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The following safety information outlines important warnings and precautions for the use of Zubsolv (buprenorphine/naloxone). It is critical to understand these risks and consult your healthcare provider if you have any concerns.

• Addiction and Misuse Risk: Zubsolv contains buprenorphine, a schedule III controlled substance, which can lead to misuse and dependence. Misuse may result in addiction, severely slow breathing, or overdose. Always take Zubsolv as prescribed and consult your healthcare provider before making any changes to your dosage. Those with a history of alcohol or substance use disorder are at increased risk.

• Respiratory Depression: Buprenorphine can cause life-threatening slowed breathing, especially when combined with substances like alcohol, benzodiazepines, or other opioids. Individuals over 65, those with COPD, or other conditions that affect breathing should exercise caution.

• Opioid Overdose Risk: Patients being treated for opioid use disorder may relapse and are at risk for opioid overdose. Overdose risks are present even at prescribed doses and are heightened with higher doses, sedatives, alcohol, and in children.

• Cognitive Impairment: Extreme sleepiness and impaired concentration can occur with Zubsolv. Alcohol and other medications that depress the central nervous system may exacerbate these effects. Elderly individuals are at heightened risk.

• Pregnancy and Newborn Risk: Long-term use during pregnancy can lead to dependency in the unborn child. Consult your healthcare provider if you are pregnant or planning to become pregnant.

• Adrenal Insufficiency: Prolonged use (over one month) may result in low adrenal hormone levels, marked by symptoms like nausea, fatigue, and dizziness. Immediate medical attention may be required, potentially needing corticosteroid treatment.

• Withdrawal Symptoms: Long-term use may lead to physical dependence, causing withdrawal symptoms upon rapid dose reduction or cessation. Symptoms include anxiety, irritability, and physical discomfort.

• Liver Damage: Liver damage has been reported with buprenorphine use. Regular liver function tests are recommended, especially for those with a history of liver damage or hepatitis.

• Dental Issues: Use of buprenorphine dissolved in the mouth has been associated with dental problems such as cavities and tooth loss.

• Heart Rhythm Concerns (QT Prolongation): Buprenorphine may cause QT prolongation, leading to potential heart rhythm issues. Individuals with existing heart conditions should be cautious.

• Hypotension: Zubsolv can cause low blood pressure, leading to dizziness or fainting. Rising slowly from sitting or lying positions can help mitigate these effects.

• Not for Opioid-Naïve Individuals or Pain Management: Zubsolv is not intended for those who have not used opioids previously or for pain relief, as it may result in fatal overdose.

Contraindications include severe allergies to buprenorphine or naloxone. Always consult your healthcare provider before starting Zubsolv if any of these conditions apply to you.

When taking this medication, some people may experience mild side effects such as drowsiness, dizziness, constipation, or headaches. These are generally manageable, and incorporating dietary fiber, adequate hydration, and regular exercise can help prevent constipation. To minimize dizziness, rise slowly from sitting or lying positions. While these effects are common, they usually do not require medical intervention unless they persist or worsen.

On the more serious side, there are potential severe side effects that necessitate immediate medical attention. These include interrupted breathing during sleep, severe mood changes like agitation or hallucinations, abdominal pain, or symptoms of adrenal insufficiency such as unusual tiredness or weight loss. This medication can also lead to opioid withdrawal symptoms, particularly if you have been using long-acting opioids like methadone. Symptoms might include anxiety, muscle stiffness, or trouble sleeping.

Very serious effects, though rare, include fainting, irregular heartbeat, severe dizziness, and significant breathing problems. Signs of potential liver damage, such as persistent nausea, dark urine, or yellowing of the skin and eyes, also require urgent care. Additionally, although rare, serious allergic reactions can occur, presenting as a rash, swelling, or trouble breathing.

Nausea and vomiting have been reported by some users, and while these are less common, they should be monitored. If any of these effects occur, consult your healthcare provider promptly to ensure your safety and well-being.

When using Zubsolv (Buprenorphine/Naloxone), there is a potential for interactions with various other medications and substances. It is important to inform your doctor or pharmacist about all other prescriptions, over-the-counter medications, and supplements you are taking.

Certain medications, such as bepridil, cisapride, dronedarone, Fluconazole, Ketoconazole, mesoridazine, nalmefene, Naltrexone, Pimozide, piperaquine, Posaconazole, safinamide, saquinavir, sparfloxacin, and terfenadine, should generally be avoided with Zubsolv. Your doctor might choose alternative treatments or adjust your medication plan if these are involved.

Other drugs, including opioid agonist-antagonists (like Butorphanol, Nalbuphine, pentazocine), alcohol, marijuana, antihistamines (such as Cetirizine, diphenhydramine), medications for sleep or anxiety (such as Alprazolam, Diazepam, Zolpidem), muscle relaxants (such as Carisoprodol, Cyclobenzaprine), and additional opioid pain relievers (like codeine, hydrocodone), could increase the risk of severe side effects such as slow or shallow breathing, marked drowsiness, or dizziness.

Special caution should be taken with benzodiazepines (e.g., diazepam) and other central nervous system depressants, as misuse or misuse involving injection, particularly when combined with these substances, has been associated with fatalities.

Additionally, using Zubsolv with medications like Clonidine or yohimbine may raise the risk of specific side effects. Your healthcare provider may need to adjust dosages or monitor you more closely if these combinations are necessary for your treatment.

Always check the labels of all your medications for ingredients that may cause drowsiness and consult with your pharmacist to ensure safe usage.