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OPTISON is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders.
DOSAGE AND ADMINISTRATION
The recommended dose of OPTISON is 0.5 mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed. See individualization of dose below.
- The injection rate should not exceed 1 mL per second.
- Follow the OPTISON injection with a flush of 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP.
- The maximum total dose should not exceed 5.0 mL in any 10 minute period.
- The maximum total dose should not exceed 8.7 mL in any one patient study.
Individualization of Dose
Image quality in cardiac ultrasound is a function of the acoustic window which is influenced by many variables including body habitus, intervening lung tissue, adequacy of transducer skin interface and other acoustic factors. These variables may influence the ultrasound contrast effect.
If the contrast enhancement is inadequate after the dose of 0.5 mL, additional doses in increments of 0.5 mL up to 5.0 mL cumulatively in a 10 minute period may be injected intravenously up to a maximum total dose of 8.7 mL in any one patient study.
Drug Handling Directions
FOR SINGLE USE ONLY.
OPTISON does not contain preservatives. Bacterial contamination with the risk of post-infusion septicemia can occur if the container has been damaged or following puncture of the rubber cap.
A single vial must not be used for more than one patient. Discard unused product properly.
DO NOT USE if the container has been damaged or the protective seal and/or rubber cap have been entered.
DO NOT USE if the upper white layer is absent. This indicates that the microspheres may have been damaged and may result in poor or no echo contrast.
DO NOT INJECT air into the vial.
- Invert the OPTISON vial and gently rotate to resuspend the microspheres. This process will allow the product to come to room temperature before use.
- Inspect the vial for complete resuspension. Failure to adequately resuspend OPTISON may cause an under delivery of the microspheres, and may result in inadequate contrast.
- Do not use OPTISON if, after resuspension, the solution appears to be clear rather than opaque milky-white.
- Vent the OPTISON vial with a sterile vent spike or with a sterile 18 gauge needle before withdrawing the OPTISON suspension into the injection syringe.
DO NOT USE if after resuspending the OPTISON, the product remains clear rather than appearing opaque and milky-white.
The time from resuspension of the OPTISON to injection must not exceed one minute. If one minute is exceeded, resuspend the microspheres in the syringe by gently rotating and inverting the syringe.
Before injection, provide intravenous access in a peripheral vein with a 20-gauge or larger angiocatheter. Suggested methods of administration include: a short extension tubing, heparin lock, or intravenous line, all with a 3-way stopcock.
For short extension tubing or heparin lock: fill one syringe with 0.9% Sodium Chloride Injection, USP, and flush the line for patency before and after the injection of OPTISON.
For a continuous intravenous line: open an intravenous line with 0.9% Sodium Chloride Injection, USP (or 5% Dextrose Injection, USP) at a slow infusion rate to maintain vascular patency. The line should be flushed immediately after injection of OPTISON.
DO NOT ASPIRATE blood back into the OPTISON containing syringe before administration; this may promote the formation of a blood clot within the syringe.
OPTISON (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) is available in a carton of five 3 mL fills in single use 3 mL vials.
Store OPTISON refrigerated between 2°-8°C (36°-46°F).
Caution: Do not freeze.
Distributed by GE Healthcare Inc., Princeton, NJ 08540. Manufactured by Mallinckrodt Inc., St. Louis, MO 63042.
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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