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The US Food and Drug Administration (FDA) will require makers of prescription testosterone products to clarify the approved uses of these medications on the product label and add information"...
(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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