Active Ingredient: Ziconotide
Ziconotide is indicated for the treatment of severe, chronic pain in adults who require intrathecal (IT) analgesia.
For this indication, competent medicine agencies globally authorize below treatments:
Intraspinal
2.4 - 21.6 ug
From 2.4 To 21.6 ug once every day
Dosing of ziconotide should be initiated at 2.4 μg/day and titrated on an individual patient basis according to the patient’s analgesic response and adverse reactions. Patients should be titrated in dose increments of ≤2.4 μg/day, up to a maximum dose of 21.6 μg/day. The minimalinterval between dose increases is 24 hours; the recommended interval, for safety reasons, is 48 hours or more. If necessary the dose can be decreased by any amount (including stopping the infusion) for the management of adverse reactions. Approximately 75% of patients who respond satisfactorily to treatment require a dose of ≤9.6 μg/day.
Ziconotide must be administered as a continuous infusion via an intrathecal catheter, using an external or internally implanted mechanical infusion pump capable of delivering an accurate infusion volume. As the risk of meningitis secondary to prolonged catheterisation of the intrathecal space is greater with an external catheter infusion system, internal systems are recommended to administer ziconotide for prolonged periods. An external catheter system should only be used when an internal system cannot be implanted.
When low doses of ziconotide are required, for example when initiating titration, ziconotide must be diluted before use with preservative-free sodium chloride 9 mg/ml (0.9%) solution for injection.
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