Ibuprofen (oral)

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Ibuprofen (oral)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Ibuprofen (oral) is an analgesic, anti-inflammatory agent that is FDA approved for the treatment of fever, headache, migraine, osteoarthritis, pain, primary dysmenorrhea, rheumatoid arthritis. Common adverse reactions include hypotension, rash, hypernatremia, hypoalbuminemia, hypoproteinemia, elevated serum LDH level, flatulence, nausea, vomiting, heart burn, thrombocytosis, bacteremia, dizziiness, headache, elevated serum BUN, bacterial pneumonia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Fever
  • Dosing Information
  • Non-prescription dosing, 200 to 400 mg orally every 4 to 6 hours as needed; maximum of 1200 mg/day. Do not take longer than 10 days unless directed by physician.
Headache
  • Dosing Information
  • Non-prescription dose recommendations are 200 to 400 mg orally ever 4 to 6 hours as needed; Maximum dose, 1200 mg in 24 hours
Migraine
  • Dosing Information
  • Non-prescription dose recommendations are 200 to 400 mg orally ever 4 to 6 hours as needed; Maximum dose, 1200 mg in 24 hours.
Osteoarthritis
  • Dosing Information
  • For osteoarthritis, the recommended dosage range is 1200 to 3200 mg daily; this may be given as 300 mg 4 times daily or as 400 mg, 600 mg, or 800 mg 3 or 4 times daily. Patients with rheumatoid arthritis often respond better to higher doses.
  • Sustained release preparations (Ibu-Slo(R), Rounlats, England; Fenlong(R), Sol Pharmaceuticals, India) in doses of 600 mg twice daily have been as effective as regular release preparations administered 400 mg three times daily.
  • Non-prescription ibuprofen should not be taken for longer than 10 days unless directed by a physician. The smallest effective dose should be used.
Pain
  • Dosing Information
  • Usual dose: 400 mg every 4 to 6 hours as needed; doses greater than 400 mg usually do not provide greater analgesic activity
  • Nonprescription ibuprofen should not be taken for longer than 10 days unless directed by a physician. The smallest effective dose should be used
Primary dysmenorrhea
  • Dosing Information
  • Usual dose: 400 mg every 4 to 6 hours as needed; doses greater than 400 mg usually do not provide greater analgesic activity.
  • Nonprescription ibuprofen should not be taken for longer than 10 days unless directed by a physician. The smallest effective dose should be used.
Rheumatoid arthritis
  • Dosing Information
  • For rheumatoid arthritis, the recommended dosage range is 1200 to 3200 mg daily; this may be given as 300 mg 4 times daily or as 400 mg, 600 mg, or 800 mg 3 or 4 times daily. Patients with rheumatoid arthritis often respond better to higher doses.
  • Sustained release preparations (Ibu-Slo(R), Rounlats, England; Fenlong(R), Sol Pharmaceuticals, India) in doses of 600 mg twice daily have been as effective as regular release preparations administered 400 mg three times daily.
  • Non-prescription ibuprofen should not be taken for longer than 10 days unless directed by a physician. The smallest effective dose should be used.
  • Non-Prescription:
  • The recommended dosage for non-prescription ibuprofen is 200 mg every 4 to 6 hours while symptoms persist. If no response occurs with the 200-mg dose, 400 mg may be taken; however, the maximum dose should not exceed 1200 mg/day (Prod Info Motrin IB(R), 1999).
  • Non-prescription ibuprofen should not be taken for longer than 10 days unless directed by a physician. The smallest effective dose should be used.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Ibuprofen (oral) in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ibuprofen (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Fever
  • Dosing Information
  • The recommended dose for the treatment of fever in pediatric patients age 17 years and older is ibuprofen 400 mg IV every 4 to 6 hours. Alternatively, 100 to 200 mg IV every 4 hours may be used. The infusion should last at least 30 minutes.
Headache
  • Dosing Information
  • The recommended dose of oral suspension in pediatric patients age 6 months to 2 years of age: dosing depends on weight and age, administer each dose orally every 6 to 8 hours as needed. For 12 to 17 pounds or 6 to 11 months of age, 50 mg For 18 to 23 pounds or 12 to 23 months of age, 75 mg; Maximum of doses/day.
  • The recommended dose of oral suspension in pediatric patients age 2 years and older: dosing depends on weight and age, administer each dose orally every 6 to 8 hour as needed. For 24 to 35 pounds or 2 to 3 years of age, the recommended dose is 100 mg. For 36 to 47 pounds or 4 to 5 years of age, the recommended dose is 150 mg. For 48 to 59 pounds or 6 to 8 years of age, the dose is 200 mg; for 60 to 71 pounds or 9 to 10 years of age, 250 mg; and for 72 to 95 pounds or 11 years of age, 300 mg. Maximum is 4 doses/day.
  • The recommended dose of oral tablets in pediatric patients age 12 years and older is 200 to 400 mg orally every 4 to 6 hours as needed. Maximum dose is 1200 mg in 24 hours.

Pain

  • Dosing Information
  • Usual dose: 4 to 10 mg/kg/dose repeated every 6 to 8 hours as needed
  • Nonprescription ibuprofen should not be taken for longer than 10 days unless directed by a physician. Do not give more than directed.

Primary dysmenorrhea

Rheumatoid arthritis

  • Dosing Information
  • The usual dosage range for treating juvenile rheumatoid arthritis is 30 to 50 mg/kg/day divided into four doses. The maximum recommended dose is 2.4 g/day.
  • Ibuprofen suspension is effective with acceptable tolerability in the treatment of JRA (juvenile rheumatoid arthritis). Ibuprofen in doses of 30 to 40 mg/kg/day was as effective as aspirin 60 to 80 mg/kg/day in a 12-week trial in 92 children with JRA; no significant differences were observed. In a 24-week open trial, favorable response rates were observed in children with JRA receiving ibuprofen 30, 40 and 50 mg/kg/day.
  • Non-prescription ibuprofen should not be given for longer than 10 days unless directed by a physician. Do not give more than directed.
  • Non-Prescription:
  • For use as an analgesic and antipyretic, the recommended dosage for children 6 months to 11 years of age is 7.5 mg/kg. This dose may be repeated every 6 to 8 hours. The maximum recommended dose is 30 mg/kg/day.
  • Non-prescription ibuprofen should not be taken for longer than 10 days unless directed by a physician. Do not give more than directed.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ibuprofen in pediatric patients.

Non–Guideline-Supported Use

Patent ductus arteriosus
  • Dosing Information
  • Study dose in premature infants younger than 37 weeks gestational age: 10 mg/kg orally, followed by 5 mg/kg orally every 24 hours for 2 doses.

Contraindications

There is limited information regarding Ibuprofen (oral) Contraindications in the drug label.

Warnings

Allergy alert:

  • Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters
  • If an allergic reaction occurs, stop use and seek medical help right away.
  • Stomach bleeding warning:
  • This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or non-prescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
  • Do not use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • Ask a doctor before use if
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
  • you are taking a diuretic
  • Ask a doctor or pharmacist before use if you are
  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug
  • When using this product
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
  • Stop use and ask a doctor if
  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • If pregnant or breast-feeding,
  • ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
  • Keep out of reach of children.
  • In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

  • There is limited information regarding Clinical Trial Experience of Ibuprofen (oral) in the drug label.

Postmarketing Experience

  • There is limited information regarding Postmarketing Experience of Ibuprofen (oral) in the drug label.

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Ibuprofen (oral) in women who are pregnant.
Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category
  • There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ibuprofen (oral) in women who are pregnant.

Labor and Delivery

  • There is no FDA guidance on use of Ibuprofen (oral) during labor and delivery.

Nursing Mothers

  • There is no FDA guidance on the use of Ibuprofen (oral) with respect to nursing mothers.

Pediatric Use

  • There is no FDA guidance on the use of Ibuprofen (oral) with respect to pediatric patients.

Geriatic Use

  • There is no FDA guidance on the use of Ibuprofen (oral) with respect to geriatric patients.

Gender

  • There is no FDA guidance on the use of Ibuprofen (oral) with respect to specific gender populations.

Race

  • There is no FDA guidance on the use of Ibuprofen (oral) with respect to specific racial populations.

Renal Impairment

  • There is no FDA guidance on the use of Ibuprofen (oral) in patients with renal impairment.

Hepatic Impairment

  • There is no FDA guidance on the use of Ibuprofen (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

  • There is no FDA guidance on the use of Ibuprofen (oral) in women of reproductive potentials and males.

Immunocompromised Patients

  • There is no FDA guidance one the use of Ibuprofen (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

  • There is limited information regarding Monitoring of Ibuprofen (oral) in the drug label.
  • Description

IV Compatibility

  • There is limited information regarding IV Compatibility of Ibuprofen (oral) in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Ibuprofen (oral) in the drug label.

Pharmacology

Mechanism of Action

Structure

File:Ibuprofen (oral)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

  • There is limited information regarding Pharmacodynamics of Ibuprofen (oral) in the drug label.

Pharmacokinetics

  • There is limited information regarding Pharmacokinetics of Ibuprofen (oral) in the drug label.

Nonclinical Toxicology

  • There is limited information regarding Nonclinical Toxicology of Ibuprofen (oral) in the drug label.

Clinical Studies

  • There is limited information regarding Clinical Studies of Ibuprofen (oral) in the drug label.

How Supplied

Advil Tablets (in each tablet)

  • Ibuprofen 200 mg (NSAID)*
  • nonsteroidal anti-inflammatory drug

Advil Caplets (in each caplet)

  • Ibuprofen 200 mg (NSAID)*
  • nonsteroidal anti-inflammatory drug

Advil Gel Caplets (in each gel caplet)

  • Ibuprofen 200 mg (NSAID)*
  • nonsteroidal anti-inflammatory drug

Storage

  • Store at 20-25°C (68-77°F)
  • Avoid excessive heat above 40°C (104°F)

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

Advil Tablets

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Advil Caplets

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Advil Gel Caplets

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 gel caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 gel caplet, 2 gel caplets may be used
  • do not exceed 6 gel caplets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Precautions with Alcohol

  • It contains an NSAID, which may cause severe stomach bleeding. The chance is higher with alcohol ingestion.

Brand Names

Advil, Motrin, A-G Profen, Addaprin, Bufen, Genpril, Caldolor, Haltran.

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "http://www.ismp.org". External link in |title= (help)

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