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OPTISON™
(perflutren protein-type A microspheres) Injectable Suspension, USP
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration.
OPTISON™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) is a sterile non-pyrogenic suspension of microspheres of human serum albumin with perflutren for contrast enhancement during the indicated ultrasound imaging procedures. The vial contains a clear liquid lower layer and a white upper layer that, after resuspension by gentle mixing, provides a homogeneous, opaque, milky-white suspension for intravenous injection.
Perflutren is chemically characterized as 1,1,1,2,2,3,3,3-perflutren with a molecular weight of 188, an empirical formula of C3F8 and it has the following structural formula:
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Each mL of OPTISON (perflutren protein-type a microspheres) contains 5.0-8.0x108 protein-type A microspheres, 10 mg Albumin Human, USP, 0.22 ± 0.11mg/mL N-acetyltryptophan, and 0.12 mg caprylic0.11 acid in 0.9% aqueous sodium chloride. The headspace of the vial is filled with perflutren gas. The pH is adjusted to 6.4-7.4. The protein in the microsphere shell makes up approximately 57% (w/w) of the total protein in the liquid. The microsphere particle size parameters are listed in Table 1.
Table 1: Microsphere Particle Size Parameters
| Mean diameter (range) | 3.0-4.5µm (max. 32.0µm) |
| Percent less than 10µm | 95% |
Last reviewed on RxList: 7/9/2008
This monograph has been modified to include the generic and brand name in many instances.
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