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Uses

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

When used for inflammatory diseases, pain, dysmenorrhea, or fever, consider potential benefits and risks of ibuprofen therapy as well as alternative therapies before initiating therapy with the drug. Use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.

Inflammatory Diseases

Symptomatic treatment of osteoarthritis and rheumatoid arthritis.

Management of juvenile rheumatoid arthritis in children.

Pericarditis

Reduction of pain, fever, and inflammation of pericarditis†; however, other drugs (i.e., aspirin) generally are preferred.

Pain

Relief of mild to moderate pain in children and adults.

NSAIAs considered first-line agents for mild to moderate migraine attacks or for severe attacks that have responded in the past to NSAIAs or nonopiate analgesics.

Self-medication in children and adults for the temporary relief of minor aches and pain associated with the common cold, influenza, or sore throat; headache (including migraine); toothache; muscular aches; backache; minor pain of arthritis.

Dysmenorrhea

Symptomatic management of primary dysmenorrhea.

Self-medication for the temporary relief of minor aches and pain associated with menstrual cramps.

Fever

Reduction of fever in children and adults.

Self-medication for reduction of fever in children and adults.

Patent Ductus Arteriosus (PDA)

Treatment of PDA in premature neonates (designated an orphan drug by FDA for this use). Used to promote closure of a clinically important PDA in premature neonates weighing 500–1500 g who are ≤32 weeks' gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support) is ineffective. Limited follow-up data available; reserve for neonates with clinically important PDA.

Dosage and Administration

General

• For inflammatory diseases, pain, dysmenorrhea, or fever, consider potential benefits and risks of ibuprofen therapy as well as alternative therapies before initiating therapy with the drug.

Administration

Administer orally (for inflammatory diseases, pain, dysmenorrhea, or fever) or by IV infusion (for PDA).

Oral Administration

If GI disturbances occur, administer with meals or milk.

Pediatric Administration

Ibuprofen oral drops generally used in infants 6–23 months of age. Use the calibrated dosing device provided by the manufacturer for measurement of the dose.

Pediatric oral suspension commonly used in children ≥2 years of age; 50-mg chewable tablets also may be used in this age group. Use the calibrated dosage cup provided by the manufacturer for measurement of the dose of the suspension.

The 100-mg chewable or film-coated tablets may be used in children ≥6 years of age.

IV Administration

Administer by IV infusion using IV port nearest to the IV insertion site.

Do not infuse simultaneously through same line as parenteral nutrition solutions. If same line must be used, interrupt infusion of the nutrition solution for 15 minutes before and after administration of ibuprofen; maintain line patency by infusing dextrose injection or sodium chloride injection.

Avoid extravasation (irritating to extravascular tissues).

Dilution

Dilute ibuprofen lysine injection with an appropriate volume of dextrose injection or sodium chloride injection.

Administer within 30 minutes of preparation; discard any unused solution.

Rate of Administration

Administer dose over 15 minutes.

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Dosage of ibuprofen lysine expressed in terms of ibuprofen.

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals. Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.

Pediatric Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Dosage in children should be guided by body weight.

Inflammatory Diseases

Juvenile Rheumatoid Arthritis

Oral

30–40 mg/kg daily divided into 3 or 4 doses. 20 mg/kg daily in divided doses may be adequate for children with mild disease.

Pain

Oral

For mild to moderate pain in children 6 months to 12 years of age, 10 mg/kg every 6–8 hours.

For self-medication of minor aches and pain in children ≥12 years of age, 200 mg every 4–6 hours; may increase dosage to 400 mg every 4–6 hours if needed.

Fever

Oral

For children 6 months to 12 years of age: 5 mg/kg for temperatures <39°C; 10 mg/kg for temperatures >39°C.

For self-medication of fever in children ≥12 years of age, 200 mg every 4–6 hours; may increase dosage to 400 mg every 4–6 hours if needed.

PDA

IV

Each course of therapy consists of 3 doses administered at 24-hour intervals.

Base dosage on neonate’s birth weight.

First dose is 10 mg/kg; second and third doses are 5 mg/kg each.

If anuria or oliguria (urine output <0.6 mL/kg per hour) is present at the time of a second or third dose, withhold the dose until laboratory determinations indicate that renal function has returned to normal.

If ductus arteriosus closes or is substantially constricted after completion of the first course, no further doses are necessary.

If ductus arteriosus fails to close or reopens, a second course of ibuprofen, alternative pharmacologic therapy, or surgery may be needed.

Adults

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

1.2–3.2 g daily, given as 300 mg 4 times daily, or 400, 600, or 800 mg 3 or 4 times daily.

Pain

Oral

For mild to moderate pain, 400 mg every 4–6 hours as needed.

For self-medication of minor aches and pain, 200 mg every 4–6 hours; may increase dosage to 400 mg every 4–6 hours if needed.

For self-medication of migraine pain, 400 mg once in a 24-hour period.

Dysmenorrhea

Oral

400 mg every 4 hours as necessary; initiate at earliest onset of pain.

For self-medication, 200 mg every 4–6 hours; may increase to 400 mg every 4–6 hours if necessary.

Fever

Oral

For self-medication, 200 mg every 4–6 hours; may increase to 400 mg every 4–6 hours if needed.

Prescribing Limits

Pediatric Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Inflammatory Diseases

Juvenile Rheumatoid Arthritis

Oral

Maximum 50 mg/kg daily.

Pain

Oral

For mild to moderate pain in children 6 months to 12 years of age, maximum 40 mg/kg daily.

For self-medication of minor aches and pain in children 6 months to 11 years of age, do not exceed recommended dosage; do not administer recommended dose more than 4 times daily. Self-medication should not exceed 3 days unless otherwise directed by a clinician.

For self-medication of minor aches and pain in children ≥12 years of age, maximum 1.2 g daily. Self-medication should not exceed 10 days unless otherwise directed by a clinician.

Fever

Oral

Maximum 40 mg/kg daily in children 6 months to 12 years of age.

For self-medication in children 6 months to 11 years of age, do not exceed recommended dosage; do not administer recommended dose more than 4 times daily. Self-medication should not exceed 3 days unless otherwise directed by a clinician.

For self-medication in children ≥12 years of age, maximum 1.2 g daily. Self-medication should not exceed 3 days unless otherwise directed by a clinician.

Adults

Inflammatory Diseases

Osteoarthritis or Rheumatoid Arthritis

Oral

Maximum 3.2 g daily.

Pain

Oral

For mild to moderate pain, maximum 3.2 g daily.

For self-medication of minor aches and pain, maximum 1.2 g daily. Self-medication should not exceed 10 days unless otherwise directed by a clinician.

For self-medication of migraine pain, maximum 400 mg in a 24-hour period unless otherwise directed by a clinician.

Dysmenorrhea

Oral

Maximum 3.2 g daily.

For self-medication, maximum 1.2 g daily.

Fever

Oral

For self-medication, maximum 1.2 g daily. Self-medication should not exceed 3 days unless otherwise directed by a clinician.

Special Populations

Dosage in Renal Impairment

Consider dosage reduction in patients with substantial renal impairment.