esophageal stricture
- Esophageal perforation
- Pleural effusion
- Acute renal failure (due to hemoglobinuria)
- Hemolysis
- Anaphylaxis
- Disseminated intravascular coagulation (DIC)
What to Do:
Management is supportive, focusing on treating the specific complications. This may include endoscopic management of perforations/ulcers, respiratory support for pleural effusion, and management of renal failure or anaphylaxis. Call 1-800-222-1222 (Poison Control) for advice in case of suspected overdose or severe complications.
Drug Interactions
Monitoring
Baseline Monitoring
Coagulation profile (PT/INR, aPTT, Platelet count)
Rationale: To assess bleeding risk, as patients with esophageal varices often have underlying liver disease affecting clotting factors.
Timing: Prior to procedure
Complete Blood Count (CBC)
Rationale: To assess baseline hemoglobin and hematocrit, and overall blood cell counts.
Timing: Prior to procedure
Liver Function Tests (LFTs)
Rationale: To assess the severity of underlying liver disease.
Timing: Prior to procedure
Renal Function Tests (BUN, Creatinine)
Rationale: To assess baseline kidney function, especially important if systemic absorption occurs.
Timing: Prior to procedure
Routine Monitoring
Endoscopic follow-up
Frequency: As clinically indicated, typically at intervals (e.g., 1-2 weeks, then monthly) to assess varix obliteration and identify complications.
Target: Obliteration of treated varices, absence of active bleeding or new varices.
Action Threshold: Persistent varices, re-bleeding, or development of new varices may require repeat sclerotherapy or alternative interventions.
Vital Signs (BP, HR, RR, Temp)
Frequency: Post-procedure and as clinically indicated.
Target: Within normal limits for the patient.
Action Threshold: Significant changes may indicate complications like bleeding, infection, or systemic reaction.
Symptom Monitoring
- Chest pain
- Dysphagia (difficulty swallowing)
- Fever
- Abdominal pain
- Shortness of breath
- Signs of gastrointestinal bleeding (hematemesis, melena, hematochezia)
- Signs of anaphylaxis (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have not been conducted with ethanolamine oleate. It is not known whether Ethamolin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Trimester-Specific Risks:
First Trimester:
Not well-studied; potential for fetal harm if significant systemic absorption occurs.
Second Trimester:
Not well-studied; potential for fetal harm if significant systemic absorption occurs.
Third Trimester:
Not well-studied; potential for fetal harm if significant systemic absorption occurs.
Lactation
Caution advised. It is not known whether ethanolamine oleate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ethamolin is administered to a nursing mother.
Infant Risk:
Unknown
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended in this population.
Geriatric Use
No specific dose adjustments are typically needed for geriatric patients. However, elderly patients may have increased susceptibility to adverse reactions due to age-related comorbidities, decreased physiological reserve, and polypharmacy. Monitor closely for complications.
Clinical Information
Clinical Pearls
- Ethamolin is intended for intraluminal injection into esophageal varices; it is NOT for intravenous administration.
- Administer by or under the supervision of a physician experienced in endoscopic sclerotherapy.
- Careful technique is crucial to minimize complications such as esophageal ulceration, stricture, and perforation.
- Monitor patients closely for signs of systemic reactions (e.g., pleural effusion, acute renal failure, anaphylaxis) which can occur if significant systemic absorption takes place.
- Patients should be monitored for re-bleeding or recurrence of varices, which may necessitate repeat procedures.
Alternative Therapies
- Endoscopic Variceal Ligation (EVL) / Band Ligation
- Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Pharmacological therapy (e.g., non-selective beta-blockers like propranolol or nadolol for prophylaxis)
- Balloon Tamponade (for acute, uncontrolled bleeding)
- Surgical shunts (rarely used now)
Cost & Coverage
Average Cost:
Not available per vial
Insurance Coverage:
Specialty drug, typically covered under medical benefit for hospital-administered procedures.
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred, as this will aid in receiving appropriate treatment.