Usual Adult Dose for Dysmenorrhea

200 to 400 mg orally every 4 hours as needed
Maximum dose: 3200 mg/day (prescription strength); 1200 mg/day (over-the-counter)

Comment:

• Treatment should begin at the earliest onset of pain.

Use: For the relief of signs and symptoms of primary dysmenorrhea

Usual Adult Dose for Osteoarthritis

For minor pains of arthritis:
Initial dose: 200 mg orally every 4 to 6 hours; may increase to 400 mg orally every 4 to 6 hours as needed
Maximum dose: 1200 mg/day (over the counter)

Rheumatoid Arthritis and Osteoarthritis (including flare-ups of chronic disease):
1200 to 3200 mg orally per day in divided doses 3 or 4 times a day

• Individualize dose; adjust dose up or down depending on severity of symptoms

Maximum dose: 3200 mg/day (prescription strength)

Comments:

• Patients with rheumatoid arthritis generally require higher doses than those with osteoarthritis.
• In chronic conditions, a therapeutic response may be seen in a few days to a week but most often is observed by 2 weeks; after a satisfactory response has been achieved, review and adjust dose to achieve the lowest dose that yields acceptable control.
• Individual patients may show a better response to 3200 mg/day compared with 2400 mg/day, although in well-controlled clinical trials, use of 3200 mg/day did not show a better mean response in terms of efficacy.

Use: For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis

Usual Adult Dose for Rheumatoid Arthritis

For minor pains of arthritis:
Initial dose: 200 mg orally every 4 to 6 hours; may increase to 400 mg orally every 4 to 6 hours as needed
Maximum dose: 1200 mg/day (over the counter)

Rheumatoid Arthritis and Osteoarthritis (including flare-ups of chronic disease):
1200 to 3200 mg orally per day in divided doses 3 or 4 times a day

• Individualize dose; adjust dose up or down depending on severity of symptoms

Maximum dose: 3200 mg/day (prescription strength)

Comments:

• Patients with rheumatoid arthritis generally require higher doses than those with osteoarthritis.
• In chronic conditions, a therapeutic response may be seen in a few days to a week but most often is observed by 2 weeks; after a satisfactory response has been achieved, review and adjust dose to achieve the lowest dose that yields acceptable control.
• Individual patients may show a better response to 3200 mg/day compared with 2400 mg/day, although in well-controlled clinical trials, use of 3200 mg/day did not show a better mean response in terms of efficacy.

Use: For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis

Usual Adult Dose for Pain

Oral:
200 to 400 mg orally every 4 to 6 hours as needed
Maximum dose: 3200 mg/day (prescription strength); 1200 mg/day (over-the-counter)

Parenteral:
IV (Caldolor): 400 to 800 mg IV every 6 hours as needed
Maximum dose: 3200 mg/day

Comments:

• The lowest effective dose for the shortest duration consistent with individual treatment goals should be used.
• In controlled analgesic clinical trials, oral doses greater than 400 mg were no more effective than a 400 mg dose.
• Patients should be well hydrated prior to IV infusion to reduce the risk of renal adverse events; doses should be infused over at least 30 minutes.

Uses:
Oral: For the relief of mild to moderate pain
IV: For the management of mild to moderate pain; and the management of moderate to severe pain as an adjunct to opioid analgesics.

Usual Adult Dose for Fever

Oral:
Initial dose: 200 mg orally every 4 to 6 hours

• May increase to 400 mg every 4 to 6 hours if needed

Maximum dose: 1200 mg/day

Parenteral (Caldolor):

• Initial dose: 400 mg IV once, then 100 to 400 mg every 4 to 6 hours IV as needed
• Maximum dose: 3200 mg/day

Comments:

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
• Patients should be well hydrated to reduce the risk of renal adverse events.
• IV doses should be infused over at least 30 minutes.

Use: For the reduction of fever

Usual Pediatric Dose for Fever

Oral:
6 months to less than 24 months:
Infant Drops (50 mg/1.25 mL):

• Weight 12 to 17 pounds (5.45 to 7.73 kg): 50 mg orally every 6 to 8 hours as needed
• Weight 18 to 23 pounds (8.18 to 10.45 kg): 75 mg orally every 6 to 8 hours as needed

Maximum: 4 doses per day

1 year to less than 12 years: 5 to 10 mg/kg orally every 6 to 8 hours as needed

• Maximum dose: 40 mg/kg/day or 4 doses per day

12 years or older:
Initial dose: 200 mg orally every 4 to 6 hours as needed

• May increase to 400 mg every 4 to 6 hours if additional analgesia is needed

Maximum dose: 1200 mg/day

Parenteral (Caldolor):
6 months to less than 12 years: 10 mg/kg IV every 4 to 6 hours as needed
Maximum single-dose: 400 mg
Maximum daily dose: 40 mg/kg or 2400 mg/day, whichever is less

12 to 17 years: 400 mg IV every 4 to 6 hours as needed
Maximum daily dose: 2400 mg/day

Comments:

• Dosing should be weight-based whenever possible.
• The oral suspension is available as 2 different concentrations: Infant drops (50 mg/1.25 mL) and Children's oral suspension (100 mg/5 mL); verify dose in strength and volume to avoid dosing errors.
• There are multiple over-the-counter products available with weight/age-based dosing charts; may consult dosing charts for suggested dosing by age.
• Patients should be well hydrated prior to infusion to reduce the risk of renal adverse events; doses should be infused over at least 10 minutes.

Use: For the relief of fever.

Usual Pediatric Dose for Pain

Oral:
6 months to less than 24 months:
Infant Drops (50 mg/1.25 mL):

• Weight 12 to 17 pounds (5.45 to 7.73 kg): 50 mg orally every 6 to 8 hours as needed
• Weight 18 to 23 pounds (8.18 to 10.45 kg): 75 mg orally every 6 to 8 hours as needed

Maximum: 4 doses per day

1 year to less than 12 years: 5 to 10 mg/kg orally every 6 to 8 hours as needed

• Maximum dose: 40 mg/kg/day or 4 doses per day

12 years or older:
Initial dose: 200 mg orally every 4 to 6 hours as needed

• May increase to 400 mg every 4 to 6 hours if additional analgesia is needed

Maximum dose: 1200 mg/day

Parenteral (Caldolor):
6 months to less than 12 years: 10 mg/kg IV every 4 to 6 hours as needed
Maximum single-dose: 400 mg
Maximum daily dose: 40 mg/kg or 2400 mg/day, whichever is less

12 to 17 years: 400 mg IV every 4 to 6 hours as needed
Maximum daily dose: 2400 mg/day

Comments:

• Dosing should be weight-based whenever possible.
• The oral suspension is available as 2 different concentrations: Infant drops (50 mg/1.25 mL) and Children's oral suspension (100 mg/5 mL); verify dose in strength and volume to avoid dosing errors.
• There are multiple over-the-counter products available with weight/age-based dosing charts; may consult dosing charts for suggested dosing by age.
• Patients should be well hydrated prior to infusion to reduce the risk of renal adverse events; doses should be infused over at least 10 minutes.

Use: For the relief of fever.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

1 year or older:
30 to 50 mg/kg/day in 4 divided doses

Comments:

• Doses greater than 40 mg/kg/day may increase risk of serious adverse effects; doses greater than 50 mg/kg/day have not been studied and are not recommended.
• With doses above 30 mg/kg/day or in patients with a history of abnormal liver function tests with previous NSAID therapy, closely monitor for signs/symptoms of early liver dysfunction.
• Therapeutic response may not be achieved for a few days or several weeks; the dosage should be lowered to the lowest effective dose once clinical effect is achieved.

Use: For the relief of signs and symptoms of juvenile rheumatoid arthritis

Usual Pediatric Dose for Patent Ductus Arteriosus

Ibuprofen lysine (NeoProfen):
Gestational age 32 weeks or less; weight 500 to 1500 g:

• Initial dose: 10 mg/kg IV once, then 5 mg/kg IV at 24 and 48 hours after first dose for a total of 3 doses
• Weight-based dosing is based on birth weight
• If anuria or marked oliguria (urinary output less than 0.6 mL/kg/hr) is evident at time of the second or third dose, hold drug until laboratory studies indicate renal function has returned to normal

Comments:

• One course of therapy is defined as 3 doses; if ductus arteriosus closes or has significantly reduced in size after completion of the first course, no further doses are needed.
• If during continued medical management the ductus arteriosus fails to close or reopens, then a second course, alternative pharmacological therapy, or surgery may be needed.
• Treatment should be reserved for infants with clear evidence of a clinically significant patent ductus arteriosus (PDA).

Use: For the closure of a clinically significant PDA in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective (e.g., fluid restriction, diuretics, respiratory support, etc.).

Usual Pediatric Dose for Dysmenorrhea

12 years or older: 200 to 400 mg orally every 4 to 6 hours as needed
Maximum dose: 3200 mg/day (prescription strength); 1200 mg/day (over-the-counter)

Comment:

• Treatment should begin at the earliest onset of pain.

Use: For the relief of signs and symptoms of primary dysmenorrhea

Renal Dose Adjustments

Advanced Renal Disease: Not recommended; if treatment is necessary, close monitoring of renal function is advised

Ibuprofen lysine injection (NeoProfen): Preterm infants with significant impairment of renal function: Contraindicated

Liver Dose Adjustments

If abnormal liver tests or signs or symptoms of liver dysfunction develop, evaluate for hepatic dysfunction.

• If liver disease develops or if systemic manifestations such as eosinophilia or rash occur, this drug should be discontinued

• Pediatric: With doses above 30 mg/kg/day or in patients with a history of abnormal liver function tests with previous NSAID therapy, closely monitor for signs/symptoms of early liver dysfunction

Precautions

US BOXED WARNINGS: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
• This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
• NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.

CONTRAINDICATIONS:
Oral Formulations:

• Known hypersensitivity to the active component (e.g., anaphylactic reactions and serious skin reactions) or any of the product ingredients
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs); severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
• In the setting of coronary artery bypass graft (CABG) surgery

Parenteral:
Adults and Pediatric Patients 6 months or older (Caldolor):

• Hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to active substance or any product ingredients
• 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
• In the setting of coronary artery bypass graft surgery

Preterm Infants (NeoProfen):

• Proven or suspected infection that is untreated
• Congenital heart disease in which patency of the patent ductus arteriosus (PDA) is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta)
• Active bleeding, especially with active intracranial hemorrhage or GI bleeding
• Thrombocytopenia
• Coagulation defects
• Known or suspected necrotizing enterocolitis
• Significant renal impairment

IV Ibuprofen (Caldolor) and Oral Suspension:
Safety and efficacy have not been established in patients younger than 6 months.

Over the Counter Capsules and Tablets:
Safety and efficacy have not been established in patients younger than 12 years.

Over the Counter Chewable Tablets and Suspension:
Safety and efficacy have not been established in patients younger than 6 months.

Oral Prescription Tablets:
Safety and efficacy have not been established in patients younger than 18 years.

Ibuprofen Lysine (NeoProfen): Safety and efficacy have not been established in patients younger than 32 weeks gestational age.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Oral Tablets and Capsules: Take with food and fluid
• Oral Suspensions: Shake well before use; multiple concentrations are available; consult manufacturer product labeling for dosing reference tables. Use with dosing device provided; do not use any other device.
• Ibuprofen Lysine (NeoProfen): For IV use only; must be diluted prior to use
• IV Ibuprofen (Caldolor): For IV use only; must be diluted prior to use to a concentration of 4 mg/mL or less
• Administer IV formulations carefully to avoid extravasation

Storage requirements:

• IV Injection (Caldolor): Diluted solution stable up to 24 hours at ambient temperature (20C to 25C) and room lighting.
• Ibuprofen Lysine (NeoProfen): Protect from light; store vials in carton until contents are used

Reconstitution/preparation techniques:

• Consult the appropriate manufacturer product information.

IV Compatibility:

• Ibuprofen Lysine (NeoProfen): Compatible with dextrose or saline. Do not administer simultaneously in the same IV line with TPN; if necessary, TPN should be interrupted for 15 minutes prior to and after drug administration; line patency should be maintained using dextrose or saline.
• IV Ibuprofen (Caldolor): Compatible with 0.9% Sodium Chloride Injection (normal saline), 5% Dextrose Injection USP (D5W), or Lactated Ringers Solution.

General:

• Consult manufacturer product labeling for weight/age based dosing charts.
• Prior to initiating treatment, the potential benefits and risks of this drug should be weighed against other treatment options.
• The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• There is an increased risk of heart attack, heart failure, and stroke when taking nonsteroidal anti-inflammatory drugs (NSAIDs); these events may occur at any time during treatment and risk increases with long term use, a history of cardiovascular (CV) disease or risk factors for CV disease, and higher doses.

Monitoring:

• Neonates: Monitor renal function and urinary output during therapy.
• Cardiovascular: Monitor blood pressure closely during initiation and throughout course of therapy.
• Gastrointestinal: Monitor for signs/symptoms of gastrointestinal bleeding.
• Renal function: Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.
• Monitor blood counts, renal, and hepatic function periodically for patients receiving long-term therapy.

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide for NSAIDs).
• Patients should seek medical advice for signs and symptoms of gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
• Patients should seek medical attention immediately if signs/symptoms of cardiovascular events occur including, shortness of breath, slurred speech, chest pain, or weakness on one side of the body.
• Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; NSAIDs should not be used at 20 weeks or later in pregnancy unless specifically advised to do so by their health care professional.
• Patients using over the counter products should contact a healthcare provider if symptoms persist for more than 3 days in pediatric patients and more than 10 days in adult patients.

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