Pefloxacin

General adverse effects and adverse reactions

The adverse effects of pefloxacin and reactions to it are those of the fluoroquinolones. Gastrointestinal complaints occur in some 3–6% and have included (in declining order of frequency) nausea, abdominal discomfort, vomiting, and diarrhea. Colitis due to Clostridium difficile infection has been reported infrequently. Nervous system reactions have been less common, but headache, dizziness, agitation, sleep disturbances. More rarely seizures, delirium, and hallucinations have been reported. Allergic reactions are infrequent. Photosensitivity reactions have been reported. The quinolones cause cartilage erosion in weight-bearing joints in young growing animals, and the long-term use of pefloxacin in growing children, such as would be required for prophylaxis, should be avoided. In bacteria that have developed resistance to fluoroquinolones, cross-resistance with chemically unrelated antibiotics, such as tetracycline and chloramphenicol, can occur.

Observational studies

Pefloxacin was tested in a dosage of 400 mg every 12 hours for 3 days against chloroquine-resistant P. falciparum infections in patients in Madagascar, and proved successful in 9 out of 22 cases; seven further cases responded at first but recrudescence followed. The investigators suggested that pefloxacin should be used as a complementary drug rather than as a primary antimalarial drug.

There was a significant reduction in proteinuria in 10 children with idiopathic nephrotic syndrome after pefloxacin therapy (mean dose 2–4.6 mg/kg/day for 4–8 weeks) [ ]. All had received a course of cyclophosphamide at least 6 months before. One patient discontinued pefloxacin within 2 weeks because of nausea and vomiting, one complained of arthralgia, and one developed nail discoloration.

The efficacy and safety of pefloxacin, 15–20 mg/kg bd for 14–28 days in combination with ceftazidime and amikacin, have been investigated in 21 children (aged 7–16 years) with mucoviscidosis or aplastic anemia [ ]. Combined therapy had good clinical efficacy. Arthropathy developed frequently and children at risk were over 10 years old and had a history of allergies.

In a retrospective study the data on fluoroquinolones and other antibacterial drugs were obtained from a spontaneous reporting system database, pefloxacin was associated with the highest reporting rate (982 reports/daily defined dose/1000 inhabitants/day), and the most frequent were musculoskeletal disorders [ ].