Monograph Details
|
|
Pain & Pyrexia
> Nonnarcotic analgesics
|
|
PRIALT |
| Manufacturer |
|
Elan Pharmaceuticals |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Analgesic (non-opioid N-type calcium channel blocker). |
| Generic Name |
|
Ziconotide acetate 25micrograms/mL, 100micrograms/mL; soln for intrathecal infusion; preservative-free. |
| 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). |
| Children |
|
Not recommended. |
| Adults |
|
Give by intrathecal infusion using appropriate microinfusion device and procedures. Individualize; see literature. Initial: up to 2.4micrograms/day (0.1microgram/hr); titrate in increments of up to 2.4micrograms/day (0.1microgram/hr) at intervals of up to 2–3 times per week; max 19.2micrograms/day (0.8microgram/hr) by day 21. |
| Contraindications |
|
History of psychosis. Inj site infections. Uncontrolled bleeding diathesis. Spinal canal obstruction. |
| Precautions |
|
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. |
| Interactions |
|
Concomitant intrathecal opiates: not recommended. CNS effects potentiated by other CNS depressants, antiepileptics, neuroleptics, diuretics; discontinue ziconotide if occurs. |
| 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. |
| How Supplied |
Soln single-use vial
25microgram/mL (20mL)—1
100microgram/mL (1mL, 5mL)—1 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
