Generic Medicine Info
Should be taken with food.
Hypersensitivity to ibuprofen; history of hypersensitivity reaction (e.g. bronchospasm, asthma, urticaria, angioedema, rhinitis) to aspirin or other NSAIDs. History of gastrointestinal bleeding, perforation, or ulceration related to NSAID therapy; active, or history of recurrent peptic ulcer or gastrointestinal haemorrhage (≥2 distinct episodes of proven ulceration or bleeding); conditions involving an increased tendency to bleeding; application on broken or damaged skin (topical). Ibuprofen lysine: Proven or suspected infection that is left untreated; congenital heart disease whom patency of PDA is necessary for satisfactory pulmonary or systemic blood flow (e.g. pulmonary artesia, severe tetralogy of Fallot, severe coarctation of the aorta); thrombocytopenia, coagulation defects, confirmed or suspected necrotising enterocolitis. Severe heart failure (New York Heart Association Class IV). Patients undergoing CABG surgery. Severe renal and hepatic impairment. Pregnancy (3rd trimester).
Special Precautions
Patient with history of ulcer (especially if complicated with haemorrhage or perforation); history of ulcerative colitis or Crohn's disease; history of bronchial asthma, chronic rhinitis, allergic disease; CV disease, risk factors of CV disease (e.g. mild to moderate CHF, ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, CVA, hypertension, hyperlipidaemia, diabetes mellitus, smoking); recent MI, SLE, mixed connective tissue disorders, acute intermittent porphyria, coagulation disorder, varicella infection; elevated total bilirubin (ibuprofen lysine). Dehydrated, hypovolaemic patients; heavy alcohol drinkers. CYP2C9 intermediate or poor metabolisers; patients carrying CYP2C9*1, CYP2C9*2, or CYP2C9*3 allele. Patient undergoing surgery. Mild to moderate renal and hepatic impairment. Children and elderly. Pregnancy (1st and 2nd trimester) and lactation. Patient Counselling This drug may cause dizziness, drowsiness, fatigue, or visual disturbances, if affected, do not drive or operate machinery. Avoid excessive exposure of treated area to sunlight (topical). Monitoring Parameters Obtain CBC, chemistry profile, occult blood loss and periodic LFTs. Monitor response (e.g. pain, range of motion, grip strength, mobility, ADL function), inflammation; renal function (e.g. urine output, serum BUN and creatinine), blood pressure. Assess for weight gain, oedema, bleeding, bruising, gastrointestinal effects (e.g. abdominal pain, bleeding, dyspepsia), mental confusion or disorientation. Perform periodic ophthalmic exams (prolonged therapy).
Adverse Reactions
Significant: New-onset hypertension or exacerbation of hypertension, platelet aggregation, prolong bleeding time, elevated transaminase levels, hyperkalaemia, drowsiness, dizziness, blurred or diminished vision, scotomata, changes in colour vision; photosensitivity (topical); renal papillary necrosis (prolonged use), mask symptoms of infection, Na and fluid retention, oedema, risk for impairment of female fertility. Rarely, aseptic meningitis, severe blood dyscrasias (e.g. agranulocytosis, thrombocytopenia, aplastic anaemia). Ear and labyrinth disorders: Tinnitus. Gastrointestinal disorders: Nausea, vomiting, abdominal pain, flatulence, diarrhoea, dyspepsia, constipation, melaena, haematemesis. General disorders and administration site conditions: Fatigue; pain and burning sensation in the administration site (inj). Investigations: Increased lactate dehydrogenase (inj). Metabolism and nutrition disorders: Hypokalaemia, hypernatraemia, hypoalbuminaemia (inj). Nervous system disorders: Headache. Psychiatric disorders: Nervousness. Renal and urinary disorders: Urinary retention (inj). Skin and subcutaneous tissue disorders: Rash, pruritus. Vascular disorders: Hypotension (inj).
Potentially Fatal: CV thrombotic events (e.g. MI or stroke), gastrointestinal ulceration, inflammation, perforation or haemorrhage; rarely, severe hepatic reactions (e.g. fulminant hepatitis, liver necrosis, hepatic failure); very rarely, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalised exanthematous pustulosis (AGEP); drug eosinophilia and systemic symptoms (DRESS) or multiorgan hypersensitivity reactions.
Drug Interactions
May increase risk of ulceration or bleeding with other NSAIDs, oral corticosteroid, anticoagulants (e.g. warfarin), anti-platelet (e.g. aspirin), SSRIs. May reduce the effect of antihypertensives (e.g. ACE inhibitors, angiotensin II receptor antagonist, β blockers); natriuretic effect of diuretics. May increase the toxicity and plasma concentration of cardiac glycosides. Decreases excretion of lithium, methotrexate, aminoglycosides. Increased risk of nephrotoxicity with ciclosporin, tacrolimus. May increase the risk of convulsions with quinolone antibiotics. May potentiate the effects of sulfonylureas. Increased risk of haematological toxicity with zidovudine. Concomitant use with CYP2C9 inhibitors (e.g. fluconazole, vorizonazole) may increase plasma concentration of ibuprofen.
CIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
G02CC01 - ibuprofen ; Belongs to the class of antiinflammatory products for vaginal administration used in the treatment and prevention of inflammation.
M02AA13 - ibuprofen ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
C01EB16 - ibuprofen ; Belongs to the class of other cardiac preparations.
R02AX02 - ibuprofen ; Belongs to the class of other throat preparations.
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