YSP Ibuprofen

YSP Ibuprofen Special Precautions



Y.S.P. Industries


Y.S.P. Industries
Full Prescribing Info
Special Precautions
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.
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 When gastrointestinal bleeding or ulceration occurs in patients receiving NSAIDs, the drug should be withdrawn immediately.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.
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.
NSAIDs may lead to the onset of new hypertension or worsening the pre-existing hypertension and patients taking anti-hypertensive with NSAIDs may have an impaired anti-hypertensive 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 intervals thereafter.
Fluid retention and oedema have been observed in some patients taking NSAIDs, therefore caution is advised in patients with fluid retention or heart failure.
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.
Ibuprofen, like other non-steroidal anti-inflammatory agents, can inhibit platelet aggregation but the effect is less than that seen with Aspirin.
It should be used with caution in patients with intrinsic coagulation defects and those on anticoagulation therapy because Ibuprofen may prolong bleeding time.
May mask diagnostic signs in detecting complications of non-infectious non-inflammatory painful conditions.
Severe hepatic reactions have been reported with Ibuprofen as with other non-steroidal anti-inflammatory drugs. Discontinue use if liver disease develops.
Since Ibuprofen is eliminated primarily by kidneys, patients with significantly impaired renal functions should be closely monitored.
Because of the known effects of non-steroidal anti-inflammatory drugs on the fetal cardiovascular system, use during late pregnancy should be avoided.
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