buprenorphine and naloxone

Pronunciation: byoo PREH nor feen and NAH lox own

Brand: Suboxone

Suboxone 8 mg-2 mg

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What is the most important information I should know about buprenorphine and naloxone?

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Using this medicine improperly will increase your risk of serious side effects or death. Even if you have used other narcotic medications, you may still have serious side effects from buprenorphine and naloxone. Follow all dosing instructions carefully.

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You should not use this medication if you are allergic to buprenorphine or naloxone (Narcan).

Never share buprenorphine and naloxone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

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Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with buprenorphine and naloxone. Check your food and medicine labels to be sure these products do not contain alcohol.

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You should not breast-feed while using this medicine.

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Do not give buprenorphine and naloxone to anyone under 18 years old without medical advice. The use of this medicine by a child can result in death. Seek emergency medical attention if a child has accidentally swallowed the medication.

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This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how buprenorphine and naloxone will affect you.

What is buprenorphine and naloxone?

Buprenorphine is an opioid medication. An opioid is sometimes called a narcotic.

Naloxone is an special narcotic drug that reverses the effects of other narcotic medicines.

Buprenorphine and naloxone is a combination medicine used to treat narcotic (opiate) addiction.

Buprenorphine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking buprenorphine and naloxone?

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You should not use this medication if you are allergic to buprenorphine or naloxone (Narcan).

To make sure buprenorphine and naloxone is safe for you, tell your doctor if you have:

  • asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
  • enlarged prostate, urination problems;
  • liver disease;
  • kidney disease;
  • curvature of the spine that affects breathing;
  • underactive thyroid;
  • gallbladder disease;
  • Addison's disease (an adrenal gland disorder);
  • a history of mental illness, hallucinations, or psychotic episode;
  • a history of drug or alcohol addiction; or
  • a history of seizures, head injury, or brain tumor.
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Buprenorphine may be habit forming. Never share buprenorphine and naloxone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

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FDA pregnancy category C. It is not known whether buprenorphine and naloxone will harm an unborn baby. Buprenorphine and naloxone may cause addiction or withdrawal symptoms in your newborn if you take the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

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Buprenorphine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

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Do not give buprenorphine and naloxone to anyone under 18 years old without medical advice. The use of this medicine by a child can result in death. Seek emergency medical attention if a child has accidentally swallowed the medication.

How should I take buprenorphine and naloxone?

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Using buprenorphine improperly will increase your risk of serious side effects or death. Even if you have used other narcotic medications, you may still have serious side effects from buprenorphine.

Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. Your doctor may occasionally change your dose to make sure you get the best results.

Before taking this medicine, drink a glass of water to moisten your mouth. Place the sublingual tablet or sublingual film under the tongue and allow it to dissolve. Do not chew the tablet or film, and do not swallow it whole.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

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Do not stop using buprenorphine and naloxone suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using buprenorphine and naloxone.

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Never crush a tablet or dissolve a film to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of buprenorphine and similar prescription drugs.

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Wear a medical alert tag or carry an ID card stating that you take buprenorphine and naloxone. Any medical care provider who treats you should know that you are being treated for narcotic addiction. Make sure your family members know you are using buprenorphine in case they need to speak for you during an emergency.

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Store at room temperature away from moisture and heat. Keep the sublingual film in the foil pouch until ready to use. After opening a pouch, you must use the medicine right away. Discard the empty pouch in a place children and pets cannot get to.

Keep track of the amount of medicine used from each new bottle. Buprenorphine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of buprenorphine can be fatal.

Overdose symptoms may include confusion, dizziness, pinpoint pupils, fainting, or slow breathing (breathing may stop).

What should I avoid while taking buprenorphine and naloxone?

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Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with buprenorphine and naloxone. Check your food and medicine labels to be sure these products do not contain alcohol.

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Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how buprenorphine and naloxone will affect you.

What are the possible side effects of buprenorphine and naloxone?

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.

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Call your doctor at once or seek emergency medical attention if you have:

  • extreme drowsiness;
  • loss of coordination, weakness or limp feeling;
  • blurred vision, slurred speech, thinking problems;
  • weak or shallow breathing;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pounding heartbeats or fluttering in your chest; or
  • withdrawal symptoms--diarrhea, vomiting, shaking or shivering, runny nose, watery eyes, muscle pain, and feeling very hot or cold.

Common side effects may include:

  • headache, mild dizziness;
  • numbness or tingling;
  • drowsiness, or sleep problems (insomnia);
  • stomach pain, vomiting, constipation;
  • redness, pain, or numbness in your mouth;
  • feeling drunk; or
  • trouble concentrating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect buprenorphine and naloxone?

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Taking buprenorphine and naloxone with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking buprenorphine and naloxone with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with buprenorphine and naloxone. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with buprenorphine and naloxone, especially:

  • St. John's wort;
  • an antibiotic--clarithromycin, erythromycin, nafcillin, rifabutin, rifapentine, rifampin, telithromycin;
  • antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;
  • heart or blood pressure medication--nicardipine or quinidine;
  • the hepatitis medications boceprevir or telaprevir;
  • HIV or AIDS medicine--atazanavir, delavirdine, efavirenz, indinavir, nevirapine, saquinavir;
  • a sedative--diazepam, alprazolam, lorazepam, temazepam, triazolam, Restoril, Valium, Xanax, and others; or
  • seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, or primidone.

This list is not complete. Other drugs may interact with buprenorphine and naloxone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide additional information about buprenorphine and naloxone.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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