Prialt (ziconatide) dosing, indications, interactions, adverse effects, and more

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Sections ziconotide
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
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Patient Handout
Formulary

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

Interaction Checker

Enter a drug name and ziconotide

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No Interactions Found

Interactions Found

Contraindicated

Serious - Use Alternative

Significant - Monitor Closely

Minor

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>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

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

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.

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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Patient Handout

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

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

Create Your List of Plans

Adding plans allows you to:

View the formulary and any restrictions for each plan.
Manage and view all your plans together – even plans in different states.
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.

View explanations for tiers and restrictions

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.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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Sections ziconotide
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

ziconotide (Rx)