VOLISTAR P is a fixed dose combination of Aceclofenac and Paracetamol. Aceclofenac belongs to a group of Non Steroidal Anti-inflammatory Drugs (NSAIDs) used to treat various painful inflammatory conditions. Aceclofenac has an outstanding anti-inflammatory profile mediated primarily through inhibition of cyclooxygenase (COX) activity and suppression of PGE2 synthesis. Paracetamol is a safe and effective analgesic-antipyretic agent with minimal effect on cardiovascular, respiratory and GI system. Paracetamol or acetaminophen is the demethylated active metabolite of phenacetin. Chemically, Paracetamol is N-acetyl-p-aminophenol.
Aceclofenac is well absorbed from gastrointestinal tract and peak plasma concentrations (Cmax) are reached 1-3 hours after an oral dose. The drug is more than 99% bound to plasma proteins and the volume of distribution (Vd) is approximately 25 liters. The presence of food reduced rate of absorption (increased tmax) but not the extent of absorption (Cmax or AUC).
Aceclofenac…….. 100 mg
Patients sensitive to Aceclofenac, Paracetamol or to any of the excipients of the product
Patients in whom aspirin or other NSAIDs, precipitate attacks of bronchospasm, acute rhinitis or urticaria or patients hypersensitive to these drugs
Patients with active or suspected peptic ulcer or gastrointestinal bleeding or bleeding disorders
Patients with severe heart failure, hypertension, hepatic or renal insufficiency
Third trimester of pregnancy