Prialt
PRIALT
(ziconotide intrathecal infusion)
For use only in the Medtronic SynchroMed® EL, SynchroMed® II Infusion System and Cadd-Micro® ambulatory infusion pump
WARNING
Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Patients with a pre-existing history of psychosis should not be treated with PRIALT. All patients should be monitored frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. PRIALT therapy can be interrupted or discontinued abruptly without evidence of withdrawal effects in the event of serious neurological or psychiatric signs or symptoms.
DRUG DESCRIPTION
PRIALT® contains ziconotide, a synthetic equivalent of a naturally occurring conopeptide found in the piscivorous marine snail, Conus magus. Ziconotide is a 25 amino acid, polybasic peptide containing three disulfide bridges with a molecular weight of 2639 daltons and a molecular formula of C102H172N36O32S7. The amino acid sequence and disulfide bridging pattern are given below:
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Ziconotide is a hydrophilic molecule that is freely soluble in water and is practically insoluble in methyl t-butyl ether.
PRIALT is formulated as a sterile, preservative-free, isotonic solution for intrathecal (IT) administration using an appropriate microinfusion device (see DOSAGE AND ADMINISTRATION). Each 1, 2, or 5 mL vial of PRIALT (100 mcg/mL) respectively contains 100, 200, or 500 mcg of ziconotide acetate, and the 20 mL vial of PRIALT (25 mcg/mL) contains 500 mcg of ziconotide acetate, with L-methionine and sodium chloride as excipients at pH 4.0–5.0. Each vial is intended for single use only, either undiluted or after dilution to the appropriate concentration with 0.9% Sodium Chloride Injection, USP (preservative free).
Generic Name: Ziconotide
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