Home Drug Guide Ziconotide Acetate

Drug Guide

Generic Name

Ziconotide Acetate

Brand Names Prialt

Classification

Therapeutic: Analgesic for severe chronic pain

Pharmacological: N-type calcium channel blocker

FDA Approved Indications

Management of severe chronic pain in patients who require intrathecal treatment and are intolerant to other therapies

Mechanism of Action

Ziconotide selectively blocks N-type voltage-sensitive calcium channels in the dorsal horn of the spinal cord, inhibiting the release of pro-nociceptive neuropeptides and reducing pain transmission.

Dosage and Administration

Adult: Initial dose is 2.4 mcg/day given as a continuous intrathecal infusion, titrated gradually based on response and tolerability, up to a maximum dose of 21 mcg/day.

Pediatric: Not established; safety and efficacy have not been evaluated in pediatric patients.

Geriatric: Use with caution; start at lower doses and titrate slowly.

Renal Impairment: No specific adjustments, but monitor for increased sensitivity.

Hepatic Impairment: No specific data; caution advised.

Pharmacokinetics

Absorption: Not applicable (intrathecal administration).

Distribution: Localized in cerebrospinal fluid, small systemic absorption.

Metabolism: Metabolized minimally; primarily via proteolytic degradation.

Excretion: Excreted mainly in the cerebrospinal fluid; systemic clearance is limited.

Half Life: Approximately 4.5 hours in CSF.

Contraindications

Hypersensitivity to ziconotide or any component of the formulation.

Precautions

Use with caution in patients with impaired cognitive function, history of mental health disorders, or when performing tasks requiring mental alertness. Risks of neuropsychiatric adverse effects and neurological impairment.

Adverse Reactions - Common

CNS effects (dizziness, confusion, hallucinations, somnolence) (Common)
Nausea, vomiting (Common)
Muscle pain, weakness (Common)

Adverse Reactions - Serious

Psychosis, severe psychiatric symptoms (Rare)
Progressive neurological toxicity, including paralysis, neurodegeneration (Rare)

Drug-Drug Interactions

Additive CNS depressant effects with sedatives or alcohol.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for neuropsychiatric symptoms, neurological status, pain relief, and signs of adverse effects.

Diagnoses:

Risk for neuropsychiatric disturbances.
Impaired comfort related to pain or adverse reactions.

Implementation: Administer intrathecal infusions via an external pump, titrate cautiously, and monitor neurological status and side effects frequently.

Evaluation: Assess pain relief, mental status, and side effect profile regularly.

Patient/Family Teaching

Warn about possible CNS side effects like hallucinations, confusion, or dizziness.
Instruct on reporting new or worsening symptoms immediately.
Discuss the importance of continuous monitoring and follow-up.

Special Considerations

Black Box Warnings:

Serious neuropsychiatric adverse reactions, including psychosis and hallucinations, have occurred.
Use only in specialized centers with continuous monitoring.

Genetic Factors: None established.

Lab Test Interference: None known.

Overdose Management

Signs/Symptoms: Excessive neurotoxicity, profound neurological impairment, coma.

Treatment: Discontinue ziconotide immediately, provide supportive care, and consider measures to reduce CSF drug levels if possible.

Storage and Handling

Storage: Store at 2°C to 8°C (36°F to 46°F). Do not freeze.

Stability: Stable until the expiration date when stored properly.