Ibuprofen / Oxycodone Hydrochloride

What it is and how it works

Oxycodone is a semi-synthetic opioid agonist acting mainly at mu-opioid receptors in the central nervous system to produce analgesia. Ibuprofen inhibits cyclo-oxygenase and prostaglandin synthesis, adding peripheral analgesic and anti-inflammatory effects.

Indications

Short-term (generally no more than 7 days) management of acute moderate to severe pain, such as post-operative pain, where an opioid is considered appropriate.

Dosage and administration (summary)

Typically 1 tablet (oxycodone 5 mg / ibuprofen 400 mg) orally every 6 hours as needed, not exceeding 4 tablets in 24 hours and not for longer than 7 days.

Contraindications

Significant respiratory depression, acute or severe bronchial asthma, paralytic ileus or gastrointestinal obstruction; active peptic ulcer or gastrointestinal bleeding; NSAID or aspirin hypersensitivity; severe heart, hepatic or renal failure; peri-operative pain in coronary artery bypass graft surgery; third trimester of pregnancy.

Warnings and precautions

Risk of addiction, abuse, misuse and life-threatening respiratory depression, particularly when combined with benzodiazepines, alcohol or other CNS depressants; CYP3A4 inhibitors increase oxycodone exposure. NSAID-related gastrointestinal bleeding, cardiovascular and renal risks apply. Drowsiness impairs ability to drive.

Pregnancy

Avoid; prolonged opioid use may cause neonatal opioid withdrawal and the NSAID component is contraindicated in the third trimester.

Storage and supply

Store below 25 °C, in a secure place as a controlled drug.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.