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Brufen 600Brufen 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
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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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