Management of pain & inflammation associated with Osteoarthritis & other musculoskeletal disorders. Symptomatic reatment of mild to moderate pain & inflammation including dysmenorrhoea & dental pain.
Dexibuprofen (S (+)-ibuprofen) is considered as the pharmacologically active enantiomer of racemic ibuprofen. Like racemic ibuprofen, Dexibuprofen is a non-steroidal anti-inflammatory drug with analgesic action. Like ibuprofen, Dexibuprofen acts by inhibiting prostaglandin synthesis.
Pharmacokinetics: Dexibuprofen is absorbed primarily from the small intestine. After metabolic transformation in the liver (hydroxylation, carboxylation) the pharmacologically inactive metabolites are completely excreted, mainly by the kidneys (90%), but also in the bile. The elimination half-life is 1.8-3.5 hours; the plasma protein binding is about 99%. Maximum plasma levels are reached about 2 hours after oral administration. The administration of dexibuprofen with a meal delays the time to reach maximum concentrations (from 2.1 hours after fasting conditions to 2.8 hours after non-fasting conditions) and decreases the maximum plasma concentrations (from 20.6 to 18.1 mcg/ml, which is of no clinical relevance), but has no effect on the extent of absorption.
The recommended dosage is 600-900 mg Dexibuprofen per day, at 2-3 divided doses. Maximum single dose is 400 mg. The dosage can be raised temporarily up to 1200 mg Dexibuprofen per day in patients with acute disorders or xacerbations. Elderly patient: Lowest Effective dose is recommended. The dosage can be raised to adult dosage if well tolerated.
The reported drug interactions of Dexibuprofen are similar to that of racemic mixture of ibuprofen. Drug interactions is noticed with simultaneous use of anticoagulant, hydantoine and sulfonamide, ticlopidine, lithium, other NSAID's, ACE inhibitors, beta blockers, cyclosporine, tacrolimus, corticosteroids, digoxin, methotrexate, pentoxyfiline, phenytoine, probenecid, sulfinpyrazon, sulfonylurea, thiazide and thiazide type diuretics, and zidovudine.
Dexibuprofen is contraindicated in patients with previous history of hypersensitivity to Dexibuprofen or other NSAIDs. Dexibuprofen is contraindicated in patients, who experience attack of asthma, bronchospasm, acute rhinitis, urticaria or edema after use of similar drugs (e.g., aspirin or other NSAIDs). It is also contraindicated in patients with active or suspected hemorrhage, Crohn’s disease or Ulcerative Colitis, patients with serious heart diseases, kidney function impairment (GFR < 30ml/min), & severe liver function impairment.
Dyspepsia, diarrhea, fatigue, & headache, nausea, vomiting, & abdominal pain. Less common Side Effect: Flatulence, urticaria, pruritus, purpura, rhinitis, bronchospasm, insomnia, & tinnitus.
Use of Dexibuprofen should be avoided during the pregnancy. Dexibuprofen should be used with cautions in nursing mothers.
Dexibuprofen has low acute toxicities. Symptoms of toxicity occur at doses between 80 and 100 mg/kg body weight. Mild symptoms are abdominal pain, nausea, vomiting, lethargy, headache, tinnitus and ataxia. Moderate to serious symptoms, such as flatulence, hypotension, hypothermia, metabolic acidosis, reduced kidney function, coma, and apnoea. The treatment must be symptomatic: there is no specific antidote. In case of large quantities of Dexibuprofen, activated charcoal should be administered. Vomiting can be induced only when life-threatening quantities of the substance ingested and the procedure can be carried out within 60 minutes after ingestion. Dialysis and hemodialysis are of little value as Dexibuprofen binds strongly to plasma protein.
Do not store above 30°C. Keep away from light and out of the reach of children
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