Technetium Tc-99m Exametazime

Generic Name: technetium tc-99m exametazime

Radioactive Diagnostic Agent [EPC]Over-the-Counter (OTC)

Brand Names:

Ceretec

DESCRIPTION The Ceretec kit is supplied as a pack of 5 vials for use in the preparation of a technetium Tc99m exametazime intravenous injection as a diagnostic radiopharmaceutical for use as an adjunct in the detection of altered regional cerebral perfusion and for the radiolabeling of autologous leukocytes.

Overview

DESCRIPTION The Ceretec kit is supplied as a pack of 5 vials for use in the preparation of a technetium Tc99m exametazime intravenous injection as a diagnostic radiopharmaceutical for use as an adjunct in the detection of altered regional cerebral perfusion and for the radiolabeling of autologous leukocytes.

Uses

INDICATIONS AND USAGE 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

DOSAGE AND ADMINISTRATION 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.

Side Effects

ADVERSE REACTIONS 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.

Warnings

CONTRAINDICATIONS None known.

Pregnancy

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.

Storage

HOW SUPPLIED The kit comprises 5 individual vials of sterile, non-pyrogenic, freeze-dried mixture of exametazime, stannous chloride dihydrate and sodium chloride, 5 radiation labels, 5 radiochemical purity worksheets, 5 labeling efficiency worksheets, 1 leukocyte labeling schematic and 1 package insert. NDC 17156-022-05 Storage Store the kit at 15°-25°C (59°-77°F).

Frequently Asked Questions

What is Technetium Tc-99m Exametazime used for?

INDICATIONS AND USAGE 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.

What are the side effects of Technetium Tc-99m Exametazime?

ADVERSE REACTIONS 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.

Can I take Technetium Tc-99m Exametazime during pregnancy?

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.

What are the important warnings for Technetium Tc-99m Exametazime?

CONTRAINDICATIONS None known.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.