pharmacopeia

Oleate

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Indications

Sourced from openFDA
  • ETHAMOLIN Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding. ETHAMOLIN is not indicated for the treatment of patients with esophageal varices that have not bled.

Contraindications

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  • ETHAMOLIN Injection should not be administered to subjects with a known hypersensitivity to ethanolamine, oleic acid, or ethanolamine oleate.contraindicated

Dosage & administration

Sourced from openFDA

Local ETHAMOLIN Injection sclerotherapy of esophageal varices should be performed by physicians who are famillar with an acceptable technique. The usual intravenous dose is 1.5 to 5.0 mL per varix. The maximum dose per treatment session should not exceed 20 mL. Patients with significant liver dysfunction (Child Class C) or concomitant cardiopulmonary disease should usually receive less than the recommended maximum dose. Submucosal injections are not recommended as they reportedly are more likely to result in ulceration at the site of injection. To obliterate the varix, injections may be made at the time of the acute bleeding episode and then after one week, six weeks, three months, and six months, as indicated. Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

Warnings & precautions

Sourced from openFDA

ETHAMOLlN Injection should be used in pregnant women only when clearly needed (see PRECAUTIONS). The practice of injecting varicosities of the leg with ETHAMOLlN Injection is not supported by adequately controlled clinical trials. Therefore, such use is not recommended.

Adverse reactions

Sourced from openFDA

The reported frequency of complications/adverse events per injection session was 13%. The most common complications were pleural effusion/infiltration (2.1%), esophageal ulcer (2.1 %), pyrexia (1.8%), retrosternal pain (1.6%), esophageal stricture (1.3%), and pneumonia (1.2%). Other adverse local esophageal reactions have also been reported at rates of 0.1 to 0.4%, including esophagitis, tearing of the esophagus, sloughing of the mucosa overlying the injected varix, ulceration, stricture, necrosis, periesophageal abscess and perforation (see PRECAUTIONS). These complications appear to be dependent upon the dose and the patient's clinical state. Bacteremia has been observed in patients following injection of esophageal varices with ETHAMOLlN. Pyrexia and retrosternal pain are not infrequently observed during the post-injection period. Fatal aspiration pneumonia has occurred in patients with esophageal varices who underwent ETHAMOLIN Injection Sclerotherapy (see PRECAUTIONS). Anaphylactic shock and acute renal failure with spontaneous recovery have occurred (see PRECAUTIONS). A case of disseminated intravascular coagulation has been reported. Spinal cord paralysis due to occlusion of the anterior spinal artery has been reported in one child eight hours after ETHAMOLIN sclerotherapy.

Use in specific populations

Sourced from openFDA

Pregnancy: (Teratogenic Effects: Pregnancy Category C) Animal reproduction studies have not been conducted with ETHAMOLlN Injection. It is also not known whether ETHAMOLIN Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ETHAMOLIN Injection should be given to a pregnant woman only if clearly needed.

Overdosage

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Overdosage of ETHAMOLIN Injection can result in severe intramural necrosis of the esophagus. Complications resulting from such overdosage have resulted in death.

Approval history

Sourced from openFDA
  • Dec 22, 1988NDANDA019357Qol Medcl

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
18 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Oesophageal Varices Haemorrhage528%
  2. 2Portal Vein Thrombosis317%
  3. 3Product Use In Unapproved Indication317%
  4. 4Off Label Use211%
  5. 5Abdominal Pain15.6%
  6. 6Abdominal Pain Upper15.6%
  7. 7Anaemia15.6%
  8. 8Arterial Haemorrhage15.6%
  9. 9Ascites15.6%
  10. 10Cataract15.6%
  11. 11Disseminated Intravascular Coagulation15.6%
  12. 12Dry Eye15.6%
  13. 13Essential Thrombocythaemia15.6%
  14. 14Gastrointestinal Ischaemia15.6%
  15. 15Haemorrhagic Ascites15.6%

Literature

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Recent PubMed references pinned to Oleate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 120 ClinicalTrials.gov registrations naming Oleate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Oleate used for?
According to FDA labeling, Oleate carries indications including: ETHAMOLIN Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding. ETHAMOLIN is not indicated for the treatment of patients with esophageal varices that have not bled.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What are the contraindications for Oleate?
Oleate labeling lists contraindications including: ETHAMOLIN Injection should not be administered to subjects with a known hypersensitivity to ethanolamine, oleic acid, or ethanolamine oleate.. Always consult the full prescribing information and a clinician.
Note. Data for oleate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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