|PHYSICIANS AND OTHER HEALTHCARE PROVIDERS MUST BECOME
FAMILIAR WITH THE IMPORTANT WARNINGS.
Actiq is indicated only for the management of breakthrough
cancer pain in patients with malignancies who are already receiving
and who are tolerant to opioid therapy for their underlying persistent
cancer pain. Patients considered opioid tolerant are those
who are taking at least 60 mg morphine/day, 50 mcg transdermal fentanyl/hour,
or an equianalgesic dose of another opioid for a week or longer.
Because life-threatening hypoventilation could occur at any dose
in patients not taking chronic opiates, Actiq is contraindicated
in the management of acute or postoperative pain. This product must
not be used in opioid non-tolerant patients.
Actiq is intended to be used only in the care of cancer
patients and only by oncologists and pain specialists who are knowledgeable
of and skilled in the use of Schedule II opioids to treat cancer
Patients and their caregivers must be instructed that Actiq
contains a medicine in an amount which can be fatal to a child.
Patients and their caregivers must be instructed to keep all units
out of the reach of children and to discard open units properly.
(See Information for Patients and Their Caregivers for disposal
WARNING: May be habit forming.
Actiq (oral transmucosal fentanyl citrate) is a solid formulation
of fentanyl citrate, a potent opioid analgesic, intended for oral transmucosal
administration. Actiq is formulated as a white to off-white solid
drug matrix on a handle that is radiopaque and is fracture resistant ABS
plastic under normal conditions when used as directed.
Actiq is designed to be dissolved slowly in the mouth in a manner
to facilitate transmucosal absorption. The handle allows the Actiq
unit to be removed from the mouth if signs of excessive opioid effects
appear during administration.
Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl)
propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound
[octanol-water partition coefficient at pH 7.4 is 816:1) that is freely
soluble in organic solvents and sparingly soluble in water (1:40). The
molecular weight of the free base is 336.5 (the citrate salt is 528.6).
The pKa of the tertiary nitrogens are 7.3 and 8.4.
Actiq is available in six strengths equivalent to 200, 400, 600,
800, 1200, or 1600 mcg fentanyl base that is identified by the text on
the foil pouch, the shelf carton, and the dosage unit handle.
Inactive Ingredients: Sucrose, liquid glucose, artificial raspberry
flavor, and white dispersion G.B. dye.