A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Actiq Patient, Information, Instructions - Fentanyl Citrate
Actiq Patient, Information, Instructions - Fentanyl Citrate
PATIENT INFORMATION
Patients and their caregivers must be instructed that Actiq
contains medicine in an amount that could be fatal to a child. Patients
and their caregivers must be instructed to keep both used and unused dosage
units out of the reach of children. Partially consumed units represent
a special risk to children. In the event that a unit is not completely
consumed it must be properly disposed as soon as possible. (See DOSAGE
AND ADMINISTRATION: SAFETY AND HANDLING, WARNINGS
and PATIENT LEAFLET for specific patient instructions.)
Frequent consumption of sugar-containing products may increase the risk of dental caries (each ACTIQ unit contains approximately 2 grams of sugar [sucrose, liquid glucose]). The occurrence of dry mouth associated with the use of opioid medications (such as fentany) may add to the risk. Therefore, patients using ACTIQ should consult their dentist to ensure appropriate oral hygiene.
Patients and their caregivers should be provided with an Actiq
Welcome Kit, which contains educational materials and safe storage containers
to help patients store Actiq and other medicines out of the reach
of children. Patients and their caregivers should also have an opportunity
to watch the patient safety video, which provides proper product use,
storage, handling and disposal directions. Patients should also have an
opportunity to discuss the video with their health care providers. Health
care professionals should call 1-800-896-5855 to obtain a supply of welcome
kits or videos for patient viewing.
Disposal of Used Actiq Units
Patients must be instructed to dispose of completely used and partially
used Actiq units.
1) After consumption of the unit is complete and the matrix is totally
dissolved, throw away the handle in a trash container that is out of the
reach of children.
2) If any of the drug matrix remains on the handle, place the handle
under hot running tap water until all of the drug matrix is dissolved,
and then dispose of the handle in a place that is out of the reach of
children.
3) Handles in the child-resistant container should be disposed of (as
described in steps 1 and 2) at least once a day.
If the patient does not entirely consume the unit and the remaining
drug cannot be immediately dissolved under hot running water, the patient
or caregiver must temporarily store the Actiq unit in the specially
provided child-resistant container out of the reach of children until
proper disposal is possible.
Disposal of Unopened Actiq Units When No Longer Needed
Patients and members of their household must be advised to dispose of
any unopened units remaining from a prescription as soon as they are no
longer needed.
To dispose of the unused Actiq units:
1) Remove the Actiq unit from its pouch using scissors, and hold
the Actiq by its handle over the toilet bowl.
2) Using wire-cutting pliers cut off the drug matrix end so that it falls
into the toilet.
3) Dispose of the handle in a place that is out of the reach of children.
4) Repeat steps 1, 2, and 3 for each Actiq unit. Flush the toilet
twice after 5 units have been cut and deposited into the toilet.
Do not flush the entire Actiq units, Actiq handles, foil
pouches, or cartons down the toilet. The handle should be disposed of
where children cannot reach it (see DOSAGE
AND ADMINISTRATION: SAFETY AND HANDLING).
Detailed instructions for the proper storage, administration, disposal,
and important instructions for managing an overdose of Actiq are
provided in the Actiq Patient Leaflet. Patients should be encouraged
to read this information in its entirety and be given an opportunity to
have their questions answered.
In the event that a caregiver requires additional assistance in disposing
of excess unusable units that remain in the home after a patient has expired,
they should be instructed to call the toll-free number (1-800-896-5855)
or seek assistance from their local DEA office.
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