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|Subutex

Subutex

Subutex 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.

Subutex 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 Subutex if:

• you are allergic to any ingredient in Subutex
• you are taking sodium oxybate (GHB)

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

Before using Subutex :

Some medical conditions may interact with Subutex . 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), or 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 Subutex . 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 the side effects of Subutex may be increased
• 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 the effectiveness of Subutex may be decreased
• Methadone because effectiveness may be decreased by Subutex

This may not be a complete list of all interactions that may occur. Ask your health care provider if Subutex 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 Subutex :

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

• Do not swallow, crush, or chew Subutex . Place Subutex under your tongue and allow it to dissolve.
• Do not eat, drink, or smoke while the sublingual tablet is dissolving.
• Use Subutex regularly to receive the most benefit from it. Taking Subutex at the same time each day will help you remember to take it.
• If you miss a dose of Subutex , 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 Subutex .

Important safety information:

• Subutex may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Subutex . Using Subutex alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Subutex . Subutex will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Do not inject Subutex . Doing so may cause severe withdrawal symptoms, severe breathing problems, and death.
• Subutex may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Subutex .
• LAB TESTS, including liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Subutex with caution in the ELDERLY because they may be more sensitive to its effects, especially decreased breathing and drowsiness.
• Subutex is not recommended for use in CHILDREN younger than 16 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Subutex may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Subutex during pregnancy. Subutex is excreted in breast milk. Do not breast-feed while taking Subutex .

When used for long periods of time or at high doses, some people develop a need to continue taking Subutex . This is known as DEPENDENCE or addiction.

If you suddenly stop taking Subutex , you may experience WITHDRAWAL symptoms, including 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 Subutex :

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; slow or shallow breathing; severe or persistent stomach pain; 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 Subutex 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 Subutex out of the reach of children and away from pets.

General information:

• If you have any questions about Subutex , please talk with your doctor, pharmacist, or other health care provider.
• Subutex 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 Subutex . 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.