Ziconotide
Prialt · ATC code N02BG08
Also known as: Ziconotid
- Key facts
- Active substance
- Ziconotide
- ATC code
- N02BG08
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Prialt 25 micrograms/mL solution for infusion · Prialt 100 micrograms/mL solution for infusion
- Marketing authorisation holder
- Esteve Pharmaceuticals GmbH
- Information as of
- 2026-10-27
Key facts
Ziconotide is an intrathecal analgesic (N-type calcium channel blocker) for severe chronic pain in adults who require intrathecal analgesia.
What it is used for
- Severe chronic pain in adults who require intrathecal analgesia
Dosing
- Only by physicians experienced in intrathecal administration; continuous infusion via intrathecal catheter and pump
- Start at no more than 2.4 μg/day; titrate in increments of ≤ 2.4 μg/day
- Minimum interval between increases 24 hours; recommended 48 hours or more
- Maximum daily dose 21.6 µg/day; in practice responsive patients may need smaller doses
- Discontinue if pain reduction is less than 20% at the maximal tolerated dose
- Caution in renal or hepatic impairment (not studied)
Contraindications
- Hypersensitivity to the active substance or any excipient
- Combination with intrathecal chemotherapy
- History of psychosis or suicidal attempt/ideation with ziconotide
- Infection at the injection site, uncontrolled bleeding diathesis, spinal canal obstruction impairing CSF circulation
Important warnings
- Neuropsychiatric evaluation before, after starting and during treatment, and immediately if depressive signs appear
- Cognitive and psychiatric reactions (confusion, hallucinations, psychosis); reduce dose or discontinue
- Risk of serious infections such as meningitis via the intrathecal route
- Creatine kinase elevations are common; monitoring recommended
- Caution in long-term treatment (possible local spinal cord toxicity)
Side effects
- Most common: dizziness, nausea, nystagmus, confusional state, gait abnormal, memory impairment, blurred vision, headache, asthenia, vomiting, somnolence
- Psychiatric: anxiety, hallucinations, depression, paranoia, suicidal ideation
- Mostly mild to moderate and resolving over time
Interactions
- Intrathecal chemotherapy contraindicated; caution with systemic chemotherapy
- Metabolic interactions are considered unlikely
Pregnancy and breastfeeding
- Not recommended during pregnancy and in women of childbearing potential not using contraception
- Breast-feeding: decision weighing breast-feeding against therapy
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- PrialtEsteve Pharmaceuticals GmbH · EMEA/H/C/000551
Source: European Medicines Agency (EMA), product information
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Another question about this substance?
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Sources
- European Medicines Agency. Prialt – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/prialt-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.