Technetium (99mTc) exametazime
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sree Teja Yelamanchili, MBBS [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Technetium (99mTc) exametazime is a diagnostic radiopharmaceutical agent that is FDA approved for the diagnosis of infectious disease of abdomen, inflammatory bowel disease, radioisotope brain imaging. Common adverse reactions include hypertension.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- 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.
Dosage
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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Diagnosis of:
- Alzheimer's disease
- Electrocerebral silence
- Epilepsy
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Technetium (99mTc) exametazime in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-labeled indications and dosage of Technetium (99mTc) exametazime in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Technetium (99mTc) exametazime in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Technetium (99mTc) exametazime in pediatric patients.
Contraindications
None known.
Warnings
- As with any injected product, acute hypersensitivity or allergic reactions are possible.
- Limited reports have been received of hypersensitivity reactions following administration of Tc99m labeled leukocytes prepared using Tc99m exametazime.
- However, the materials used in leukocyte cell separation may cause hypersensitivity reactions.
- It is essential that cells are washed free of sedimentation agents before they are reinjected into the patient.
- In case of side effects following administration of radiopharmaceuticals, users should ensure the availability of appropriate medical treatment at the time of administration of any radiopharmaceutical to the patient.
- A thorough knowledge of the normal distribution of intravenously administered technetium Tc99m exametazime injection is essential in order to interpret pathologic studies accurately.
- Caution should be exercised in making the final diagnosis.
- Results can be affected by the presence of tumor, infarction, peritonitis, non-gastrointestinal or bony sites of inflammatory cell collections.
- The contents of the Ceretec vial are not radioactive.
- After the sodium pertechnetate Tc99m is added, the product is radioactive and adequate shielding of the final preparation must be maintained.
- The contents of the Ceretec vial are intended only for use in preparation of technetium Tc99m exametazime injection and are NOT to be administered directly to the patient.
General
- The contents of the Ceretec vial are sterile and pyrogen free.
- The vial contains no bacteriostatic preservative.
- It is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation of the radiopharmaceutical.
- Radiopharmaceuticals should be used only by or under the control of physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
- To minimize radiation dose to the bladder, the patient should be encouraged to void when the examination is completed and as often thereafter as possible.
- Adequate hydration should be encouraged to permit frequent voiding.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Technetium (99mTc) exametazime Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Technetium (99mTc) exametazime Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Technetium (99mTc) exametazime Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Technetium (99mTc) exametazime in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Technetium (99mTc) exametazime in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Technetium (99mTc) exametazime during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Technetium (99mTc) exametazime in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Technetium (99mTc) exametazime in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Technetium (99mTc) exametazime in geriatric settings.
Gender
There is no FDA guidance on the use of Technetium (99mTc) exametazime with respect to specific gender populations.
Race
There is no FDA guidance on the use of Technetium (99mTc) exametazime with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Technetium (99mTc) exametazime in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Technetium (99mTc) exametazime in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Technetium (99mTc) exametazime in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Technetium (99mTc) exametazime in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Technetium (99mTc) exametazime Administration in the drug label.
Monitoring
There is limited information regarding Technetium (99mTc) exametazime Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Technetium (99mTc) exametazime and IV administrations.
Overdosage
There is limited information regarding Technetium (99mTc) exametazime overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Technetium (99mTc) exametazime Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Technetium (99mTc) exametazime Mechanism of Action in the drug label.
Structure
There is limited information regarding Technetium (99mTc) exametazime Structure in the drug label.
Pharmacodynamics
There is limited information regarding Technetium (99mTc) exametazime Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Technetium (99mTc) exametazime Pharmacokinetics in the drug label.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
- Long term animal studies have not been performed to evaluate carcinogenic potential or whether exametazime affects fertility in males or females.
- When evaluated in the Ames test, exametazime increased the apparent rate of gene mutation in the TA100 strain of S. typhimurium.
- Exametazime did not cause chromosomal aberrations in vitro (Chinese Hamster Ovary cells) or in vivo (rat bone marrow).
Clinical Studies
There is limited information regarding Technetium (99mTc) exametazime Clinical Studies in the drug label.
How Supplied
There is limited information regarding Technetium (99mTc) exametazime How Supplied in the drug label.
Storage
There is limited information regarding Technetium (99mTc) exametazime Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Technetium (99mTc) exametazime |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Technetium (99mTc) exametazime |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Technetium (99mTc) exametazime Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Technetium (99mTc) exametazime interaction has not been established.
Brand Names
There is limited information regarding Technetium (99mTc) exametazime Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Technetium (99mTc) exametazime Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.