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DOSAGE AND ADMINISTRATION
- The recommended dose of Optison is 0.5 mL injected into a peripheral vein.
- If the contrast enhancement is inadequate after the dose of 0.5 mL, additional doses in increments of 0.5 mL may be repeated for further contrast enhancement as needed.
- The maximum total dose should not exceed 5mL in any 10 minute period.
- The maximum total dose should not exceed 8.7 mL in any one patient study.
- Do not use if the container has been damaged, the protective seal and/or rubber cap have been entered, or the upper white layer is absent (may indicate the microspheres have been damaged and may result in poor or no echo contrast).
- 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. Do not use if the solution appears to be clear rather than opaque and 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 inject air into the vial.
- Use the product within one minute of suspension. If one minute is exceeded, resuspend by inverting and gently rotating the microsoheres in the syringe. Failure to adequately resuspend Optison may cause inadequate delivery of the microspheres, and may result in inadequate contrast.
- Inspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not inject if the solution is not opaque, milky-white, and absent particulate matter.
- Inject through a 20-gauge or larger angiocatheter into a peripheral vein at a rate not exceeding 1 mL per second. Suggested methods of administration include: a short extension tubing, heparin lock, or intravenous line, all with a 3-way stopcock.
- Administer intravenously; do not administer Optison by intra-arterial injection [see WARNINGS AND PRECAUTIONS].
- Do not aspirate blood back into the Optison containing syringe before administration; this may promote the formation of a blood clot within the syringe.
- 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. Flush the line immediately after injection of Optison
- Do not use the single-patient use vial for more than one patient. Discard unused product.
Dosage Forms And Strengths
Injectable suspension: 3 mL single-patient use vial containing a clear liquid lower layer and a white liquid upper layer, and a headspace filled with perflutren gas. Each mL of Optison contains 5-8x108 protein-type A microspheres, 10 mg albumin human, and 0.22 ± 0.11 mg perflutren. The sterile suspension is homogeneous, opaque, and milky-white after resuspension.
Optison is supplied as 3 mL single-patient use vials containing a clear liquid lower layer, a white liquid upper layer, and a headspace filled with perflutren gas and is homogeneous, opaque, and milky-white after resupsension. Each mL contains 5-8 x108 protein-type A microspheres, 10 mg albumin human, and 0.22 ± 0.11 mg perflutren:
Five (5) - 3 mL vials per carton NDC 0407-2707-03
Eighteen (18) - 3mL vials per carton NDC 0407-2707-18
Storage And Handling
Store OPTISON refrigerated between 2°-8°C (36°-46°F).
Caution: Do not freeze.
Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A. Manufactured by GE Healthcare AS, Oslo, Norway. Revised: Sep 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/21/2016
Additional Optison Information
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