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Please take a moment to review the following important safety information regarding the use of this medication. It is essential to understand these risks and precautions to ensure safe usage. Consult your healthcare provider if you have any questions or concerns.

• Risk of Addiction and Misuse: Oxycodone is a controlled substance with a potential for addiction and misuse. Use it strictly as prescribed. Do not alter the dosage or frequency without consulting your healthcare provider. Individuals with a personal or family history of substance use disorder or mental health issues may be at higher risk.

• Respiratory Depression: Oxycodone can cause dangerously slow breathing, which can be life-threatening, even at recommended doses. The risk is heightened when starting the medication or increasing the dose, and for those taking medications that depress breathing, consuming alcohol, or having conditions like COPD, asthma, or a head injury.

• Opioid Overdose Risk: Follow the prescription exactly to avoid overdose. Keep oxycodone out of reach of children, pets, and visitors to prevent accidental ingestion. The risk is elevated for individuals with a history of opioid use disorder or previous overdose, those taking high doses, and those consuming alcohol.

• Impaired Concentration and Drowsiness: Oxycodone may cause extreme drowsiness and impair your ability to concentrate. Avoid alcohol and other medications that cause drowsiness, such as benzodiazepines, muscle relaxants, and sleep aids, as these effects may increase.

• Drug Interactions: Oxycodone interacts with various medications. Inform your healthcare team about all medications you are taking to ensure compatibility. Do not make any changes to your medication regimen without consulting your healthcare provider.

• Harm to Newborns: Long-term use during pregnancy can lead to newborn dependency due to oxycodone passing through the placenta.

• Physical Dependence and Withdrawal: Regular long-term use can lead to physical dependence, resulting in withdrawal symptoms such as anxiety, restlessness, and sweating if the medication is stopped suddenly or the dose is reduced quickly.

• Low Blood Pressure: Oxycodone may cause significant drops in blood pressure, particularly when standing up from a seated or lying position, leading to dizziness or fainting. Rise slowly to avoid these effects.

• Low Adrenal Hormone Levels: Long-term use may lead to reduced adrenal hormone levels, causing symptoms like fatigue and nausea. Consult your healthcare provider if you experience these symptoms.

• Seizures: Oxycodone may increase seizure risk, especially in those with a history of seizures. Seek medical help immediately if a seizure occurs during your treatment.

Contraindications: Oxycodone should not be used under the following conditions due to potential serious health risks:

• Severe respiratory depression
• Severe asthma
• Blockage in the stomach passageway
• Allergy to oxycodone

If any of these conditions apply to you, please discuss them with your healthcare provider before using this medication.

When taking Roxicodone, it's crucial to be aware of potential interactions with other substances, as these can significantly impact your health and the effectiveness of the medication.

Central Nervous System (CNS) Depressants: Combining Roxicodone with other CNS depressants—such as benzodiazepines, sedatives, tranquilizers, muscle relaxants, antipsychotics, other opioids, or alcohol—can lead to severe side effects. These may include profound sedation, respiratory depression, coma, and even death. It's essential to inform your healthcare provider about all medications and substances you're using to avoid these dangerous interactions.

Cytochrome P450 3A4 Inhibitors and Inducers: Roxicodone is metabolized in the liver by an enzyme called CYP3A4. Certain medications can affect this enzyme's activity:

• Inhibitors (e.g., macrolide antibiotics like Erythromycin, azole antifungals like Ketoconazole, and protease inhibitors like Ritonavir) can increase oxycodone levels in your blood, potentially leading to enhanced or prolonged effects, including respiratory depression.

• Inducers (e.g., Rifampin, Carbamazepine, Phenytoin) can decrease oxycodone levels, reducing its effectiveness and possibly causing withdrawal symptoms in individuals dependent on opioids.

Always discuss any new medications with your healthcare provider to manage these interactions appropriately.

Serotonergic Drugs: Using Roxicodone alongside medications that influence serotonin levels—such as certain antidepressants (SSRIs, SNRIs, TCAs), triptans, and others—can increase the risk of serotonin syndrome. This rare but serious condition may present with symptoms like confusion, hallucinations, rapid heartbeat, high blood pressure, fever, sweating, shivering, tremors, muscle stiffness, nausea, vomiting, or diarrhea. Seek immediate medical attention if you experience any of these symptoms.

Monoamine Oxidase Inhibitors (MAOIs): Combining Roxicodone with MAOIs (e.g., phenelzine, Tranylcypromine, Linezolid) can lead to severe reactions, including serotonin syndrome or opioid toxicity. It's recommended to avoid using Roxicodone if you're currently taking MAOIs or have taken them within the past 14 days.

Muscle Relaxants: Concurrent use of Roxicodone and muscle relaxants may enhance the effects of both drugs, leading to increased respiratory depression. Your healthcare provider may need to adjust dosages and monitor you closely if these medications are used together.

Alcohol and Grapefruit Juice: Avoid consuming alcohol while taking Roxicodone, as it can intensify side effects like drowsiness, dizziness, and respiratory depression. Additionally, grapefruit juice can increase oxycodone levels in your blood, potentially leading to enhanced effects and side effects. It's advisable to limit or avoid grapefruit juice during your treatment.

Cannabis: Using cannabis while on Roxicodone can amplify central nervous system depression, leading to increased drowsiness, dizziness, and respiratory issues. It's best to avoid cannabis use during your treatment with Roxicodone.

Always inform your healthcare provider about all medications, supplements, and substances you're using to ensure safe and effective treatment with Roxicodone.