BUPRENORPHINE (ORAL)

(byoo pre NOR feen) Brand: Subutex

What is the most significant information I must know about buprenorphine?

• Using buprenorphine improperly will magnify your risk of serious side effects or death. Even if you have used another narcotic medications, you may still have serious side effects from buprenorphine. Follow all dosing instructions carefully.

• Like another narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.

• Never crush a tablet or another pill to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of buprenorphine and similar prescription drugs.

• Avoid drinking alcohol, which can magnify some of the side effects of buprenorphine. Using too many of this medication in addition to drinking alcohol can reason death.

• Do not stop using buprenorphine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using buprenorphine. You may need to use smaller and smaller till you stop the medicine completely.

• This medicine may impair your thinking or reactions. Avoid driving or operating machinery before you know how buprenorphine will affect you.

What is buprenorphine?

• Buprenorphine is an opioid pain medicine. An opioid is sometimes called a narcotic.

• Buprenorphine is used to treat narcotic addiction.

• Buprenorphine may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking buprenorphine?

• Do not use this medicine if you are allergic to buprenorphine or naloxone (Narcan), or if you have used other narcotic drug within the past 4 hours.

• To create certain you can safely take buprenorphine, speak your doctor if you have any of these another conditions:

· asthma, COPD, sleep apnea, or another breathing disorders;

· liver malady (especially hepatitis B or C);

· kidney disease;

· a thyroid disorder;

· stomach problems;

· enlarged prostate, urination problems;

· gallbladder disease;

· curvature of the spine;

· Addison's malady (an adrenal gland disorder);

· a history of mental diseases, personality mess, or psychotic episode;

· a history of drug or alcohol addiction; or

· a history of seizures, head injury, or brain tumor.

• Buprenorphine may be habit forming and must be used only by the face it was predesigned for. Never share buprenorphine with other face, especially somebody with a history of drug abuse or addiction. Buprenorphine can reason withdrawal effects in a face who is addicted to narcotics. Hold the medicine in a seat where others can't get to it.

• FDA pregnancy category C. It is not known whether buprenorphine will harm an unborn child. Buprenorphine may reason addiction or withdrawal symptoms in a newborn if the mother takes the medicine during pregnancy. Speak your doctor if you are pregnant or plan to become pregnant while using buprenorphine.

• Buprenorphine can pass into breast milk and may harm a nursing child. You must not breast-feed while you are using buprenorphine.

• Do not give this medicine to a child.

How must I take buprenorphine?

• Never take buprenorphine in larger amounts, or for longer than recommended by your doctor. Using buprenorphine improperly will magnify your risk of serious side effects or death. Even if you have used another narcotic medications, you may still have serious side effects from buprenorphine. Follow all dosing instructions carefully. Speak your doctor if the medication seems to stop working as well in relieving your pain.

• The buprenorphine sublingual tablet must be placed under the tongue and allowed to dissolve. Do not chew the tablet or swallow it intact. If your doctor has predesigned more than 2 tablets for doze, seat the correct number of tablets under your tongue at the same time and let them to dissolve completely.

• Wear a medical alert tag or carry an ID card stating that you take buprenorphine, in case of abnormal. Any doctor, dentist, or abnormal medical care provider who treats you must know that you are being treated for narcotic addiction. Create certain your family members know you are using buprenorphine in case they need to say for you during an emergency.

• To be certain this medicine is not causing deleterious effects, your liver function will need to be checked with frequent blood trials. Visit your doctor regularly.

• If you need to have any type of surgery, speak the surgeon onward of time that you are using buprenorphine. You may need to stop using the medication for a short time.

• Store at room temperature away from moisture and heat.

• Hold track of the amount of medication used from every new bottle. Buprenorphine is a drug of abuse and you must be aware if anyone is using your medication improperly or without a prescription.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222. An overdose of buprenorphine can be fatal.

• Overdose symptoms may include extreme drowsiness or weakness, cool or clammy skin, pinpoint pupils, fainting, slow heart course, weak pulse, weak or shallow slowed breathing (breathing may stop).

What must I avoid while taking buprenorphine?

• Avoid drinking alcohol, which can magnify some of the side effects of buprenorphine. Using too many of this medication in addition to drinking alcohol can reason death.

• This medicine may impair your thinking or reactions. Avoid driving or operating machinery before you know how buprenorphine will affect you.

What are the possible side effects of buprenorphine?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Like another narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.

• Call your doctor at once if you have a serious side effect such as:

· slow or shallow breathing;

· feeling light-headed, fainting;

· confusion, unusual thoughts or behavior; or

· nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

• Smaller serious side effects may be more likely to occur, such as:

· headache;

· stomach pain, nausea, vomiting, constipation;

· warmth or tingly feeling;

· chills, heighten sweating;

· weakness;

· back pain;

· anxiety, depression;

· sleep problems (insomnia); or

· runny nose.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect buprenorphine?

• Do not take buprenorphine with any another narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or another medicines that can create you sleepy or slow your breathing. Dangerous side effects may result.

• Speak your doctor about all another medicines you use, especially:

· conivaptan (Vaprisol);

· imatinib (Gleevec);

· isoniazid (for treating tuberculosis);

· nefazodone;

· an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifampin (Rifadin, Rifater, Rifamate, Rimactane), or telithromycin (Ketek);

· antifungal medicine such as itraconazole (Sporanox), ketoconazole (Nizoral), or miconazole (Oravig);

· heart or blood pressure medicine such as nicardipine (Cardene) or quinidine (Quin-G);

· HIV/AIDS medication such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or

· a sedative such as diazepam (Valium), midazolam (Versed), alprazolam (Xanax) lorazepam (Ativan), clorazepate (Tranxene), triazolam (Halcion), flurazepam (Dalmane), or temazepam (Restoril).

• This list is not complete and another drugs may interact with buprenorphine. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist has information about buprenorphine written for health professionals that you may read.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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