Acetaminophen 325 mg + Oxycodone 5 mg

Oxycodone  + Acetaminophen is a combination of Acetaminophen 325 mg and Oxycodone immediate-release (at different dosages: 5,10mg) formulation; has a synergistic mechanism of action, and produces an analgesic effect greater than that obtained by doubling the dose of either constituent administered alone.

Oxycodone is a semisynthetic opiate partial agonist derived from the opioid alkaloid, thebaine. Oxycodone is used to control moderate to severe pain. It is available as immediate-release tablets (IR), extended-release (ER), and in combination with acetaminophen. Oxycodone undergoes low first-pass metabolism and has a higher bioavailability (60%-87%) compared with morphine. It is slightly more potent than morphine (Oral Oxycodone is roughly 1.5 times more potent than oral morphine).

Therapeutic Fields​ of Acetaminophen 325 mg + Oxycodone 5 mg

Effective Combination for Add-on Therapy and Rescue Dose
As an adjutant therapy if necessary

Rescue dose for Breakthrough Pain (BTP)

High potency due to its synergistic effect

Oxycodone  + Acetaminophen 325 mg is an Excellent Choice for the Relief of Moderate-to-Severe Pain

• Useful in Patients nonresponsive to NSAIDs or Acetaminophen alone.
• Double central analgesic mechanism of action and rapid pain
• Fewer adverse effects in comparison with either agent as monotherapy (at equivalent dosages).
• Possible to individually titrate the dose based on analgesic response (absence of ceiling effect).

Chronic Cancer Pain

Chronic low Back Pain

Chronic Osteoarthritic Pain

Postoperative Pain

Rheumatoid Arthritic Pain

Neuropathic Pain

Clinical Research

Oral OXYCODONE is as effective as IV Morphine Sulfate (MS) in the Management of Acute Pain Following limb trauma

Based on a clinical trial performed in 2018 there was no significant difference between the two groups regarding the decrease in pain within 0, 30, and 60 minutes after administration of either 5mg IV MS or 5mg oral oxycodone. Drowsiness was reported more frequently in the MS group after 30 minutes. Eight participants asked for rescue analgesia in the MS group, while only one patient asked for more analgesia in the oxycodone group. Other adverse effects were similar in both groups.​

Calculating Total Daily Dose of OXYCODONE for Safer Dosage

Calculating total daily doses of opioids is important to appropriately and effectively prescribe, manage, and taper opioid medications. Patients prescribed higher opioid dosages are at higher risk of overdose death. The daily dose calculation of new opioids is as follows.

Total Daily Dose of New Opioid

The obtained total daily dose divided by 2 is for OXYCODONE ER and divided by 4 is for OXYCODONE IR. These dose conversions are estimated and cannot account for all individual differences in genetics and pharmacokinetics.

Dosing Acetaminophen 325 mg + Oxycodone 5 mg

Moderate pain & severe pain

Pediatrics: Oral Initial dose: 0.1 to 0.2 mg/kg/dose every 4-6 hours as needed.

Adults: 5mg every 4 to 6 hours

Pediatrics: 0.2mg/kg/dose every 4-6 hours

Adults: 10-20mg every 4-6 hours

Note: The initial dose is based on the oxycodone content

Administration

Maximum Dose

Based on the Acetaminophen content.

Contraindication

• Hypersensitivity to oxycodone or other
• Patients with circulatory shock and
• Significant respiratory depression, acute or severe bronchial asthma, moderate to severe sleep disorder
• Known or suspected paralytic ileus and gastrointestinal
• not recommended during pregnancy and breast

Warning and Precautions

• Use with caution: in CNS depression, Severe hypotension, Respiratory depression, Seizures, Constipation, Mental health conditions, Obesity, Thyroid dysfunction, adrenal insufficiency, Prostatic hyperplasia/urinary stricture, acute alcoholism, underlying GI disorders, difficulty in swallowing, Pancreatic and Biliary disease, Head trauma, Hepatic and renal impairment G6PD deficiency.
• Cytochrome P450 3A4 inhibitors: The concomitant use may increase in oxycodone plasma
• Hepatotoxicity: Most of the cases of liver injury are associated with the use of Acetaminophen at doses that exceed 4g/day in
• Skin reactions: Discontinue therapy at the first appearance of skin rash.

Drug Interactions

• Risk X: Abametapir, Azelastine (Nasal), Bromperidol, Eluxadoline, Fusidic Acid, MAOls, opioids (Mixed Agonist/ Antagonist), Orphenadrine, paraldehyde, Samidorphan,
• SSRls, SNRls, MAOls, 5-HT1, 3 receptor antagonists, Buspirone, Dextromethorphan, Lithium, Cyclobenzaprine, linezolid, John’s wort: concomitant use may cause serotonin syndrome.
• CNS depressants (other opioid analgesics, general anesthetics, phenothiazines, tranquilizers, centrally-acting anti-emetics, sedative-hypnotics, and alcohol): concomitant use may cause hypotension, respiratory depression, coma and

Side Effects

• Drowsiness, headache, dizziness, Pruritus, Nausea, constipation, vomiting, Fever.