Ibuprofen (oral): Difference between revisions
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:* | :*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. | ||
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:* | :*1) 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 [38]. | ||
2) 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 [39]. | |||
3) 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 [37]. | |||
====Pain==== | ====Pain==== |
Revision as of 15:30, 15 October 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]
Disclaimer
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Overview
Ibuprofen (oral) is an analgesic, anti-inflammatory agent that is FDA approved for the treatment of minor aches and pains. 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
- Dosage
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
- 1) 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 [38].
2) 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 [39]. 3) 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 [37].
Pain
- Dosing Information
- Dosage
Primary dysmenorrhea
- Dosing Information
- Dosage
Rheumatoid arthritis
- Dosing Information
- Dosage
Off-Label Use and Dosage (Pediatric)
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 pediatric patients.
Non–Guideline-Supported Use
Patent ductus arteriosus
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ibuprofen (oral) in pediatric patients.
Contraindications
- Condition1
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.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Ibuprofen (oral) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- 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
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Ibuprofen (oral) in the drug label.
Pharmacology
Mechanism of Action
Structure
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
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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