FENTANYL CITRATE - fentanyl citrate lozenge 
Physicians Total Care, Inc.


Oral Transmucosal Fentanyl Citrate CII (OTFC) 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, 1600 mcg

image of warning signWARNING:

  1. Do not use Oral Transmucosal Fentanyl Citrate (OTFC) unless you are regularly using other opioid pain medicines around-the-clock for your constant cancer pain and your body is used to these medicines.
  2. You MUST keep OTFC in a safe place out of the reach of children. Accidental ingestion by a child is a medical emergency and can result in death. Death has been reported in children who have accidentally taken OTFC. If a child accidentally takes OTFC, get emergency help right away.

Read the Medication Guide that comes with Oral Transmucosal Fentanyl Citrate (OTFC) before you start taking it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or your treatment. Share this important information with members of your household.

What is the most important information I should know about Oral Transmucosal Fentanyl Citrate (OTFC)?

  1. OTFC can cause life threatening breathing problems which can lead to death:
    • if you are not regularly using other opioid pain medicines around-the-clock for your constant cancer pain and your body is not used to these medicines. This means that you are not opioid tolerant.
    • if you do not use it exactly as prescribed by your doctor.
  2. Your doctor will prescribe a starting dose of OTFC that is different than other fentanyl containing medicines you may have been taking. Do not substitute OTFC for other fentanyl medicines without talking with your doctor.
  3. Use no more than 2 units of OTFC per episode of breakthrough cancer pain. You must wait at least 4 hours before using OTFC again for another episode of breakthrough cancer pain.

What is Oral Transmucosal Fentanyl Citrate (OTFC)?

Who should not take Oral Transmucosal Fentanyl Citrate (OTFC)?

Do Not Take OTFC: 

What should I tell my doctor before I start taking Oral Transmucosal Fentanyl Citrate (OTFC)?

Tell your doctor about all of your medical and mental problems, especially the ones listed below:

Tell your doctor if you are:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal and dietary supplements. Some medicines may cause serious or life-threatening medical problems when taken with OTFC. Sometimes, the doses of certain medicines and OTFC need to be changed if used together.

Do not take any medicine while using OTFC until you have talked to your doctor. Your doctor will tell you if it is safe to take other medicines while you are using OTFC.  Be especially careful about other medicines that make you sleepy such as other pain medicines, anti-depressant medicines, sleeping pills, anxiety medicines, antihistamines, or tranquilizers.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist.

How should I use Oral Transmucosal Fentanyl Citrate (OTFC)?

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How should I dispose of Oral Transmucosal Fentanyl Citrate (OTFC) after use?

Partially used OTFC units may contain enough medicine to be harmful or fatal to a child or other adults who have not been prescribed OTFC. You must properly dispose of the OTFC handle right away after use even if there is little or no medicine left on it. Please follow these directions to dispose of the handle:

  1. Once you have finished the OTFC unit and the medicine is totally gone, throw the handle away in a place that is out of the reach of children.
  2. If any medicine remains on the handle after you have finished, place the handle under hot running water until the medicine is gone, and then throw the handle away out of the reach of children and pets. 
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  3. If you did not finish the entire OTFC unit and you cannot dissolve the medicine under hot running water right away, put the OTFC in the temporary storage bottle that you received in the OTFC Child Safety Kit for safe keeping. Push the OTFC unit into the opening on the top until it falls completely into the bottle. Never leave unused or partially used OTFC units where children or pets can get to them.
  4. Dispose of the handles in the temporary storage bottle as soon as you can by following the directions in steps 1 and 2. You must dispose of all handles in the temporary storage bottle at least once a day.

Do not flush entire unused OTFC units, OTFC handles, or blister packages down the toilet.

What should I avoid while taking Oral Transmucosal Fentanyl Citrate (OTFC)?

What are the possible or reasonably likely SIDE EFFECTS of Oral Transmucosal Fentanyl Citrate (OTFC)?

These can be symptoms that you have taken too much (overdose) OTFC or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. Do not take another dose of OTFC.

The most common side effects of OTFC are nausea, vomiting, dizziness and sleepiness. Other side effects include headache, low energy and constipation. Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including OTFC and is unlikely to go away without treatment. Talk to your doctor about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking OTFC.

OTFC contains sugar. Cavities and tooth decay have occurred in patients taking OTFC. When taking OTFC, you should talk to your dentist about proper care of your teeth.

Talk to your doctor about any side effects that bother you or that do not go away.

These are not all the possible side effects of OTFC. For a complete list, ask your doctor.Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

How should I store Oral Transmucosal Fentanyl Citrate (OTFC)?

How should I dispose of unopened Oral Transmucosal Fentanyl Citrate (OTFC) units when they are no longer needed?

If you need help with disposal of OTFC, call Cephalon, Inc., at 1-800-896-5855.

General Information About the Safe and Effective Use of Oral Transmucosal Fentanyl Citrate (OTFC)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use OTFC only for the purpose for which it was prescribed.

Do not give OTFC to other people, even if they have the same symptoms you have.

OTFC can harm other people and even cause death.

Sharing OTFC is against the law

This Medication Guide summarizes the most important information about OTFC. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about OTFC that is written for healthcare professionals. You can also call Cephalon, Inc., at 1-800-896-5855.

What are the ingredients of Oral Transmucosal Fentanyl Citrate (OTFC)?

Active Ingredient: fentanyl citrate.

Inactive Ingredients: Sugar, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, modified food starch, and confectioner's sugar.

How do I use the Oral Transmucosal Fentanyl Citrate (OTFC) Child Safety Kit?

The OTFC Child Safety Kit contains important information on the safe storage and handling of OTFC. The kit contents include:

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This Medication Guide has been approved by the U.S. Food and Drug Administration.

Rx Only

Manufactured by:
Anesta Corp., Salt Lake City, UT 84116, USA

Reference Number: 00010677.05

Printed in USA

Relabeling of "Additional barcode label" by:
Physicians Total Care, Inc.
Tulsa, OK       74146

Revised: 3/2011
Physicians Total Care, Inc.