Pharmacology: Pharmacodynamics: Ibuprofen is a propionic acid derivative, having analgesic, anti-inflammatory and antipyretic activity. The drug's therapeutic effects as a non-steroidal anti-inflammatory are thought to inhibit prostaglandin synthetase and therefore the synthesis of prostaglandins which are known to be involved in the sensitisation of pain receptors and the inflammatory process.
Pharmacokinetics: Ibuprofen is rapidly absorbed from the gastrointestinal tract, peak serum concentrations occurring 1-2 hours after administration. Elimination half life is approximately 2 hours.
Ibuprofen is metabolised in the liver to two major inactive metabolites and these together with unchanged ibuprofen are excreted by the kidney either as such or as conjugates. Excretion by the kidney is both rapid and complete. Ibuprofen is extensively bound to plasma proteins.
As an analgesic and anti-inflammatory in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's Disease), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies.
In the treatment of non-articular rheumatic conditions, including frozen shoulder (capsulitis), bursitis, tendonitis, tendosynovitis, low back pain and soft-tissue injuries such as sprains and strains.
As an analgesic in the relief of mild to moderate pain such as dysmenorrhoea, dental and post-operative pain and for the symptomatic relief of headache including migraine.
Adults: The recommended dosage is 1200-1800 mg daily in 3-4 divided doses preferably after food; some patients can be maintained on 600-1200 mg daily. In severe or acute conditions the dose can be increased until the acute phase is brought under control; the total daily dosage should not exceed 2400 mg in divided doses.
Children: Daily dosage is 20 mg/kg of body weight in divided doses.
Not recommended for children under 7 kg weight. In juvenile rheumatoid arthritis up to 40 mg/kg body weight daily in divided doses may be taken.
Elderly: No special dosage modifications, unless renal or hepatic function is impaired, in which case dosage should be assessed individually. Owing to the increased susceptibility of the elderly to side effects of NSAID's, they should be recommended only after other forms of treatment have been carefully considered.
Brumed should be used at the lowest effective dose for shortest possible time.
Ibuprofen may cause nausea, vomiting, and tinnitus, but more serious toxicity is very uncommon. Gastric emptying is indicated if more than 100 mg/kg has been ingested within the preceding 4 hours, followed by symptomatic measures and, if necessary, correction of serum electrolytes. There is no specific antidote to ibuprofen.
Brumed should not be given to patients with a history of, or active, peptic ulceration. It is contra-indicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis or urticaria) in response to Ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs. Bronchospasm may be precipitated in patients suffering from, or with a previous history of, bronchial asthma.
Brumed is contraindicated: i) In patient with severe heart failure.
ii) For the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.
History of gastrointestinal bleeding or perforation related to previous NSAIDs therapy; active, or history of recurrent peptic ulcer/haemorrhage.
In rare cases, Brumed has been associated with serious liver injury.
Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.
NSAIDs have been reported to cause nephrotoxicity in various forms; interstitial nephritis, nephrotic syndrome and renal failure. In patients with renal, cardiac or hepatic impairment, caution is required since the use of NSAIDs may result in deterioration of renal function. The dose should be kept as low as possible and renal function should be monitored in these patients.
Cardiovascular risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Oral ibuprofen at a daily dose of 2400 mg should be avoided in patients with ischemic heart disease, cerebrovascular disease, congestive heart failure or with risk factors for cardiovascular disease.
Gastrointestinal risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease: No information is available from controlled clinical studies regarding the use of "BRUMED" in patients with advanced renal disease. Therefore, treatment with "BRUMED" is not recommended in patients with advanced renal disease. If therapy must be initiated, close monitoring of the patient's renal function is advisable.
Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Brumed during pregnancy should, if possible, be avoided. In the limited studies so far available, Ibuprofen appears in the breast milk in very low concentrations and is likely to affect the breast-fed infant adversely.
Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis and gastrointestinal haemorrhage.
Hypersensitivity: Hypersensitivity reactions have been reported following treatment with ibuprofen. Less frequently, thrombocytopenia has occurred. Other side effects associated with NSAID's include fluid retention, headache, dizziness and vertigo.
In therapeutic doses, no evidence of clinically significant interactions with other commonly used drugs has so far been observed. However, as with other NSAIDs, caution should be exercised in patients receiving oral anticoagulants, heparin via parenteral route and ticlopidine, thiazide diuretics, moclobemide, lithium, sulphonamide hypoglycemiant, methotrexate, pentoxifylline, zidovudine and baclofen.
Take into account interactions with antihypertensives (beta-blockers, conversion enzyme inhibitors, and diuretics), digoxin, and thrombolytics.
Taken on an empty stomach, peak serum levels of ibuprofen occur 45 minutes after ingestion whereas, taken after a meal, the peak is delayed up to 90 minutes.
Keep out of reach and sight of children.
M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Brumed FC tab 200 mg
3 × 10's
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