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Hydromorphone Extended-Release Capsules (Palladone) (C-II)
By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD
The FDA has approved a new formulation of hydromorphone for the management of pain. This extended-release formulation is designed to deliver hydromorphone over 24 hours with once daily dosing. It will be marketed by Purdue Pharma as Pallone.
Hydromorphone extended-release (ER) capsules are indicated for the management of persistent, moderate to severe pain in patients requiring continuous, long-term, around-the-clock analgesia with a high potency opioid analgesic. It should be used only in patients who are already receiving opioid therapy, have demonstrated tolerance, and who require at least a total daily equivalent of 12 mg of hydromorphone. Opioid tolerance is defined as at least 60 mg daily of oral morphine, 30 mg of oral oxycodone, or 8 mg of oral hydromorphone.1
The initial dose of hydromorphone ER is based on the patient’s prior opioid daily dose, potency, and type of opioid. To avoid overdose, conservative dose conversion is recommended. The dose should be titrated to adequate pain relief, and may be taken without regard to food. If cessation of therapy is indicated, the dose should be tapered gradually to prevent signs and symptoms of withdrawal in physically dependant patients. The capsules should be swallowed whole and not be broken, chewed, opened, dissolved, or crushed.1
Hydromorphone ER is available as 12 mg, 16 mg, 24 mg, and 32 mg capsules.
The extended-release formulation permits dosing every 24 hours, and significantly reduces fluctuation in steady-state peak and trough levels, compared to immediate release hydromorphone tablets.1
The long elimination of hydromorphone ER (18 hours) reduces dose adjustment flexibility. Adverse effects or overdosing will require monitoring and treatment for 18 hours or longer. It is not indicated as the first opioid product in patients who require treatment for a short period of time. The drug must be swallowed whole because chewing or crushing the capsule could result in rapid absorption of the full dose and a potentially fatal overdose.
One of the major disadvantages of previously available forms of hydromorphone is the short plasma half life (2-3 hours).2 Hydromorphone ER is formulated in an oral extended release delivery formulation for once every 24-hour dosing. The extent of absorbed drug is the same as immediate-release hydromorphone, but with 2-3 fold reduction in fluctuation between peak and trough drug levels.1 Hydromorphone ER is expected to be available the first half of 2005.
Opioids are the mainstay of therapy for moderate to severe pain and generally considered as first-line therapy in nocieptive, neuropathic, and mixed pain syndromes.3 Hydromorphone ER provides a long-acting opioid in a defined role. It is only indicated in patients who are already receiving an opioid, have demonstrated opioid tolerance, who required an equivalent of 12 mg of oral hydromorphone, and required long term around-the-clock pain control not adequately achieved with immediate-release opioid formulations.
Dr. Elliott is Chair, Formulary Committee, Northern California Kaiser Permanente; Asst. Clinical Professor of Medicine, University of California, San Francisco. Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA. Both are Associate Editors of Internal Medicine Alert.
1. Palladone Product Information. Purdue Pharma L.P. September 2004.
2. Inturrisi CE. Clin J Pain. 2002;18:S3-S13.
3. Thomas JR, von Gunten CF. CNS Drugs. 2003; 17(9):621-631.