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 Brufen 600
PRODUCT DESCRIPTION
Brufen 600mg Tablet contains ibuprofen 600mg as an active ingredient, is a
white pillow-shape film-coated tablet and has a black imprint "BRUFEN 600"
on one side of the tablet.
Brufen Suspension 100mg/5ml contains ibuprofen 100mg per 5m1 as active
ingredient, available as an orange coloured and flavoured syrup suspension.
Ibuprofen is a member of the propionic acid group of nonsteroidal
antiinflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of [+]S- and
[]R-enantiomers.
Ibuprofen has shown anti-inflammatory analgesic and antipyretic activity in
both animal and human studies. These properties provide symptomatic relief
of inflammation and pain.
CLINICAL PHARMACOLOGY
Actions
Ibuprofen is a propionic acid derivative with analgesic anti-inflammatory
and anti-pyretic activity. The drug's therapeutic effects are thought to
result from its inhibitory effect on the enzyme cyclo-oxygenase which
results in a marked reduction in prostaglandin synthesis.
Pharmacokinetics
Ibuprofen is rapidly absorbed from the gastrointestinal tract peak serum
concentrations occurring one to two hours after administration. The
elimination half-life is approximately two hours.
Ibuprofen is metabolized in the liver to two inactive metabolites and the
kidney excretes these together with unchanged ibuprofen, either as such or
as conjugates. Excretion by the kidney is both rapid and complete.
Ibuprofen is extensively bound to plasma proteins.
INDICATIONS
Ibuprofen is indicated for the treatment of rheumatoid arthritis, including
juvenile arthritis or Still's disease, ankylosing spondylitis,
osteoarthritis and other non-rheumatoid (seronegative) arthropathies and
acute gouty arthritis. It is also indicated for the treatment of non-articular
rheumatic conditions and periarticular conditions such as frozen shoulder (capsulitis),
bursitis, tendinitis, tenosynovitis and low-back pain.
It is also used in the treatment of soft-tissue injuries such as sprains and
strains, for relief of mild tomoderate pain such as primary dysmenorrhea,
dental and post-operative pain, post-episiotomy pain, post-partum pain and
for the symptomatic relief of headache including migraine headache.
In addition, the suspension is indicated in short-term use for the treatment
of pyrexia in children over one year of age.
CONTRAINDICATIONS
Ibuprofen is contraindicated in patients with active peptic ulceration and
those with a history of hypersensitivity reactions including asthma,
rhinitis or urticaria in response to ibuprofen, aspirin or other NSAIDs.
ADVERSE REACTIONS
The pattern of adverse events reported for ibuprofen is similar to that for
other NSAIDs.
Immune System Disorders
Hypersensitivity reactions have been reported following treatment with
Ibuprofen. These may consist of (a) non-specific allergic reaction and
anaphylaxis. (b) respiratory tract reactivity comprising asthma, aggravated
asthma, bronchospasm or dyspnea, or (c) assorted skin disorders, including
rashes of various types, pruritus, urticaria, purpura, angioedema and less
commonly, bullous dermatoses (including epidermal necrolysis and erythema
multiforme).
Gastrointestinal Disorders
The most commonly observed adverse events are gastrointestinal in nature.
Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, melena, hematemesis,
ulcerative stomatitis and gastrointestinal hemorrhage have been reported
following ibuprofen administration. Less frequently, gastritis, duodenal
ulcer and gastric ulcer have been observed. Epidemiological data indicate
that of the seven most widely used oral non-aspirin NSAIDs, ibuprofen
presents the lowest risk of upper gastrointestinal toxicity.
General Disorders and Administration Site Conditions
Edema has been reported in association with ibuprofen treatment.
Other adverse events reported less commonly and for which causality has not
necessarily been established include:
Blood and lymphatic system disorders
Thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and
hemolytic anemia
Psychiatric disorders
Depression, confusion
Nervous system disorders
Headaches, paresthesia, dizziness, drowsiness
Eye disorders
Disturbances of vision, optic neuritis
Ear and labyrinth disorders
Vertigo, tinnitus
Hepatobiliary disorders
Hepatitis, jaundice
Skin and subcutaneous tissue disorders
Photosensitivity
Renal and urinary disorders
Renal nephrotoxicity in various forms, including interstitial nephritis,
nephrotic syndrome and penal failure
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