Acetaminophen / Ibuprofen

What it is and how it works

Mechanism of Action COMBOGESIC IV contains acetaminophen and ibuprofen as active drug substances. Acetaminophen is a non-opiate, non-salicylate analgesic. The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to primarily involve central actions. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Its mechanism of action for analgesia, like that of other NSAIDs, is not completely understood, but involves inhibition of cyclooxygenase (COX-1 and COX-2). Ibuprofen is a potent inhibitor of prostaglandin synthesis in vitro. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models.

Mechanism class: Cyclooxygenase Inhibitors

Indications

is indicated in adults where an intravenous route of administration is considered clinically necessary for: • the relief of mild to moderate pain • the management of moderate to severe pain as an adjunct to opioid analgesics Limitations of Use COMBOGESIC IV is indicated for short-term use of five days or less. COMBOGESIC IV is indicated in adults where an intravenous route of administration is considered clinically necessary for: • the relief of mild to moderate pain • the management of moderate to severe pain as an adjunct to opioid analgesics Limitations of Use COMBOGESIC IV is indicated for short-term use of five days or less.

Dosage and administration (summary)

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. . • Do not exceed the maximum total daily dose of COMBOGESIC IV (4,000 mg acetaminophen and 1,200 mg ibuprofen) in 24 hours. • Do not exceed a total daily dose of 4,000 mg (4 g) of acetaminophen from all sources. • Do not administer with other acetaminophen-containing products. • For adult patients weighing greater than or equal to 50 kg (actual body weight): The recommended dosage is 1,000 mg of acetaminophen and 300 mg of ibuprofen administered as a 15-minute infusion, every 6 hours, as necessary .

Contraindications

is contraindicated in: • patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to acetaminophen, ibuprofen, other NSAIDs or to any other components of this product • patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

Warnings and precautions

• Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. • Heart Failure and Edema: Avoid use of COMBOGESIC IV in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. • Renal Toxicity: Long-term administration of NSAIDs, including the ibuprofen component of COMBOGESIC IV, has resulted in renal papillary necrosis and other renal injury. • Anaphylactic Reactions: Discontinue use immediately if symptoms occur.

Pregnancy

Pregnancy Risk Summary Use of NSAID-containing products, including COMBOGESIC IV, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Storage and supply

(acetaminophen/ ibuprofen) injection 1,000 mg/300 mg per 100 mL (10 mg/3mg per mL): clear, colorless solution in single-dose vial. Discard unused portion. NDC # 0143-9150-10: pack of 10 vials. COMBOGESIC IV is a clear, colorless solution, free from visible particles. Store at 20°C to 25°C (68°F to 77°F).

Source: Acetaminophen And Ibuprofen Injection (Combogesic Iv) — US FDA prescribing information, 2024-11-25, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.