pharmacopeia

Mebrofenin

US-FDASourced from openFDA
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Indications

Sourced from openFDA
  • Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.

Contraindications

Sourced from openFDA
  • Hypersensitivity to this compound.contraindicated

Dosage & administration

Sourced from openFDA

The suggested intravenous dose range of Technetium Tc 99m Mebrofenin in the average patient (70 kg) is: Nonjaundiced patient: 74-185 MBq (2-5 mCi) Patient with serum bilirubin level greater than 1.5 mg/dL: 111-370 MBq (3-10 mCi) The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. The patient should be in a fasting state, 4 hours is preferable. False positives (non-visualization) may result if the gallbladder has been emptied by ingestion of food. An interval of at least 24 hours should be allowed before repeat examination. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Warnings & precautions

Sourced from openFDA

The theoretical possibility of allergic reactions should be considered in patients who receive multiple doses.

Adverse reactions

Sourced from openFDA

Urticaria and rash have been rarely reported with the use of Technetium Tc 99m Mebrofenin since market introduction. Rare cases of chills and nausea have been reported with related compounds. Infrequently, death has been reported in association with the use of this class of agents.

Use in specific populations

Sourced from openFDA

Pregnancy Animal reproduction studies have not been conducted with Technetium Tc 99m Mebrofenin. It is also not known whether Technetium Tc 99m Mebrofenin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Technetium Tc 99m Mebrofenin should be given to a pregnant woman only if the expected benefits to be gained clearly outweigh the potential hazards.

Approval history

Sourced from openFDA
  • Jan 21, 1987NDANDA018963Bracco
  • Jan 29, 2008ANDAANDA078242Sun Pharm Inds Inc

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.
94 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. 1Drug Effect Decreased3436%
  2. 2Multiple Use Of Single-use Product2931%
  3. 3Nausea1112%
  4. 4Hypersensitivity66.4%
  5. 5Vomiting66.4%
  6. 6Drug Ineffective55.3%
  7. 7Asthenia44.3%
  8. 8Chills44.3%
  9. 9Diarrhoea44.3%
  10. 10Dyspnoea44.3%
  11. 11Headache44.3%
  12. 12Therapeutic Response Unexpected44.3%
  13. 13Abdominal Pain Upper33.2%
  14. 14Dizziness33.2%
  15. 15Dysgeusia33.2%

Clinical trials

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The 8 most recently updated of 8 ClinicalTrials.gov registrations naming Mebrofenin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Mebrofenin used for?
According to FDA labeling, Mebrofenin carries indications including: Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What are the contraindications for Mebrofenin?
Mebrofenin labeling lists contraindications including: Hypersensitivity to this compound.. Always consult the full prescribing information and a clinician.
Note. Data for mebrofenin 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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