Ziconotide

FDA label

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Titration Increase by up to 2.4 mcg/day (0.1 mcg/hr) no more than 2-3 times per week

Renal Undefined

Hepatic Undefined

Recommended maximum 19.2 mcg/day (0.8 mcg/hr) reached by about Day 21

Instructions

• Intrathecal only; not for IV administration
• Administer via programmable implanted or external microinfusion device by/under a physician experienced in intrathecal administration
• Do not use preservative-containing saline (neurotoxicity risk); refrigerate, do not freeze, begin infusion within 24 h of preparation
• Do not abruptly withdraw opiates — taper over a few weeks and replace with equivalent oral opiates
• Start elderly at low end of dosing range

Contraindications

• Preexisting history of psychosis
• Any concomitant treatment or medical condition rendering intrathecal administration hazardous (e.g., infection at injection site, uncontrolled bleeding diathesis, spinal canal obstruction impairing CSF circulation)

Cautions

• Cognitive and neuropsychiatric reactions (hallucinations, depression/suicidality)
• Meningitis and other infections (higher with external devices)
• Reduced level of consciousness (unresponsiveness/stupor)
• Elevation of serum creatine kinase; monitor periodically
• Not an opiate — cannot prevent opiate withdrawal
• Impaired alertness — avoid driving/machinery

Adverse reactions

• Dizziness
• Nausea
• Confusional state
• Nystagmus

Pregnancy Insufficient data to identify drug-associated risk

Lactation No milk data; monitor breastfed infants for sedation (respiratory depression/feeding problems)