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Drug Details

OPTISON

• Generic Name
  Perflutren
• Presentation
  OPTISON is a sterile non-pyrogenic suspension of microspheres of human serum albumin with perflutren for contrast enhancement during the indicated ultrasound imaging procedures.
• Description
  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.
• Indications
  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.
• Adult Dosage
  

  The recommended dose of OPTISON is 0.5 Ml injected into a peripheral vein. This may berepeated for further contrast enhancement asneeded.

  1. The injection rate should not exceed 1 mL persecond.

  2. Follow the OPTISON injection with a flush of0.9% Sodium Chloride Injection, USP, or 5%Dextrose Injection, USP.

  3. The maximum total dose should not exceed5.0 mL in any 10 minute period.

  4. The maximum total dose should not exceed 8.7 mL in any one patient study. Individualization of DoseImage quality in cardiac ultrasound is a function ofthe acoustic window which is influenced by manyvariables including body habitus, intervening lungtissue, adequacy of transducer skin interface andother acoustic factors.

• Child Dosage
  The effects of age on the pharmacokinetics of OPTISON have not been studied.
• Elderly Dosage
  The effects of age on the pharmacokinetics of OPTISON have not been studied.
• Contra Indications
  Do not administer OPTISON to patients with known or suspected hypersensitivity to blood, blood products, or albumin.
• Special Precautions
  

  OPTISON should be administered with caution to patients with confirmed or suspected severe liver disease or respiratory distress syndrome.

  The safety of microspheres in patients on mechanical ventilation has not been studied. Whenever protein-containing materials such as OPTISON are used in humans, hypersensitivity reactions may occur. In clinical studies of OPTISON, one patient had acute nausea, flushing, dizziness, tachycardia and fever that required treatment with antihistamines.

  Epinephrine, antihistamines, and corticosteroids should be available for immediate treatment of the patient’s symptoms. Diagnostic echocardiography procedures that involve the use of OPTISON should be carried out under the direction of a licensed practitioner having a thorough knowledge of the procedure and the safe use of the product.

• Interactions
  Interactions for OPTISON have not been studied.
• Adverse Drug Reactions
  

  OPTISON was administered in clinical studies in 279 patients. Of these patients there were 192 (68.8%) men and 87 (31.2%) women.

  The racial demographics were 199 (71.3%) Caucasian, 52 (18.6%) Black, 24 (8.6%) Hispanic, and 4 (1.4%) other racial or ethnic groups. In these patients, 47 (16.8%) reported at least one adverse event. Of these one event was serious and required treatment with antihistamines for hypersensitivity manifestations of dizziness, nausea, flushing and temperature elevation.

  Deaths were not reported during the clinical studies. Of the reported adverse reactions following the use of OPTISON the most frequently reported were headache (5.4%), nausea and/or vomiting (4.3%), warm sensation or flushing (3.6%), and dizziness (2.5%).