Fentanyl (Page 10 of 12)

Dose Titration

The recommended initial fentanyl transdermal system dose based upon the daily oral morphine dose is conservative, and 50% of patients are likely to require a dose increase after initial application of fentanyl transdermal system. The initial fentanyl transdermal system dose may be increased after 3 days based on the daily dose of supplemental opioid analgesics required by the patient in the second or third day of the initial application.

Physicians are advised that it may take up to 6 days after increasing the dose of fentanyl transdermal system for the patient to reach equilibrium on the new dose (see graph in CLINICAL PHARMACOLOGY). Therefore, patients should wear a higher dose through two applications before any further increase in dosage is made on the basis of the average daily use of a supplemental analgesic.

Appropriate dosage increments should be based on the daily dose of supplementary opioids, using the ratio of 45 mg/24 hours of oral morphine to a 12.5 mcg/h increase in fentanyl transdermal system dose. Fentanyl transdermal system – 12 delivers 12.5 mcg/h of fentanyl.

Discontinuation of FENTANYL TRANSDERMAL SYSTEM

To convert patients to another opioid, remove fentanyl transdermal system and titrate the dose of the new analgesic based upon the patient’s report of pain until adequate analgesia has been attained. Upon system removal, 17 hours or more are required for a 50% decrease in serum fentanyl concentrations. Opioid withdrawal symptoms (such as nausea, vomiting, diarrhea, anxiety, and shivering) are possible in some patients after conversion or dose adjustment. For patients requiring discontinuation of opioids, a gradual downward titration is recommended since it is not known at what dose level the opioid may be discontinued without producing the signs and symptoms of abrupt withdrawal.

Tables C, D, and E should not be used to convert from fentanyl transdermal system to other therapies. Because the conversion to fentanyl transdermal system is conservative, use of Tables C, D, and E for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible.

HOW SUPPLIED

Fentanyl transdermal system is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems.

Fentanyl Transdermal System Dose (mcg/h)	System Size (cm2)	Fentanyl Content (mg)	NDC Number
Fentanyl transdermal system-12	5.25	2.1	0781-7240-55
Fentanyl transderml system-25	10.5	4.2	0781-7241-55
Fentanyl transdermal system-50	21	8.4	0781-7242-55
Fentanyl transdermal system-75	31.5	12.6	0781-7243-55
Fentanyl transdermal system-100	42	16.8	0781-7244-55

Safety and Handling

Fentanyl transdermal system is supplied in sealed transdermal systems which pose little risk of exposure to health care workers. Do not use a fentanyl transdermal system patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way.

KEEP FENTANYL TRANSDERMAL SYSTEM OUT OF THE REACH OF CHILDREN AND PETS.

Store in original unopened pouch. Store up to 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). Apply immediately after removal from individually sealed pouch. Do not use if the pouch seal is broken. For transdermal use only.

Bioclusive™ is a trademark of Ethicon, Inc.
Tegaderm™ is a trademark of 3M

A schedule CII narcotic. DEA order form required.

Manufactured by:
ALZA CorporationVacaville, CA 95688 for

Sandoz Inc. Broomfield, CO 80020

Revised July 2009

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MEDICATION GUIDE

FENTANYL TRANSDERMAL SYSTEM CII

IMPORTANT:

Keep fentanyl transdermal system in a safe place away from children and pets. Accidental use by a child or pet is a medical emergency and may result in death. If a child or pet accidentally uses fentanyl transdermal system, get emergency help right away. Make sure you read the separate “Instructions for Applying a Fentanyl Transdermal System Patch.” Always use a fentanyl transdermal system patch the right way. Fentanyl transdermal system can cause serious breathing problems and death, especially if it is used the wrong way. Fentanyl transdermal system is a federally controlled substance (C-II) because it can be abused. Keep fentanyl transdermal system in a safe place to prevent theft. Selling or giving away fentanyl transdermal system may harm others, and is against the law. Tell your doctor if you (or a family member) have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Read the Medication Guide that comes with fentanyl transdermal system before you start using 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 healthcare provider about your medical condition or your treatment. Make sure you read and understand all the instructions for using fentanyl transdermal system. Do not use fentanyl transdermal system unless you understand everything. Talk to your healthcare provider if you have questions.

What is the most important information I should know about fentanyl transdermal system?

Fentanyl transdermal system is a skin patch that contains fentanyl. Fentanyl is a very strong opioid narcotic pain medicine that can cause serious and life-threatening breathing problems. Serious and life-threatening breathing problems can happen because of an overdose or if the dose you are using is too high for you. Call your doctor right away or get emergency medical help if you:

• have trouble breathing, or have slow or shallow breathing
• have a slow heartbeat
• have severe sleepiness
• have cold, clammy skin
• feel faint, dizzy, confused, or cannot think, walk, or talk normally
• have a seizure
• have hallucinations

Fentanyl transdermal system is only for adults and children over the age of two with persistent, moderate to severe chronic pain and who:

• are already using another strong opioid narcotic pain medicine around-the-clock, and have been using the medicine regularly for a week or longer. This is called being opioid-tolerant.
• have pain that cannot be controlled with other medicines

Do not use fentanyl transdermal system:

• if you are not already using another opioid narcotic medicine and are not opioid tolerant
• if you need opioid pain medicines for only a short time
• for pain from surgery, medical or dental procedures
• if your pain can be taken care of by occasional use of other pain medicines
• in children who are less than 2 years of age
• if you have asthma symptoms or have severe asthma

A fentanyl transdermal system patch must be used only on the skin of the person for whom it was prescribed. If the patch comes off and accidentally sticks to the skin of another person, take the patch off of that person right away, wash the area with water, and get medical care for them right away.

Fentanyl transdermal system patch is not safe for everyone. Tell your doctor about all of your medical conditions.

Tell your doctor if you are planning to become pregnant, are pregnant, or breastfeeding. Fentanyl transdermal system may cause serious harm to a baby.

Tell your doctor about all the medicines you take. Some medicines may cause serious or life-threatening side effects when used with fentanyl transdermal system. Your doctor will tell you if it is safe to take other medicines while you are using fentanyl transdermal system.

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

How should I use fentanyl transdermal system?

Read the separate “Instructions for Applying a Fentanyl Transdermal System Patch”.

• You must always use fentanyl transdermal system patches the right way:
  • Do not use a fentanyl transdermal system patch if the pouch seal is broken, or the patch is cut, damaged, or changed in any way.
  • Do not use heat sources such as heating pads, electric blankets, heat lamps, tanning lamps, saunas, hot tubs, or heated waterbeds while wearing a fentanyl transdermal system patch.
  • Do not take hot baths or sunbathe while wearing a fentanyl transdermal system patch.
• If you have problems with the fentanyl transdermal system patch not sticking:
  1. Apply first aid tape only to the edges of the patch.
  2. If problems with the patch not sticking persist, cover the patch with Bioclusive™ or Tegaderm™. These are special see-through adhesive dressings. Never cover a fentanyl transdermal system patch with any other bandage or tape.
• If your fentanyl transdermal system patch falls off before 3 days or 72 hours, fold the sticky side together and flush down a toilet. Put a new one on at a different skin site.
• Do not change your dose unless your doctor tells you to. Your doctor may change your dose after seeing how the medicine affects you. Do not use fentanyl transdermal system more often than prescribed. Call your doctor if your pain is not well controlled while using fentanyl transdermal system.
• Do not stop using fentanyl transdermal system suddenly. Stopping fentanyl transdermal system suddenly can make you sick with withdrawal symptoms (for example, nausea, vomiting, diarrhea, anxiety, and shivering). Your body can develop a physical dependence on fentanyl transdermal system. If your doctor decides you no longer need fentanyl transdermal system, ask how to slowly reduce this medicine so you don’t have withdrawal symptoms. Do not stop taking fentanyl transdermal system without talking to your doctor.
• Do not wear more than one fentanyl transdermal system patch at a time, unless your doctor tells you to do so.
• Call your doctor right away if
  • You get a fever higher than 102°F
  • Your body temperature increases from exercise
    A fever or increase in body temperature may cause too much of the medicine in fentanyl transdermal system to pass into your body.
• If you use more fentanyl transdermal system than your doctor has prescribed, get emergency medical help right away.
• Do not drink any alcohol while using fentanyl transdermal system. Alcohol can increase your chances of having serious side effects.
• Do not drive, operate heavy machinery, or do other possibly dangerous activities until you know how fentanyl transdermal system affects you. Fentanyl transdermal system can make you sleepy. Ask your doctor to tell you when it is okay to do these activities.
• When you remove your fentanyl transdermal system patch, fold the sticky sides of a used fentanyl transdermal system patch together and flush it down the toilet. Do not put used fentanyl transdermal system patches in a trash can.

What are the possible side effects of fentanyl transdermal system?

Serious side effects include:

• Life-threatening breathing problems. See “What is the most important information I should know about fentanyl transdermal system?”
• Low blood pressure. This can make you feel dizzy if you get up too fast from sitting or lying down.

The common side effects with fentanyl transdermal system are nausea, vomiting, constipation, dry mouth, sleepiness, confusion, weakness, sweating, and pain and redness where the patch was applied.

Constipation is a very common side effect of all opioid medicines. Talk to your doctor about the use of laxatives and stool softeners to prevent or treat constipation while taking fentanyl transdermal system.

Talk to your doctor about any side effect that concerns you.

These are not all the possible side effects of fentanyl transdermal system. For a complete list, ask your doctor or pharmacist.

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 fentanyl transdermal system?

• Store in original unopened pouch at room temperature.
• Keep a fentanyl transdermal system patch in its protective pouch until you are ready to use it.
• Keep fentanyl transdermal system in a safe place out of the reach of children and pets.
• Dispose of fentanyl transdermal system patches you no longer need. Open the unused packages, fold the sticky sides of the patches together, and flush them down the toilet.

General information about the safe and effective use of fentanyl transdermal system

• Do not use fentanyl transdermal system for a condition for which it was not prescribed.
• Do not give fentanyl transdermal system to other people, even if they have the same symptoms you have. Fentanyl transdermal system can harm other people and even cause death. Sharing fentanyl transdermal system is against the law.

This Medication Guide summarizes the most important information about fentanyl transdermal system. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about fentanyl transdermal system that is written for doctors.

For questions about the Sandoz fentanyl transdermal system, call the Sandoz Customer Relations Center at 1-800-525-8747. If this is a medical emergency, please call 911.

What are the ingredients of fentanyl transdermal system?

Active Ingredient: fentanyl
Inactive ingredients: polyester/ethyl vinyl acetate film backing, polyacrylate adhesive.

This Medication Guide has been approved by the United States Food and Drug Administration.

Bioclusive™ is a trademark of Ethicon, Inc.
Tegaderm™ is a trademark of 3M

Manufactured by:
ALZA CorporationVacaville, CA 95688 for

Sandoz Inc., Broomfield, CO 80020

Insert new code

July 2009