Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

BUPRENORPHINE - SUBLINGUAL

(byoo-pre-NOR-feen)

COMMON BRAND NAME(S): Subutex

Uses

This medication is used to treat narcotic (opioid) dependence. It works by preventing withdrawal symptoms, since it is actually a type of narcotic (opioid) itself. It should be used as part of a complete narcotic dependence treatment plan.

How To Use

Place this medication under your tongue and let it dissolve completely, usually once daily for two days, or as directed. Then your doctor usually will switch you to the buprenorphine/naloxone medication, which works the same way as this medication. This medicine comes with a patient information leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Do not swallow this medication, as it will not be as effective if it is swallowed. If you are prescribed more than one tablet each day, you may place all of the tablets under your tongue at once. If this is not possible, then you may place two tablets at a time under your tongue, until they all have dissolved. Use this medication exactly as prescribed. Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed. Also, if used for an extended period of time, do not suddenly stop using this drug without your doctor's approval, or withdrawal symptoms may occur. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not inject ("shoot up") buprenorphine. Injecting it is dangerous and you may have severe withdrawal symptoms (see Side Effects section). Consult your doctor or pharmacist for more details. Buprenorphine can cause withdrawal symptoms if you use it soon after using narcotics such as heroin, morphine, or methadone. Follow your doctor's instructions for your treatment plan.

Side Effects

Drowsiness, dizziness, weakness, constipation, headache, nausea, or vomiting may occur. If any of these effects persist or worsen, notify your doctor or pharmacist immediately. Tell your doctor immediately if any of these unlikely but serious side effects occur: slow, shallow breathing, mental/mood changes (e.g., depression), stomach/abdominal pain. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: dark urine, yellowing eyes and skin, vision changes. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. Narcotic withdrawal symptoms include diarrhea, severe mental/mood changes (such as anxiety, irritability, trouble sleeping), muscle stiffness or shakiness. If such symptoms occur, notify your doctor or pharmacist immediately. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease, liver disease, serious head injury or brain diseases (lesions), low thyroid problems (hypothyroidism), adrenal problems (Addison's disease), psychiatric problems (toxic psychosis), difficulty urinating (enlarged prostate or urethral narrowing), acute alcoholism (with or without delirium tremens), spinal problems (kyphoscoliosis), gallbladder (biliary tract) disease and other abdominal conditions, any allergies. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the possible decreased breathing and drowsiness effects. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Due to the potential risk to the infant, breast-feeding while using this drug is not recommended.

Drug Interactions

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: MAO inhibitors (e.g., furazolidone, linezolid, moclobemide, phenelzine procarbazine, selegiline, isocarboxazid, tranylcypromine), drugs which decrease liver metabolism (inhibitors of cytochrome 3A4 enzymes such as itraconazole, ketoconazole, erythromycin, clarithromycin, ritonavir, indinavir, saquinavir), local anesthetics (e.g., bupivacaine), sedative drugs (benzodiazepines such as diazepam, lorazepam). Deaths have occurred when buprenorphine has been misused by injecting it ("shooting up"), especially when used in combination with benzodiazepines (e.g., diazepam) or other depressants such as alcohol or additional narcotics. Also report the use of other drugs that cause drowsiness such as: medicine for sleep (e.g., sedatives), tranquilizers, anti-anxiety drugs (e.g., temazepam), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), anti-seizure drugs (e.g., carbamazepine), muscle relaxants, antihistamines that cause drowsiness (e.g., diphenhydramine). Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: excessive drowsiness, severe dizziness, very slow, shallow breathing.

Notes

Do not share this medication with others. Tell all of your doctors that you use this medication and have regularly used narcotics, especially in cases of emergency treatment. Laboratory and/or medical tests (e.g., liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature - 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).