Cefpodoxime proxetil (Vantin - Upjohn), a new third-generation oral cephalosporin, has been approved for marketing by the US Food and Drug Administration. It is available for twice-daily treatment of pharyngitis, upper and lower respiratory infections, otitis media, urinary tract infections, skin and soft tissue infections, and for single-dose treatment of uncomplicated gonorrhea in men or women and anorectal gonorrhea in women.

Olanzapine (Zyprexa - Lilly), a thienobenzodiazepine that structurally resembles and binds to many of the same receptors as clozapine (Clozaril), is now available in the USA for treatment of schizophrenia and other psychotic disorders.

The FDA has added a boxed warning to fluoroquinolone package inserts about tendon injuries that may occur as a result of their use. Tendinitis or tendon rupture may occur rarely with systemic use of any fluoroquinolone, either while the drug is being taken or for up to several months afterwards.Fluoroquinolone-related tendon injury is rare; estimates for its incidence in the general population range from 0.14% to 0.4%. The risk is higher for patients >60 years old and for those taking corticosteroids. For patients with organ transplants, the incidence may be as high as 15%.1 A case-control...

The FDA has announced that it is requiring changes in the labeling of systemic fluoroquinolones to warn that the risk of serious adverse effects, including tendinitis, peripheral neuropathy and CNS effects, generally outweighs their benefit for the treatment of acute sinusitis, acute exacerbations of chronic bronchitis, and uncomplicated urinary tract infections. For these infections, the new labels will recommend reserving fluoroquinolones for patients with no other treatment options.

Gemifloxacin (Factive - Oscient), a new oral fluoroquinolone antibiotic, has been approved by the FDA for 5 days' treatment of acute bacterial exacerbations of chronic bronchitis (ABECB) and 7 days' treatment of mild to moderate community-acquired pneumonia (CAP) in adults. For the next 6-8 months it will only be available, presumably for commercial reasons, in states east of the Rocky Mountains.

Terfenadine (Seldane - Marion Merrell Dow) and astemizole (Hismanal - Janssen) are nonsedating antihistamines widely used to treat symptoms of allergic rhinitis (Medical Letter, 27:65, 1985; 31:43, 1989). Both are available without a prescription in Canada, and the US Food and Drug Administration is apparently considering terfenadine for over-the-counter availability in the USA.

The text that follows reviews some common bacterial infections and their empiric treatment pending the results of culture and susceptibility testing. The recommendations made here are based on the results of susceptibility studies, clinical trials, and the opinions of Medical Letter reviewers. Tables 1 and 2 list the usual dosages of antibacterial drugs.

The FDA has approved the fluoroquinolone besifloxacin 0.6% ophthalmic suspension (Besivance - Bausch & Lomb) for treatment of bacterial conjunctivitis caused by susceptible bacteria. According to the manufacturer, this product was developed specifically for ophthalmic use in a specialized vehicle designed to prolong contact time on the ocular surface. Besifloxacin is not available for systemic use.

The FDA has approved ceftolozane/tazobactam (Zerbaxa – Cubist), a combination of a new cephalosporin antibiotic and a beta-lactamase inhibitor, for intravenous treatment of complicated urinary tract and intra-abdominal infections in adults.

Pramipexole (Mirapex - Pharmacia & Upjohn) and ropinirole (Requip - SmithKline Beecham), two new dopamine agonists, have been approved by the US Food and Drug Administration (FDA) for treatment of both early (without levodopa) and advanced (with levodopa) Parkinson's disease. Bromocriptine (Parlodel) and pergolide (Permax) are older dopamine agonists marketed in the USA for adjunctive use with levodopa.