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(Perflutren Protein-Type A Microspheres) Injectable Suspension, USP
WARNING: SERIOUS CARDIOPULMONARY REACTIONS
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration (see WARNINGS AND PRECAUTIONS).
- Assess all patients for the presence of any condition that precludes OPTISON administration (see CONTRAINDICATIONS).
- Always have resuscitation equipment and trained personnel readily available.
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:
Each mL of OPTISON contains 5.0-8.0x108 protein-type A microspheres, 10 mg Albumin Human, USP, 0.22 ±0.11 mg/mL perflutren, 0.2 mg N-acetyltryptophan, and 0.12 mg caprylic 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 5-7% (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: 9/6/2012
This monograph has been modified to include the generic and brand name in many instances.
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