Scientific product monograph [antikvár]

Tarivid - For use in hospitals The use of parenteral broad-spectrum antimicrobial agents in the management of severe infections is standard. Very often, however, inadequate oral bioavailability of such broad spectrum agents necessitates continuance of the parenteral route of administration till the end of the therapy. With TARTVID, however, the nearly 100% bioavailability of the drug orally, as well as its availability now in the parenteral form permits change over from parenteral to oral therapy when desired. With TARTVID, there now exists a possibility of choice between parenteral and oral therapy with the same drug, at the same concentrations, with the same bioavailability. 1 Introduction and product summary TARTVID (ofloxacin) is a new parenteral and oral anti-infective agent from Hoechst AG. This pyridone carboxylic acid derivative represents a significant advance in antibacterial therapy and the clinical management of infections by an entirely new group of antimicrobial agents - the gyrase inhibitors, fluorinated quinolones. TARTVTD is a broad-spectrum bactericidal agent which acts by inhibiting bacterial DNA gyrase, the enzyme responsible for uncoiling genetic material as a prerequisite to bacterial multiplication. TARIVID has been shown, through worldwide clinical studies in patients with both simple and complex infections, to cover a broad range of indications - chronic and recurrent infections of upper and lower respiratory tract, the genitourinary tract, and of the skin and soft tissue septicaemia and associated with post-operative infections. TARIVID has a bactericidal effect, at low concentrations, on both gram-positive and gram-negative rods. It is effective against Pseudomonas aeruginosa, Chlamydia spp., Mycoplasma spp., Legionella pneumophila and Campylobacter spp. TARIVID is the first agent developed during the past few years to exhibit therapeutic activity superior to other existing parenteral and oral antibiotics or chemo-therapeutic agents. Its antibacterial activity is comparable to that of highly active modern parenteral antibiotics, and like these agents TARIVID is unaffected by beta-lactamases. TARTVID's high antibacterial activity against Neisseria gonorrhoeae (including those strains producing beta-lactamases that are mainly responsible for resistance to penicillin and ampicillin-like agents) and its remarkable in-vivo activity against Chlamydia trachomatis (an important organism in nonspecific and postgono-coccal urethritis) further confirm TARI-VID's superior broad-spectrum activity. The activity of TARIVID includes multi-resistant (e.g. methicillin-resistant) pathogens. The antibacterial activity of TARIVID against the major causative pathogens of bacterial infection is greater than that of penicillins, ampicillins, amoxicillin, all generations of cephalosporins, aminoglycosides, co-trimoxazole and tetracyclines. TARIVID has also proved to be very effective in cases where other agents have failed. TARTVID has an exceptional pharmacokinetic profile. It is virtually 100% bio-available, after oral administration. It shows excellent penetration into body fluids and tissues with over 90% of the drug being excreted in the kidneys in its unchanged form. About 5% of the ingested compound is excreted as metabolites. TARIVID also has a long half-life (6 hours), facilitating economical twice daily dosage. Protein binding: about 25%.