Ibut 200Mg Tablets

DESCRIPTION Ibut Tablet contains Ibuprofen a nonsteroidal anti-inflammatory drug (NSAID), used for variety of inflammatory conditions. 

CLINICAL PHARMACOLOGY: Ibuprofen is a non-steroidal anti-inflammatory drug which is very well-tolerated acts by inhibiting cyclo-oxygenase enzyme responsible for biosynthesis of prostaglandins. 

PHARMACOKINETICS: Ibuprofen is well absorbed from the gastrointestinal tract and is extensively bound to plasma proteins. It diffuses into the synovial fluid, metabolized in the liver and excreted rapidly and completely by the kidney. The elimination half-life is approximately 2 hours. 

CONTRAINDICATION: Ibuprofen should be contraindicated to use in patients with asthma, active gastro-intestinal (GI) bleeding, ulceration, history of GI bleeding, GI perforation related to previous NSAID therapy, history of recurrent GI hemorrhage (two or more distinct episodes), severe heart failure. Ibuprofen is contraindicated to use in children under 3 months or body weight under 5kg. 

ALLERGY AND CROSS-SENSITIVITY: Contra-indicated in patients with a history of hypersensitivity to aspirin or any other NSAID-which includes those in whom attacks of asthma, angioedema, urticaria or rhinitis have been precipitated by Aspirin or any other NSAID. 

CAUTIONS AND WARNINGS: Allergic disorders (in adults), cardiac impairment (NSAIDs may impair renal function), cerebrovascular disease, coagulation defects, connective tissue disorders, Crohn’s disease (may be exacerbated), elderly (risk of serious side-effects and fatalities) (in adults), heart failure, ischemic heart disease, peripheral arterial disease, risk factors for cardiovascular events, ulcerative colitis (may be exacerbated), uncontrolled hypertension. High dose Ibuprofen (22.4 g) daily may show increase in cardiovascular risk. 

CONCEPTION AND CONTRACEPTION: Long-term use of some NSAIDs is associated reduced female fertility, which is reversible on stopping treatment. 

HEPATIC AND RENAL IMPAIRMENT: Hepatic Impairment: Ibuprofen should be avoided or use with caution as there is an increased risk of GI bleeding and fluid retention. Avoid in severe liver disease. Renal Impairment: Ibuprofen should be avoided or used with caution in severe renal impairment.

PREGNANCY AND LACTATION: Pregnancy: Avoid unless the potential benefit outweighs the risk. Avoid during the third trimester (risk of closure of fetal ductus arteriosus in utero and possibly persistent pulmonary hypertension of the newborn); onset of labor may be delayed, and duration may be increased. Lactation: Use Ibuprofen with caution during breast-feeding. Ibuprofen amount too small to be harmful. A study of pregnant women suggests that those taking type or amount of NSAIDs (including ibuprofen) were 2.4 times more likely to miscarry than those not taking the medications. 

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Undesirable effects such as dizziness. drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected patients should not drive or operate machinery. 

SIDE EFFECTS: Ibuprofen may show side effects like-alveolitis. aseptic meningitis (patients with connective-tissue disorders such as systemic lupus erythematosus may be especially susceptible), hepatic damage, interstitial fibrosis associated with NSAIDs can lead to renal failure, pancreatitis, papillary necrosis associated with NSAIDs can lead to renal failure, pulmonary eosinophilia. Stevens-Johnson syndrome, toxic epidermal necrolysis visual disturbances, a possible exacerbation of symptoms in asthma. 

DRUG INTERACTIONS: Fluconazole, Voriconazole increases plasma concentration of Ibuprofen Antiplatelet effect of Aspirin possibly reduced by Ibuprofen. Excretion of Baclofen, Methotrexate reduced by Ibuprofen. Increased risk of nephrotoxicity when Ibuprofen given with Tacrolimus. 

Manufactured in India by: LEBEN LABORATORIES (PVT) LTD