What is Suboxone?
Suboxone 8mg contains a combination of buprenorphine and naloxone. Buprenorphine is an opioid medication, sometimes called a narcotic.
Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.
Suboxone is used to treat narcotic (opiate) addiction.
Suboxone 8mg is not for use as a pain medication.
Suboxone 8mg can slow or stop your breathing, and may be habit-forming.
Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Addiction, Abuse, And Misuse
SUBOXONE 8mg sublingual film contains buprenorphine, a schedule III controlled substance that can be abused in a manner similar to other opioids, legal or illicit.
Prescribe and dispense buprenorphine with appropriate precautions to minimize risk of misuse, abuse, or diversion, and ensure appropriate protection from theft, including in the home.
Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.
Risk Of Life-Threatening Respiratory And Central Nervous System (CNS) Depression
Buprenorphine has been associated with life-threatening respiratory depression and death. Many, but not all, post-marketing reports regarding coma and death involved misuse by self-injection or were associated with the concomitant use of buprenorphine and benzodiazepines or other CNS depressants, including alcohol.
The manifestations of acute overdose include pinpoint pupils, sedation, hypotension, respiratory depression, and death.
Treatment Of Overdose
In the event of overdose, the respiratory and cardiac status of the patient should be monitored carefully. When respiratory or cardiac functions are depressed, primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation.
Oxygen, IV fluids, vasopressors, and other supportive measures should be employed as indicated.
In the case of overdose, the primary management should be the re-establishment of adequate ventilation with mechanical assistance of respiration, if required.
Naloxone may be of value for the management of buprenorphine overdose. Higher than normal doses and repeated administration may be necessary. The long duration of action of SUBOXONE sublingual film should be taken into consideration when determining the length of treatment and medical surveillance needed to reverse the effects of an overdose. Insufficient duration of monitoring may put patients at risk.
The following serious adverse reactions are described elsewhere in the labeling:
Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
Respiratory and CNS Depression [see WARNINGS AND PRECAUTIONS]
Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
Opioid Withdrawal [see WARNINGS AND PRECAUTIONS]
Hepatitis, Hepatic Events [see WARNINGS AND PRECAUTIONS]
Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
Elevation of Cerebrospinal Fluid Pressure [see WARNINGS AND PRECAUTIONS]
Elevation of Intracholedochal Pressure [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of SUBOXONE 8mg sublingual film is supported by clinical trials using buprenorphine sublingual tablets and SUBOXONE (buprenorphine and naloxone) sublingual tablets, and other trials using buprenorphine sublingual solutions, as well as an open-label study in 194 patients treated with SUBOXONE 8mg sublingual film administered sublingually and 188 patients treated with the film administered buccally.
In total, safety data from clinical studies are available from over 3000 opioid-dependent subjects exposed to buprenorphine at doses in the range used in the treatment of opioid dependence.
Few differences in the adverse event profile were noted with regard to sublingually and buccally administered SUBOXONE sublingual film, SUBOXONE sublingual tablets, SUBUTEX sublingual tablets and a buprenorphine ethanolic sublingual solution.
The most common adverse event (>1%) associated with the sublingual administration of the SUBOXONE sublingual film was oral hypoesthesia. Other adverse events were constipation, glossodynia, oral mucosal erythema, vomiting, intoxication, disturbance in attention, palpitations, insomnia, withdrawal syndrome, hyperhidrosis, and blurred vision.
The most common adverse events associated with the buccal administration were similar to those observed with sublingual administration of the film.
Before taking Suboxone 8mg
You should not use Suboxone 8mg if you are allergic to buprenorphine or naloxone.
To make sure Suboxone is safe for you, tell your doctor if you have ever had:
Breathing problems, sleep apnea;
Enlarged prostate, urination problems;
Liver or kidney disease;
Abnormal curvature of the spine that affects breathing;
Problems with your gallbladder, adrenal gland, or thyroid;
A head injury, brain tumor, or seizures;
Alcoholism or drug addiction.
If you use Suboxone 8mg while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.
Ask a doctor before using Suboxone 8mg if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.