Buprenorphine intradermal implant

What is this medicine?

BUPRENORPHINE (byoo pre NOR feen) is used to treat certain types of drug dependence.

How should I use this medicine?

The implants will be inserted under the skin in your upper arm by a specially trained physician in a hospital or clinic setting. Follow your doctor's instructions for care of the area where the implants were inserted. Apply an ice pack to your arm for 40 minutes every 2 hours for the first 24 hours after insertion of the implants and as needed. Removal of the implants will also be done in a hospital or clinic setting by a specially trained physician. Do not try to remove the implants yourself. This could lead to infection or you could experience withdrawal symptoms. Your doctor will decide how long the implants will stay in your arm.

Your healthcare provider will give you a Patient Identification Card to carry with you. Keep track of the date the implants are to be removed. Schedule an appointment with your healthcare provider to remove the implants on or before the removal date.

A special MedGuide will be given to you by your healthcare provider each time this medicine is inserted into your arm. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 16 years for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bleeding or symptoms of infection at the implant site, such as excess or worsening itching, pain, irritation, redness, or swelling

• breathing problems

• confusion

• numbness or weakness in your arm after the implant is inserted or removed

• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellow of the eyes or skin

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• trouble passing urine or change in the amount of urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• dry mouth

• nausea, vomiting

• tiredness

What may interact with this medicine?

Do not take this medication with any of the following medicines:

• cisapride

• certain medicines for fungal infections like ketoconazole and itraconazole

• dronedarone

• pimozide

• thioridazine

This medicine may interact with the following medications:

• alcohol

• antihistamines for allergy, cough and cold

• antiviral medicines for HIV or AIDS

• atropine

• certain antibiotics like clarithromycin, erythromycin, linezold, rifampin

• certain medicines for anxiety or sleep

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for depression like amitriptyline, fluoxetine, sertraline

• certain medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

• certain medicines for nausea or vomiting like dolasetron, ondansetron, palonosetron

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

• certain medicines for seizures like phenobarbital, primidone

• certain medicines for stomach problems like cimetidine, dicyclomine, hyoscyamine

• certain medicines for travel sickness like scopolamine

• diuretics

• dofetilide

• general anesthetics like halothane, isoflurane, methoxyflurane, propofol

• ipratropium

• local anesthetics like lidocaine, pramoxine, tetracaine

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• medicines that relax muscles for surgery

• methylene blue

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• other narcotic medicines for pain or cough

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine

• ritonavir

• ziprasidone

What if I miss a dose?

This does not apply.

Where should I keep my medicine?

This medicine is inserted in a hospital or clinic and will not be stored at home.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• Addison's disease

• adrenal gland problem

• brain tumor

• head injury

• heart disease

• history of alcoholism

• history of keloid formation or connective tissue disease (such as scleroderma)

• history of skin infections, conditions, or sensitivities

• liver disease

• lung or breathing disease, like asthma

• mental illness

• problems urinating

• prostate disease

• thyroid disease

• an unusual or allergic reaction to buprenorphine, morphine, codeine, other medicines, antiseptics, anesthetics, ethylene vinyl acetate, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your health care provider regularly. Attend counseling or support groups that your health care provider recommends. Do not try to overcome the effects of the drug by taking large amounts of narcotics. This can cause severe problems including death. Also, you may be more sensitive to lower doses of narcotics after you stop taking this drug.

Do not suddenly stop taking your drug because you may develop a severe reaction. Your body becomes used to the drug. Your health care provider will tell you how much drug to take. If your health care provider wants you to stop the drug, the dose will be slowly lowered over time to avoid any side effects.

If you take other drugs that also cause drowsiness like other narcotic pain drugs, benzodiazepines, or other drugs for sleep, you may have more side effects. Give your health care provider a list of all drugs you use. He or she will tell you how much drug to take. Do not take more drug than directed. Get emergency help right away if you have trouble breathing or are unusually tired or sleepy.

Talk to your health care provider about naloxone and how to get it. Naloxone is an emergency drug used for an opioid overdose. An overdose can happen if you take too much opioid. It can also happen if an opioid is taken with some other drugs or substances, like alcohol. Know the symptoms of an overdose, like trouble breathing, unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where it is stored. Make sure they know how to use it. After naloxone is given, you must get emergency help right away. Naloxone is a temporary treatment. Repeat doses may be needed.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this drug. Avoid alcoholic drinks.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the drugs and doses you take on the card.

This drug will cause constipation. If you do not have a bowel movement for 3 days, call your health care provider.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your health care provider if the problem does not go away or is severe.

If an implant sticks out or comes out of your skin, wash your hands if you touch the implant. Cover the area where the implant was inserted with a clean bandage. Put the implant in a plastic bag and in a safe place out of reach of children and theft. Do not let others touch or use the implant. If a child puts an implant in his/her mouth, get emergency help right away. Return the implant to your healthcare provider as soon as possible. Never give your medicine to others, because it may cause serious harm, including death. Selling or giving away your medicine is against the law.