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Prialt Generic Name & Formulations
Legal Class
Rx
General Description
Ziconotide acetate 25mcg/mL, 100mcg/mL; soln for intrathecal infusion; preservative-free.
Pharmacological Class
Analgesic (non-opioid N-type calcium channel blocker).
How Supplied
Soln single-use vial; 25mcg/mL (20mL)—1; 100mcg/mL (1mL, 5mL)—1
Manufacturer
Prialt Indications
Indications
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).
Prialt Dosage and Administration
Adult
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.
Children
Not recommended.
Prialt Contraindications
Contraindications
History of psychosis. Inj site infections. Uncontrolled bleeding diathesis. Spinal canal obstruction.
Prialt Boxed Warnings
Boxed Warning
Neuropsychiatric adverse reactions.
Prialt Warnings/Precautions
Warnings/Precautions
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.
Prialt Pharmacokinetics
See Literature
Prialt Interactions
Interactions
Concomitant intrathecal opiates: not recommended. CNS effects potentiated by other CNS depressants, antiepileptics, neuroleptics, diuretics; discontinue ziconotide if occurs.
Prialt Adverse Reactions
Adverse Reactions
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.
Prialt Clinical Trials
See Literature
Prialt Note
Not Applicable
Prialt Patient Counseling
See Literature
