Ibuprofen is a non-steroidal anti-inflammatory agent. It also possesses both
analgesic and antipyretic properties. Its mode of action like that of other
non-steroidal anti-inflammatory agents, may be related to prostaglandin
Each capsule contains:
Ibuprofen .......... 200mg
Ibuprofen Film Coated Tablet:
Ibuprofen .......... 400mg
1. In clinical studies in patients with rheumatoid arthritis and
osteoarthritis, Ibuprofen has been shown to be comparable to Aspirin in
controlling pain and inflammation and with a statistically significant
reduction in the milder gastrointestinal side effects.
2. Ibuprofen is rapidly absorbed when administered orally. Peak serum
Ibuprofen levels are generally attained one to two hours after
3. Ibuprofen is rapidly metabolised and eliminated in the urine. The
excretion is virtually complete 24 hours after the last dose. The serum
half-life is 1.8 to 2.0 hours.
Rheumatoid arthritis, osteoarthritis, relief of pain due to musculoskeletal
Ibuprofen is also indicated for the treatment of primary dysmenorrhea.
Dosage and Administration
Do not exceed 3200mg total daily dose. If gastrointestinal complaints occur,
administer Ibuprofen with meals or milk.
Analgesic & antipyretic: 600 -
1200mg daily, in divided doses. For rheumatoid arthritis and osteoarthritis:
1200 - 3200mg daily in divided doses. When treating patients with
3200mg/day, the physician should observe sufficient increased clinical
benefit to offset potential increased risk. In general, patients with
rheumatoid arthritis seem to require higher doses of Ibuprofen than patients
Dysmenorrhea: 400mg every 4 hours when necessary for relief of pain.
A suggested dose for children:
20mg/kg body weight daily, in divided doses.
Not recommended for children under the age of 1 year or for children
weighing less than 7kg. For short term use only.
After assessing the risk/
benefit ratio in each individual patient, the lowest effective dose for the
shortest possible duration should be used.
Side Effect(s) / Adverse Reaction(s)
Gastrointestinal: Nausea, epigastric pain, heartburn, diarrhea. Others:
Dizziness, dyspepsia, headache, nervousness, pruritus, tinnitus, depression,
insomnia, blurred vision and other ocular reactions.
Thrombocytopenia, agranulocytosis, hypersensitivity reaction, abnormalities
of liver function test, impairment of renal function including interstitial
nephritis or nephrotic syndrome.
Precaution(s) / Warning(s)
1. Should not be used in patients who have previously exhibited
hypersensitivity to the drugs, or in individuals with the symptoms of nasal
polyps, angioedema and bronchospastic reactivity to Aspirin or other
non-steroidal anti-inflammatory agents.
2. All NSAIDs can cause gastrointestinal discomfort and rarely serious,
potentially fatal gastrointestinal effects such as ulcers, bleeding and
perforation which may increase with dose or duration of use, but can occur
at any time without warning. Caution is advised in patients with risk
factors for gastrointestinal
events e.g. the elderly, those with a history of serious gastrointestinal
events, smoking and alcoholism. When gastrointestinal bleeding or ulceration
occurs in patients receiving NSAIDs, the drug should be withdrawn
immediately. Doctors should warn patients about signs and symptoms of
serious gastrointestinal toxicity. The concurrent use of aspirin and NSAIDs
also increases the risk of serious gastrointestinal adverse events.
3. Observational studies have indicated that non-selective NSAIDs may be
associated with an increased risk of serious cardiovascular events,
principally myocardial infarction, which may increase with dose or duration
of use. Patients with cardiovascular disease or cardiovascular risk of an
adverse cardiovascular event in patient taking NSAID, especially in those
with cardiovascular risk factors, the lowest effective dose should be used
for the shortest possible duration.
There is no consistent evidence that the concurrent use of aspirin mitigates
the possible increased risk of serious cardiovascular thrombotic events
associated with NSAID use.
4. NSAIDs may lead to the onset of new hypertension or worsening the
pre-existing hypertension and patients taking antihypertensive with NSAIDs
may have an impaired antihypertensive response. Caution is advised when
prescribing NSAIDs to patients with hypertension. Blood pressure should be
monitored closely during initiation of NSAID treatment and at regular
5. Fluid retention and oedema have been observed in some patients taking
NSAIDs, therefore caution is advised in patients with fluid retention or
6. NSAIDs may very rarely cause serious cutaneous adverse events such as
exfoliative dermatitis, toxic epidermal necrolysis (TEN) and Stevens-Johnson
Syndrome (SJS), which can be fatal and occur without warning. These serious
adverse events are idiosyncratic and are independent of dose or duration of
use. Patients should be advised of the signs and symptoms of serious skin
reaction and to consult their doctor at the first appearance of a skin rash
or any other sign of hypersensitivity
7. Ibuprofen, like other non-steroidal anti-inflammatory agents, can inhibit
platelet aggregation but the effect is less than that seen with Aspirin.
8. It should be used with caution in patients with intrinsic coagulation
defects and those on anticoagulation therapy because Ibuprofen may prolong
9. May mask diagnostic signs in detecting complications of noninfectious
non-inflammatory painful conditions.
10. Severe hepatic reactions have been reported with Ibuprofen as with other
non-steroidal anti-inflammatory drugs. Discontinue use if liver disease
11. Since Ibuprofen is eliminated primarily by the kidneys, patients with
significantly impaired renal functions should be closely monitored.
12. Because of the known effects of non-steroidal anti-inflammatory drugs on
the fetal cardiovascular system, use during late pregnancy should be
Symptoms and Treatment for Overdosage and Antidote(s)
Treatment of overdosage consists of emptying the stomach via induction of emesis or
gastric lavage, administration of activated charcoal and antacids,
monitoring and supporting vital functions, and institution of symptomatic
and other supportive treatment as needed. Induction of diuresis may be
useful in overdoses with Ibuprofen.
Keep in a tight container.
Store at temperature below 30°C.
light and moisture.
Plastic Bottle : 5 years from the date of manufacture.
Blister Pack : 3
years from the date of manufacture.
Plastic bottle of 1000's and 1500's (for export only). Blister packing of
10's x 10 and 10's x 100. Tablet:
Plastic bottle of 500's, 1000's and 1500's (for export only). Blister
packing of 10's x 10 and 10's x 100.
RISK OF GI ULCERATION, BLEEDING AND PERFORATION WITH NSAID
Serious GI toxicity such as bleeding, ulceration and perforation can occur
at any time, with or without warning symptoms, in patients treated with
NSAID therapy. Although minor upper GI problems (eg. dyspepsia) are common,
usually developing early in therapy, prescribers should remain alert for
ulceration and bleeding in patients treated with NSAIDs even in the absence
of previous GI tract symptoms.
Studies to date have not identified any subset of patients not at risk of
developing peptic ulceration and bleeding. Patients with prior history of
serious adverse events and other risk factors associated with peptic ulcer
disease (eg. alcoholism, smoking, and corticosteroid therapy) are at
increased risk. Elderly or debilitated patients seem to tolerate ulceration
or bleeding less than other individuals and account for most spontaneous
reports for fatal GI events.