Pefloxacin - Licensed Uses

Licensed Uses

Oral and I.V. fluoroquinolones are not licensed for use in children due to the risk of permanent injury to the musculoskeletal system. At least ten cases of arthropathy occurred in pediatric patients receiving fluoroquinolones; seven of these cases involved pefloxacin. Clinical features included joint swelling or pain in one or more joints. Usually the knees were most oftentimes reported. One patient had evidence of significant joint damage to the right hip and both knees. One study that calculated the risk of such injury had stated that such injury occurred more often with Pefloxacin.

However, the fluoroquinolones are licensed to treat lower respiratory infections in children with cystic fibrosis in the UK. Prescribing a fluoroquinolone to treat an unapproved use within the pediatric (as well as the adult population) exposes the treating physician to the risk of being sued for malpractice should the treating physician fail to both warn the patient of this fact, as well as the risks of any adverse drug reactions the patient may experience.

Note: Not recommended for the treatment of infections which can be treated by simple and established antibiotics.

In the adult population Pefloxacin is generally limited to the treatment of proven serious and life threatening bacterial infections such as:

  • Uncomplicated gonococcal urethritis in males.
  • Bacterial infections in the gastrointestinal system.
  • Genitourinary tract infections.
  • Lower respiratory tract
  • Bone and joint infections
  • Renal and abdominal infections
  • Infections of skin and soft tissues
  • Gonorrhoeae. however this indication is no longer effective due to bacterial resistance.

Pefloxacin has been increasingly used as a veterinary medicine to treat microbial infections.

Antibiotics such as Pefloxacin do not improve sinusitis symptoms. When prescribed for Community Acquired Pneumonia, Chronic Bronchitis, and Acute Bacterial Sinusitis the use of the fluoroquinolone class offers no compelling advantages over established treatment Nor does antibiotic treatment help sore throats. The use of antibiotics such as Pefloxacin to treat bronchitis is to be considered unnecessary and as such exposes the patient to an unacceptable risk of suffering a severe adverse reaction. Antibiotics' futility against bronchitis had been confirmed in 2002. Since Streptococci and Pneumococci show only intermediate susceptibility to pefloxacin, the drug should not be prescribed as 1st-line treatment in respiratory tract infections, when bacteriological examination has not been carried out.

Additionally Pefloxacin and other fluoroquinolones have no effect upon viral infections such as the common head cold.

NOTE: Pefloxacin may be licensed for other uses, or restricted, by the various regulatory agencies worldwide.

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