Ibuprofen IV

Ibuprofen IV is a prescription medication used for relieving pain or fever, and for the treatment of patent ductus arteriosus in the pediatric population.

• Ibuprofen IV is available under the following different brand names: Caldolor, NeoProfen

Adult and pediatric dosage

Injectable solution

• 800mg8/mL (100mg/mL single-dose vial, Caldolor); must dilute further
• 800mg/200mL (4mg/mL ready-to-use bag, Caldolor)

Injectable solution, ibuprofen lysine

• 10mg/mL (2mL single-dose vial, Neoprofen)

Pain

Adult dosage

• Caldolor: 400-800 mg IV every 6 hours or as needed; not to exceed 3200 mg/day

Fever

Adult dosage

• Caldolor: 400 mg IV, THEN
• 400 mg IV every 4-6 hours or 100-200 mg every 4 hours or as needed; not to exceed 3200 mg/day

Pediatric dosage

• Children below 6 years: Safety and efficacy not established
• Children between 6 months to 11 years:10 mg/kg IV every 4-6 hours or as needed; not to exceed 12-17 years: 400 mg IV every 4-6 hours or as needed; do not exceed 2,400 mg, whichever is less, total daily dose in pediatric patients aged below 17 years

Patent Ductus Arteriosus

Pediatric dosage

• Initial dose: 10 mg/kg IV, THEN  
• Additional 2 doses of 5 mg/kg each, at 24 and 48 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Ibuprofen IV include:

• nausea,
• vomiting,
• gas,
• bleeding,
• dizziness, and
• headache.

Serious side effects of Ibuprofen IV include:

• vision changes,
• shortness of breath or feeling light-headed,
• swelling in the hands or feet, face or tongue,
• rapid weight gain,
• skin rash that is red or purple with blisters,
• bloody or tarry stools,
• coughing up blood or vomit that looks like coffee grounds,
• nausea,
• upper stomach pain,
• itching,
• feeling tired,
• flu-like symptoms,
• loss of appetite,
• little or no urination,
• dark urine,
• clay-colored stools,
• yellowing of skin or eyes (jaundice),
• rapid heart rate,
• trouble concentrating,
• fever, and
• burning in the eyes

Rare side effects of Ibuprofen IV include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ibuprofen IV has severe interactions with no other drugs.
• Ibuprofen IV has serious interactions with at least 25 other drugs.
• Ibuprofen IV has moderate interactions with at least 245 other drugs.
• Ibuprofen IV has minor interactions with at least 67 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Caldolor
  • Hypersensitivity
  • History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
  • Coronary artery bypass graft (CABG): Increased risk of MI and stroke if administered in the first 10-14 days following CABG
• NeoProfen
  • Untreated proven or suspected infection
  • Congenital heart disease where PDA patency is necessary for satisfactory pulmonary or systemic blood flow (eg, pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta)
  • Bleeding, especially active intracranial hemorrhage or GI bleeding
  • Thrombocytopenia; coagulation defects
  • Necrotizing enterocolitis
  • Significant renal impairment

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ibuprofen IV?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ibuprofen IV?”

Cautions

• Caldolor
  • Increased risk for serious CV thrombotic events, myocardial infarction (MI), and stroke (use lowest effective dose for the shortest duration possible); additionally, increased MI and stroke if administered in the first 10-14 days following CABG (see Contraindications)
  • Risk of GI ulceration, bleeding, and perforation
  • May cause borderline LFT elevations; rare reports of notable ALT or AST (ie, 3xULN) or severe hepatic reactions (eg, jaundice, fulminant hepatitis, liver necrosis, hepatic failure)
  • May cause new-onset hypertension, or exacerbation of existing hypertension
  • Fluid retention and edema observed; caution in patients with heart failure
  • Long-term administration of NSAIDs may result in renal papillary necrosis and another renal injury; patients at greatest risk include the elderly, or those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, and individuals taking diuretics, ACE inhibitors, or ARBs
  • Anaphylactoid reactions reported (see Contraindications)
  • Serious skin reactions may occur (eg, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis)
  • Avoid in pregnancy after 30 weeks gestation; associated with premature closure of the ductus arteriosus
  • Diminishes utility of inflammation and fever as diagnostic signs for infection
  • Concentrated formulation (ie, 100 mg/mL) must be diluted before use; infusing undiluted may result in hemolysis
  • Patients with asthma may have aspirin-sensitive asthma; use of aspirin or NSAIDs may cause severe bronchospasm in these patients
  • Blurred or diminished vision, scotomata, and changes in color vision were reported with oral ibuprofen
  • Aseptic meningitis with fever and coma observed with oral ibuprofen therapy
• NeoProfen
  • Diminishes utility of inflammation and fever as diagnostic signs for infection
  • Inhibits platelet aggregation; caution with underlying hemostatic defects (see Contraindications)
  • Displaces bilirubin from albumin binding-sites
  • Administer cautiously to avoid extravasation
• Drug reaction with eosinophilia and systemic symptoms
  • Drug Reaction reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
  • Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
  • Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
  • Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately

Pregnancy and Lactation

• There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
• Clinical considerations
  • There are no studies on effects during labor or delivery
  • In animal studies, NSAIDs, including ibuprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth
• Fetal toxicity
  • Use of NSAIDs 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 use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy
  • There are no available data with use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage; however, there are published studies with each component of the drug combination
  • Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
  • In animal reproduction studies, there were no clear developmental effects at doses up to 0.4-times the maximum recommended human dose (MRHD) in the rabbit and 0.5-times in the MRHD rat when dosed throughout gestation
  • In contrast, an increase in membranous ventricular septal defects was reported in rats treated on gestation days 9 & 10 with 0.8-times the MRHD
  • Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen resulted in increased pre-and post-implantation loss
  • Prostaglandins also have been shown to have an important role in fetal kidney development; in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses
  • Avoid the use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, can cause premature closure of fetal ductus arteriosus
  • If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to the lowest effective dose and shortest duration possible
  • If treatment is needed for a pregnant woman, consider monitoring with ultrasound for oligohydramnios; if oligohydramnios occurs, discontinue therapy and follow up according to clinical practice
• Labor or Delivery
  • There are no studies on the effects of drug combination during labor or delivery; in animal studies, NSAIDs, including ibuprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth
• Lactation
  • No lactation studies have been conducted; however, limited published literature reports that, following oral administration, ibuprofen is present in human milk at relative infant doses of 0.06-0.6% of the maternal weight-adjusted daily dose; no information is available on the effects of ibuprofen on milk production or a breastfed infant
  • Use of NSAIDs at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of fetal ductus arteriosus
  • Use of NSAIDs 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