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Pregnancy Category: C
Pharmacologic: n type calcium channel blockers
Pharmacologic: n type calcium channel blockers
Management of severe chronic pain when conventional therapies (analgesics or other adjunctive measures) have failed.
Blocks spinal N-channel calcium channels, decreasing transmission of pain signals to the brain.
Has no effect on opioid receptors.
Decrease in severe pain.
Absorption: IT administration results in complete bioavailability in the CSF. Minimal plasma distribution.
Distribution: Distributes in entire CSF volume.
Metabolism and Excretion: Degraded by enzymes in tissues and fluids.
Half-life: 4.6 hr (in CSF).
Contraindicated in: Hypersensitivity; History of psychosis; Infection at microinfusion injection site; Uncontrolled bleeding; Spinal cord obstruction; Lactation: Can cause sedation and side effects in the infant.
Use Cautiously in: History of suicidal ideation/psychiatric disorder; Pediatric: Safety not established; Obstetric: Pregnancy; Geriatric: ↑ susceptibility to adverse CNS effects.
Adverse Reactions/Side Effects
Central nervous system
- meningitis (life-threatening)
- confusion (most frequent)
- dizziness (most frequent)
- drowsiness (most frequent)
- headache (most frequent)
- impaired memory (most frequent)
- weakness (most frequent)
- ↓ alertness/responsiveness
- cognitive impairment
- memory impairment
- psychiatric symptoms
- speech disorder
- changes in BP
Ear, Eye, Nose, Throat
- nystagmus (most frequent)
- abnormal vision
- nausea (most frequent)
- catheter/injection site reactions
- hypertonia (most frequent)
- urinary retention (most frequent)
- ↑ creatine kinase
- abnormal gait (most frequent)
- ataxia (most frequent)
Drug-Drug interaction↑ risk of CNS depression with other CNS depressants including anticonvulsants, phenothiazines, antipsychotics, antihistamines, opioids, sedatives, or diuretics.
Intrathecal (Adults) up to 2.4 mcg/day initially (0.1 mcg/hr), may be gradually ↑ 2–3 times/wk in increments of 2.4 mcg/day up to a maximum of 19.2 mcg/day (0.8 mcg/hr) over 21 days.
Solution for intrathecal use: 25 mcg/mL, 100 mcg/mL
- Assess level of pain prior to and periodically during therapy.
- Assess mental status during therapy. If psychiatric symptoms (cognitive impairment, hallucinations, changes in mood or level of consciousness) or neurological impairment. Discontinuation of therapy may be required, but other causes should be considered. Ziconotide may be discontinued abruptly without withdrawal symptoms.
- Monitor for signs of meningitis (fever, headache, stiff neck, altered mental status, nausea, vomiting, seizures) frequently during therapy. May occur within 24 hr of breach in sterility. If meningitis occurs, obtain CSF cultures and institute antibiotic therapy. Usually requires removal of microinfusion system, catheter, and any other foreign body within the IT space.
- Lab Test Considerations: Monitor serum CK levels every other week for the first month, monthly thereafter, and if neuromuscular symptoms (myalgias, myasthenia, muscle cramps, asthenia, reduction in physical activity) occur. May cause ↑CK levels. If symptoms continue and CK remains ↑ or continues to rise, dose reduction or discontinuation may be required.
Potential Nursing DiagnosesChronic pain (Indications)
- Ziconotide is not an opioid and cannot prevent or relieve symptoms of opioid withdrawal. Do not discontinue opioids abruptly. For withdrawal from IT opioid, gradually taper opioid IT infusion over several weeks, and replace with an equianalgesic dose of oral opioids. Ziconotide does not potentiate opioid-induced respiratory depression.
- Ziconotide should be administered under the direction of a physician experienced in IT therapy. Do not administer IV.
- Intrathecal: IT dose is delivered using a programmable implanted variable-rate microinfusion device or an external microinfusion device and catheter. Ziconotide may be administered undiluted (25 mcg/mL in 20-mL vial) or diluted (100 mg/mL in 1-, 2-, or 5-mL vials). Dilute with 0.9% NaCl (preservative—free) using aseptic technique. 100 mg/mL formulation may be administered undiluted once an appropriate dose is established. Refrigerate, but do not freeze, after preparation; administer within 24 hr. Discard solution if discolored or containing particulate matter or any unused portion in vial. Pump refills should be done every 40 days if diluted solution is used or every 60 days if solution is undiluted. Pump should be rinsed and filled according to manufacturer's directions.
- Rate: Dose should be adjusted according to patient's severity of pain, response to therapy, and occurrence of side effects.
- Instruct patient on correct technique for care of equipment.
- May cause dizziness and drowsiness. Caution patient to avoid driving and other activities requiring alertness until response to ziconotide is known.
- Advise patient to avoid taking alcohol and other CNS depressants during ziconotide therapy. Consult health care professional prior to taking Rx, OTC, or herbal products during therapy.
- Instruct patient and caregiver to contact health care professional immediately if changes in mental status (lethargy, confusion, disorientation, decreased alertness), changes in mood or perception (hallucinations, including unusual tactile sensations in oral cavity), symptoms of depression or suicidal ideation, or nausea, vomiting, seizures, fever, headache, or still neck occur; may be symptoms of developing meningitis.
- Advise patient to consult health care professional if new or worsening muscle pain, soreness, or weakness with or without darkened urine occur.
- Decrease in pain intensity.