Combogesic Iv Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose vials—10
Manufacturer
Generic Availability
NO
Mechanism of Action
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). Because ibuprofen is also an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Combogesic Iv Indications
Indications
For the relief of mild to moderate pain or management of moderate to severe pain as adjunct to opioid analgesics, where an IV route is considered clinically necessary.
Limitations of Use
For short-term use of ≤5 days.
Combogesic Iv Dosage and Administration
Adult
Use lowest effective dose for shortest duration. Give as an IV infusion over 15mins. <50kg: acetaminophen 15mg/kg and ibuprofen 4.5mg/kg every 6hrs, as necessary; max single dose: 750mg/225mg; total daily dose: 3000mg/900mg. ≥50kg: 1000mg/300mg (100mL) every 6hrs, as necessary.
Children
<18yrs: not indicated.
Combogesic Iv Contraindications
Contraindications
Allergy to aspirin or other NSAIDs. Coronary artery bypass graft (CABG) surgery. Severe hepatic impairment or severe active liver disease.
Combogesic Iv Boxed Warnings
Boxed Warning
Hepatotoxicity. Cardiovascular risk. Gastrointestinal risk.
Combogesic Iv Warnings/Precautions
Warnings/Precautions
Ensure correct prescribing, preparing, and administering to avoid dosing errors. Risk of acute liver failure (may result in liver transplant or death) associated with the use of doses higher than recommended or involving >1 acetaminophen-containing product. Alcoholism. Discontinue if signs/symptoms of liver disease develop, or if systemic manifestations occur. Hepatic or renal impairment: not recommended. Dehydration. Hypovolemia. Hyperkalemia. Advanced renal disease. Correct volume status prior to initiation. Risk for renal papillary necrosis, other renal injury with long-term NSAIDs therapy. Increased risk for serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk for serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of peptic ulcer disease and/or GI bleeding. Coagulation disorders. Hypertension; monitor BP closely. Preexisting asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function as clinically necessary. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.
Combogesic Iv Pharmacokinetics
Distribution
Apparent volume of distribution: ~0.9 L/kg (acetaminophen). Plasma protein bound: ~20% (acetaminophen).
Elimination
Renal. Half-life: 2–3 hours (acetaminophen); 1.8–2.0 hours (ibuprofen).
Combogesic Iv Interactions
Interactions
Concomitant aspirin, salicylates (eg, diflunisal, salsalate), other NSAIDs: not recommended. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.
Combogesic Iv Adverse Reactions
Adverse Reactions
Infusion site pain, nausea, constipation, dizziness, infusion site extravasation, vomiting, headache, somnolence; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, serious skin reactions (eg, exfoliative dermatitis, AGEP, SJS, TEN), DRESS, asthma exacerbation, hematological toxicity, visual changes, aseptic meningitis.
Combogesic Iv Clinical Trials
See Literature
Combogesic Iv Note
Not Applicable
Combogesic Iv Patient Counseling
See Literature