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|Buprenorphine/Naloxone

Buprenorphine/Naloxone

Buprenorphine/Naloxone is used for:

Treating opioid dependence. It should be used as part of a complete narcotic dependence treatment plan. It may also be used for other conditions as determined by your doctor.

Buprenorphine/Naloxone is an opioid (narcotic) partial agonist-antagonist. It works by binding to receptors in the brain and nervous system to help prevent withdrawal symptoms in someone who has stopped taking narcotics (eg, heroin, oxycodone).

Do NOT use Buprenorphine/Naloxone if:

• you are allergic to any ingredient in Buprenorphine/Naloxone
• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Buprenorphine/Naloxone :

Some medical conditions may interact with Buprenorphine/Naloxone . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of blood or electrolyte problems, breathing or lung problems (eg, chronic obstructive pulmonary disease), underactive thyroid, adrenal gland problems (eg, Addison disease), liver or kidney problems, an enlarged prostate gland, trouble urinating, a blockage of your bladder or urethra, gallbladder problems, or stomach problems
• if you have a history of recent head injury, growths in the brain (eg, tumor), increased pressure in the brain, or muscle problems (eg, myasthenia gravis)
• if you have a history of mental or mood problems or drug or alcohol abuse

Some MEDICINES MAY INTERACT with Buprenorphine/Naloxone . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, erythromycin) because they may increase the risk of Buprenorphine/Naloxone "s side effects
• Benzodiazepines (eg, diazepam), cimetidine, narcotic pain medicine (eg, codeine), phenothiazines (eg, chlorpromazine), or sodium oxybate (GHB) because the risk of severe drowsiness, severe breathing problems, and seizures may be increased
• Naltrexone or rifampin because they may decrease Buprenorphine/Naloxone "s effectiveness
• Methadone because its effectiveness may be decreased by Buprenorphine/Naloxone

This may not be a complete list of all interactions that may occur. Ask your health care provider if Buprenorphine/Naloxone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Buprenorphine/Naloxone :

Use Buprenorphine/Naloxone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not swallow, crush, or chew sublingual tablets. Place the tablet under your tongue and allow it to slowly dissolve. Do not eat, drink, or smoke while the tablet is dissolving.
• Take Buprenorphine/Naloxone on a regular schedule to get the most benefit from it.
• Taking Buprenorphine/Naloxone at the same time each day will help you remember to take it.
• If you miss a dose of Buprenorphine/Naloxone , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Buprenorphine/Naloxone .

Important safety information:

• Buprenorphine/Naloxone may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Buprenorphine/Naloxone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Buprenorphine/Naloxone ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do not inject Buprenorphine/Naloxone . Doing so may cause severe withdrawal symptoms, severe breathing problems, and death.
• Buprenorphine/Naloxone may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Tell your doctor or dentist that you take Buprenorphine/Naloxone before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including liver function tests, may be performed while you use Buprenorphine/Naloxone . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Buprenorphine/Naloxone with caution in the ELDERLY; they may be more sensitive to its effects, especially decreased breathing and drowsiness.
• Buprenorphine/Naloxone should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Buprenorphine/Naloxone may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Buprenorphine/Naloxone while you are pregnant. Buprenorphine/Naloxone is found in breast milk. Do not breast-feed while taking Buprenorphine/Naloxone .

Some people who use Buprenorphine/Naloxone for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking Buprenorphine/Naloxone suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Buprenorphine/Naloxone :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Chills; constipation; diarrhea; dizziness; drowsiness; flushing; headache; nausea; sleeplessness; stomach pain; sweating; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety or nervousness; dark urine; mental or mood changes (eg, depression); pale stools; severe or persistent stomach pain; slow or shallow breathing; yellowing of eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include excessive drowsiness; severe dizziness; very slow and shallow breathing; very small pupils.

Store Buprenorphine/Naloxone at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Buprenorphine/Naloxone out of the reach of children and away from pets.

General information:

• If you have any questions about Buprenorphine/Naloxone , please talk with your doctor, pharmacist, or other health care provider.
• Buprenorphine/Naloxone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Buprenorphine/Naloxone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.