Buprenorphine/naloxone (By mouth)

Introduction

Buprenorphine Hydrochloride (bue-pre-NOR-feen hye-droe-KLOR-ide), Naloxone Hydrochloride (nal-OX-one hye-droe-KLOR-ide)

Treats an addiction or dependence to narcotic medicine.

Brand Name(s)

Suboxone

When This Medicine Should Not Be Used

How to Use This Medicine

Thin Sheet, Tablet

• Using this medicine wrong can cause trouble breathing and other serious health problems, including death. If you do not understand the directions or warnings, ask your doctor.
• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Do not crush or swallow the sublingual tablet. Place the tablet under the tongue until it is dissolved. If you take 2 or more tablets at a time, place all of the tablets under the tongue together. If this is uncomfortable, place 2 tablets at a time under the tongue and repeat the process until all tablets have been taken.
• If you are using the sublingual film: Place the film under the tongue until it is dissolved. If you need to take an additional film, place the new film on the opposite side from the first film. Do not chew, swallow, or move the film after placing it under the tongue.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed. To dispose any unneeded films: remove the film from its foil package and flush down the toilet. Do not flush the foil packages or cartons down the toilet.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using antibiotic medicine (such as erythromycin, Ery-tab®), medicine to treat fungal infection (such as ketoconazole, itraconazole, Nizoral®, or Sporanox®), or medicine to treat HIV/AIDS (such as indinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, or Norvir®).
• Tell your doctor if you are also using atazanavir (Kaletra®, Reyataz®), carbamazepine (Tegretol®), delavirdine (Rescriptor®), efavirenz (Sustiva®), phenobarbital (Luminal®), phenytoin (Dilantin®), rifampicin (Rifadin®, Rimactane®), or medicine for nerves or sleeping (such as alprazolam, diazepam, Valium®, or Xanax®).
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine. Do not breast feed while you are using this medicine.
• Make sure your doctor knows if you or anyone in your family has ever abused drugs or alcohol or had a drug addiction. Tell your doctor if you have kidney disease, liver disease (including hepatitis B or C), adrenal problems, enlarged prostate, gallbladder problems, low blood pressure, heart disease, mental illness, or thyroid problems.
• Tell your doctor knows if you have any kind of breathing problem, such as chronic obstructive pulmonary disease (COPD), cor pulmonale, hypoxia or hypercapnia (low oxygen or high carbon dioxide level in your blood), or hypoventilation (breathing too slowly). Tell your doctor if you have a recent head injury, brain tumor, or other problem that could increase the pressure in your head.
• Using too much of this medicine can cause death. Symptoms of getting too much medicine include: trouble breathing, slow or shallow breathing, extreme dizziness or weakness, slow heartbeat, fainting, pinpoint pupils, seizures, cold, clammy skin, or extreme sleepiness.
• This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• It is against the law and dangerous for anyone else to use your medicine. Keep your unused films in a safe and secure place. People who are addicted to drugs might want to steal this medicine.
• Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious unwanted effects can occur if certain medicines are given together with buprenorphine and naloxone combination.
• This medicine may make you dizzy or drowsy. Avoid driving, using machine, or doing anything else that could be dangerous if you are not alert. You may also feel lightheaded when standing up suddenly from a sitting or lying position, so get up slowly.
• This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools.
• Fever, chills, cough, sore throat, or body aches.
• Lightheadedness, dizziness, or fainting.
• Nausea, vomiting, loss of appetite, or pain in your stomach.
• Severe headache.
• Tremors or seizures.
• Trouble breathing, slow or shallow breathing, sighing, or extreme weakness or sleepiness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Headache, anxiety, or trouble sleeping.
• Mild stomach pain or constipation.
• Pain, tired feeling.
• Sweating.
• Warmth or redness in your face, chest, or arms.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088