pharmacopeia

Exametazime

US-FDASourced from openFDA
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Indications

Sourced from openFDA
  • Technetium Tc99m exametazime scintigraphy may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. Tc99m exametazime is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.ICD-10: I63.9

Contraindications

Sourced from openFDA
  • None known.contraindicated

Dosage & administration

Sourced from openFDA

Tc99m labeled leukocytes for adjunctive localization of intra-abdominal infection or inflammation. The normal adult (70 kg) dose is 0.259-0.925 GBq (7-25 mCi) as Tc99m labeled leukocytes by intravenous injection. Optimal planar imaging is between 2-4 hours. Cerebral Scintigraphy The recommended dose range for i.v. administration, of reconstituted sodium pertechnetate Tc99m exametazime in the average adult (70 kg) is 370-740 MBq (10-20 mCi). Dynamic imaging may be performed between 0 to 10 minutes following injection. Static imaging may be performed from 15 minutes up to 6 hours after injection.

Adverse reactions

Sourced from openFDA

Rash with generalized erythema, facial edema and fever has been reported in less than 1% of patients. A transient increase in blood pressure was seen in 8% of patients.

Use in specific populations

Sourced from openFDA

Pregnancy Category C Animal reproduction studies have not been conducted with Tc99m exametazime. It is also not known whether Tc99m exametazime can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Therefore, Tc99m exametazime should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.

Approval history

Sourced from openFDA
  • Dec 30, 1988NDANDA019829Ge Healthcare
  • Aug 17, 2017NDANDA208870Jubilant

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.
38 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. 1No Adverse Event1334%
  2. 2Drug Ineffective821%
  3. 3Radioisotope Scan Abnormal718%
  4. 4Rash411%
  5. 5Chills37.9%
  6. 6Headache37.9%
  7. 7Condition Aggravated25.3%
  8. 8Dyspnoea25.3%
  9. 9Malaise25.3%
  10. 10Unresponsive To Stimuli25.3%
  11. 11Vasospasm25.3%
  12. 12Abdominal Discomfort12.6%
  13. 13Anaphylactic Reaction12.6%
  14. 14Autoimmune Thyroiditis12.6%
  15. 15Blood Creatinine Increased12.6%

Clinical trials

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The 1 most recently updated of 1 ClinicalTrials.gov registrations naming Exametazime as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Exametazime used for?
According to FDA labeling, Exametazime carries indications including: Technetium Tc99m exametazime scintigraphy may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. Tc99m exametazime is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What are the contraindications for Exametazime?
Exametazime labeling lists contraindications including: None known.. Always consult the full prescribing information and a clinician.
Note. Data for exametazime 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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