ethanolamine oleate (Rx)

Brand and Other Names:Ethamolin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 50mg/mL
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Bleeding Esophageal Varices

20 mL maximum per session

Injections may be made at time of bleeding, then after 1 week, 6 week, 3 month and 6 month

Hepatic Impairment

Hepatic impairment (Child-Pugh Class C)/Concomitant cardiopulmonary disease: Reduce dose

Esophageal Varices (Orphan)

Orphan designation for prophylactic use in pediatric patients (aged 0 through 16 yr) with esophageal varices that are at risk of bleeding to obliterate varices and to prevent bleeding

Orphan sponsor

  • QOL Medical, LLC; 4445 North Highway A1A, 241; Vero Beach, FL 32963
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Adverse Effects

1-10%

Esophageal ulcer (2.1%)

Pleural effusion (2.1%)

Pyrexia (1.8%)

Retrosternal pain (1.6%)

Esophageal stricture (1.3%)

Pneumonia (1.2%)

Frequency not defined

Fever

Esophagitis

Sloughing of the mucosa overlying the injected varix

Anaphylactic shock

Acute renal failure (reversible)

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Warnings

Contraindications

Hypersensitivity to ethanolamine oleate, oleic acid or ethanolamine

Not indicated for esophageal varices that have not bled

Cautions

Risk of severe esophageal necrosis (potentially fatal)

Risk of severe aspiration pneumonia (potentially fatal especially in elderly)

Caution in hepatic impairment, cardiopulmonary disease, the elderly and critically ill patients

Submucosal injections not recommended

Extreme anaphylactic reaction may be treated with 0.25 mL of 1:1000 epinephrine IV & side effects controlled by antihistamines; fatal anaphylactic shock reported

Do not use if solution has particulate matter or discoloration

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: excretion in milk unknown; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Sclerosing agent, produces a sterile inflammatory response leading to fibrosis and vein occlusion

Oleic acid is the inflammatory component

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Images

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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