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Acetaminophen And Ibuprofen Injection

Also known as: Combogesic Iv

Nonsteroidal Anti-inflammatory DrugCyclooxygenase Inhibitors

Route: Intravenous

Check Acetaminophen And Ibuprofen Injection Interactions →

4 interactions on record⛔ Black Box Warning

Acetaminophen And Ibuprofen Injection has 4 known drug interactions based on U.S. FDA drug labeling data. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Acetylsalicylic Acid, Warfarin, Furosemide. Patients taking Acetaminophen And Ibuprofen Injection should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 4
Major: 2
Moderate: 2

Major (2)

Acetaminophen And Ibuprofen Injection + Acetylsalicylic Acid— Concomitant use of NSAID and aspirin is associated with significantly increased incidence of GI adverse reactions and in…
Acetaminophen And Ibuprofen Injection + Warfarin— Ibuprofen and warfarin have synergistic effect on bleeding with increased risk of serious bleeding compared to either dr…

Moderate (2)

Acetaminophen And Ibuprofen Injection + Furosemide— NSAIDs reduced the natriuretic effect of loop diuretics. Monitor renal function and fluid status during concomitant use.
Acetaminophen And Ibuprofen Injection + Propranolol— NSAIDs may diminish antihypertensive effect of beta-blockers. Monitor blood pressure during concomitant use.

Acetaminophen And Ibuprofen Injection + Acetylsalicylic Acid⚠️Major

Concomitant use of NSAID and aspirin is associated with significantly increased incidence of GI adverse reactions and increased risk of bleeding.

Acetaminophen And Ibuprofen Injection + Warfarin⚠️Major

Ibuprofen and warfarin have synergistic effect on bleeding with increased risk of serious bleeding compared to either drug alone.

Acetaminophen And Ibuprofen Injection + Furosemide🟡Moderate

NSAIDs reduced the natriuretic effect of loop diuretics. Monitor renal function and fluid status during concomitant use.

Acetaminophen And Ibuprofen Injection + Propranolol🟡Moderate

NSAIDs may diminish antihypertensive effect of beta-blockers. Monitor blood pressure during concomitant use.

⛔ FDA Black Box Warning

BOXED WARNING WARNING: HEPATOTOXICITY, CARDIOVASCULAR RISK, and GASTROINTESTINAL RISK RISK OF MEDICATION ERRORS: Take care when prescribing, preparing, and administering COMBOGESIC IV to avoid dosing errors which could result in accidental overdose and death ( 5.1 ). HEPATOTOXICITY: COMBOGESIC IV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with doses of acetaminophen that exceed 4,000 mg per day, and often involve more than one acetaminophen-containing product [see Warnings and Precautions (5.2) ] . CARDIOVASCULAR RISK: COMBOGESIC IV contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.3) ] . COMBOGESIC IV is contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.3) ] . GASTROINTESTINAL RISK: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [see Warnings and Precautions (5.4) ] . WARNING: HEPATOTOXICITY, CARDIOVASCULAR RISK, and GASTROINTESTINAL RISK See full prescribing information for complete boxed warning. • Take care when prescribing, preparing, and administering COMBOGESIC IV to avoid dosing errors which could result in accidental overdose and death. ( 5.1 ) • COMBOGESIC IV contains acetaminophen, which has been associated with cases of acute liver failure, at times result

Contraindications

4 CONTRAINDICATIONS COMBOGESIC IV 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 [see Warnings and Precautions (5.8 , 5.10 , 5.11 )] • patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.8 , 5.9 )] • in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.3) ] • patients with severe hepatic impairment or severe active liver disease [see Warnings and Precautions (5.2) ] COMBOGESIC IV is contraindicated in: • patients who have previously demonstrated hypersensitivity to acetaminophen, ibuprofen, other NSAIDs or to any of the excipients in the IV formulation ( 4 ) • patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients ( 4 , 5.9 , 5.11 ) • the setting of coronary artery bypass graft (CABG) surgery ( 4 , 5.3 ) • patients with severe hepatic impairment or severe active liver disease ( 4 )

Pregnancy & Breastfeeding

8.1 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. Because of these risks, limit dose and duration of COMBOGESIC IV use between about 20 and 30 weeks of gestation and avoid COMBOGESIC IV use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data) . Premature Closure of Fetal Ductus Arteriosus: Use of NSAID-containing products, including COMBOGESIC IV, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Use of NSAID-containing products, including COMBOGESIC IV, at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimester of pregnancy are inconclusive. No adequate and well-controlled studies have been conducted using COMBOGESIC IV in pregnant women. Animal reproduction studies have also not been conducted with COMBOGESIC IV. The following describes animal reproduction studies for Acetaminophen and Ibuprofen: Acetaminophen: Reproductive and developmental studies in rats and mice from the published literature have identified adverse events at clinically relevant doses of acetaminophen. Fetotoxicity, increases in bone variations in the fetuses, and necrosis in the fetus liver and kidney have been noted in studies in rats. In mice treated with acetaminophen at doses within the clinical dosing range, cumulative adverse effects on reproduction were seen in a continuous breeding study. A reduction in number of litters of the parental mating pair was observed as well as retarded growth and ab

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.