OptiMARK

The below information on OptiMARK has been taken from official FDA sources, but we cannot guarantee it's accuracy. Please use this site for educational purposes only. This site does not replace a proper discussion with your doctor.


    Brand Name:OptiMARK
    Generic:Gadoversetamide
    Availability:Prescription
This drug was approved by the FDA in one form or another on:
1999-12-08 ,
This drug is made in one form or another by the following companies:
Mallinckrodt
This drug is available in the following forms:
Intravenous Injections
View the actual FDA approved label for this drug at the following links:
http://www.fda.gov/cder/foi/label/2006/020937,020975,020976s009lbl.pdf

About OptiMARK

OptiMARK® (gadoversetamide injection) is a formulation of a nonionic gadolinium chelate of diethylenetriamine pentaacetic acid bismethoxyethylamide (gadoversetamide), for use in magnetic resonance imaging (MRI). OptiMARK® Injection is to be administered by intravenous injection only.

OptiMARK® Injection is provided as a sterile, nonpyrogenic, clear, colorless to pale yellow, aqueous solution of gadoversetamide. No preservative is added. Each mL of OptiMARK® Injection contains 330.9 mg of gadoversetamide (0.5 millimole), 28.4 mg of calcium versetamide sodium (0.05 millimole), 0.7 mg calcium chloride dihydrate (0.005 millimole), and water for injection. Sodium hydroxide and/or hydrochloric acid may have been added for pH adjustment.

Precautions for OptiMARK

Some paramagnetic contrast agents may impair the visualization of existing lesions, which are seen on the unenhanced, noncontrast MRI. This may be due to effects of the paramagnetic contrast agent, imaging parameters, misregistration, etc. CAUTION SHOULD BE EXERCISED WHEN A CONTRAST ENHANCED INTERPRETATION IS MADE IN THE ABSENCE OF A COMPANION UNENHANCED MRI.

Since gadoversetamide is cleared from the body by glomerular filtration, caution should be exercised in patients with impaired renal function. Dose adjustments in renal impairment have not been studied. Dialysis may be needed to clear OptiMARK® Injection if it is administered to patients with significant renal impairment. OptiMARK® Injection has been shown to be removed from the body by hemodialysis.

The possibility of a reaction, including serious, life threatening, fatal, anaphylactoid or cardiovascular reactions or other idiosyncratic reactions should always be considered especially in those patients with a known clinical hypersensitivity, a history of asthma, or other respiratory disorders.

Repeat procedures: The safety of repeated doses has not been studied.

Diagnostic procedures involving the use of MRI contrast agents should be conducted under supervision of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed. Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of severe reactions to the contrast itself.

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