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How should this medicine be used?

Buprenorphine and the combination of buprenorphine and naloxone come as sublingual tablets to taken under the tongue. They are usually taken once a day. To help you remember to take buprenorphine or buprenorphine and naloxone, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take buprenorphine or buprenorphine and naloxone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

You will start your treatment with buprenorphine, which you will take in the doctor's office. Your doctor will start you on a low dose of buprenorphine and will increase your dose for several days before switching you to buprenorphine and naloxone. Your doctor may increase or decrease your buprenorphine and naloxone dose until the medication works properly.

Place the tablets under your tongue until they melt. This should take 2 to 10 minutes. If you are taking more than two tablets, either place them all under your tongue at the same time or place them under your tongue 2 at a time. Do not chew the tablets or swallow them whole.

Do not stop taking buprenorphine and naloxone without talking to your doctor. Stopping buprenorphine and naloxone too quickly can cause withdrawal symptoms. Your doctor will tell you when and how to stop taking buprenorphine and naloxone.

Other uses for this medicine

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking buprenorphine or buprenorphine and naloxone,

• tell your doctor and pharmacist if you are allergic to buprenorphine, naloxone, or any other medications.
• do not take antidepressants ('mood elevators'), narcotic pain killers, sedatives, sleeping pills, or tranquilizers while taking buprenorphine or buprenorphine and naloxone.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: acetaminophen (Tylenol, others); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); carbamazepine (Tegretol); cholesterol-lowering medications (statins); cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); dexamethasone (Decadron); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); ethosuximide (Zarontin);fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir); iron products; isoniazid (INH, Nydrazid); medications for anxiety, mental illness, and seizures; methotrexate (Rheumatrex); metronidazole (Flagyl);nefazodone (Serzone); niacin (nicotinic acid); oral contraceptives (birth control pills); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); troglitazone (Rezulin); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you drink large amounts of alcohol and if you have or have ever had adrenal problems such as Addison's disease; benign prostatic hypertrophy (BPH, enlargement of the prostate gland); difficulty urinating; head injury; hallucinations (seeing things or hearing voices that do not exist); a curve in the spine that makes it hard to breathe; gallbladder disease; stomach conditions; and thyroid, kidney, liver, or lung disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking buprenorphine or buprenorphine and naloxone, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking buprenorphine or buprenorphine and naloxone.
• you should know that buprenorphine or buprenorphine and naloxone may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the breathing difficulties that can be caused by this medication.
• you should know that buprenorphine or buprenorphine and naloxone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking buprenorphine or buprenorphine and naloxone. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What special dietary instructions should I follow?

Talk to your doctor about drinking grapefruit juice while taking this medicine.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

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

• headache
• stomach pain
• constipation
• vomiting
• difficulty falling asleep or staying asleep
• sweating

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• hives
• skin rash
• itching
• difficulty breathing or swallowing
• slowed breathing
• upset stomach
• extreme tiredness
• unusual bleeding or bruising
• lack of energy
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• flu-like symptoms

Buprenorphine or buprenorphine and naloxone may cause other side effects. Call your doctor if you have any unusual problems while taking 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 [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Buprenorphine or buprenorphine and naloxone can be a target for people who abuse prescription medications or street drugs. Keep your medication in a safe place to protect from theft. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

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:

• pinpoint pupils
• extreme drowsiness
• dizziness
• blurred vision
• slowed breathing

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to buprenorphine and naloxone.

In case of an emergency, you or a family member should tell the treating doctor or emergency room staff that you are taking buprenorphine or buprenorphine and naloxone.

Do not inject buprenorphine or buprenorphine and naloxone sublingual tablets. Severe reactions may happen, including withdrawal symptoms.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand Names

• Subutex®

Brand Names of Combination Products

• Suboxone® (containing Buprenorphine and Naloxone)