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The following information highlights crucial safety warnings and precautions for the use of Trezix. Carefully consider these details and consult your healthcare provider with any concerns.

• Addiction, Abuse, and Misuse: Trezix poses a risk of addiction, abuse, and misuse, even when taken as prescribed. Misuse or excessive use can lead to overdose and potentially fatal consequences. To minimize this risk, your healthcare provider will prescribe the minimum effective dose for the shortest duration. Increased risk for individuals with a personal or family history of substance abuse and those with mental health conditions.

• Respiratory Depression: Trezix may cause dangerously slowed or irregular breathing. This risk is heightened at the start of treatment or after a dose increase and can occur even at prescribed doses. Immediate medical attention is necessary if symptoms such as shortness of breath or bluish extremities appear. Higher risk for individuals over 65, those with COPD, or taking sedatives.

• Overdose: Overdose can occur from taking Trezix as prescribed, incorrect dose conversion from another opioid, or accidental ingestion by others. Overdose symptoms necessitate urgent treatment to prevent fatal outcomes. Increased risk for those with a history of opioid use disorder, concurrent use of sedatives, or alcohol consumption.

• Child Safety: Trezix is particularly dangerous for children, who are more susceptible to life-threatening respiratory depression and overdose. It should not be given to children under 12 or those under 18 who have recently had tonsil or adenoid surgery. Keep this medication out of reach of children and seek emergency help if accidental ingestion occurs.

• Liver Damage: Trezix contains acetaminophen, and exceeding the daily limit of 3 to 4 grams can cause liver harm. Consult your healthcare provider for your daily acetaminophen limit, especially if you have a history of liver issues or consume alcohol.

• Drug Interactions: Certain medications can alter the effectiveness and safety of Trezix. Discuss all medications you are taking with your healthcare provider to avoid adverse interactions.

• Pregnancy and Newborn Risk: Opioids can harm an unborn baby, leading to neonatal opioid withdrawal syndrome, which is potentially life-threatening. Inform your healthcare provider if you have used Trezix during pregnancy.

• Breastfeeding: Dihydrocodeine in Trezix can transfer to breast milk, posing a risk of severe respiratory issues and death in infants. Alternative pain relief options should be considered for breastfeeding individuals.

• Concentration and Sleepiness: Trezix may cause significant drowsiness and impair concentration. Avoid alcohol and other sedatives, and assess your response to the medication before engaging in tasks requiring alertness.

• Dependence and Withdrawal: Long-term use can lead to physical dependence and withdrawal symptoms if stopped abruptly. Consult your provider before making any changes to your dosage.

• Serotonin Syndrome: Combining Trezix with drugs that increase serotonin can cause serotonin syndrome, a serious condition. If symptoms such as hallucinations or high fever occur, seek immediate medical care.

• Hormonal Effects: Chronic use of opioids can lead to decreased hormone levels, manifesting as nausea, fatigue, or dizziness. Report these symptoms to your healthcare provider.

• Seizures: Trezix may increase seizure frequency in susceptible individuals. Inform your provider if you experience seizures while on this medication.

Contraindications: Do not use Trezix if you are:

• Under 12 years of age
• Under 18 years with recent tonsil or adenoid surgery
• Experiencing severe respiratory depression
• Suffering from severe asthma
• Having a stomach blockage

Always discuss your medical history and any concerns with your healthcare provider to ensure the safe use of Trezix.

When taking Trezix, it's important to be aware of potential interactions with other substances, as these can affect how the medication works and may lead to serious side effects. Here are some key interactions to consider:

Central Nervous System (CNS) Depressants: Combining Trezix with other medications that depress the central nervous system, such as benzodiazepines, sedatives, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, or other opioids, can increase the risk of profound sedation, respiratory depression, coma, and even death. Alcohol also falls into this category and should be avoided while taking Trezix.

Serotonergic Drugs: Using Trezix alongside medications that affect serotonin levels, like certain antidepressants (SSRIs, SNRIs, TCAs), migraine treatments (triptans), or other serotonergic drugs, may lead to serotonin syndrome. This rare but serious condition can cause symptoms such as confusion, hallucinations, rapid heartbeat, high blood pressure, fever, sweating, shivering, tremors, muscle stiffness, nausea, vomiting, and diarrhea. If you experience any of these symptoms, seek medical attention immediately.

Monoamine Oxidase Inhibitors (MAOIs): Taking Trezix with MAOIs, a class of antidepressants, can cause dangerous interactions, including severe high blood pressure and central nervous system excitation. It's recommended to avoid using Trezix if you are currently taking MAOIs or have taken them within the past 14 days.

CYP450 Enzyme Interactions: Trezix contains dihydrocodeine, which is metabolized by liver enzymes CYP2D6 and CYP3A4. Medications that inhibit or induce these enzymes can alter the effectiveness and safety of Trezix. For example:

• CYP2D6 Inhibitors: Drugs like quinidine, Fluoxetine, paroxetine, and bupropion can increase dihydrocodeine levels but decrease its active metabolite, potentially reducing pain relief or causing withdrawal symptoms.

• CYP3A4 Inhibitors: Medications such as Erythromycin, Ketoconazole, and Ritonavir can raise dihydrocodeine levels, increasing the risk of serious side effects like respiratory depression.

• CYP3A4 Inducers: Drugs like Rifampin, Carbamazepine, and Phenytoin can lower dihydrocodeine levels, possibly leading to decreased effectiveness or withdrawal symptoms.

Acetaminophen Considerations: Trezix contains acetaminophen, and taking other acetaminophen-containing products concurrently can increase the risk of liver damage. Be cautious with over-the-counter medications, as many contain acetaminophen. Additionally, chronic and excessive alcohol consumption can heighten the risk of liver toxicity when combined with acetaminophen.

Caffeine Interactions: The caffeine in Trezix can interact with certain medications. For instance, it may enhance the effects of beta-adrenergic stimulants, and its clearance can be reduced when taken with Disulfiram. Consuming large amounts of caffeine from other sources while taking Trezix can lead to side effects like nervousness, irritability, and insomnia.

Always inform your healthcare provider about all medications, supplements, and substances you are currently using to ensure safe and effective use of Trezix.