WILMINGTON, DelThe FDA has cleared an alternative method of administration of the pellets contained in Zenecas Kadian (morphine sulfate sustained release) capsules.
Rather than being swallowed whole, now the capsules may be opened and the entire contents sprinkled on a small amount of applesauce immediately prior to ingestion. The pellets should not be chewed, crushed, or dissolved due to risk of overdose, the company said.
In a study of healthy volunteers, Kadian pellets sprinkled over applesauce were found to be bioequivalent to Kadian capsules swallowed whole with apple-sauce under fasting conditions. With the sprinkle administration, patients should consume the entire portion and should not divide the applesauce into separate doses. Other foods for use with Kadian pellets have not been tested in patients.
Kadian is prescribed for the management of moderate-to-severe chronic pain when treatment with an opioid analgesic is indicated for more than a few days.
The recent approval of Kadian in sprinkle-supplement form allows patients who experience moderate-to-severe pain, and have difficulty swallowing capsules or tablets, 24-hour pain control with the option of a single dose, said oncologist Robert Kerr, MD, of Southwest Regional Cancer Center, Austin, Tex.