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Oxycodone/acetaminophen is associated with a risk of misuse, addiction, overdose, and potentially fatal outcomes. It can cause serious breathing difficulties, which could be life-threatening. To minimize these risks, it is important to take the lowest effective dose for the shortest duration possible as prescribed by your healthcare provider.

• Consider keeping naloxone on hand for emergency treatment of opioid overdose; discuss this with your doctor or pharmacist.
• Educate family or household members on recognizing and responding to signs of an opioid overdose.
• The likelihood of severe breathing problems is increased when starting this medication, after a dosage increase, or if taken incorrectly.
• Avoid combining this medication with alcohol or other substances that induce drowsiness or impair breathing, as serious, even fatal, side effects may occur.
• Certain medications may alter the elimination of oxycodone/acetaminophen from the body, thus affecting its efficacy. Understand the correct usage of this medication and be aware of any drugs to avoid.
• Seek immediate medical attention if you experience symptoms like slow or shallow breathing, extreme lightheadedness, severe drowsiness, dizziness, or trouble waking up.

Store this medication securely to prevent theft, misuse, or abuse. In the event of accidental ingestion, seek medical help promptly.

Acetaminophen, one of the components, can lead to serious, potentially fatal liver damage if too much is consumed. Adults should limit acetaminophen intake to no more than 4,000 milligrams (4 grams) daily. Those with liver issues and children should consume even less. Consult your healthcare provider to determine a safe amount.

• Do not combine with other acetaminophen-containing drugs without consulting your doctor or pharmacist, as acetaminophen is present in many over-the-counter and prescription products.
• Verify medication labels for acetaminophen content, and seek advice from your pharmacist if unsure.
• In the event of an acetaminophen overdose, even if you feel well, seek medical assistance immediately. Symptoms can include nausea, vomiting, lack of appetite, sweating, abdominal pain, extreme fatigue, jaundice, and dark urine.
• Refrain from alcohol consumption as it can exacerbate liver damage, particularly when taken with acetaminophen.

Women of childbearing age should discuss potential risks and benefits with their healthcare provider before using this medication. Inform your doctor if you are pregnant or planning to become pregnant. Use during pregnancy should be limited to essential cases, as there is a slight risk of birth defects if used in the first two months. Prolonged use or high doses near term may harm the unborn child. To reduce risks, use the smallest effective dose for the shortest duration. Newborns whose mothers used this drug long-term may experience severe withdrawal symptoms. Contact a doctor immediately if your newborn shows signs such as persistent crying, slow or shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.

Experiencing nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness is common with this medication. These side effects may lessen as your body adjusts to the treatment. If they persist or become bothersome, consult your healthcare provider. To manage constipation, incorporate dietary fiber, stay hydrated, and maintain regular physical activity. A laxative might be necessary, so ask your pharmacist for a recommendation. To minimize dizziness and lightheadedness, rise slowly from sitting or lying positions.

While serious side effects are less common, they require immediate attention. Contact your healthcare provider if you experience sleep apnea, significant mood changes, severe stomach pain, difficulty urinating, or symptoms indicating adrenal gland issues, such as loss of appetite, unusual fatigue, or weight loss.

In rare instances, severe side effects like fainting, seizures, and shallow breathing can occur, necessitating urgent medical care. Similarly, a serious allergic reaction is rare, but requires immediate help if symptoms like rash, swelling, severe dizziness, or breathing difficulties arise. If you notice any other unusual effects, reach out to your healthcare provider for guidance.

Please refer to the Warning and How to Use sections for more information. This medication may interact with certain other drugs, including specific pain medications like mixed opioid agonist/antagonists (such as butorphanol, nalbuphine, and pentazocine), as well as naltrexone and samidorphan. Combining this medication with other substances that cause drowsiness or breathing issues can increase the risk of serious side effects, such as slow or shallow breathing and severe drowsiness or dizziness. Inform your doctor or pharmacist if you are using other opioid pain or cough medications (like codeine or hydrocodone), alcohol, marijuana (cannabis), sleep or anxiety medications (like alprazolam, lorazepam, or zolpidem), muscle relaxants (like carisoprodol or cyclobenzaprine), or antihistamines (such as cetirizine or diphenhydramine).

Be sure to check the labels on all your medications, including those for allergies or cough-and-cold, as they may contain ingredients that cause drowsiness. Consult your pharmacist on how to use these products safely. Certain medications can affect how oxycodone/acetaminophen is processed in your body, impacting its effectiveness. These include azole antifungals (like ketoconazole), macrolide antibiotics (such as erythromycin), levoketoconazole, mifepristone, HIV medications (such as tipranavir), rifamycins (such as rifabutin and rifampin), ritonavir, and certain seizure medications (like carbamazepine and phenytoin), among others. Additionally, this medication may interfere with certain laboratory tests, such as amylase or lipase levels, potentially causing inaccurate test results. Ensure all your healthcare providers and lab personnel are aware of your medication use.