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buprenorphine (oral)

buprenorphine (oral)

Pronunciation: byoo pre NOR feen

Brand: Subutex

Buprenorphine 8 mg-TEV

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Buprenorphine 2 mg-TEV

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Subutex 8 mg

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

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Buprenorphine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Buprenorphine may be habit-forming, even at regular doses. Never share this medicine 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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MISUSE OF NARCOTIC MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

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Tell your doctor if you are pregnant. Buprenorphine may cause life-threatening addiction and withdrawal symptoms in a newborn.

What is buprenorphine?

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

Buprenorphine is used to treat narcotic addiction. Buprenorphine is not for use as a pain medication.

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

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

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You should not use this medication if you are allergic to buprenorphine, or if you have used another narcotic drug within the past 4 hours.

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

  • any type of breathing problem or lung disease;
  • curvature of the spine that affects breathing;
  • liver disease (especially hepatitis B or C);
  • enlarged prostate, urination problems;
  • problems with your gallbladder, adrenal gland, or thyroid;
  • a history of head injury, brain tumor, or seizures; or
  • a history of drug abuse, alcohol addiction, or mental illness.
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FDA pregnancy category C. It is not known whether buprenorphine will harm an unborn baby. Buprenorphine may cause breathing problems, behavior changes, or life-threatening addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy. Tell your doctor if you are pregnant.

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

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Do not give this medication to a child.

How should I take buprenorphine?

Follow all directions on your prescription label. Buprenorphine can slow or stop your breathing. Never use buprenorphine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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Buprenorphine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away buprenorphine is against the law.

The buprenorphine sublingual tablet should be placed under the tongue and allowed to dissolve. Do not chew the tablet or swallow it whole. If your doctor has prescribed more than 2 tablets per dose, place the correct number of tablets under your tongue at the same time and allow them to dissolve completely.

While using buprenorphine, you may need frequent blood tests to check your liver function.

If you need surgery, tell the surgeon ahead of time that you are using buprenorphine. You may need to stop using the medicine for a short time.

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Wear a medical alert tag or carry an ID card stating that you take buprenorphine. 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.

Do not stop using buprenorphine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using buprenorphine.

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Never crush or break a buprenorphine pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of buprenorphine and similar prescription drugs.

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Store at room temperature away from moisture and heat.

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. A buprenorphine overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, pinpoint pupils, fainting, slow heart rate, weak pulse, weak or shallow slowed breathing (breathing may stop).

What should I avoid while taking buprenorphine?

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

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This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how buprenorphine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

What are the possible side effects of buprenorphine?

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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 if you have:

  • weak or shallow breathing;
  • a light-headed feeling, like you might pass out;
  • confusion, unusual thoughts or behavior; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may be more likely to occur, such as:

  • constipation, nausea, vomiting;
  • headache;
  • increased sweating;
  • sleep problems (insomnia); or
  • pain anywhere in your body.

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?

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

Other drugs may interact with buprenorphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist has information about buprenorphine written for health professionals that you may read.


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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