buprenorphine and naloxone

Generic Name: buprenorphine and naloxone (BUE pre NOR feen and nal OX one)
Brand Name: Suboxone, Zubsolv

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 and naloxone is not for use as a pain medication.

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

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

This medicine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Buprenorphine and naloxone may also 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 medicine in a place where others cannot get to it.

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MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

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

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

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

  • any type of breathing problem or lung disease;

  • enlarged prostate, urination problems;

  • liver or kidney disease;

  • curvature of the spine that affects breathing;

  • problems with your gallbladder, adrenal gland, or thyroid;

  • a history of drug abuse, alcohol addiction, or mental illness; or

  • a history of head injury, brain tumor, or seizures.

This medicine is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

FDA pregnancy category C. It is not known whether buprenorphine and naloxone will harm an unborn baby. Buprenorphine and naloxone 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.

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

How should I take buprenorphine and naloxone?

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

This medicine 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 MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away buprenorphine and naloxone is against the law.

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.

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.

If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.

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

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.

Never crush or break a buprenorphine and naloxone 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 naloxone and similar prescription drugs.

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.

After you have stopped using this medicine, flush any unused pills or sublingual film down the toilet.

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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A buprenorphine and naloxone overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose symptoms may include blurred vision, severe drowsiness, slurred speech, loss of coordination, thinking problems, weakness or limp feeling, and weak or shallow breathing (breathing may stop).

What should I avoid while taking buprenorphine and naloxone?

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.

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

Buprenorphine and naloxone side effects

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.

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

  • extreme weakness or drowsiness;

  • a light-headed feeling, like you might pass out; or

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • withdrawal symptoms--diarrhea, vomiting, shaking or shivering, runny nose, watery eyes, muscle pain, and feeling very hot or cold.

Common side effects may include:

  • tongue pain, redness or numbness inside your mouth;

  • constipation, mild nausea, vomiting;

  • headache or other pain;

  • sleep problems (insomnia);

  • increased sweating; or

  • swelling in your arms or legs.

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.

See also: Side effects (in more detail)

Buprenorphine and naloxone dosing information

Usual Adult Dose for Opiate Dependence:

Buprenorphine-naloxone sublingual tablets or film should be used in patients who have been initially inducted using buprenorphine sublingual tablets.

Sublingual tablets (Suboxone[R]):
-Initial dose: 8 mg on day 1.
Maintenance dose: Rapidly titrate to the recommended target dose of 16 mg/day. In clinical trials, patients received 8 mg on day 1 and 16 mg on day 2 and thereafter. Further dose adjustments may be made in 2 mg to 4 mg increments up to a level that suppresses opioid withdrawal symptoms and holds the patient in treatment. The usual daily range is 4 mg to 24 mg.
-The tablets should be placed under the tongue at the same time and allowed to dissolve. If patients are taking more than 2 tablets per dose and cannot hold more than 2 under the tongue comfortably, they should use 2 tablets at a time, allowing them to dissolve completely before taking more tablets.
-For patients taking heroin or short-acting opioids, the first dose should be administered at least 4 hours after the patient last used opioids or preferably when early withdrawal symptoms appear.
-Withdrawal symptoms may occur during buprenorphine induction treatment of patients taking methadone or long-acting opioids, especially high opioid doses or when buprenorphine is administered shortly after the last opioid dose. The optimal time for the first dose has not been reported.
-The optimal method of tapering to discontinuation has not been reported.

Sublingual tablets (Zubsolv [R]):
-Zubsolv [R] compared to Suboxone [R] tablet requires a different tablet strength to be given to the patient. One Zubsolv [R] 5.7/1.4 mg sublingual tablet provides equivalent buprenorphine exposure to one Suboxone [R] 8/2 mg sublingual tablet.
The corresponding doses going from induction to maintenance treatment are:
-One 8 mg buprenorphine tablet = One 5.7 mg/1.4 mg ZUBSOLV [R] tablet
-One 8 mg buprenorphine tablet AND Two 2 mg buprenorphine tablets = One 5.7 mg/1.4 mg ZUBSOLV [R] tablet AND Two 1.4 mg/0.36 mg ZUBSOLV [R] tablets
-Two 8 mg buprenorphine tablets = Two 5.7 mg/1.4 mg ZUBSOLV [R] tablets
Maintenance dose: 11.4 mg/2.8 mg buprenorphine/naloxone/day (two 5.7/1.4 mg tablets) as a single daily dose.
-The dosage should be progressively adjusted in increments/decrements of 1.4 mg/0.36 mg or 2.8 mg/0.72 mg buprenorphine/naloxone to a level that holds the patient in treatment and suppresses opioid withdrawal signs.
-The maintenance dose of ZUBSOLV [R] sublingual tablet is generally in the range of 2.8 mg/0.72 mg buprenorphine/naloxone to 17.1 mg/4.2 mg buprenorphine/naloxone per day depending on the patient.
-Do not cut, chew, or swallow sublingual tablets. Place under the tongue until dissolved. The dissolve time varies between individuals. For dosages requiring more than one sublingual tablet, place all tablets in different places under the tongue at the same time. Patients should keep the tablets under the tongue until dissolved. Swallowing the tablets reduces the bioavailability of the drug. Patients should not eat or drink anything until the tablet is completely dissolved.
-Patients should follow the same manner of dosing with continued use of the product, to ensure consistency in bioavailability.

Sublingual film:
-Initial dose: Buprenorphine/naloxone sublingual film is administered sublingually as a single daily dose. The sublingual film should be placed under the tongue. If an additional sublingual film is necessary to achieve the prescribed dose, place the additional sublingual film sublingually on the opposite side from the first film. The sublingual film should be placed in a manner to minimize overlapping as much as possible. The sublingual film must be kept under the tongue until the film is completely dissolved. Buprenorphine/naloxone sublingual film should not be chewed, swallowed, or moved after placement.
-Maintenance: Buprenorphine/naloxone sublingual film is indicated for maintenance treatment. The recommended target dosage of buprenorphine/naloxone sublingual film is 16/4 mg buprenorphine/naloxone/day as a single daily dose.
-The dosage of buprenorphine/naloxone sublingual film should be progressively adjusted in increments/decrements of 2/0.5 mg or 4/1 mg buprenorphine/naloxone to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms.
-The maintenance dose of buprenorphine/naloxone sublingual film is generally in the range of 4/1 mg buprenorphine/naloxone to 24/6 mg buprenorphine/naloxone per day depending on the individual patient. Dosages higher than this have not been demonstrated to provide any clinical advantage.

What other drugs will affect buprenorphine and naloxone?

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.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with buprenorphine and naloxone, especially:

  • a sedative--diazepam, alprazolam, lorazepam, temazepam, triazolam, Restoril, Valium, Xanax, and others.

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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.03. Revision Date: 2014-05-01, 12:46:46 PM.

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