Țară: Africa de Sud
Limbă: engleză
Sursă: South African Health Products Regulatory Authority (SAHPRA)
Boots-h
TRANSACT SCHEDULING STATUS Schedule 1 PROPRIETARY NAME (and dosage form) TRANSACT An adhesive patch (TransAct patch - local action transcutaneous patch) COMPOSITION TransAct patch : Each TransAct patch contains 40 mg flurbiprofen PHARMACOLOGICAL CLASSIFICATION A 3.1 Antirheumatics (anti-inflammatory agents) PHARMACOLOGICAL ACTION TransAct contains flurbiprofen, chemically described as 2 - (2-fluoro-4-biphenylyl) propionic acid, a non-steroidal anti- inflammatory agent which has anti-inflammatory, analgesic and anti-pyretic properties. Flurbiprofen is an inhibitor of prostaglandin synthetase enzymes. Application of TransAct results in the diffusion of the flurbiprofen molecule through the skin and subcutaneous fat to the deeper tissues. Although the bioavailability from the formulation is low (approximately 2%), concentrations of flurbiprofen in the deeper tissues around joints are similar to those seen after conventional oral dosing. Concentrations of flurbiprofen in the blood are, however, much lower, with maximal plasma levels of 38,5 ng/mL observed at 13.8 hours after a single 14 hour application. Plasma concentrations of flurbiprofen continue to rise on repeated application to reach steady state in about 1-2 weeks. However, steady state plasma levels (about 100- 200 ng/mL) remain very much lower than after oral therapy. After removal, plasma flurbiprofen levels decline more slowly than after oral administration due to continued distribution from the tissues, and fall to undetectable levels within 48 hours. In blood, flurbiprofen is highly protein bound (>99%). Elimination of flurbiprofen is via the kidney, mostly in the form of metabolites. The metabolic profile following topical administration is similar to that after oral dosing; hydroxyflurbiprofen is the principle metabolite. INDICATIONS Citiți documentul complet