PROLATE HB 120ML SYP

Acetaminophen, Oxycodone hydrochloride syrup/suspension has a dual mechanism of action. Oxycodone, an opioid agonist, binds to mu-opioid receptors in the central nervous system, reducing the perception of pain and eliciting analgesic effects. It modifies pain perception and emotional responses to pain by inhibiting ascending pain pathways. Acetaminophen, on the other hand, has analgesic and antipyretic properties. While its exact mechanism is not fully understood, it is believed to inhibit the synthesis of prostaglandins, which play a role in pain and inflammation. This combination allows for enhanced pain relief, with acetaminophen targeting peripheral pain sites and oxycodone acting centrally to provide more comprehensive analgesia.

Acetaminophen, Oxycodone hydrochloride

Opioid-analgesic combination

Suspension

The following are the uses of Acetaminophen, Oxycodone hydrochloride Syrup/Suspension:

• Used for relieving severe pain associated with conditions like cancer or post-surgical pain.
• Used for managing pain that is not adequately controlled by other opioid medications.
• Used to treat breakthrough pain in patients already on chronic opioid therapy.
• Used for providing extended pain relief due to its long-acting properties.
• Used to alleviate pain and improve quality of life in palliative care settings.
• Used under careful medical supervision to minimize risks and optimize benefits.
• Used as part of a comprehensive pain management plan tailored to individual needs.

In the case of an overdose of Acetaminophen and Oxycodone hydrochloride Syrup/Suspension, prompt medical attention is necessary. Symptoms may include nausea, vomiting, drowsiness, and in severe cases, liver damage or respiratory depression. Treatment involves supportive care, with the focus on managing symptoms and ensuring the patient's vital signs are stable. Quick action can prevent serious complications, and healthcare professionals should be contacted immediately for guidance and treatment options.

In the case of a missed dose of Acetaminophen, Oxycodone hydrochloride Syrup/Suspension, it is generally recommended to take the missed dose as soon as you remember. However, if it is almost time for the next scheduled dose, skip the missed dose and continue with your regular dosing schedule. It is important not to double the dose to make up for a missed one, as this may increase the risk of side effects. If you miss multiple doses, contact your healthcare provider for guidance on how to safely resume your medication regimen.

To administer the Acetaminophen, Oxycodone hydrochloride Syrup/Suspension, shake the bottle well, use an oral syringe or dosing cup to measure the prescribed amount, and take it orally as directed by your healthcare professional, typically every 4 to 6 hours or as needed for pain relief, without exceeding the maximum daily dose.

Following are the conditions/situations when Acetaminophen and Oxycodone Hydrochloride Syrup/Suspension should not be used:

• Should not be used in individuals with a known allergy or hypersensitivity to acetaminophen, oxycodone, or any other ingredients in the medication.
• Contraindicated in patients with severe respiratory depression or asthma, as it can worsen breathing difficulties.
• Not suitable for individuals with paralytic ileus or severe intestinal obstruction.
• Should not be used in patients with acute or severe liver impairment, as it can lead to liver toxicity.
• Contraindicated in individuals currently using or have recently used Monoamine Oxidase Inhibitors (MAOIs).
• Not recommended for patients with a history of head injuries or increased intracranial pressure.
• Should be avoided in patients with severe hypotension (low blood pressure) or hypovolemia.
• Not suitable for individuals with known or suspected gastrointestinal obstruction, including paralytic ileus.
• Should not be used in patients with a history of seizures or conditions that lower the seizure threshold.
• Contraindicated in women who are breastfeeding, as oxycodone can pass into breast milk.

The side effects of Acetaminophen, Oxycodone hydrochloride Syrup/Suspension may include:

• Nausea and vomiting
• Dizziness or lightheadedness
• Constipation
• Dry mouth
• Sweating
• Itching
• Sedation or drowsiness
• Respiratory depression (difficulty breathing)

Following are the precautions and warnings for Acetaminophen, Oxycodone hydrochloride Syrup/Suspension:

• Do not exceed the recommended dosage, as it may lead to liver damage or respiratory depression.
• This medication contains acetaminophen, which can cause severe liver damage if taken in excess. Avoid other medications containing acetaminophen to prevent overdose.
• Oxycodone can be habit-forming. Use only as directed and do not increase your dose without medical advice.
• Do not use this medication if you have a known allergy to acetaminophen or oxycodone hydrochloride.
• Patients with a history of respiratory issues, such as asthma or COPD, should use this medication with caution as it can suppress breathing.
• It may impair your thinking or reactions, so avoid driving or operating heavy machinery until you know how this medicine affects you.
• Elderly patients may be more sensitive to the side effects of this medication, especially breathing problems.
• Inform your doctor about all the medications you are currently taking to avoid potential drug interactions.

Following are the drug interactions for Acetaminophen, Oxycodone hydrochloride Syrup/Suspension:

• Alcohol and other central nervous system depressants (e.g., benzodiazepines, barbiturates) can increase sedation and respiratory depression, potentially leading to serious adverse events.
• The risk of liver toxicity may be elevated when taken with other medications containing acetaminophen, or with substances that are metabolized by the liver, such as alcohol.
• Monoamine oxidase inhibitors (MAOIs) should be avoided due to the potential for serious, possibly fatal, drug interactions.
• Opioid antagonists, such as naloxone or naltrexone, can displace oxycodone from its receptors, reducing its analgesic effects.
• Certain antidepressants (e.g., SSRIs, SNRIs) may increase the risk of serotonin syndrome when used concurrently.
• Drugs that inhibit CYP3A4 enzyme activity may increase oxycodone levels, enhancing its effects and side effects.
• Oxycodone may increase the blood levels of other opioids, sedatives, or muscle relaxants, leading to enhanced respiratory depression.

Following are the food interactions for Acetaminophen, Oxycodone hydrochloride Syrup/Suspension:

• Grapefruit and grapefruit juice should be avoided as they may interfere with the metabolism of the medication, potentially leading to increased drug levels in the body and a higher risk of side effects.
• Alcohol consumption should be minimized or avoided as it can enhance the sedative effects of Oxycodone, leading to increased drowsiness, impaired coordination, and respiratory depression.
• High-fat meals may slightly delay the absorption of Oxycodone, but it generally does not significantly impact the overall effectiveness of the medication.
• Avoid caffeine-rich foods and beverages as they may interact with the pain-relieving effects of Acetaminophen and increase the risk of liver-related issues when consumed in excess.
• Consuming cranberry juice or foods high in salicylates (e.g., strawberries, tomatoes, spices) may increase the risk of bleeding when taken with Acetaminophen, especially in high doses.
• Avoid excessive consumption of foods rich in tyramine (aged cheeses, cured meats, fermented foods) as they can potentially interact with Oxycodone and increase blood pressure.
• It is generally recommended to maintain a balanced diet and stay well-hydrated when taking this medication to support overall health and medication effectiveness.
• Always consult your healthcare provider for personalized advice regarding specific food interactions and dietary recommendations.

Acetaminophen, Oxycodone hydrochloride Syrup/Suspension should be stored with caution, preferably in a secure, locked cabinet at room temperature, away from direct sunlight and moisture. It is crucial to keep the medication in its original container, tightly sealed, to maintain its integrity and prevent contamination. Avoid extreme temperatures, such as storing it in the refrigerator or leaving it in a hot car, as this can impact the medication's effectiveness. Always check the expiration date, and if the medication is expired or no longer needed, proper disposal is essential. Contact your pharmacist or healthcare professional for guidance on safe disposal methods, ensuring it is not poured down the drain or flushed, as this can cause environmental harm. Keep the medication away from children to prevent accidental consumption.

Following are the quick tips for Acetaminophen, Oxycodone hydrochloride Syrup/Suspension:

• Always follow your healthcare provider's instructions for dosage and administration.
• Measure the syrup accurately using the provided measuring device.
• Do not exceed the recommended dosage, as it may lead to serious side effects.
• Store the medication at room temperature, away from direct sunlight and moisture.
• Keep a record of your medication intake to track your usage.
• Inform your doctor about any other medications you are taking to avoid potential interactions.
• Do not share your medication with others, as it is prescribed specifically for your condition.