Drug Information For: SUBOXONE 8MG/2MG SUBLINGUAL TABLETS
Ingredient Name: BUPRENORPHINE (byoo-pre-NOR-feen) and NALOXONE (na-LOX-one)
Drug Manufacturer: RECKITT BENCKISER
Common Uses: This medicine is an opioid (narcotic) partial agonist-antagonist used to treat 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.
Before Using This Medicine: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are taking sodium oxybate (GHB). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking azole antifungals (eg, ketoconazole, voriconazole), benzodiazepines (eg, diazepam), carbamazepine, delavirdine, efavirenz, etravirine, HIV protease inhibitors (eg, atazanavir, ritonavir), macrolide antibiotics (eg, erythromycin), methadone, naltrexone, narcotic pain medicine (eg, codeine), nevirapine, perampanel, phenobarbital, phenothiazines (eg, chlorpromazine), phenytoin, or rifamycins (eg, rifampin). Tell your doctor if you are taking medicines that may harm the liver (eg, acetaminophen, methotrexate, isoniazid, certain medicines for HIV infection). Ask your doctor if you are unsure if any of your medicines might harm the liver. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of blood or electrolyte problems; breathing or lung problems (eg, asthma, chronic obstructive pulmonary disease / COPD); a curvature of the spine (eg, scoliosis); certain heart problems (eg, cor pulmonale); thyroid problems; adrenal gland problems (eg, Addison disease); liver problems (eg, hepatitis B or C); abnormal liver enzyme tests; kidney problems; an enlarged prostate gland; trouble urinating; a blockage of your bladder or urethra; seizures; gallbladder problems; low blood oxygen levels; high blood carbon dioxide levels; stomach or bowel problems (eg, inflammatory bowel disease), blockage, or surgery; recent head injury, growths in the brain (eg, tumor, lesion), or increased pressure in the brain; mental or mood problems (eg, hallucinations); suicidal thoughts or behaviors; drug or alcohol abuse; allergies; pregnancy; or breast-feeding. Tell your doctor if you have slow or shallow breathing, severe drowsiness, stomach problems, poor health, or if you are in alcohol withdrawal. Tell your doctor if you have never taken buprenorphine or an opioid (narcotic) pain medicine before. Use of this medicine in CHILDREN is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. DO NOT SWALLOW, CRUSH, OR CHEW THE TABLET. Place the tablet under your tongue and allow it to slowly dissolve. Do not eat, drink, smoke, or talk while the tablet is dissolving. IF YOUR DOCTOR TELLS YOU TO USE MORE THAN ONE TABLET at the same time, ask your doctor for instructions on the right way to take this medicine. THIS MEDICINE SHOULD ONLY BE TAKEN BY MOUTH. Life-threatening and sometimes fatal side effects may occur if this medicine is administered by injection. DO NOT SUDDENLY STOP TAKING THIS MEDICINE without checking with your doctor. You may experience withdrawal symptoms, such as pain, cramps, vomiting, diarrhea, anxiety, sleeping problems, and cravings. If you need to stop this medicine, your doctor may need to gradually lower your dose. STORE THIS MEDICINE at 77 degrees F (25 degrees C), away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. TAKE THIS MEDICINE ON A REGULAR SCHEDULE to get the most benefit from it. Taking this medicine at the same time each day will help you remember to take it. IF YOU MISS A DOSE OF THIS MEDICINE, 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 unless your doctor tells you to. If you are not sure what to do if you miss a dose, check with your doctor.
Cautions: DO NOT USE THIS MEDICINE if you have had an allergic reaction to it or if you are allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. DO NOT CHANGE YOUR DOSE, use more often than prescribed, or suddenly stop taking this medicine without checking with your doctor. LABORATORY AND/OR MEDICAL TESTS, including liver function, may be performed to monitor your progress or to check for side effects. Keep all doctor and laboratory appointments while you are taking this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, emergency care, or surgery, tell the doctor or dentist that you are taking this medicine. THIS MEDICINE MAY CAUSE DIZZINESS OR DROWSINESS. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. DO NOT DRINK ALCOHOL while you are using this medicine. CHECK WITH YOUR DOCTOR before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using this medicine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. THIS MEDICINE 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. DO NOT SWITCH to another doseform of this medicine without talking to your doctor. DO NOT INJECT THIS MEDICINE. Doing so may cause severe withdrawal symptoms, severe breathing problems, and death. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of this medicine, especially breathing problems and drowsiness. CHILDREN MAY BE AT GREATER RISK of severe and possibly fatal breathing problems. If a child takes this medicine, seek medical attention immediately. FOR WOMEN: IF YOU THINK YOU MAY BE PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. Use of this medicine during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine.
Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include constipation, dizziness, drowsiness, headache, lightheadedness, mild stomach pain, nausea, sweating, trouble sleeping, vomiting, or weakness. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience anxiety or nervousness; blurred vision; confusion; decreased attention; fainting; feeling of intoxication (feeling drunk); fever, chills, or persistent sore throat; irregular heartbeat; loss of coordination; mental or mood changes (eg, depression); persistent trouble sleeping; severe or persistent dizziness, drowsiness, or lightheadedness; severe or persistent stomach pain or constipation; slow, shallow, or difficult breathing; slowed reflexes; slurred speech; swelling of the hands, ankles, or feet; or symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, unusual nausea, yellowing of the eyes or skin). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; or wheezing. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose: IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms may include fainting; severe dizziness or drowsiness; slow, shallow, or difficult breathing; or very small pupils.
Additional Information: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. Tell your doctors that you use this medicine and have regularly used narcotics, especially in cases of emergency treatment. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2012 Wolters Kluwer Health, Inc.
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