• Subutex was a brand (trade) name for a buprenorphine sublingual product that was available as a tablet and a buccal film. Subutex buccal film was used to relieve pain severe enough to require daily around-the-clock, long-term, opioid treatment, and Subutex sublingual tablets were used to treat opioid misuse disorder in adults.
• Buprenorphine is a partial opioid agonist which means it binds to and activates opioid receptors (particularly mu receptors) but less strongly than full agonists do. This means it can reduce cravings and withdrawal symptoms in a person with an opioid use disorder without producing euphoria. Buprenorphine helps to reduce withdrawal symptoms and curb cravings for opioids by tricking the brain into thinking that a full agonist like oxycodone or heroin has been taken. Some forms of buprenorphine can be used to provide pain relief because activating mu opioid receptors also relieves pain.
• Subutex belonged to the class of medicines known as narcotic analgesics. It was also called an opioid analgesic. Subutex was only used for the treatment of opioid (narcotic) addiction.
• Subutex has been discontinued in the U.S. Other brands of buprenorphine include Belbuca.

• Subutex buccal film was available to relieve pain severe enough to require daily, around-the-clock, long-term opioid treatment that is not relieved by other pain medicines or other pain medicines are not tolerated. Subutex was not suitable for minor pain or pain that only sometimes occurred.
• Subutex sublingual tablets were used to treat opioid use disorder in adults as part of a complete treatment program that included counseling and psychosocial support.
• Buprenorphine, the ingredient in Subutex, has advantages over other medication-assisted treatments (such as methadone and naltrexone) in that it suppresses withdrawal symptoms and cravings for opioids, does not cause euphoria (the feeling or state of intense excitement and happiness), and also blocks the effects of other opioids for at least 28 days.
• Buprenorphine helps people to change their thinking, behavior, and environment. Complements education, counseling, and other support measures that focus on the behavioral aspects of opioid addiction.
• Subutex buccal film for pain relief was usually taken as 75 micrograms (mcg) as a single dose once a day or every 12 hours for at least 4 days. Dosages greater than 900mcg every 12 hours were uncommon.
• Subutex sublingual tablets were usually taken as a single daily dose of 4 to 24mg once a day, under the tongue.
• Generic Subutex is available under the name buprenorphine

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Back pain, cough, chills, a headache, gastrointestinal disorders (eg, constipation, nausea, or vomiting), fatigue, constipation, painful and difficult urination, nasal congestion, and trouble sleeping were the most common side effects reported. Could also cause increases in liver enzymes (eg, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase), and blood creatine phosphokinase.
• Allergic reactions (including breathing difficulties, rash, and anaphylactic shock) and liver damage (hepatitis) have been reported.
• Abuse potential exists with any form of buprenorphine, although it is substantially lower than methadone.
• Buprenorphine has been associated with breathing difficulties and death, most often when used at the same time as benzodiazepines, alcohol, or other CNS depressant drugs.
• Buprenorphine can also cause dependence and a withdrawal syndrome on abrupt discontinuation although this is typically milder than that seen with full agonists.
• May cause drowsiness and affect a person's ability to drive or operate machinery.
• May interact with several other drugs including other opioids, benzodiazepines, and other central nervous system depressants resulting in profound sedation, respiratory depression, and sometimes death. May also interact with drugs metabolized through several CYP hepatic enzyme systems (such as CYP3A4 or CYP2D6) or drugs that also release serotonin (such as antidepressants, antipsychotics, and tramadol). There is a risk of heart rhythm disorders (such as QT prolongation) associated with buprenorphine, particularly when used with other drugs that prolong the QT interval.
• The need for continuing medication-assisted treatment should be re-evaluated periodically.
• Subutex may not have been suitable for some people such as those with liver disease, cardiac arrhythmias, the elderly or frail, with a history of drug or alcohol abuse, with psychiatric disorders, previous head injury, or raised intracranial pressure, a history of seizure disorders, with certain gastrointestinal conditions, respiratory disease, liver disease, physically dependent on full agonists, or certain other concomitant conditions. Use during pregnancy could potentially cause withdrawal symptoms in the newborn baby.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Subutex sublingual tablets were used as part of a complete treatment plan that included counseling and psycho-social support.
• Continued treatment with Subutex depended on compliance with all elements of the treatment plan and abstinence from illicit drug use.
• Immediate medical help was needed for people taking Subutex who developed blurred vision, excessive sleepiness, or who became uncoordinated, with slurred speech, slowed reflexes or breathing, or confusion.
• Subutex required people to rise carefully from a sitting to a standing position to minimize blood pressure-lowering effects which could have resulted in dizziness increasing the risk of falls.
• Subutex could cause constipation laxatives may have been required by some people.
• Subutex had been associated with androgen deficiency which can cause symptoms such as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. Talk to your doctor if this happens to you.
• If Subutex was administered with other drugs that also released serotonin, such as tramadol, lithium, or antidepressants, a condition called serotonin syndrome could develop. Symptoms of serotonin include agitation or restlessness, sweating, diarrhea, headache, confusion, rapid heart rate, high blood pressure, dilated pupils, loss of muscle coordination, twitching muscles, or muscle rigidity.
• Women of childbearing age were instructed to use adequate contraception to ensure they did not become pregnant while being administered Subutex, because of the risk of the baby being born with neonatal withdrawal syndrome. Breastfeeding was not recommended while being administered Subutex.
• Subutex could impair your ability to drive or operate machinery unless you were tolerant of its effects.
• Subutex was a schedule III product.

• Sublingual preparations of buprenorphine vary in the time they take to dissolve (from just a few minutes to up to 12 minutes). People should not eat, drink, or talk during this time. Some relief from withdrawal symptoms should be expected within 30 minutes of the first dose. It may take several doses before the full effects are seen. A decrease in the response to buprenorphine may indicate that a higher dosage is needed.

Medicines that interacted with Subutex either decreased its effect, affect how long it worked, increased side effects, or had less of an effect when taken with Subutex. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that interacted with Subutex included:

• antidepressants, such as tricyclic antidepressants (eg, amitriptyline), monoamine oxidase inhibitors (eg, isocarboxazid, phenelzine, and tranylcypromine), or SSRIs (eg, fluoxetine, sertraline)
• antipsychotics (such as butyrophenones, phenothiazines, or thioxanthenes) and atypical antipsychotics (eg, olanzapine, quetiapine, ziprasidone)
• any medication that inhibits or induces CYP3A4
• any medication that may cause drowsiness, such as amphetamines, benzodiazepines (eg, diazepam, lorazepam), first-generation antihistamines (such as doxylamine or promethazine), metoclopramide, or opioids (such as codeine, methadone, or morphine)
• HIV medications such as ritonavir
• naloxone and naltrexone
• QT-prolonging medications such as amiodarone and flecainide
• rifampin
• St. John's Wort.

Alcohol or illegal or recreational drugs were not recommended with Subutex.

Note that this list is not all-inclusive and includes only common medications that interacted with Subutex. You should refer to the prescribing information for Subutex for a complete list of interactions.