Buprenorphine Transdermal Patch

Buprenorphine patches are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications. It is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

Unless your doctor tells you otherwise, continue your normal diet.

Buprenorphine patches may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• difficulty falling asleep or staying asleep
• headache
• dry mouth
• stomach pain
• skin irritation, itching, swelling, or redness in the area where you wore the patch

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• difficulty breathing or swallowing
• shortness of breath
• changes in heartbeat
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• inability to get or keep an erection
• irregular menstruation
• decreased sexual desire
• chest pain
• swelling of your face, tongue or throat
• rash
• hives
• itching

Buprenorphine patches may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• small, pinpoint pupils (black circles in the center of the eye)
• extreme sleepiness or drowsiness
• slowed or difficulty breathing
• coma (loss of consciousness for a period of time)

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Take buprenorphine transdermal patch at the same time of day.
• Do not use if the pouch that holds this medicine is torn, open, or not sealed all the way.
• Do not use for fast pain relief or on an as needed basis.
• Do not use for pain relief after surgery if you have not been taking drugs like buprenorphine transdermal patch.
• Do not use patches that are cut or do not look right.
• Wash your hands before and after use.
• Take off old patch first.
• Put patch on clean, dry, healthy skin on the upper arm, upper back, upper chest, or side of the chest.
• Clip hair at site before putting patch on. Do not shave.
• Put the patch in a new area each time you change the patch.
• Do not put a new patch on the same skin area as an old patch for at least 21 days.
• If the patch falls off, put a new one on.
• If the patch loosens, put tape ONLY on the edges of the patch to hold it in place.
• If there are problems with the patch not sticking, cover the patch with dressings as you have been told.
• Do not put on more than 1 patch at the same time unless your doctor tells you to.

What do I do if I miss a dose?

• Put on a missed patch as soon as you think about it after taking off the old one.
• Do not apply double dose or extra doses.

Buprenorphine can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Food interactions

You shouldn’t eat grapefruit, grapefruit juice, or Seville oranges while you’re taking this drug. These foods can increase the amount of buprhenorphine in your body. This raises your risk of side effects.

Alcohol interaction

Drinking alcohol with buprenorphine can cause death or loss of consciousness. Do not drink alcohol while taking this drug.

Medications that might interact with this drug

• Increased side effects from buprenorphine: Taking buprenorphine with certain medications raises your risk of side effects from buprenorphine. This is because the amount of buprenorphine in your body may be increased. Examples of these drugs include:
  • Antifungal drugs, such as ketoconazole
    • Taking these drugs together may cause dizziness, nausea, trouble breathing, and other side effects. Your doctor may decrease the dosage of your antifungal drug or buprenorphine if you have to take them together.
  • Antibiotics, such as erythromycin
    • Taking these drugs together may cause dizziness, nausea, trouble breathing, and other side effects. Your doctor may decrease the dosage of your antibiotic or buprenorphine if you have to take them together.
  • HIV drugs, such as ritonavir and atazanavir
    • Taking any of these drugs with buprenorphine may cause dizziness, nausea, trouble breathing, and other side effects. Your doctor may decrease the dosage of your HIV drug or buprenorphine if you have to take them together.
• Increased side effects fromother drugs: Taking ;buprenorphine with certain medications raises your risk of side effects from those drugs. This is because the amount of the other drug in your body may be increased. Examples of these drugs include:
  • Serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs)
    • Taking these drugs with buprenorphine may cause serotonin syndrome, which can be fatal. Symptoms can include agitation, sweating, muscle twitches, and confusion.
  • Benzodiazepines and sedating medications, such as alprazolam or lorazepam
    • Taking these medications with buprenorphine may cause breathing problems, coma, and death. You should only take benzodiazepines with buprenorphine if your doctor gives them to you together.
• Increased side effects from both drugs: Taking buprenorphine with certain medications raises your risk of side effects. This is because buprenorphine and these other medications can cause the same side effects. As a result, these side effects can be increased. Examples of these drugs include:
  • Benzodiazepines and sedating medications, such as alprazolam or lorazepam
    • Taking these medications with buprenorphine may cause breathing problems, coma, and death. You should only take benzodiazepines with buprenorphine if your doctor gives them to you together.

• When buprenorphine is less effective: When buprenorphine is used with certain drugs, it may not work as well to treat your condition. This is because the amount of buprenorphine in your body may be decreased. Examples of these drugs include:
  • Seizure drugs, such as phenobarbital, carbamazepine, and phenytoin
    • You may have withdrawal symptoms if you take any of these drugs with buprenorphine.
  • Rifampin
    • You may have withdrawal symptoms if you take any of these drugs with buprenorphine.
  • Efavirenz, nevirapine, and etravirine
    • Your doctor may monitor your dosage of these drugs if you take any of them with buprenorphine.

People with liver problems

If you have liver problems or a history of liver disease, you may not be able to clear this drug from your body well. This may increase the levels of this drug in your body and cause more side effects. If you have severe liver problems, your doctor may switch you to a different pain medication.

People with trouble breathing or other lung problems

This drug can make it harder to breathe. If you have a lung problem, you may already have trouble breathing. Ask your doctor if this drug is safe for you to take.

People with bowel blockage

If you have a bowel blockage or narrowing of your stomach or intestines, you shouldn’t use this drug. It may make your condition worse.

People with heart problems

If you have the heart rhythm problem called QT prolongation, ask your doctor if this drug is safe for you. This medication may cause QT prolongation. Your risk may be higher if you have a history of long QT syndrome or if you take medication for irregular heart rate or rhythm.

People with a history of head injury

If you have a history of a head injury or increased pressure in your skull, this drug may increase the pressure in your skull more. Ask your doctor whether this medication is safe for you.

People with a low body weight

You may be more sensitive to the effects of this drug. These can include trouble breathing, which can be life-threatening.

Pregnant women

Buprenorphine is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Talk to your doctor if you’re pregnant or plan to become pregnant. This drug should only be used if the potential benefit justifies the potential risk to the fetus.

Buprenorphine use during pregnancy can cause neonatal opioid withdrawal syndrome in your newborn. Symptoms can include irritability, a high-pitched cry, vomiting, diarrhea, and failure to gain weight.

Women who are breast-feeding

Buprenorphine may pass into breast milk and cause side effects in a child who is breastfed. These side effects can include drowsiness and trouble breathing.

Talk to your doctor about breastfeeding your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors

The kidneys, liver, and heart of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

If you’re older than 65 years, you may be more sensitive to side effects, such as trouble breathing. This can be fatal (cause death).

For children

This drug hasn’t been studied in children. It shouldn’t be used in people younger than 18 years of age.

Contact with drug

If other people touch the sticky side of the patch, they may absorb some of the drug. This can cause side effects, especially in children. When you’re done wearing a patch, fold the sticky sides together before throwing it away.

Allergies

Buprenorphine can cause a severe allergic reaction. Symptoms can include:

• rash
• hives
• swelling of your face
• wheezing
• extremely low blood pressure
• loss of consciousness

Call 9-1-1 or go to the nearest emergency room if you develop these symptoms.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death.