Actiq manages breakthrough cancer pain. Can cause constipation. Talk to your doctor about which laxatives and/or stool softeners are best for you to use while taking this medication.
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Actiq Cautionary Labels
Uses of Actiq
Fentanyl is a prescription medication used to treat breakthrough cancer pain.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Actiq Drug Class
Actiq is part of the drug class:
Side Effects of Actiq
Serious side effects have been reported with fentanyl. See the “Fentanyl Precautions” section.
Common side effects of fentanyl include the following:
- Stomach pain
- Loss of appetite
- Weight loss
- Difficulty urinating
- Vision changes
- Changes in thinking or dreams
- Dry mouth
- Difficulty sleeping
- Reddening of the face, neck, or chest
- Swelling of the extremities
- Hives, rash, and itching
Irritation at the site of application may also occur after administration of fentanyl.
This is not a complete list of fentanyl side effects. Ask your doctor or pharmacist for more information.
Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- Barbiturates such as phenobarbital (Luminal)
- Buprenorphine (Buprenex, Subutex, in Suboxone)
- Butorphanol (Stadol)
- Carbamazepine (Carbatrol, Epitol, Tegretol)
- Efavirenz (in Atripla, Sustiva)
- Modafinil (Provigil)
- Nalbuphine (Nubain)
- Nalmefene (Revex)
- Naloxone (Narcan)
- Nevirapine (Viramune)
- Oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone
- Oxcarbazepine (Trileptal)
- Other pain medications
- Pentazocine (Talwin)
- Phenytoin (Dilantin, Phenytek)
- Pioglitazone (Actos, in Actoplus Met, in Duetact)
- Rifabutin (Mycobutin)
- Rifampin (Rifadin, Rimactane, in Rifamate, in Rifater)
- Sedatives, sleeping pills, or tranquilizers
Also tell your doctor or pharmacist if you are taking any of the following medications or if you have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).
This is not a complete list of fentanyl drug interactions. Ask your doctor or pharmacist for more information.
Serious side effects have been reported with oral, topical, inhalational, and injectable forms of fentanyl, including the following:
- Changes in heart rate
- Slowed or shallow breathing
- Difficulty breathing or swallowing
- Extreme drowsiness
Fentanyl can cause drowsiness and vision changes. Do not drive or operate heavy machinery until you know how fentanyl affects you.
Do not take fentanyl if you are allergic to fentanyl or to any of its ingredients.
Actiq Food Interactions
Grapefruit and grapefruit juice may interact with fentanyl and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
Before taking fentanyl, tell your doctor about all of your medical conditions. Especially tell your doctor if you:
- are allergic to fentanyl or to any of its ingredients
- are taking herbal supplements, especially St. John’s Wort
- drink large amounts of alcohol or use illegal drugs
- have had a head injury, brain tumor, stroke, or seizures
- have liver problems
- have kidney problems
- have heart problems, especially problems with your heart rate
- have low blood pressure
- have mental illness, such as depression, schizophrenia, or hallucinations
- have breathing disorders, such as asthma or chronic obstructive pulmonary disorder
- are pregnant or breastfeeding
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Actiq and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
Fentanyl falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.
Actiq and Lactation
Tell your doctor if you are breastfeeding or plan to breastfeed.
Fentanyl has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from fentanyl, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.
Take fentanyl exactly as prescribed.
This medication comes in nasal spray, sublingual spray, sublingual tablet, lozenge, and transdermal patch forms. The dose and frequency of administration will vary with the indication and dosage form.
Instructions for use of lozenges:
Place ACTIQ in your mouth between your cheeks and gums and actively suck on the medicine. Move the lozenge around in your mouth, especially along the inside of your cheeks. Twirl the handle often. Finish the ACTIQ unit completely in 15 minutes to get the most relief. If you finish ACTIQ too quickly, you will swallow more of the medicine and get less relief. Do not bite or chew ACTIQ. You will get less relief for your breakthrough cancer pain.
Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The dose your doctor recommends may be based on the following:
- the condition being treated
- how you respond to this medication
- your weight
- your age
The recommended dose/dose range of ACTIQ (fentanyl) lozenge for the treatment of breakthrough cancer pain is 200 mcg to 1600 mcg. The lozenge should be consumed over 15 minutes. ACTIQ is only indicated for patients who are already taking around-the-clock opioid medications. The dose of ACTIQ is titrated based on your response to the medication and the dose may be repeated once in 30 minutes if additional pain relief is needed. Wait at least 4 hours before treating another episode of pain.
If you take too much fentanyl, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.
If fentanyl is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
- Store fentanyl at room temperature.
- Keep this and all medicines out of the reach of children.
- Special instructions for discarding used and unused fentanyl doses are provided in the medication guide you will receive with your medication. Follow these instructions carefully and ask your pharmacist for more information or if you are unclear how to dispose of fentanyl products safely.
Actiq FDA Warning
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL
Due to the risk of fatal respiratory depression, fentanyl oral transmucosal lozenge is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.
Keep out of reach of children.
Use with CYP3A4 inhibitors may cause fatal respiratory depression.
When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to fentanyl oral transmucosal lozenge.
When dispensing, do not substitute with any other fentanyl products.
Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.
Fentanyl oral transmucosal lozenge is available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.