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All about: Actiq Lozenge

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Generic Name: Fentanyl Lozenge (FEN-ta-nil)
Brand Name: Actiq

Actiq Lozenge is only for breakthrough pain caused by cancer in patients who are already taking a narcotic pain medicine. Severe, sometimes life-threatening, breathing problems can occur in patients using Actiq Lozenge even if they are not already using other narcotic medicines. Do not use Actiq Lozenge for pain that is short-term or for pain that occurs after surgery. Keep Actiq Lozenge out of the reach of children and make sure that it is disposed of properly. Actiq Lozenge can be harmful, and even fatal, to a child.

Actiq Lozenge is used for:

Managing continual breakthrough cancer pain in patients who are already receiving and are tolerant to narcotic (opioid) medicines.

Actiq Lozenge is a narcotic (opioid) analgesic. It relieves pain by dulling the pain center in the brain.

Do NOT use Actiq Lozenge if:

  • you are allergic to any ingredient in Actiq Lozenge or any related medicine (eg, sufentanil)
  • you have not already been taking other prescription narcotic pain medicines (eg, morphine, codeine) on a regular schedule
  • you have mild or short-term pain, including pain from injuries and surgery
  • you drink alcoholic beverages, you are taking sodium oxybate (GHB) or other sedatives which cause drowsiness and decrease breathing rate
  • you are taking or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Actiq Lozenge:

Some medical conditions may interact with Actiq Lozenge. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, plan to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have or have ever had alcoholism, substance abuse, or narcotic dependence or if you consume more than 3 alcohol-containing drinks per day
  • if you have diabetes, asthma or other breathing problems, fever, increased pressure or a lesion on the brain, heart problems, liver or kidney disease, pancreatitis, thoughts of hurting or killing yourself (suicidal thoughts), or had recent surgery or head trauma
  • if you weigh less than 110 pounds (50 kilograms)

Some MEDICINES MAY INTERACT with Actiq Lozenge. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Naltrexone because the effectiveness of Actiq Lozenge may be decreased
  • Alcohol, amiodarone, azole antifungals (eg, fluconazole), barbiturate anesthetics (eg, thiopental), benzodiazepines (eg, alprazolam), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolides (eg, erythromycin), MAO inhibitors (eg, phenelzine), or sodium oxybate (GHB) because side effects such as difficulty breathing, seizures, and disorientation may occur
  • Barbiturate anesthetics (eg, thiopental), benzodiazepines (eg, alprazolam), sibutramine, orsodium oxybate (GHB) because actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Actiq Lozenge may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Actiq Lozenge:

Use Actiq Lozenge as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Actiq Lozenge comes with an additional patient leaflet. Read it carefully.
  • Open the foil packaging with scissors just before using. Do not use Actiq Lozenge if the foil packaging has been damaged or opened before you are ready to use it.
  • Using the handle, place the unit between the cheek and lower gum, occasionally moving it from one side of the mouth to the other. Twirl the handle often.
  • Suck on the lozenge for 15 minutes. Do not chew or bite the lozenge. Swallow excessive saliva. If you finish the unit too quickly, you will swallow more of the medicine and get less pain relief.
  • Do not eat, drink, or smoke while the unit is dissolving.
  • If excessive drowsiness, slowed breathing, or dizziness occurs before the dose is used, use the handle to remove the unit from your mouth and dispose of it immediately. Do not save or reuse partially used doses.
  • If you do not finish the entire unit each time you have breakthrough pain or if you are using more than 4 units per day, call your doctor or health care provider.
  • If you cannot finish an entire dose of Actiq Lozenge and cannot immediately dissolve the medicine in hot tap water, immediately put it in the temporary storage bottle for safe keeping. Push the unit into the opening on the top until it falls completely into the bottle. Properly dispose of the unit as soon as possible according to your doctor's instructions.
  • When you finish the unit and the medicine is completely gone, dispose of the handle in a place that is out of the reach of children. If any medicine is left on the handle when you are finished, put the handle under hot tap water until the medicine is gone. Dispose of the handle out of the reach of children and pets.
  • If you are no longer using Actiq Lozenge or if you have extra medicine you do not need in your home, dispose of it as soon as possible. Remove the medicine from the locked storage space and remove 1 unit from the foil packaging with scissors. Hold the unit by its handle over the toilet bowel and, using wire-cutting pliers, cut the medicine end off so that it falls in the toilet. Dispose of the handle in a place that is out of the reach of children and away from pets. Do not flush more than 5 units at a time. Flush the toilet twice after the 5 units have been cut.
  • If you miss a dose of Actiq Lozenge and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Actiq Lozenge.

Important safety information:

  • Actiq Lozenge may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Actiq Lozenge. Using Actiq Lozenge alone, with certain other medicines (especially muscle relaxants, antihistamines, or sleeping pills), or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
  • Avoid drinking alcohol while taking Actiq Lozenge.
  • Actiq Lozenge contains sugar (about a half teaspoon of sugar per unit) and may increase the risk of dental cavities or tooth decay. The side effect of dry mouth may add to this risk. Ask your dentist about proper dental care while you are using Actiq Lozenge (eg, brushing and flossing your teeth).
  • Actiq Lozenge can be fatal to a child. Keep both the used and unused medicine out of the reach of children. Throw away this medicine properly according to the instructions given to you by your health care provider. If a child accidentally takes Actiq Lozenge remove the medicine from their mouth, keep them awake by calling their name and shaking their arm, and call the emergency room or poison control center immediately.
  • Secure the space where you keep Actiq Lozenge with the child-resistant lock included in your patient kit. You can keep a small supply of Actiq Lozenge in the portable locking pouch so that it is nearby for your immediate use. Keep the rest of the medicine in the locked storage space. Keep the pouch locked and away from the reach and sight of children.
  • Contact your doctor if your usual dose stops providing pain relief. Be sure to tell your doctor or health care provider about your pain and if Actiq Lozenge is working so that your dose can be adjusted if needed.
  • Diabetes patients - Actiq Lozenge contains about 2 grams of sugar per unit.
  • Use Actiq Lozenge with caution in the ELDERLY because they may be more sensitive to its effects.
  • Actiq Lozenge is not recommended for use in CHILDREN younger than 16 years of age; safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you are pregnant or plan on becoming pregnant, discuss with your doctor the benefits and risks of using Actiq Lozenge during pregnancy. Actiq Lozenge is excreted in breast milk. Do not breast-feed while taking Actiq Lozenge.

When used for long periods of time or at high doses, Actiq Lozenge may not work as well and may require higher doses to obtain the same effect as when first taken. This is known as TOLERANCE. Talk with your doctor if Actiq Lozenge stops working well. Do not take more than is prescribed.

Additionally, when used for long periods of time or at high doses, some people develop a need to continue taking Actiq Lozenge. This is known as DEPENDENCE or "addiction.". If you suddenly stop taking Actiq Lozenge, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; hallucinations (seeing, hearing, or feeling things that are not really there); shivering or tremors; sweating; and trouble sleeping. Stop using Actiq Lozenge gradually as instructed by your health care provider.

Possible side effects of Actiq Lozenge:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Accidental injury; anxiety; confusion; constipation; difficulty walking; dizziness; drowsiness; dry mouth; headache; indigestion; itching; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive dizziness; excessive drowsiness; fainting; fatigue; hallucinations; muscle rigidity; seizures; shock (changes in skin color); slow heartbeat; slowed breathing; trouble breathing; weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include loss of consciousness; muscle rigidity; slow or shallow breathing; unusual drowsiness or dizziness; very slow or weak heartbeat.

Proper storage of Actiq Lozenge:

Store Actiq Lozenge at room temperature between 68 and 77 degrees F (20 and 25 degrees C), in the original package away from heat, moisture, and light. Do not store in the bathroom. Do not refrigerate or freeze. Do not remove from package until ready to use. Do not store it above 77 degrees F (25 degrees C). Do not use if the foil pouch has been opened. Keep Actiq Lozenge out of the reach of children and away from pets.

General information:

  • If you have any questions about Actiq Lozenge, please talk with your doctor, pharmacist, or other health care provider.
  • Actiq Lozenge is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Actiq Lozenge. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: September 5, 2007
Database Edition
Copyright © 2007 Wolters Kluwer Health, Inc.

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