Transmucosal fentanyl contains a medicine in an amount which can be fatal to a child. Patients and their caregivers should keep transmucosal fentanyl out of the reach of children and discard open units properly. Transmucosal fentanyl comes with patient instructions. Read them carefully before using the product.
Type of medication:
Rx, narcotic analgesic
Fentanyl is a narcotic analgesic. Narcotic analgesics are used to relieve
pain. Fentanyl acts in the central nervous system (CNS) to relieve pain.
Some of its side effects are also caused by actions in the CNS. When a
narcotic is used for a long time, it may become habit-forming (causing
mental or physical dependence). However, people who have continuing pain
should not let the fear of dependence keep them from using narcotics to
relieve their pain. Mental dependence (addiction) is not likely to occur
when narcotics are used for this purpose. Physical dependence may lead to
withdrawal side effects if treatment is stopped suddenly. However, severe
withdrawal side effects can usually be prevented by reducing the dose
gradually over a period of time before treatment is stopped completely.
Your health care professional will take this into consideration when
deciding on the amount of transmucosal fentanyl you should receive.
Fentanyl is used for patients who need relief from moderate to severe
pain.
Precautions:
- This medicine should be used with caution by patients with a known allergy to morphine, codeine, or acetaminophen products.
- Alcohol can have added side effects, such as, drowsiness and mental clouding.
- Do not drive until you know how this medicine affects you.
- This medicine can cause dizziness or drowsiness.
- The appropriate dosing and safety of Actiq in opioid tolerant children with breakthrough cancer pain have not been established below the age of 16 years.
- Diabetic patients should be advised that Actiq contains approximately 2 grams of sugar per unit.
- Patients must be instructed to dispose of completely used and partially used Actiq units.
Pregnancy and Breastfeeding:
- FDA pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Actiq should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Fentanyl is excreted in human milk; therefore Actiq should not be used in nursing women because of the possibility of sedation and/or respiratory depression in their infants.
Other medical
conditions:
Be sure to tell your
doctor if you have any other medical problems, especially:
- Alcohol abuse or history of alcohol abuse
- Drug dependence, especially narcotic abuse or dependence, or history of dependence or abuse
- Kidney disease
- Liver disease
- Emphysema or other chronic lung disease or
- Head injuries
- Slow heartbeat
Other
medications:
Although certain medicines
should not be used together at all, in other cases two different
medicines may be used together even if an interaction might occur. In
these cases, your doctor may want to change the dose, or other
precautions may be necessary. When you are taking fentanyl, it is
especially important that your health care professional know if you are
taking any of the following:
- Alcohol
- Central nervous system (CNS) depressants (medicines that cause drowsiness), including other narcotics
- Erythromycin
- Itraconazole (Diflucan)
- Ketoconazole (Nizoral)
- Ritanovir (Norvir)
- Monoamine oxidase (MAO) inhibitor activity (isocarboxazid/Marplan], phenelzine/Nardil, procarbazine/Matulane, selegiline/Eldepryl, tranylcypromine/Parnate - Taking transmucosal fentanyl while you are taking or within 2 weeks of taking MAO inhibitors may cause an increased chance of serious side effects
