Ziconotide

Dosage Forms And Strengths

PRIALT (ziconotide) solution, intrathecal infusion is supplied as a 25 mcg/mL concentration in single-use 20 mL glass vials and as a 100 mcg/mL concentration in single-use glass vials containing 1 mL or 5 mL of solution.

Storage And Handling

PRIALT is supplied as a 25 mcg/mL solution in a single-use 20 mL glass vial and as a 100 mcg/mL solution in single-use glass vials containing 1 mL or 5 mL of solution. One vial is packaged per carton.

• 25 mcg/mL: 20 mL vial (18860-723-10). Only the undiluted 25 mcg/mL formulation should be used for PRIALT naïve pump priming.
• 100 mcg/mL: 1 mL vial (18860-720-10) 5 mL vial (18860-722-10)

• Refrigerate PRIALT during transit.
• Store PRIALT at 2°C to 8°C (36°F to 46°F).
• PRIALT, once diluted aseptically with saline, may be stored at 2°C to 8°C for 24 hours.
• Do NOT freeze PRIALT.
• Protect from light.

Distributed by: Jazz Pharmaceuticals, Inc., Palo Alto, CA 94304. Revised: Feb 2013

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• Ziconotide Acetate

Refer to adult dosing. Use with caution.

Not for IV administration. For intrathecal administration only using Medtronic SynchroMed® EL, SynchroMed® II Infusion System, or CADD-Micro® ambulatory infusion pump.

Medtronic SynchroMed® EL or SynchroMed® II Infusion Systems:

Naive pump priming (first time use with ziconotide): Use 2 mL of undiluted ziconotide 25 mcg/mL solution to rinse the internal surfaces of the pump; repeat twice for a total of 3 rinses

Initial pump fill: Use only undiluted 25 mcg/mL solution and fill pump after priming. Following the initial fill only, adsorption on internal device surfaces will occur, requiring the use of the undiluted solution and refill within 14 days.

Pump refills: Contents should be emptied prior to refill. Subsequent pump refills should occur at least every 40 days if using diluted solution or at least every 84 days if using undiluted solution.

CADD-Micro® ambulatory infusion pump: Refer to manufacturer's manual for initial fill and refill instructions

Concerns related to adverse effects:

• CNS toxicity: [U.S Boxed Warning]: Severe psychiatric symptoms and neurological impairment have been reported; interrupt or discontinue therapy if cognitive impairment, hallucinations, mood changes, or changes in consciousness occur. May cause or worsen depression and/or risk of suicide. Cognitive impairment may appear gradually during treatment and is generally reversible after discontinuation (may take up to 2 weeks for cognitive effects to reverse). May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Elevated serum creatine kinase: With use, elevated serum creatine kinase can occur; particularly during the first 2 months of therapy. Consider dose reduction or discontinuing if combined with new neuromuscular symptoms (myalgias, myasthenia, muscle cramps, weakness) or reduction in physical activity.

• Meningitis: May occur with use of intrathecal pumps; monitor for signs of meningitis; treatment of meningitis may require removal of system and discontinuation of intrathecal therapy.

Disease-related concerns:

• Hepatic impairment: Safety and efficacy have not been established in patients with hepatic impairment.

• Renal impairment: Safety and efficacy have not been established in patients with renal impairment.

Concurrent drug therapy issues:

• CNS depressants: May have additive effects with ethanol and CNS-depressant medications.

• Opioids: May have additive CNS effects with opioids and may potentiate opioid-induced decreased GI motility; does not interact with opioid receptors or potentiate opioid-induced respiratory depression.

Special populations:

• Elderly: Use with caution in the elderly; may experience a higher incidence of confusion.

• Pediatric: Safety and efficacy have not been established in children.

Other warnings/precautions:

• Withdrawal: Will not prevent or relieve symptoms associated with opioid withdrawal; unlike opioids, ziconotide therapy can be interrupted abruptly or discontinued without evidence of withdrawal.

Monitor for psychiatric or neurological impairment; signs and symptoms of meningitis or other infection; serum CPK (every other week for first month then monthly); pain relief

You should not use Ziconotide if you are allergic to ziconotide, or if you have an uncontrolled bleeding or blood clotting disorder.

Severe psychiatric symptoms and neurological impairment may occur during treatment with ziconotide. You should not receive ziconotide if you have a history of psychiatric illness or psychotic event.

Ziconotide must be given only as an intrathecal injection through an infusion pump and should not be injected directly into a vein or other part of the body. Your doctor, nurse, or other healthcare provider will give you this injection.

Your doctor may occasionally change your dose or infusion pump flow rate to make sure you get the best results from Ziconotide.

Tell your doctor if the medicine seems to stop working as well in relieving your pain. Tell your doctor if you regularly use other medicines that make you sleepy. Ziconotide can add to sleepiness caused by these other medications.

Call your doctor at once if you have a serious side effect, especially fever, neck stiffness, seizure (convulsions), extreme drowsiness or tired feeling, confusion, disorientation, hallucinations, thoughts of hurting yourself, or decreased consciousness.

Seek emergency medical attention if you think you have used too much of this medicine or if your infusion pump is not working properly.

Overdose symptoms may include extreme drowsiness, vision problems, confusion, speech problems, stiffness in your neck or back, nausea and vomiting, or loss of consciousness.

Avoid drinking alcohol while you are using ziconotide. Ziconotide can cause side effects that may impair your thinking or reactions. Avoid driving or doing anything that requires you to be awake and alert.

Data not available

Because of the lower incidence of serious adverse events and discontinuations for adverse events associated with the slower titration, a faster titration schedule should only be used if there is an urgent need for analgesia that outweighs the risk to patient safety.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).