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ziconotide (Rx)Brand and Other Names:Prialt

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intrathecal injection

  • 25mcg/mL
  • 100mcg/mL

Chronic Pain

2.4 mcg/day intrathecal (IT), (0.1 mcg/hour)

Titrate up by 2.4 mcg/day at intervals 2-3 times per week or less if necessary; no more than 19.2 mcg/day (0.8 mcg/hour) by Day 21

Administration

Use in only the Medtronic SynchroMed® EL or SynchroMed® II Infusion System or Simms Deltec Micro® External Microinfusion Device & Catheter

Medtronic Devices: Only the 25 mcg/mL undiluted solution is used for naive pump priming & initial pump fill

Simms Deltec Device: use 5 mcg/mL Prialt diluted in NS

See manufacturer's package inserts for details

Monitor

Cognitive functions, mood alterations

Safety/efficacy not established

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Interactions

Interaction Checker

ziconotide and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Abnormal gait (14%)

            Abnormal vision (12%)

            Anorexia (10%)

            Asthenia (22%)

            Ataxia (14%)

            Confusion (15%)

            Diarrhea (18%)

            Headache (13%)

            Hypertonia (11%)

            Memory impairment (12%)

            Nausea (40%)

            Somnolence (17%)

            Vomiting (16%)

            Frequency Not Defined

            Anxiety

            Aphasia

            Dysesthesia

            Fever

            Hallucinations

            Nervousness

            Nystagmus

            Paresthesia

            Speech disorder

            Vertigo

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            Warnings

            Black Box Warnings

            Severe psychiatric symptoms and neurologic impairment may occur during treatment with ziconotide. Patients with a preexisting history of psychosis should not be treated with ziconotide.

            All patients should be monitored frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Ziconotide therapy can be interrupted or discontinued abruptly without evidence of withdrawal effects in the event of serious neurologic or psychiatric signs or symptoms.

            Contraindications

            Hypersensitivity

            History of psychosis

            IV administration

            IT administration to patients with uncontrolled bleeding, infection at the injection site, spinal obstruction that impairs CSF circulation

            Cautions

            IT administration only

            Possibility of severe psychiatric & neurological complications

            • Risk of severe or worsening depression w/ suicide risk in susceptible pts
            • Monitor for cognitive impairment, hallucinations & mood swings
            • Can be interrupted or discontinued abruptly without withdrawal effects

            Possibility of meningitis & other infections

            Levels of serum creatinine kinase may increase

            Pregnancy, lactation

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Excretion into breast milk unknown; discontinue drug or do not nurse

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Putative calcium channel blocker, synthetic conopeptide; binds to N-type voltage sensitive calcium channels located in nociceptive afferent nerves of the dorsal horn in the spinal cord

            Not an opioid and does not bind to opioid receptors

            Distribution

            Protein Bound: 50%

            Vd: 140 mL

            Metabolism

            Metabolism: by peptidases outside of CSF

            Metabolites: small peptides/amino acids

            Elimination

            Half-life: 1-1.6hr in plasma (IV); 2.9-6.5hr in CSF (IT)

            Excretion: Urine (<1%)

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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