buprenorphine and naloxone (oral/sublingual)

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

What is buprenorphine and naloxone?

Buprenorphine and naloxone is a combination medicine used to treat opioid addiction. Buprenorphine and naloxone is not for use as a pain medication.

Buprenorphine and naloxone 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?

Tell your doctor if you have ever had:

• tooth problems, including a history of cavities;
• breathing problems, sleep apnea;
• enlarged prostate, urination problems;
• liver or kidney disease;
• abnormal curvature of the spine that affects breathing;
• problems with your gallbladder, adrenal gland, or thyroid;
• a head injury, brain tumor, or seizures; or
• alcoholism or drug addiction.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

How should I take buprenorphine and naloxone?

Follow the directions on your prescription label and read all medication guides. Never use buprenorphine and naloxone in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Rinse your mouth with water after buprenorphine and naloxone dissolves. Wait one hour after the medicine dissolves to brush your teeth to prevent damage to the teeth and gums. You should receive regular dental checkups while taking buprenorphine and naloxone.

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.

You will need frequent blood tests to check your liver function.

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.

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?

What should I avoid while taking buprenorphine and naloxone?

What are the possible side effects of buprenorphine and naloxone?

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

• any problems with your teeth or gums;
• weak or shallow breathing, breathing that stops during sleep;
• a light-headed feeling, like you might pass out;
• confusion, loss of coordination, extreme weakness;
• blurred vision, slurred speech;
• liver problems --upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• high levels of serotonin in the body --agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea;
• low cortisol levels --nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• opioid withdrawal symptoms --shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.

Serious breathing problems may be more likely in older adults and those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects may include:

• dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;
• withdrawal symptoms;
• tongue pain, redness or numbness inside your mouth;
• nausea, vomiting, constipation;
• headache, back pain;
• fast or pounding heartbeats, increased sweating; or
• sleep problems (insomnia).

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?

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.

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids --pain medicine or prescription cough medicine;
• a sedative like Valium --diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, 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 affect buprenorphine and naloxone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about buprenorphine and naloxone.