Ziconotide U.S. label context · version 1
This page preserves this version's wording and source pins. Open the current profile →
What does the U.S. product label say?
Prialt · Read September 15, 2026 · Preserved label summary 1
Which population and use does the label cover?
The cited label concerns intrathecal management of severe chronic pain in adults for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatment. This is a specialized route and population. Label: 1 ↗
Which safety limits matter?
The boxed warning addresses severe psychiatric and neurological effects; pre-existing psychosis is a contraindication. Other intrathecal contraindications include relevant infection, uncontrolled bleeding problems and obstruction impairing cerebrospinal-fluid circulation. Pediatric safety and effectiveness have not been established. Label: 1, 4, 5, 8.4, boxed warning ↗
Label edition and source pins
U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.
PRIALT (ziconotide acetate) injection, solution · SPL version 6 · published 2025-07-14
Label ZIP SHA-256: a0b31d16771b167c912140ba2b59337f79cfddd632109f3ed8c1556065e8b9e5. Extracted XML SHA-256: 101aad729a27b6c532f9e28f511dcac5a723e305274e0a2703ecc1119c76a748.