Medically reviewed on December 15, 2017.
Applies to the following strengths: 100 mcg/mL; 25 mcg/mL
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Chronic Pain
Initial dose: No more than 2.4 mcg per day (0.1 mcg/hour) by intrathecal (IT) administration via Medtronic Synchro Med(R) System and CADD-Micro Ambulatory Infusion Pump
Titration: Dosage should be titrated to patient response; doses may be titrated upward by up to 2.4 mcg/day (0.1 mcg/hour) at intervals of no more than 2 to 3 times per week
Maximum dose: 19.2 mcg/day (0.8 mcg/hour)
Comments: Dose increases in increments of less than 2.4 mcg/day (0.1 mcg/hour) and increases in dose less frequently than 2 to 3 times per week may be used. The average dose level at the end of a 21 day clinical study was 6.9 mcg per day (0.29 mcg/hour).
Use: For the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine.
Renal Dose Adjustments
Use with caution
Liver Dose Adjustments
Use with caution
Elderly: Dose selection should be cautious, usually starting at the low end of the dosing range
Elevation of Serum Creatine Kinase (CK):
-In the setting of new neuromuscular symptoms or a reduction in physical activity, evaluate and obtain CK measurements; if symptoms continue and CK levels remain elevated or continue to rise, reduce the dose or discontinue use.
The dose of ziconotide should be adjusted according to the severity of pain, response to therapy, and the occurrence of adverse events. The effective dose of ziconotide for analgesia is variable.
The dose of ziconotide should be reduced or discontinued if signs or symptoms of cognitive impairment develop, but other contributing causes should also be considered.
US BOXED WARNINGS: NEUROPSYCHIATRIC ADVERSE REACTIONS:
-This drug is contraindicated in patients with a preexisting history of psychosis. Severe psychiatric symptoms and neurological impairment may occur during treatment. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Discontinue this drug in the event of serious neurological or psychiatric signs or symptoms.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-For intrathecal (IT) administration via Medtronic Synchro Med(R) System and CADD-Micro Ambulatory Infusion Pump; Not for IV administration
-Should be administered by or under the direction of a physician experienced in the technique of intrathecal administration and familiar with drug and device labeling
-Refrigerate, do not freeze ziconotide solutions after preparation and begin infusion within 24 hours
-Refrigerate during transit; protect from light
-Saline solutions containing preservatives are not appropriate for intrathecal drug administration
-Refer to Product Labeling for specific preparation and stability information
-Refer to manufacturer's manuals for specific instructions and precautions for using Medtronic SynchroMed II Infusion System
-This drug is not an opiate and cannot prevent or relieve symptoms associated with opiate withdrawal.
-Meningitis can occur due to inadvertent contamination of the microinfusion device; particular vigilance for signs and symptoms of meningitis is necessary.
-Patients may become unresponsive or stuporous while on therapy; if reduced levels of consciousness occur, discontinue therapy until the event resolves.
-The greatest incidence of creatine kinase elevations was within the first 2 months, although it has been observed at other times as well.
-Periodically monitor serum creatine kinase (CK) levels; e.g., every other week for the 1st month and monthly thereafter as appropriate
-Monitor for cognitive and neuropsychiatric adverse events
-Monitor for meningitis and other infections
-Monitor for reduced level of consciousness
-Patients should be advised that severe psychiatric symptoms and neurological impairment may occur during treatment; they should contact their health care professional immediately if these develop.
-Patients should be advised to avoid engaging in hazardous activity such as driving a car during treatment.
-Patients should be advised to speak with their healthcare professional about combining this drug with other CNS drugs.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: miscellaneous analgesics
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