Generic Name and Formulations:
Ziconotide acetate 25mcg/mL, 100mcg/mL; soln for intrathecal infusion; preservative-free.
Jazz Pharmaceuticals plc
Indications for PRIALT:
Management of severe chronic pain in patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatment (eg, systemic analgesics, adjunctive therapies, intrathecal morphine).
Give by intrathecal infusion using appropriate microinfusion device and procedures. Individualize; see literature. Initial: up to 2.4mcg/day (0.1microgram/hr); titrate in increments of up to 2.4mcg/day (0.1mcg/hr) at intervals of up to 2–3 times per week; max 19.2mcg/day (0.8mcg/hr) by day 21.
History of psychosis. Inj site infections. Uncontrolled bleeding diathesis. Spinal canal obstruction.
Neuropsychiatric adverse reactions.
Risk of severe psychiatric symptoms and neurological impairment. Monitor for signs/symptoms of meningitis and other infections. Discontinue if infection, cognitive impairment, hallucinations, mood changes, or impaired consciousness occur. Reduce dose or discontinue if myasthenias, myalgia, or persistent increases in serum creatine kinase occur. Hepatic or renal impairment. Elderly. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.
Analgesic (non-opioid N-type calcium channel blocker).
Concomitant intrathecal opiates: not recommended. CNS effects potentiated by other CNS depressants, antiepileptics, neuroleptics, diuretics; discontinue ziconotide if occurs.
Dizziness, GI upset, fever, headache, somnolence, nystagmus, asthenia, ataxia, abnormal vision, dysesthesia, parasthesia, urinary retention, psychiatric effects (eg, hallucinations, mania), cognitive/memory impairment (eg, confusion, aphasia, stupor), worsening depression/suicidal ideation.
Soln single-use vial; 25mcg/mL (20mL)—1; 100mcg/mL (1mL, 5mL)—1