Patient Information for SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII)

What is the most important information I should know about SUBOXONE Sublingual Film?

Keep SUBOXONE Sublingual Film in a secure place out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes SUBOXONE Sublingual Film, get emergency help or call 911 right away. Tell your healthcare provider if you are living in a household where there are small children.

SUBOXONE Sublingual Film contains an opioid medicine called buprenorphine that can cause serious and life-threatening breathing problems, especially if you take or use certain other medicines or drugs.

Talk to your healthcare provider about naloxone, a medicine available to patients for emergency treatment of an opioid overdose, including accidental use of SUBOXONE Sublingual Film by a child. If naloxone is given, you must call 911 or get emergency medical help right away to treat an overdose or accidental use of an opioid.

SUBOXONE Sublingual Film can cause serious and life‐threatening breathing problems. Get emergency help right away if you:

• feel faint
• feel dizzy
• are confused
• feel sleepy or uncoordinated
• have blurred vision
• have slurred speech
• are breathing slower than normal
• cannot think well or clearly

Do not take SUBOXONE Sublingual Film with certain medicines. Taking SUBOXONE Sublingual Film with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Do not inject (“shoot-up”) SUBOXONE Sublingual Film. Injecting SUBOXONE Sublingual Film may cause life-threatening infections and other serious health problems. Injecting SUBOXONE Sublingual Film may cause sudden serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Do not switch from SUBOXONE Sublingual Film to other medicines that contain buprenorphine without talking with your healthcare provider. The amount of buprenorphine in a dose of SUBOXONE Sublingual Film is not the same as in other medicines that contain buprenorphine. Your healthcare provider will prescribe a starting dose of SUBOXONE Sublingual Film that may be different than other buprenorphine containing medicines you may have been taking.

Do not stop taking SUBOXONE Sublingual Film suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine (physical dependence). Physical dependence is not the same as drug addiction.

In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with SUBOXONE Sublingual Film.

Never give anyone else your SUBOXONE Sublingual Film. They could die from taking it. Selling or giving away SUBOXONE Sublingual Film is against the law.

Death has been reported in those who are not opioid dependent.

Who should not take SUBOXONE Sublingual Film?

Do not take SUBOXONE Sublingual Film if you are allergic to buprenorphine or naloxone.

Do not take SUBOXONE Sublingual Film before the effects of other opioids (e.g., heroin, hydrocodone, methadone, morphine, oxycodone) have started to wear off as you may experience withdrawal symptoms.

Before taking SUBOXONE Sublingual Film, tell your healthcare provider about all of your medical conditions, including if you have:

• trouble breathing or lung problems
• a curve in your spine that affects your breathing
• Addison’s disease
• an enlarged prostate gland (men)
• problems urinating
• liver, kidney, or gallbladder problems
• alcoholism
• a head injury or brain problem
• mental health problems
• adrenal gland or thyroid gland problems
• tooth problems, including a history of cavities

Tell your healthcare provider if you are:

• pregnant or plan to become pregnant. Opioid-dependent women on buprenorphine maintenance therapy may require additional analgesia during labor. If you take SUBOXONE Sublingual Film while pregnant, your baby may have symptoms of opioid withdrawal at birth that could be life-threatening if not recognized and treated. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• breastfeeding or plan to breastfeed. SUBOXONE Sublingual Film can pass into your breast milk and harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take SUBOXONE Sublingual Film. Monitor your baby for increased drowsiness and breathing problems if you breastfeed during treatment with SUBOXONE Sublingual Film.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking SUBOXONE Sublingual Film?

• Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBOXONE Sublingual Film affects you. Buprenorphine can cause drowsiness and slow reaction times. SUBOXONE Sublingual Film can make you sleepy, dizzy, or lightheaded.
• You should not drink alcohol or take prescription or over‐the‐counter medicines that contain alcohol while taking SUBOXONE Sublingual Film, because this can lead to loss of consciousness or even death.

What are the possible side effects of SUBOXONE Sublingual Film?

SUBOXONE Sublingual Film can cause serious side effects, including:

• Trouble breathing. Taking SUBOXONE Sublingual Film with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants can cause breathing problems that can lead to coma and death.
• Sleepiness, dizziness, and problems with coordination.
• Physical dependence or abuse. SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit.
• Liver problems. Call your healthcare provider right away if you notice any of these symptoms:
  • your skin or the white part of your eyes turning yellow (jaundice)
  • dark or “tea-colored” urine
  • light colored stools (bowel movements)
  • loss of appetite
  • pain, aching, or tenderness on the right side of your stomach area
  • nausea
• Your healthcare provider should do blood tests to check your liver before you start taking and while you take SUBOXONE Sublingual Film.
• Allergic reaction. You may have a rash, hives, swelling of your face, wheezing, low blood pressure, or loss of consciousness. Call your healthcare provider or get emergency help right away.
• Opioid withdrawal. Call your healthcare provider right away if you get any of these symptoms:
  • shaking
  • sweating more than normal
  • feeling hot or cold more than normal
  • runny nose
  • watery eyes
  • goosebumps
  • diarrhea
  • vomiting
  • muscle aches
• Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.
• The most common side effects of SUBOXONE Sublingual Film include:
  • headache
  • nausea
  • vomiting
  • constipation
  • pain
  • increased sweating
  • decrease in sleep (insomnia)
• SUBOXONE Sublingual Film may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.

To report pregnancy or side effects associated with taking SUBOXONE Sublingual Film, please call 1-877-782-6966. You are encouraged to report negative side effects of drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information about SUBOXONE Sublingual Film, see the full Prescribing Information, and Medication Guide or talk to your healthcare provider. For REMS information visit www.BTODREMS.com.

5 myths about using Suboxone to treat opiate addiction

What is Suboxone and how does it work?

Suboxone, a combination medication containing buprenorphine and naloxone, is one of the main medications used to treat opioid addiction. Using ‘medications for opioid use disorder’ is known as MOUD. Use of MOUD has been shown to lower the risk of fatal overdoses by approximately 50%. It also reduces the risk of nonfatal overdoses which are traumatic and medically dangerous.

Suboxone works by tightly binding to the same receptors in the brain as other opiates, such as heroin, morphine, and oxycodone. By doing so, it blunts intoxication with these other drugs, it prevents cravings, and it allows many people to transition back from a life of addiction to a life of normalcy and safety.

A key goal of many advocates is to make access to Suboxone much more widely available, so that people who are addicted to opiates can readily access it. Good places to start are in the emergency department and in the primary care doctor’s office. More doctors need to become “waivered” to prescribe this medication, which requires some training and a special license.

The vast majority of physicians, addiction experts, and advocates agree: Suboxone saves lives. The U.S. Government has recently been lightening up on the requirements needed for doctors and nurses to “get waivered” in an urgent attempt to increase the availability of Suboxone prescribers, as the number of opioid deaths keeps rising.

Common myths about using Suboxone to treat addiction

Unfortunately, within the addiction community and among the public at large, certain myths about Suboxone persist, and these myths add a further barrier to treatment for people suffering from opiate addiction.

Myth #1: You aren’t really in recovery if you’re on Suboxone.

Reality: While it depends on how you define “recovery,” the circa 1930’s era AA-influenced abstinence-based models that have dominated the past century of addiction care are generally giving way to more modern conceptions of recovery that encompass the use of medications such as Suboxone that  help regulate your brain chemistry. As addiction is increasingly viewed as a medical condition. Suboxone is viewed as a medication for a chronic condition, similar to a person with type 1 diabetes needing to take insulin. To say that you aren’t really in recovery if you are on Suboxone is stigmatizing to people who take Suboxone, and it’s not the medical reality of effective addiction treatment.

Myth #2: People frequently misuse Suboxone.

Reality: Suboxone, like any opiate, and many other medications, can be misused. However, because it is only a “partial” agonist of the main opiate receptor (the “mu” receptor), it causes  much less euphoria than the other opiates such as heroin and oxycodone. In many cases, people may use Suboxone (or “misuse” it, if that is defined as using it illegally) to help themselves manage their withdrawal, or even to get themselves off heroin or fentanyl. If Suboxone were more available to those who need it, they wouldn’t have to self-treat. We are, in effect, blaming the victims here.

Myth #3: It’s as easy to overdose on Suboxone as it is to overdose with other opiates.

Reality: It is extremely difficult to overdose on Suboxone alone. It is much more difficult to overdose on Suboxone compared to other opiates, because Suboxone is only a partial opiate receptor agonist, so there is a built-in “ceiling” effect. This means there is a limit to how much the opioid receptors can be activated by Suboxone, so there isn’t as great a risk of slowed breathing compared with potent opiates such as heroin, oxycodone, or morphine. When people do overdose on Suboxone, it is almost always because they are mixing it with sedatives such as benzodiazepines, medicines that also slow breathing.

Myth #4: Suboxone isn’t treatment for addiction if you aren’t getting therapy along with it.

Reality: Ideally, addiction treatment should include MOUD as well as therapy, recovery coaching, support groups, housing assistance, and employment support. But that doesn’t mean that one component, in the absence of all of the others, doesn’t constitute valid treatment for addiction. Currently, about 10-20% of people with opioid use disorder are getting anything that qualifies as adequate treatment for their disease, due to flaws in our healthcare system and shortages in qualified providers. So, while combination treatment is an admirable goal, it is unrealistic to expect that everyone with an addiction will receive all the aspects of treatment that they need, especially if you add in that many people who suffer from addiction often also lack access to regular healthcare and  health insurance. Further, treatment with Suboxone alone, without therapy, has been proven to be effective. But it can be even more effective if combined with additional supports, such as therapy, recovery coaching, etc.

Myth #5: Suboxone should only be taken for a short period of time.

Reality: Expert practitioners have different theories on how long Suboxone treatment should last for, but there is no evidence to support the claim that Suboxone should be taken for a short period of time as opposed to being maintained on it for the long term, just as a person would manage their diabetes with insulin for the long term. Ultimately, this comes down to patient preference.

One of the main obstacles to getting lifesaving treatment for addiction is the stigma people face. Fortunately, our society’s perception is slowly starting to transform away from an outdated view of addiction as a moral failing, toward a more realistic, humane view of addiction as a complex disease that needs to be addressed with compassion, as well as modern medical care. Eliminating myths and misinformation about addiction, and supplanting them with up-to-date, evidence-based treatments, is a critical step in the evolution and improvement of addiction treatment.

Tablets Subutex – Is it a drug or not, how does it affect the body?

Contents:

Buprenorphine (brand name Subutex), is a powerful pain reliever and belongs to semi-synthetic apioids. This drug is not officially recognized as a drug and, due to its abilities, belongs to drugs with a psychotropic effect on the human body. In European countries, this drug was replaced in the form of Suboxone, and before that, Subutex was replaced by Methadone. Despite the abundance of names, this drug is potent and has narcotic properties. It is used in substitution therapy for drug addiction.

What is the purpose of using Buprenorphine (Subutex)

This drug has found its wide application in substitution therapy for narcotic drugs, as well as in pain relief and pain relief. In terms of its qualities, it is many times stronger than the narcotic drug Morphine. The reason for the creation of this psychotropic drug was the belief that drug addiction could not be defeated and cured. Therefore, it was decided to create a remedy that will replace drugs and bring the least harm to the health of a person dependent on them.

Effects on the human body

Experts believe that tablets of the psychotropic drug Subutex are the least toxic among the “substitutes” of narcotic drugs and bring the least harm to the dependent patient during treatment. This psychotropic drug gives the drug addict less euphoria and more analgesic effect, which, with its small volume and quantity, does not significantly load the body with toxins.

Buprenorphine, acts on a person after a minute from the time of administration when injected and 10-13 minutes after intramuscular use. The use of Subutex under the tongue is also provided, which gives an effect after 20 minutes. After 25 minutes, in the blood plasma, its maximum value is detected.

Since Subutex is a drug that is 25-35 times stronger in its analgesic properties than Morphine. One third of a milligram (mg) of this drug is equivalent to 11 (mg) of morphine. An increased dose of the drug leads to respiratory depression and causes the following symptoms of poisoning:

• shortness of breath;
• tachycardia;
• severe dizziness;
• vomiting and nausea;
• hallucinogenic visions, delusions;

• jumping consciousness and confused thoughts;
• severe pupillary constriction;
• increased sweating;
• dry mouth;
• if an overdose occurs, then a coma occurs, leading to death.

Subutex, causes a slight but rapid dependence on the use. When taken together with analgesics, the narcotic component, sedatives, benzodiazepines, as well as alcoholic products, will cause a violation in the Central nervous system (CNS).

Dependence on Subutex

Many “specialists” believe that this drug does not harm the use, or does, but very slowly, which makes it possible to avoid overdoses and dependence. This mistake costs many of the emergence of drug addiction from this psychotropic drug, and this is today a proven fact.

During the substitution, no one has yet been able to independently refuse to use this narcotic psychotropic drug. Whoever tries to try to do this will get the resulting withdrawal and “breaking”, which will not be able to be transferred at home. The abstinence from this drug itself is very difficult, because of the synthetic tablets that make up Subutex. Withdrawal syndrome passes with the following symptoms:

• severe pain;
• convulsive impulses;
• vomiting;
• nausea;
• anorexia;
• insomnia;
• hallucinations;
• unstoppable aggression.

Such symptoms cannot be endured by the human psyche and this can lead the drug addict to attempt suicide. This condition requires urgent intervention of a drug treatment clinic and a phased treatment of this disease. Western countries, seeing what is happening, do not abandon this substitution method and began to offer another drug, Suboxone, but where is the guarantee that this method will not bring a more deplorable result than Subutex, because they used to also speak for Buprenorphine.

Distribution of Subutex

Legal narcotic drug involved in the substitution of narcotic drugs and fully controlled by the Government. Let’s see how this happens? You use heroin, and the State gives you Subutex instead, which reduces the euphoric state, or in another way of dating, as an analgesic narcotic drug. In the second method, trying to get away from the pain symptom, you, using Subutex, get drug dependence.

Such narcotic and psychotropic substances, one way or another, end up on the black market, where anyone can buy it for some financial means. More often, it gets on sale from those who themselves, trying to recover from drug addiction, take them out into the masses in the mouth under the tongue or by other methods.

The strong distribution of Buprenorphine, at present, is in trend among drug addicts and it surpassed heroin in its use. What can this fact say? Only that substitution treatment does not bring the expected benefits of therapy, but creates big problems and a new addiction.

What danger does the use of Subutex bring? The addict simply exchanges one drug for another that is milder and less euphoric. As well as in the case of refusal to use, abstinence passes in a milder form, and in order to set the required euphoric state, an increase in the dose of the drug.

This regularity often leads a drug-addicted person into a state of overdose and severe malfunction of the internal organs. According to world-class statistics, substitution therapy significantly reduces the death rate from the use of narcotic drugs, but at the same time leaves the drug addict – a drug addict. It turns out that there is no benefit from treatment with this remedy, in terms of complete recovery, and dependence is intensifying.

How to get rid of dependence on psychotropic Subutex

If you decide to start treatment with drug substitution, you need to remember that this therapy is eternal. You can be treated all your life, and you can return to the previous path from the Subutex medication at any time. Also, dependence on Buprenorphine gradually causes the body to take an increased dose. What to do in order to quit and remove dependence on this drug?

One and the right way out of this situation is a comprehensive course of rehabilitation measures. Our narcological clinic “Hummingbird” can offer complex therapy and complete healing not just from the psychotropic substance Subutex, but from drug addiction to any narcotic drugs.

Narcological assistance – Narcological Clinic “Kolibri”

The specialists of our clinic are well aware of the problems of substitution therapy, therefore, this method is not considered for treatment. After all, if the treatment is violated by the patient, after a while he gets a strong dependence on a psychotropic drug. This happens in 90% of cases after undergoing complex treatment. Narcological clinic “Hummingbird”, in its methods, focuses on:

• psychological assistance to restore social balance in the environment of life;
• restoration of physical health damaged by drug use;
• using the system of American scientists “12 steps”, modernized for our life;
• systems of physiotherapeutic measures, where the procedures accelerate the process of starting the recovery functions of the body;
• folk and Oriental medicine according to the ancient Chinese teachings.

All these methods have shown their capabilities and results, so the percentage of recovering wards is constantly increasing.

The beginning of drug addiction treatment takes place after diagnostic measures in the quarantine sector of the Hummingbird Narcological Clinic. At this stage, the ward will pass the withdrawal syndrome with the help of our methods of treatment and preparatory psychological rehabilitation courses.

We understand that your relative will not agree to decide on treatment for addiction, so our clinic has a new service “narcologist at home”. When leaving for your address, our employee will find the right words for the ward to make the right choice in favor of a happy and healthy life.

After passing through the quarantine sector of treatment and withdrawal of abstinence, the ward switches to inpatient therapy. At the second stage, a drug addict will be offered a choice of 2-3-4-bed comfortable places in our residential housing construction. All courses of treatment and intensive care are under the round-the-clock supervision of our medical staff, therefore, all unforeseen situations with the patient’s health are resolved quickly and without delay.

Turning to the NC “Hummingbird”, after undergoing rehabilitation measures, you get the opportunity to look at the world with different and more sober eyes.

All information about our clinic is available on our official website, where you can leave questions or ask for help from our specialists. Helping you, we make the world cleaner from the vices of drug addiction and other pathogenic addictions.

Charlette’s Story – Client Story

You saw me – all of me – within the first day.

By the summer of 2019, Charlette had been living on the streets of Seattle for six years. The heroin took a toll on her body and mind. But she wasn’t ready for the change until she lost six of her friends to an overdose in one week.

Grieving, Charlett called her sister to bring her back to Portland.

When she entered the new Blackburn Center on the east side of Portland, Charlett was one of the first to walk through its doors. She expected to fill out some paperwork and schedule an admissions meeting a few weeks later.

But that’s not the case at Blackburn.

Within an hour, Charlette transferred her insurance to Oregon, she saw a primary care physician who treated her long-neglected thyroid condition, and visited a mental health practitioner who prescribed medication to ease her withdrawal symptoms. Shortly thereafter, she was able to buy the drug, Suboxone, from the Blackburn Pharmacy.

If Charlett’s story had stopped there, it would have been powerful compared to many other recovery journeys. But at Blackburn, things are not like that.

The center was designed to break the stigma of addiction and reduce systemic barriers to health by prioritizing the needs of its residents.

In the coming weeks, Charlett received individual and group counseling about her substance use. And she joined 80 other residents of the Blackburn Flats, CCC’s newest alcohol- and drug-free temporary housing.

Community recovery

Living in Blackburn meant Charlett wasn’t just in good health – she had neighbors who understood what she was going through.

The floors are designed with wide corridors and seating areas to bring people together. Each floor also has a communal kitchen to encourage sharing meals and peer support.

Every day at 4:00 pm she joined the rest of the residents and Blackburn staff in the community common room.