INDICATION:

Suboxone (buprenorphine and naloxone) Sublingual Film is a prescription medication formulated to address opioid addiction in adults. It plays a pivotal role in a comprehensive treatment program that incorporates counseling and behavioral therapy to help individuals regain control over their lives and overcome opioid dependence.

IMPORTANT SAFETY INFORMATION:

• Child Safety: Ensuring the safety of Suboxone Sublingual Film is paramount, especially in households with children. It is essential to store this medication securely in a location out of children’s sight and reach, inaccessible to anyone else, including visitors to the home. Accidental ingestion of Suboxone Sublingual Film by a child constitutes a medical emergency and can have fatal consequences. In the event that a child inadvertently takes Suboxone Sublingual Film, immediate emergency assistance by calling 911 is crucial. Furthermore, it is advisable to inform your healthcare provider if you reside in a household with small children to ensure awareness of the potential risks.

• Breathing Problems: Suboxone Sublingual Film contains buprenorphine, a potent opioid medication that has the potential to induce severe and life-threatening respiratory complications, particularly when used concomitantly with specific other medications or substances. Engaging in a thorough discussion with your healthcare provider regarding the availability of naloxone is highly recommended. Naloxone serves as an emergency treatment for opioid overdoses, including accidental exposure to Suboxone Sublingual Film by a child. However, it is essential to emphasize that if naloxone is administered, immediate summoning of emergency medical assistance (calling 911) is imperative to manage the overdose or unintended opioid exposure effectively.

• Signs of Breathing Problems: Vigilance is key for individuals using Suboxone Sublingual Film, as recognizing the early signs of respiratory distress is vital. These signs may include feelings of faintness, dizziness, confusion, drowsiness, blurred vision, slurred speech, abnormally slow breathing, cognitive impairment, or difficulties in clear thinking. Should any of these symptoms manifest, prompt medical attention becomes a priority.

• Interactions: The simultaneous use of Suboxone Sublingual Film with other opioid medications, benzodiazepines, alcohol, or other substances that depress the central nervous system (including illicit drugs) can lead to severe drowsiness, reduced consciousness, breathing difficulties, coma, and, in severe cases, fatality. Thus, it is essential to exercise extreme caution and consult with your healthcare provider about potential interactions when using Suboxone Sublingual Film alongside other substances.

• Injection Warning: It is of utmost importance to emphasize that Suboxone Sublingual Film should never be injected or “shot-up.” This improper administration method can result in life-threatening infections and various other serious health problems. Furthermore, injecting Suboxone Sublingual Film may lead to abrupt and severe withdrawal symptoms, including pain, cramps, vomiting, diarrhea, anxiety, sleep disturbances, and intense cravings. Patients must be educated on the dangers of injection and discouraged from engaging in this risky behavior.

• Switching Medicines: Transitioning from Suboxone Sublingual Film to other medications containing buprenorphine should not be undertaken without consulting your healthcare provider. It is important to understand that the dosage of buprenorphine in Suboxone Sublingual Film differs from that in other buprenorphine-containing medications. Therefore, your healthcare provider will carefully determine an appropriate starting dose of Suboxone Sublingual Film, which may differ from the dosage you were previously using with other buprenorphine-containing medications. This differentiation underscores the need for professional guidance and medical supervision during such transitions.

• Discontinuation: Abruptly discontinuing Suboxone Sublingual Film is discouraged, as it can lead to illness and withdrawal symptoms. This occurs because the body has developed a physical dependence on the medication. In emergency situations, family members must inform emergency department staff that the patient is physically dependent on an opioid and undergoing treatment with Suboxone Sublingual Film. This information is crucial for providing appropriate medical care.

• No Sharing: Sharing Suboxone Sublingual Film with others is strictly prohibited. Ingesting Suboxone Sublingual Film without a prescription can be fatal. Distributing or giving it to others is not only dangerous but also illegal. Reports have surfaced of deaths in individuals who were not opioid-dependent but had access to Suboxone Sublingual Film. This underscores the importance of responsible medication use and storage.

Who Should Not Take SUBOXONE Sublingual Film?

• Allergies: Suboxone Sublingual Film should be avoided if there are known allergies to buprenorphine or naloxone. Patients with a history of hypersensitivity to these components must exercise caution and discuss alternative treatment options with their healthcare provider.

• Timing of Use: Initiation of Suboxone Sublingual Film should not occur until the effects of other opioids, such as heroin, hydrocodone, methadone, morphine, or oxycodone, have substantially subsided. Starting Suboxone Sublingual Film too early can trigger withdrawal symptoms, which can be highly uncomfortable and distressing.

• Pre-existing Conditions: Patients must provide comprehensive information to their healthcare provider regarding any pre-existing medical conditions, as this can significantly impact the safety and effectiveness of Suboxone Sublingual Film. Conditions to report include respiratory problems, spinal curvature that affects breathing, Addison’s disease, an enlarged prostate gland (for males), urinary difficulties, liver, kidney, or gallbladder disorders, a history of alcoholism, head injuries or brain disorders, mental health conditions, adrenal or thyroid gland problems, and dental health history.

• Pregnancy and Breastfeeding: Special attention is required for pregnant individuals or those planning to become pregnant while taking Suboxone Sublingual Film. Pregnant women on buprenorphine maintenance therapy may necessitate additional pain relief during labor, and the management of opioid dependence during pregnancy should be carefully monitored by healthcare providers. The use of Suboxone Sublingual Film during pregnancy can result in opioid withdrawal symptoms in the newborn, which, if left unrecognized and untreated, can be life-threatening. Therefore, open and thorough discussions with healthcare providers are vital for individuals who are pregnant or planning to become pregnant. For breastfeeding mothers, consulting a healthcare provider about the best way to feed their baby is important, as Suboxone Sublingual Film can be transmitted through breast milk, potentially affecting the infant. During breastfeeding while on Suboxone Sublingual Film treatment, it is recommended to monitor the baby for increased drowsiness and breathing issues.

• Medication Interaction: To ensure patient safety and therapeutic efficacy, it is imperative to inform the healthcare provider about all medications being taken, including prescription drugs, over-the-counter medications, vitamins, and herbal supplements. Potential interactions and their implications can then be evaluated and managed accordingly.

What to Avoid:

• Activities: Individuals taking Suboxone Sublingual Film should exercise caution and avoid engaging in activities that demand full alertness, concentration, and rapid reactions, such as driving, operating heavy machinery, or other potentially hazardous tasks. This caution stems from the potential side effect of drowsiness induced by buprenorphine, a key component of Suboxone Sublingual Film. Users may experience feelings of sleepiness, dizziness, or lightheadedness, which can pose risks when performing tasks that require vigilance and coordination. It is advisable to gauge one’s individual response to Suboxone Sublingual Film and assess the ability to safely undertake such activities before doing so.

• Alcohol and Alcohol-Containing Products: Consuming alcohol or using medications that contain alcohol is strongly discouraged while taking Suboxone Sublingual Film. Combining Suboxone Sublingual Film with alcohol can lead to severe central nervous system depression, resulting in a heightened risk of adverse effects such as extreme sedation, impaired judgment, loss of consciousness, and even life-threatening respiratory depression. Therefore, individuals on Suboxone Sublingual Film should refrain from alcohol consumption entirely and meticulously check the labels of over-the-counter medications to ensure they do not contain alcohol. To ensure safety, it is important to consult with a healthcare provider before using any medications or substances containing alcohol.

• Benzodiazepines and Sedatives: Avoid concurrent use of Suboxone Sublingual Film with benzodiazepines and other sedative medications, as this combination can potentiate central nervous system depression, leading to severe drowsiness, impaired coordination, and potentially life-threatening respiratory depression. Benzodiazepines are a class of medications commonly used to treat anxiety, insomnia, and certain medical conditions. It is essential for individuals using Suboxone Sublingual Film to inform their healthcare provider about any existing prescriptions for benzodiazepines or sedatives to assess the necessity of alternative treatment options and the potential for interactions.

• Other Opioid Medications: The simultaneous use of Suboxone Sublingual Film with other opioid medications, whether prescription or illicit, is strongly discouraged. This combination can result in excessive sedation, respiratory depression, and an increased risk of overdose. Individuals should inform their healthcare provider of any opioid medications they may be using to determine the most appropriate course of treatment. In cases where alternative medications are needed for pain management or other medical conditions, healthcare providers can work with patients to develop a safe and effective treatment plan.

• Street Drugs and Illicit Substances: Avoid using street drugs or illicit substances while taking Suboxone Sublingual Film. Illicit drugs, including opioids and other central nervous system depressants, can interact with Suboxone Sublingual Film, amplifying the risk of serious side effects, including respiratory depression, loss of consciousness, and overdose. It is essential to prioritize one’s health and well-being by abstaining from the use of illicit substances and seeking professional help if struggling with substance abuse or addiction. Healthcare providers can offer guidance and support in addressing addiction-related concerns.

• Prescription Medications: It is crucial to inform healthcare providers of all prescription medications being taken while using Suboxone Sublingual Film. Certain prescription drugs may interact with Suboxone Sublingual Film, potentially leading to adverse effects or reduced medication efficacy. Healthcare providers can assess these potential interactions and make necessary adjustments to medication regimens to ensure safe and effective treatment. Patients should never discontinue or alter their prescribed medications without consulting their healthcare provider.

• Over-the-Counter Medications and Herbal Supplements: Even over-the-counter medications and herbal supplements have the potential to interact with Suboxone Sublingual Film. To avoid adverse effects and ensure the safe and effective use of Suboxone Sublingual Film, it is essential to discuss the use of all over-the-counter medications, vitamins, and herbal supplements with a healthcare provider. This comprehensive review can help identify potential interactions and inform decisions regarding their continued use.

• Smoking and Tobacco Products: While there is no specific contraindication related to smoking or tobacco use while taking Suboxone Sublingual Film, it is important to consider potential interactions and health implications. Smoking can affect the metabolism and effectiveness of certain medications, potentially impacting the response to Suboxone Sublingual Film. Additionally, smoking has its own health risks, including cardiovascular and respiratory issues. Individuals using Suboxone Sublingual Film who smoke or use tobacco products should discuss this habit with their healthcare provider and explore smoking cessation options if desired.

• Grapefruit and Grapefruit Juice: Some medications can interact with grapefruit and grapefruit juice, affecting their absorption and metabolism in the body. While there is limited information about grapefruit interactions with Suboxone Sublingual Film specifically, it is advisable to exercise caution and consult with a healthcare provider if significant grapefruit consumption is a regular part of one’s diet. Healthcare providers can offer guidance based on individual circumstances and potential interactions.

• High Heat and Humidity: To maintain the stability and effectiveness of Suboxone Sublingual Film, it is important to store the medication in a controlled environment with moderate temperatures and low humidity. Exposure to high heat and humidity can alter the composition and integrity of the film, potentially affecting its efficacy. Therefore, individuals should store Suboxone Sublingual Film according to the provided instructions, ensuring it remains in optimal condition.

• Misuse and Non-Prescribed Use: Suboxone Sublingual Film should only be used as prescribed by a healthcare provider for the intended purpose of opioid addiction treatment. It is imperative to avoid any misuse or non-prescribed use of Suboxone Sublingual Film. Using the medication inappropriately can lead to serious health risks, including overdose and withdrawal symptoms. Patients should always follow their prescribed dosages and administration instructions and promptly report any concerns or questions to their healthcare provider.

Possible Side Effects:

• Suboxone Sublingual Film use may result in a range of side effects, encompassing serious issues such as difficulty breathing when combined with other opioid medications, benzodiazepines, alcohol, or other central nervous system depressants. These respiratory complications can escalate to coma and death, highlighting the importance of adhering to medication instructions and seeking medical guidance.

• Other common side effects include sleepiness, dizziness, and difficulties with coordination. Users may experience physical dependence or exhibit patterns of abuse, mirroring the characteristics of other opioids, whether legally prescribed or illicitly obtained.

• In certain cases, Suboxone Sublingual Film use has been associated with liver problems, characterized by symptoms such as the yellowing of the skin or the white part of the eyes (jaundice), dark or “tea-colored” urine, light-colored stools (bowel movements), loss of appetite, pain, aching, or tenderness on the right side of the abdomen, or nausea. To monitor liver function, healthcare providers should conduct blood tests before initiating and during the course of Suboxone Sublingual Film treatment.

• Allergic reactions are possible, and they may manifest as rashes, hives, swelling of the face, wheezing, low blood pressure, or loss of consciousness. In the presence of such symptoms, immediate medical attention is essential to assess and manage the allergic reaction.

• The discontinuation of Suboxone Sublingual Film may precipitate opioid withdrawal symptoms, including shaking, excessive sweating, temperature fluctuations, runny nose, watery eyes, goosebumps, diarrhea, vomiting, or muscle aches. Patients should be prepared for this possibility and consult with their healthcare provider for guidance on managing withdrawal symptoms.

• A potential decrease in blood pressure may occur, leading to feelings of dizziness when transitioning from a seated or lying position to a standing one. This sensation is known as orthostatic hypotension and should be reported to the healthcare provider if experienced.

• Among the more frequently reported side effects of Suboxone Sublingual Film are headaches, nausea, vomiting, constipation, pain, increased sweating, and insomnia. These side effects can vary in intensity and duration, and patients should communicate with their healthcare provider to manage any discomfort.

• Importantly, Suboxone Sublingual Film may have an impact on fertility in both males and females. Patients concerned about the implications of this on their reproductive health should initiate a conversation with their healthcare provider for personalized guidance and considerations.

• It is essential to understand that this list of side effects is not exhaustive, and individuals using Suboxone Sublingual Film should remain vigilant and communicate with their healthcare provider about any adverse reactions, concerns, or questions they may have.

Reporting Adverse Events:

To ensure ongoing safety monitoring and contribute to the continuous improvement of healthcare, individuals who experience side effects or suspect a pregnancy while using Suboxone Sublingual Film are strongly encouraged to contact their healthcare providers and report these events. Reporting adverse drug reactions to regulatory agencies is crucial for maintaining medication safety and quality. Adverse events can be reported to the U.S. Food and Drug Administration (FDA) through the MedWatch program, accessible at www.fda.gov/medwatch or by calling 1-800-FDA-1088. Additionally, a specific reporting hotline is available at 1-877-782-6966 for reporting pregnancies or side effects associated with Suboxone Sublingual Film.

This detailed and comprehensive overview underscores the critical importance of adhering to safety guidelines when using Suboxone Sublingual Film. It provides a comprehensive understanding of potential risks, interactions, and considerations while emphasizing the necessity of medical supervision and responsible medication use. For personalized guidance and additional information, individuals should consult with their healthcare provider, who can provide tailored recommendations based on their unique circumstances and needs.