Drugs & Vitamins

Oralet Active Ingredients: Fentanyl Transmucosal Lozenge Representative Names: Oralet What are fentanyl transmucosal lozenges? What should I tell my health care provider before I take this medicine? How should I use this medicine? What if I miss a dose? What drug(s) may interact with fentanyl? What side effects may I notice from receiving fentanyl? What should I watch for while taking fentanyl? Where can I keep my medicine? What are fentanyl transmucosal lozenges? (Back to top) FENTANYL (Fentanyl Oralet®) was a pain medicine used to help produce anesthesia before surgery or other procedures. Federal law prohibits the transfer of fentanyl to any person other than the patient for whom it was prescribed. Do not share this medicine with anyone else. Generic fentanyl transmucosal lozenges are not yet available. NOTE: This drug is discontinued in the United States. What should I tell my health care provider before I take this medicine? (Back to top) They need to know if you have any of these conditions: •head injury •heart disease •intestinal disease •kidney disease •liver disease •lung disease or breathing difficulties •seizures (convulsions) •an allergic or unusual reaction to fentanyl, meperidine, other medicines, sulfites, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should I use this medicine? (Back to top) Fentanyl transmucosal lozenges are only administered under supervision by a health-care professional in a hospital or clinic setting. The lozenge is for use 20 to 40 minutes before the effect is needed. Remove the foil overwrap just before use. After removing cap, place the lozenge in the mouth between the cheek and gum and suck it; do not chew. When you place the lozenge in your mouth it will dissolve slowly and the medicine is absorbed through the lining of your mouth. The lozenge can be removed using the handle once the desired effect is seen. If any medicine remains on the handle, replace the cap and dispose of properly. The maximum dose is 400 mcg. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. Fentanyl transmucosal lozenges should not be used in children weighing less than 10 kg (22 lbs). The maximum dose is 400 mcg. What if I miss a dose? (Back to top) This does not apply. What drug(s) may interact with fentanyl? (Back to top) •amiodarone •antidepressant drugs called MAOIs •anti-retroviral protease inhibitors, especially ritonavir •bosentan •butorphanol •delavirdine •efavirenz •erythromycin •fluconazole •fluvoxamine •fluoxetine •imatinib, STI-571 •itraconazole •herbal products containing St. John's wort •ketoconazole •medicines for diarrhea •medicines for high blood pressure •medicines for seizures •mifepristone, RU-486 •nalbuphine •nefazodone •nevirapine •other strong medicines for pain •pentazocine •rifabutin •rifampin Because fentanyl may cause drowsiness, other medications that also cause drowsiness may increase this effect of fentanyl. Some medicines that cause drowsiness are: •alcohol and alcohol-containing medicines •barbiturates, such as phenobarbital •certain antidepressants or tranquilizers •muscle relaxants •certain antihistamines used in cold medicines Ask your prescriber or health care professional about other medicines that may increase the effect of fentanyl. Tell your prescriber or health care professional about all other medicines you that are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also, tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from receiving fentanyl? (Back to top) Side effects that you should report to your prescriber or health care professional as soon as possible: Rare or uncommon: •breathing difficulties, wheezing •cold, clammy skin •seizures •slow or fast heartbeat •severe rash •unusual weakness More common: •confusion •lightheadedness or fainting spells •nervousness or restlessness Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •itching •blurred vision •clumsiness, unsteadiness •constipation •decrease or difficulty passing urine •dizziness, drowsiness •dry mouth •flushing •headache •nausea/vomiting •pinpoint pupils •sweating What should I watch for while taking fentanyl? (Back to top) You should be attended at all times by a healthcare professional while you suck the transmucosal lozenge. The lozenge should be removed if there is any sign of breathing difficulty. You may get drowsy or dizzy when you are taking fentanyl. Do not drive, use machinery, or do anything that needs mental alertness until you know how fentanyl affects you. Stand or sit up slowly, this reduces the risk of dizzy or fainting spells. These effects may be worse if you are an older patient. Be careful taking other medicines which may also make you tired. This effect may be worse when taking these medicines with fentanyl. Alcohol can increase possible drowsiness, dizziness, and confusion and may affect your breathing. Avoid alcohol while taking fentanyl. Where can I keep my medicine? (Back to top) Keep out of the reach of children. This medicine is only used in a hospital or clinic prior to surgery or other procedures. You should not have this medication at home. Last Updated:11/14/2003 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.