Ceretec
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Uses
Technetium Tc99m exametazime scintigraphy (with or without methylene blue stabilization) may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke.
Tc99m exametazime without methylene blue stabilization is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.
History
There is currently no drug history available for this drug.
Other Information
The Ceretec kit is supplied as five packs of three 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. Each vial of Ceretec contains a pre-dispensed sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime [(RR,SS)-4.8-diaza-3,6,6,9-tetramethylundecane-2, 10-dione bisoxime], 7.6 µg stannous chloride dihydrate (minimum stannous tin 0.6 µg; maximum total stannous and stannic tin 4.0 µg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative.
In addition, each package contains five 1 mL vials of Methylene Blue Injection USP 1% containing 10 mg methylene blue USP in Water for Injection q.s. pH adjusted with sodium hydroxide and/or hydrochloric acid, when necessary. Methylene Blue Injection USP is a sterile, non-pyrogenic solution of phenothiazin-5-ium,3,7-bis (dimethylamino)-chloride, trihydrate. Each package also contains five 4.5 mL vials of 0.003 M Monobasic Sodium Phosphate USP and Dibasic Sodium Phosphate USP in 0.9% Sodium Chloride Injection USP. The solution is sterile and non-pyrogenic. Each mL contains 0.276 mg monobasic sodium phosphate monohydrate (equivalent to 0.312 mg monobasic sodium phosphate dihydrate), 0.142 mg dibasic sodium phosphate anhydrous (equivalent to 0.178 mg dibasic sodium phosphate dihydrate) and 9 mg sodium chloride in Water for Injection q.s. The total calculated osmolarity of the 0.003 M Monobasic Sodium Phosphate USP and Dibasic Sodium Phosphate USP in 0.9% Sodium Chloride Injection USP is 317 mOsmol/L. Each mL provides 0.285 mg (3mM) of phosphate, 0.157 mEq of sodium and 0.154 mEq of chloride. When used according to the preparation instructions (see DOSAGE AND ADMINISTRATION), Methylene Blue Sodium Phosphates/Sodium Chloride mixture acts as a stabilizer.
Prior to publication of the USAN, exametazime was formerly known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications.
The structural formula of exametazime is:
When sterile pyrogen-free sodium pertechnetate Tc99m in isotonic saline is added to the vial of Ceretec, a Tc99m complex of exametazime is formed.
Administration is by intravenous injection for diagnostic use.
Technetium Tc99m decays by isomeric transition with a physical half-life of 6.03 hours.(1) Photons that are useful for imaging studies are listed in Table 1.
| Radiation | Mean %/ Disintegration |
Mean Energy (keV) |
|---|---|---|
| (1)Dillman, L.T. and Von der Lage, F.C. Radionuclide decay schemes and nuclear parameters for use in radiation-dose estimation. MIRD Phamphlet No. 10, p. 62, 1975. | ||
| Gamma 2 | 87.87 | 140.5 |
The specific gamma ray constant for technetium Tc99m is 206 microCoulomb kg-1/37 MBq-h, (0.8 R/millicurie-h) at 1 cm. The first half-value thickness of lead (Pb) for technetium Tc99m is 0.2 mm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of a 2.7 mm thickness of Pb will decrease the external radiation exposure by a factor of 1,000.
| Shield Thickness (Pb) mm |
Coefficient of Attenuation |
|---|---|
| 0.2 | 0.5 |
| 0.95 | 10–1 |
| 1.8 | 10–2 |
| 2.7 | 10–3 |
| 3.6 | 10–4 |
| 4.5 | 10–5 |
To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 3.
| Hours | Fraction Remaining |
Hours | Fraction Remaining |
|---|---|---|---|
|
|||
| 0* | 1.000 | 7 | 0.447 |
| 1 | 0.891 | 8 | 0.399 |
| 2 | 0.795 | 9 | 0.355 |
| 3 | 0.708 | 10 | 0.317 |
| 4 | 0.631 | 11 | 0.282 |
| 5 | 0.563 | 12 | 0.252 |
| 6 | 0.502 | 24 | 0.063 |
Sources
Ceretec Manufacturers
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Medi-physics Inc.
![Ceretec (Exametazime) Kit [Medi-physics Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ceretec | Medi-physics Inc.
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. Do not use methylene blue in the preparation of the Tc99m labeled leukocytes (See preparation and handling section).
Cerebral ScintigraphyThe recommended dose range for i.v. administration, of reconstituted sodium pertechnetate Tc99m exametazime (with or without methylene blue) 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.
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Medi-physics Inc. Dba Ge Healthcare.
Ceretec | Medi-physics Inc. Dba Ge Healthcare.
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 ScintigraphyThe 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.
![Ceretec (Technetium Tc-99m Exametazime) Injection, Powder, Lyophilized, For Solution [Medi-physics Inc. Dba Ge Healthcare.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3c1eca7e-57a0-4876-8ed6-cd655ef5e296&name=ceretec-02.jpg)
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