this file contain information on the maximum dose ibuprofen for adult

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Maximum tolerated daily dose of
ibuprofen for a healthy adult
Hawkar Hama Rasheed-----Miran Mustafa Hama Rasheed
Muhamad Akram ---- Muhamad abdul rahman
Department of pharmacy informatics
School of pharmacy
University of Sulaimani
11/9/2013, 3rd stage, Group 4
Question
what is the maximum tolerated daily
dose of ibuprofen for a healthy adult ?

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Introduction
Ibuprofen, a propionic acid derivative, Nonsteroidal
anti-inflammatory drugs have analgesic, antipyretic,
and anti-inflammatory activities. Major mechanism is
believed to be inhibition of cyclooxygenase activity
and prostaglandin synthesis.
Methodology
Primary resouces: Primary acticle;
1- Alimentary Pharmacology & Therapeutics:
A randomized, double-blind trial of 125 patients was
performed. A dose of 2400 mg⁄day of ibuprofen or
an equivalent dose of ibuprofen-PC (ibuprofen-
phosphatidylcholine) was administered for 6 weeks.
GI safety was assessed by endoscopy. Efficacy was
assessed by scores of analgesia and anti inflammatory
activity. Bioavailability of ibuprofen was
pharmacokinetically assessed.

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Result
Ibuprofen-PC and ibuprofen provided similar
bioavailability ⁄therapeutic efficacy.
In the evaluable subjects, a trend for improved GI
safety in the ibuprofen-PC group compared with
ibuprofen that did not reach statistical significance
was observed. However, in patients aged >55 years, a
statistically significant advantage for ibuprofen-PC
treatment vs. ibuprofen in the prevention of NSAID-
induced gut injury was observed with increases in
both mean Lanza scores and the risk of developing
>2 erosions or an ulcer. Ibuprofen-PC was well
tolerated with no major adverse events observed.
( Clinical trial: comparison of ibuprofen phosphatidylcholine and
ibuprofen on the gastrointestinal safety and analgesic efficacy in
osteoarthritic patients ,Aliment Pharmacol Ther 28, 431–442)
2) Primary article: ibuprofen Nonsteroidal anti-
inflammatory drugs (NSAIDs) inhibit both
cyclooxygenase-1 (COX-1) and cyclooxygenase-2
(COX-2) because use for treatment osteoarthritis
(OA) maximum tolerated dose is 2.4g daily.
(Ric Day, MD; Briggs Morrison, MD; Armando Luza, MD; Oswaldo Castaneda,
MD; Alberto Strusberg, MD; Menachem Nahir, MD; Knut Bjorn Helgetveit, MD;
Barbara Kress, RN; Brian Daniels, MD; James Bolognese; Dave Krupa; Beth
Seidenberg, MD; Elliot Ehrich, MD; Arch Intern Med. 2000;160(12):1781-1787 )

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Secondary resources: Abstract;
3) PubMed:Medications containing the drug
ibuprofen relieve pain and reduce inflammation. They
are often used in mild to moderate migraine attacks. In
Germany, pharmacies sell ibuprofen in dosages up to
400 mg per tablet without prescription. To treat
migraine, a healthy adult takes between 200 and 400 mg
at a time. The maximum dose of ibuprofen for
otherwise healthy adults is 1,200 mg per day and
should not be exceeded to ensure safe use
(Rabbie R, Derry S, Moore RA, McQuay HJ. Ibuprofen with or
without an antiemetic for acute migraine headaches in adults.
Cochrane Database Syst Rev. 2010)
4) Abstract:Fever was reduced significantly by IV
ibuprofen in burn patients over the initial 24-hour dosing
period and remained reduced throughout the dosing
period. Exposure to the maximum daily recommended
dose of 3200 mg (800 mg every 6 hours) for a total of
120 hours (5 days) was well tolerated.
(Promes JT, Safcsak K, Pavliv L, Voss B, Rock A. Source
Department of Surgical Education, Orlando Regional Medical Center,
Orlando, Florida 32806, USA.)

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 Tertiary resources: Textbooks;
5) Drug Fact And Comparison:Adults dose –
Do not exceed 3.2 g/day. If GI upset occurs, take
with meals or milk.
Rheumatoid arthritis and osteoarthritis: 1.2 to 3.2
g/day (300 mg 4 times/day or 400, 600, or 800 mg
3 or 4 times/day).
Mild to moderate pain: 400 mg every 4 to 6 hours,
as necessary.
Primary dysmenorrhea: 400 mg every 4 hours, as
necessary.
OTC use (minor aches and pains, dysmenorrhea,
fever reduction): 200 mg every 4 to 6 hours while
symptoms persist. If pain or fever do not respond
to 200 mg, 400 mg may be used. Do not exceed 1.2
g in 24 hours. Do not take for pain for longer than
10 days or for fever for longer than 3 days
unless directed.
(Drug Fact And Comparison 2007 Edition)
6) Renal drug hand book:
Initially: 1.2–1.8 g daily in 3–4 divided doses, after
food. Maximum 2.4 g daily dose for pain
(The Renal Drug Handbook ,Third Edition,Edited by Caroline Ashley
and Aileen Currie, UK Renal Pharmacy Group)

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7) American Society of Healthsystem Pharmacists
(AHFS Drug): Adults dose
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.
IV:
Individuals ≥17 years of age: 400-800 mg every 6
hours as needed.

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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.
IV:
Individuals ≥17 years of age: 400 mg initially; then
400 mg every 4-6 hours or 100-200 mg every 4
hours.
(AHFS Drug information book 2008)
8) Drug Information Handbook: Inflammatory
disease: Oral: 400-800 mg/dose 3-4 times/day
(maximum: 3.2 g/day)
Analgesia/pain/fever/dysmenorrhea: Oral: 200-400
mg/dose every 4-6 hours (maximum daily dose: 1.2
g, unless directed by physician; under physician
supervision daily doses 2.4 g may be used)

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OTC labeling (analgesic, antipyretic): Oral: 200 mg
every 4-6 hours as needed (maximum: 1200 mg/24
hours); treatment for >10 days is not recommended
unless directed by healthcare provider.
(Drug Information Handbook, 17th Edition)
9) Martindale: The usual oral dose for painful
conditions is 1.2 to 1.8 g daily in divided doses
although maintenance doses of 600 mg to 1.2 g daily
may be effective in some patients. If necessary the
dose may be increased; in the UK the maximum
recommended dose is 2.4 g daily whereas in the USA
it is 3.2 g daily. Modified-release preparations of
ibuprofen are available for once- or twice-daily
dosing, although actual dosages vary with different
preparations. Patients with rheumatoid arthritis
generally require higher doses of ibuprofen than
those with osteoarthritis. The recommended dose for
fever reduction is 200 to 400 mg every 4 to 6 hours to
a maximum of 1.2 g daily.
[Martindale: The Complete Drug Reference, (2009) 36th ed.]

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10) BNF : . ADULT, initially 300–400 mg 3– 4
times daily; increased if necessary to max. 2.4 g
Daily for Analgesia/pain/fever/dysmenorrhea .
[BNF:British National Formulary (2011) 61th ed.]
11) National drug formulay Ethiopia:
Antirheumatic: Oral: 1.2 to 3.2gms a day in three or
four divided doses. After a satisfactory response has
been obtained, the dosage should be reduced to the
lowest maintenance dose that provides continuing
control of symptoms. Note - Higher doses are
generally required in rheumatoid arthritis than in
osteoarthritis.
(Drug Administration and Control Authority of Ethiopia September
2007)

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 Tertiary Resources: Databases;
12) Medscape: Adult dose
Pain
300-800 mg PO q6hr
Fever
100-200 mg PO q4-6hr PRN
Inflammatory Disease
400-800 mg/dose PO q6-8hr
Dysmenorrhea
400-600 mg PO q6-8hr or 800 mg PO q8hr; not to
exceed 2,400 mg/day
Osteoarthritis
300 mg, 400 mg, 600 mg, or 800 mg PO q6-8hr; not
to exceed 3.2 g/day Monitor for GI risks
Rheumatoid Arthritis
300 mg, 400 mg, 600 mg, or 800 mg PO q6-8hr; not
to exceed 3.2 g/dayMonitor for GI risks

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 Tertiary Resources :Review article;
13) Review Articles:Low doses of ibuprofen
(200 mg, and sometimes 400 mg) are available over
the counter (OTC) in most countries. Ibuprofen has a
dose-dependent duration of action of approximately
4–8 hours, which is longer than suggested by its short
half-life. The recommended dose varies with body
mass and indication. Generally, the oral dose is 200–
400 mg (5–10 mg/kg in children) every 4–6 hours,
adding up to a usual daily dose of 800–1,200 mg.
1,200 mg is considered the maximum daily dose for
over-the-counter use, though under medical direction,
the maximum amount of ibuprofen for adults is 800
milligrams per dose or 3200 mg per day (4 maximum
doses).
(News Medical:www.news-medical.net)
 Consumer health information
14) FDA: Ibuprofen has been available as
aprescription drug for the treatment of osteoarthritis
and rheumatoid arthritisat a dose of 1,200 to 3,200
milligrams(mg) per (/) day
(FDA: www.fda.gov/cder)

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15) Drug info: Ibuprofen Dosing for Adult
Usual Adult Dose for Dysmenorrhea: 200 to 400 mg
orally every 4 to 6 hours as needed.
Usual Adult Dose for Osteoarthritis:
Maintenance dose: May be increased to a maximum
daily dose of 3200 mg based on patient response and
tolerance.
Usual Adult Dose for Rheumatoid Arthritis:.
Maintenance dose: May be increased to a maximum
daily dose of 3200 mg based on patient response and
tolerance.
Usual Adult Ibuprofen Dose for Pain:
Oral: Mild to moderate pain:
200 to 400 mg orally every 4 to 6 hours as needed.
Doses greater than 400 mg have not been proven to
provide greater efficacy.
IV: (Patients should be well hydrated before IV
ibuprofen administration):
Pain: 400 to 800 mg intravenously over 30 minutes
every 6 hours as needed.

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Usual Adult Dose for Fever:
Oral: 200 to 400 mg orally every 4 to 6 hours as
needed.
IV: (Patients should be well hydrated before IV
ibuprofen administration):
Fever: Maintenance: 400 mg every 4 to 6 hours or
100 to 200 mg every 4 hours as needed.
(drug info:www.drug.com)
16) Mayo Clinic:For mild to moderate pain:
Adults 400 mg every four hours, 2400 mg per day
For osteoarthritis and rheumatoid arthritis:
Adults 1200 milligrams (mg) up to 3200 mg per day.
(mayo clinic:www.mayo clinic.com)

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Answer the question
Ibuprofen use as analgesic, antipyretic, and anti-
inflammatory for adult ,according to maximum
daily dose :
*osteoarthritis
[300-800 mg PO tid-qid]
Max: 3200 mg/day; Info: use lowest effective dose,
shortest effective tx duration; give water and food
if GI upset occurs
*rheumatoid arthritis
[300-800 mg PO tid-qid]
Max: 3200 mg/day; Info: use lowest effective dose,
shortest effective tx duration; give w/ food if GI
upset occurs
*dysmenorrhea
[400 mg PO q4-6h]
Max: 2400 mg/day; Info: use lowest effective dose,
shortest effective tx duration; give w/ food if GI
upset occurs

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*pain, mild-moderate
[400 mg PO q4-6h]
Max: 2400 mg/day; Info: use lowest effective dose,
shortest effective tx duration; give w/ food if GI
upset occurs
*fever
[200-400 mg PO q4-6h]
Max: 1200 mg/day; Info: use lowest effective dose,
shortest effective tx duration; give w/ food if GI
upset occurs
*for anti-inflammatory uses
[600 mg PO qid x7-14 days]
Max: 2400 mg/day; Alt: 800 mg PO tid; Info: use
lowest effective dose, shortest effective tx duration;
give w/ food if GI upset occurs

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Stop Ibuprofen use or continue?
Stop use and ask a doctor if
1-an allergic reaction occurs. Seek medical help
right away.
2-pain gets worse or lasts more than 10 days
3-fever gets worse or lasts more than 3 days
4-stomach pain gets worse or lasts occurs with
the use of this product
5-redness or swelling is present in the painful
area is red or swollen
6-any new or unexpected symptoms appear
occur

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Alternative
1-Acetaminophen (Paracetamol) is used for the
relief of pains and reducing fever .The common
adult dose is 500 mg to 1000 mg. The
recommended maximum daily dose, for adults,
is 4000 mg.
2-Naproxen is commonly used for the reduction of
pain, fever, inflammation. The maximum daily
dose is 1000 mg .
3-ibuprofen-PC (ibuprofen-phosphatidylcholine)
have analgesia and anti inflammatory activity, the
maximum daily dose is 2400 mg⁄day .
4-Dexibuprofen is the S(+)-enantiomer of
ibuprofen and is used similarly in the management
of mild to moderate pain , inflammation and It may
be used as an antipyretic to reduce fever.The usual
adult dose is 600 to 900 mg daily by mouth in up to
3 divided doses, adjusted according to response, to
a usual maximum of 1.2 g daily