FDA Label for Exametazime Hmpao

Description

AnazaoHealth’s compounded Exametazime vial is a sterile, non-pyrogenic preparation that consists of a lyophilized mixture of 1 mg of Exametazime, 6.75 mg of Sodium Chloride, 11.4 µg of Stannous Chloride Dihydrate and is maintained under an inert nitrogen atmosphere. The kit also contains a vial of Cobalt Chloride, which contains 0.3 mg of cobalt chloride hexahydrate, or Methylene Blue 1% (methylene blue 10 mg/mL) and Phosphate Buffer (monobasic sodium phosphate, sodium chloride, dibasic sodium phosphate This kit contains no antimicrobial preservative

Clinical Pharmacology

Cerebral Scintigraphy
When Exametazime is reconstituted with Tc99m pertechnetate, a lipophilic complex of Tc99m Exametazime is formed and is the active ingredient of the reconstituted product. The lipophilic complex crosses the blood-brain barrier. It converts to the less lipophilic complex 12% per hour. The preparation is good for 30 minutes without the use of a stabilizer. The in vitro addition of cobalt chloride helps to stabilize the complex for 6 hours.

Leukocyte (WBC) Labeling
The lipophilic complex of Tc99m Exametazime is taken up by leukocytes and selectively     retained by neutrophils. Cobalt chloride, as a stabilizer, may be used with this procedure as well

Indications And Usage

Exametazime is a diagnostic agent used as an adjunct in the detection of altered cerebral perfusion in stroke patients and is also indicated for white blood cell labeling as an adjunct in the localization of abdominal infections and inflammatory bowel disease

Physical Half-Life & Target Organs

The physical half-life of technetium, Tc99m, is 6 hours and has a principal radiation emission of gamma photons with a mean energy of 140 KeV.

Contraindications

There are no known contraindications for this preparation.

Dosage And Administration

Cerebral Scintigraphy

The recommended dose range for IV administration is 10 to 20 mCi (370 to 740 MBq).

Leukocyte (WBC) Labeling

The recommended dose range for IV administration is 7 to 25 mCi (259 to 925 MBq)

Preparation

For best results, use tc99m from a generator eluted within 24 hours.  The eluate should be used within 2 hours of elution.

Reconstitution Instructions:

• Snap off the plastic lid and place in appropriate lead shielding. Wipe the septum with 70% isopropyl alcohol and allow it to dry
• Using a 10 mL syringe, draw up 15-80 mCi of tc99m. Dilute this to 7.5 mL with sterile preservative free saline and inject into the vial, being sure to withdraw an equal amount of gas from the vial to neutralize pressure.
• Rock and invert the shielded vial for 10 seconds. Wait 2 minutes before adding stabilizer to allow for tagging.
• Add stabilizer to extend the length of time before use
• If no stabilizer is added, use the vial within 30 minutes.

Stabilizer Use:

Cobalt Chloride as a stabilizer: Wait 2 minutes after adding tc99m. Then add 3 mL of Cobalt Chloride to tc99m HMPAO. Solution is clear but slightly tan, which is normal. Swirl contents to mix and inspect solution for particulates. Draw 0.1 mL for a quality control sample. Solution is stable for 6 hours. This stabilizer can be used in WBC labeling

Methylene blue and Phosphate buffer as a stabilizer: Add 0.5 mL of 1% methylene blue to 4.5 mL of phosphate buffer solution. Swirl contents to mix then draw 3 mL and add to HMPAO within 2 minutes of mixing tc99m. Filter the final solution using a 0.22µm filter into an empty sterile vial. Draw 0.1 mL sample for quality control. Radiochemical purity must be 80% or higher. Solution is stable for 4 hours. This stabilizer is not recommended for use in WBC labeling

Storage And Handling

The preparation is recommended to be stored in the refrigerator at 2- 8(C (36 - 46(F)