Suboxone

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you are using the buccal film:

• Use your tongue to wet the side of your cheek or rinse your mouth with water in the area where you will place the film.
• Do not cut or tear the film. Hold the film on a clean, dry finger. If you are using Bunavail®, hold with the text (BN2, BN4, or BN6) facing up.
• Place the side of the film against the inside of your cheek. If you are using Bunavail®, place with the text (BN2, BN4, or BN6) against the inside of your cheek.
• Press the film and hold it there for 5 seconds.
• Leave the film in place until it dissolves. Do not touch, move, chew, or swallow it.
• If you must use more than one film, place the second film on the other side of your mouth. Do not place more than 2 buccal films to the inside of one cheek at a time.
• Do not eat or drink anything until the film is completely dissolved.

If you are using the sublingual tablet:

• Do not cut, crush, chew, or swallow it.
• Place the tablet under the tongue until it is dissolved.
• If you take 2 or more tablets at a time, place all of the tablets in different places under the tongue at the same time.
• If this is uncomfortable, place 2 tablets at a time under the tongue and repeat the process until all the tablets have been taken.
• Do not eat or drink anything until the tablets are completely dissolved.

If you are using the sublingual film:

• Drink water before taking this medicine to help moisten your mouth.
• Place the film under the tongue until it is dissolved.
• If you need to take an additional film, place the new film on the opposite side from the first film.
• Do not cut, chew, swallow, or move the film after placing it under the tongue.

Check with your doctor first before changing dosage forms (eg, films, tablets) or dosage strengths. These forms are very different from each other.

The dose of suboxone pills 8mg will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For buccal dosage form (film):
  • For induction treatment of opioid dependence:
    • Adults—On Day 1, your doctor may give you an induction dosage up to 4.2 milligrams (mg) of buprenorphine and 0.7 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 8.4 mg of buprenorphine and 1.4 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting, or long-acting opioid medicines, your doctor may recommend you to take buprenorphine alone.
    • Children—Use and dose must be determined by your doctor.
  • For maintenance treatment of opioid dependence:
    • Adults—8.4 milligrams (mg) of buprenorphine and 1.4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
• For sublingual dosage form (film):
  • For induction treatment of opioid dependence:
    • Adults—On Day 1, your doctor may give you an induction dosage up to 8 milligrams (mg) of buprenorphine and 2 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 16 mg of buprenorphine and 4 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting, or long-acting opioid medicines, your doctor may recommend you to take buprenorphine alone.
    • Children—Use and dose must be determined by your doctor.
  • For maintenance treatment of opioid dependence:
    • Adults—16 milligrams (mg) of buprenorphine and 4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
• For sublingual dosage form (tablets):
  • For induction treatment of opioid dependence:
    • Adults—On Day 1, your doctor may give you an induction dosage up to 5.7 milligrams (mg) of buprenorphine and 1.4 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 11.4 mg of buprenorphine and 2.9 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting or long-acting opioid medicines, your doctor may recommend you take buprenorphine alone.
    • Children—Use and dose must be determined by your doctor.
  • For maintenance treatment of opioid dependence:
    • Suboxone™:
      • Adults—16 milligrams (mg) of buprenorphine and 4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • Zubsolv®:
      • Adults—11.4 milligrams (mg) of buprenorphine and 2.9 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of buprenorphine and naloxone buccal film, sublingual film, or sublingual tablet in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buprenorphine and naloxone combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine and naloxone combination.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.