SUBOXONE® (buprerphine and naloxone) Sublingual Film (CIII)
Opioid dependence—physical addiction to prescription painkillers and heroin—affects many people in the US. Unfortunately, many people who struggle with opioid dependence may be reluctant to ask for help because of the stigma attached to the notion of “drug dependence.”
Opioid dependence is a complex health condition with many elements that are caused or made worse by continued opioid use. Key elements include social, psychological, and biological components. Opioid dependence can occur as the brain adapts to the regular use of opioids over time. People who are opioid dependent may continue using opioids despite experiencing harmful consequences.
Opioid dependence is a chronic disease that can affect anyone. It could be a friend, a co-worker, a spouse, a brother, a sister, or a parent.
If you or someone you know may be dependent on opioids, you are not alone. In 2013, there were nearly 2.4 million reports of people that had abused or were dependent on opioids—such as heroin—or prescription painkillers.
Opioids can be prescription painkillers. For example, Oxycodone, hydrocodone, and fentanyl—better known by the brand names as OxyContin, Vicodin, Percocet, and Actiq—are opioids. The street drug heroin is also an opioid.
SUBOXONE (buprenorphine and naloxone) Sublingual Film (CIII)
It is possible to get on the path to recovery and there are many different treatment options.
Here are some of the types of treatment available:
· —methadone is medication-assisted treatment used to block the euphoria or “high” associated with other opioids
· —addresses the psychological and behavioral aspects of addiction
· —highly structured programs in hospitals and residential treatment centers that offer around-the-clock support
· —based on a set of guiding principles that outline a course of action to work towards recovery from addiction
· —prescription medications are used to help suppress withdrawal symptoms and decrease cravings, along with counseling and other support
One type of medication-assisted treatment is SUBOXONE Film, with counseling and psychosocial support. Together with a doctor who is qualified to treat opioid dependence, SUBOXONE Film may help you—or someone you care about manage opioid dependence.
Treatment with SUBOXONE Film
· For dependence on short-acting opioids, like heroin or prescription painkillers, SUBOXONE Film, which contains buprenorphine and naloxone, may be recommended to help you begin and maintain continuity of treatment
· When transitioning from dependence on long-acting opioids, like methadone, a buprenorphine-only medication may be recommended
If a doctor qualified to treat opioid dependence prescribes SUBOXONE Film, your treatment can begin. The following are potential stages of treatment with SUBOXONE Film. Only your doctor can decide what is an appropriate treatment plan for you.
1. —you begin your treatment (or restart it if you’ve relapsed) under the supervision of a doctor. For your first dose, you must be in a moderate state of withdrawal. You work with your doctor to reach a dose of SUBOXONE Film that works for you.
2. —Your doctor will help you to transition to the maintenance phase of treatment when you:
· Are no longer experiencing withdrawal symptoms
· Have minimal to no side effects
· Do not have uncontrollable cravings
You can take your medication regularly as prescribed as long as you comply with all of the elements in your treatment plan including responsibly handling the medication, staying free from illicit drug use, and seeking counseling and/or psychosocial support.
3. —The decision to discontinue therapy with SUBOXONE Film after a period of maintenance should be made as part of a comprehensive treatment plan. It is important that you work with your doctor to determine when the time is right to slowly lower your dose, taking care to minimize withdrawal symptoms. Throughout treatment, you should discuss any concerns you have about relapse with your doctor.
*SUBOXONE Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. However, SUBOXONE Film may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.