Buprenorphine (bue-pre-NOR-feen), Naloxone (nal-OX-one)

Treats narcotic dependence.

Brand Name(s):

Suboxone, Zubsolv

When This Medicine Should Not Be Used:

How to Use This Medicine:

Thin Sheet, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• You must let the medicine dissolve. Never swallow the film or tablet. Your body may not absorb enough of the medicine if you swallow it.
• Your health caregiver should show you how to use the medicine. If you do not understand, ask for help. It is important to use the medicine correctly.
• Do not talk while the medicine is inside your mouth.
• Buccal film: Rinse your mouth with water to moisten it. Place the film against the inside of your cheek. If your doctor told you to use more than 1 film, place the second film inside your other cheek. Do not place more than 2 films inside of 1 cheek at a time. Do not move or touch the film. After the film has completely dissolved, take a sip of water, swish gently around your teeth and gums, and swallow. Wait at least one hour before brushing your teeth.
• Sublingual tablet: Place the tablet under your tongue. If your doctor told you to use more than 1 tablet, place all of the tablets in different places under your tongue at the same time. You can use 2 tablets at a time until you have taken all of the medicine, if that is easier for you. Let the tablets dissolve completely in your mouth. Do not eat or drink anything until the tablets are completely dissolved. Rinse your mouth with water and swallow. Wait for at least one hour before brushing your teeth.
• Sublingual film: Drink some water to help moisten your mouth. Place the film under your tongue. If your doctor told you to use more than 1 film, place the second film on the opposite side from the first one. Do not move the film after you placed it under your tongue. If you are supposed to use more than 2 films, use them the same way, but do not start until the first 2 films are completely dissolved. After the film has completely dissolved, take a sip of water, swish gently around your teeth and gums, and swallow. Wait at least one hour before brushing your teeth.
• Do not break, crush, chew, or cut the film or tablet.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website:www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how buprenorphine/naloxone works. Tell your doctor if you are using the following:
  • Carbamazepine, cyclobenzaprine, erythromycin, ketoconazole, metaxalone, mirtazapine, phenobarbital, phenytoin, rifampin, tramadol, trazodone
  • Diuretic (water pill)
  • Medicine to treat depression or mental health problems (including SNRIs, SSRIs, TCAs)
  • Medicine to treat HIV/AIDS (including atazanavir, delavirdine, efavirenz, etravirine, nevirapine, ritonavir)
  • Phenothiazine medicine
  • Triptan medicine to treat migraine headaches
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using butorphanol, nalbuphine, pentazocine, or a muscle relaxer.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease (including hepatitis), lung or breathing problems (including sleep apnea), tooth problems (including history of cavities), adrenal gland problems, an enlarged prostate, trouble urinating, gallbladder problems, thyroid problems, stomach problems, or a history of depression. Tell your doctor if you have heart disease, congestive heart failure, a slow heartbeat, or a history of heart rhythm problems (including long QT syndrome). Tell your doctor if you have a brain tumor, head injury, or alcohol or drug abuse.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Adrenal gland problems
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
  • Low blood pressure
  • Liver problems
  • QT prolongation (heart rhythm problem)
  • Tooth problems (including tooth fracture, tooth loss)
  • Serotonin syndrome, when used with certain medicines
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• Tell any doctor or dentist who treats you that you are using this medicine. Schedule regular dental checkups while taking this medicine.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fever, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
• Blue lips, fingernails, or skin, trouble breathing
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme dizziness, drowsiness, or weakness, slow heartbeat, sweating, seizures, cold or clammy skin
• Fast, pounding, or uneven heartbeat
• Severe confusion, lightheadedness, dizziness, or fainting
• Shaking, trembling, hunger
• Trouble breathing or slow breathing
• Toothache

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, nausea, vomiting, stomach upset
• Headache
• Stuffy or runny nose

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088