Brand Names: Probuphine
Generic Name: buprenorphine (implant)
- What is buprenorphine (Probuphine)?
- What are the possible side effects of buprenorphine (Probuphine)?
- What is the most important information I should know about buprenorphine (Probuphine)?
- What should I discuss with my healthcare provider before using buprenorphine (Probuphine)?
- How is buprenorphine implant given (Probuphine)?
- What happens if I miss a dose (Probuphine)?
- What happens if I overdose (Probuphine)?
- What should I avoid while using buprenorphine (Probuphine)?
- What other drugs will affect buprenorphine (Probuphine)?
- Where can I get more information (Probuphine)?
What is buprenorphine (Probuphine)?
Buprenorphine implant (placed under the skin) is used to treat opioid addiction in certain people whose addiction has already been controlled with other forms of buprenorphine. The implant is for adults and teenagers who are at least 16 years old.
Buprenorphine implants are available only from a certified pharmacy under a special program. Buprenorphine implants are not for use as a pain medication.
Buprenorphine implants may also be used for purposes not listed in this medication guide.
What are the possible side effects of buprenorphine (Probuphine)?
Inserting or removing the implants can cause serious or life-threatening complications, including damage to nerves or blood vessels. Ask your doctor about these risks.
Call your doctor at once if you have:
- opioid withdrawal symptoms--shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, vomiting;
- confusion, agitation, or other changes in your mental status;
- extreme drowsiness, trouble concentrating;
- a light-headed feeling, like you might pass out;
- weak or shallow breathing, breathing that stops during sleep;
- blurred vision, slurred speech, problems with walking, reflexes, or coordination; or
- low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common side effects may include:
- pain, itching, redness, swelling, bruising, or bleeding where the implants were inserted;
- headache, depressed mood;
- nausea, vomiting, constipation;
- back pain;
- tooth pain; or
- sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about buprenorphine (Probuphine)?
Inserting and removing buprenorphine implants can cause serious or life-threatening complications.
Talk with your doctor about the risks and benefits of using this medicine. Read all patient information, medication guides, and instruction sheets provided to you.
What should I discuss with my healthcare provider before using buprenorphine (Probuphine)?
You should not use the implants if you are allergic to buprenorphine.
Tell your doctor if you have ever had:
- breathing problems, sleep apnea;
- liver disease;
- problems with your gallbladder or thyroid;
- an enlarged prostate, urination problems;
- Addison's disease (an adrenal gland disorder);
- abnormal curvature of the spine that affects breathing;
- a head injury, brain tumor, or spinal cord problems;
- mental illness or psychosis;
- alcoholism; or
- skin problems such as unusual scars or growths.
If you use buprenorphine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on buprenorphine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.
Buprenorphine can pass into breast milk and may cause drowsiness or breathing problems in a nursing baby. Ask your doctor about any risks.
Buprenorphine implants not approved for use by anyone younger than 16 years old.
How is buprenorphine implant given (Probuphine)?
A buprenorphine implant is a 1-inch rod that is inserted through a needle (under local anesthesia) into the skin of your inside upper arm. You will receive a total of 4 implants.
After the implants are inserted, your arm will be covered with 2 bandages. Remove the top bandage after 24 hours, but leave the smaller bandage on for 3 to 5 days. Keep the area clean and dry. Apply an ice pack to the area every 2 hours during the first day, leaving the ice pack on for 40 minutes at a time.
For at least 1 week, check the incision area for warmth, redness, swelling, or other signs of infection.
Call your doctor at once if you notice any of the following symptoms after the implants are inserted:
- an implant sticks out of your skin or comes out by itself;
- you have pain, itching, redness, swelling, bleeding or severe irritation;
- you have numbness or weakness in your arm; or
- you feel short of breath.
Tell your doctor if you cannot feel the implants under your skin. Your doctor may perform medical tests or refer you to a surgeon.
Buprenorphine implants can remain in place for up to 6 months and must be surgically removed. Do not attempt to remove the implants yourself.
If an implant comes out of your arm, keep it in a place where others cannot get to it. As soon as possible, return the implant to your doctor. MISUSE OF A BUPRENORPHINE IMPLANT CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the implant improperly or without a prescription. Selling or giving away a buprenorphine implant is against the law.
Buprenorphine is only part of a complete treatment program that may also include counseling and other types of addiction support. Tell your doctor if the implants are not helping to improve your symptoms of addiction.
Any medical care provider who treats you should know that you are being treated for opioid addiction and using buprenorphine. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.
What happens if I miss a dose (Probuphine)?
Because this medicine is implanted under your skin, low-level doses of buprenorphine will be continuously delivered into your body for up to 6 months.
What happens if I overdose (Probuphine)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of buprenorphine can be fatal.
Overdose symptoms may include severe drowsiness, pinpoint pupils, weak or shallow breathing, or loss of consciousness.
What should I avoid while using buprenorphine (Probuphine)?
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Avoid using any opioid pain medicine without approval from your doctor. Opioid pain medicine will not work as well while you are using buprenorphine. Talk with your doctor about other options for pain relief.
What other drugs will affect buprenorphine (Probuphine)?
You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.
Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
- cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
- medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
- other narcotic medications--opioid pain medicine or prescription cough medicine;
- a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
- drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
- drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.
This list is not complete. Other drugs may affect buprenorphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Where can I get more information (Probuphine)?
Your pharmacist can provide more information about buprenorphine implants.
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