Buprenorphine

Generic name: buprenorphine (oral/sublingual) (BUE pre NOR feen (OR al / sub LIN gwal))
Brand name: Subutex
Drug class: Narcotic analgesics

Buprenorphine is an opioid medication.

Buprenorphine sublingual tablets (given under the tongue) are a prescription medicine used to treat opioid addiction (either prescription or illegal drugs), as part of a complete treatment program that also includes counseling and behavioral therapy.

Buprenorphine sublingual tablets are most often used for the first 1 or 2 days to help you start with treatment.

Other forms of buprenorphine are used to treat moderate to severe pain.

Warnings

Buprenorphine sublingual tablets are not for use as a pain medication.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep buprenorphine in a place where others cannot get to it.

Taking buprenorphine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use buprenorphine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use this medicine 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 ever had:

• methadone treatment;
• breathing problems, sleep apnea;
• abnormal curvature of the spine that affects breathing;
• liver disease (especially hepatitis B or C);
• kidney disease;
• enlarged prostate, urination problems;
• a head injury or brain tumor;
• alcoholism, hallucinations, mental illness; or
• problems with your stomach, gallbladder, adrenal gland, or thyroid.

If you use buprenorphine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Buprenorphine can pass into breast milk and may cause drowsiness, and breathing problems in a nursing baby. Ask your doctor about any risk.

Buprenorphine is not approved for use by anyone younger than 18 years old.

How should I take buprenorphine sublingual?

Use buprenorphine exactly as it was prescribed for you. Follow the directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Never use buprenorphine in larger amounts, or for longer than prescribed.

Buprenorphine sublingual is usually taken for only at the start of treatment for addiction. Most people are later switched to another medicine that contains buprenorphine (Bunavail, Sublocade, Suboxone, Zubsolv).

You may receive your first doses of buprenorphine sublingual in a hospital or clinic setting until your condition improves.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Use dry hands when handling the tablet. Place the tablet under your tongue and allow it to dissolve with your mouth closed. 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.

Do not eat or drink anything until the tablet or film has completely dissolved in your mouth.

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.

Never crush or break a buprenorphine pill to inhale the powder or mix it into a liquid to inject the drug into your vein. Doing so could result in death.

Any medical care provider who treats you should know that you are being treated for opioid addiction, and that you are taking buprenorphine sublingual. Make sure your family members know how to provide this information 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 this medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. Buprenorphine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

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, slow heart rate, weak pulse, very slow breathing, or coma.

What to avoid

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how buprenorphine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Buprenorphine side effects

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• opioid withdrawal symptoms - shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain;
• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• slow heartbeat or weak pulse;
• a light-headed feeling, like you might pass out;
• chest pain, trouble breathing;
• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• liver problems - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common buprenorphine 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?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Buprenorphine can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other narcotic medications - opioid pain medicine or prescription cough medicine;
• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

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

Buprenorphine drug interactions (more detail)

Alternatives to buprenorphine

Buprenorphine is available in different dosage forms and there are other alternative drugs used to treat opioid use disorder or severe pain. Talk with your healthcare provider which option would be best suited to you

Medicines used to treat opioid addiction:

Buprenorphine:

• Subcutaneous injection, abdominal (Sublocade);
• Implant (Probuphine);
• Sublingual tablets (Subutex).

Buprenorphine and naloxone

• Sublingual film (Bunavail);
• Sublingual film and sublingual tablets (Suboxone);
• Sublingual tablets (Zubsolv).

Lofexidine

• Tablets (Lucemyra).

Naltrexone

• IM injection (Vivitrol);
• Tablets (Naltrexone).

For opioid overdose in an emergency situation:

Naloxone

• Nasal spray (Narcan, Kloxxado);
• Naloxone injection.

Medicines used to treat severe pain:

Buprenorphine:

• IM and IV injection (Buprenex);
• Buccal film (Belbuca);
• Transdermal patch (Butrans).

There are other groups of pain relieving medicines (including narcotic analgesics).

Medicine to treat opioid addiction or moderate to severe pain:

Methadone

• Tablets (Dolophine).