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Ofloxacin: Side Effects

See also Fluoroquinolones

Ofloxacin is a fluoroquinolone antibacterial drug similar to ciprofloxacin.

Comparative studies

The safety and efficacy of topical ofloxacin ear-drops 0.3% (0.25 ml bd) have been compared with that of co-amoxiclav oral suspension (40 mg/kg/day) for acute otitis media in 286 children aged 1-12 years with tympanostomy tubes in place. Topical ofloxacin was as effective as and better tolerated than systemic therapy with co-amoxiclav. Treatment-related adverse event rates were 31% for co-amoxiclav and 6% for ofloxacin.

Organs and Systems

Nervous system

Headache was recorded in 9% taking ofloxacin during short-course treatment of urinary tract infections.

Seizures have occurred in patients taking ofloxacin.

A Tourette-like syndrome developed in a 71-year-old patient, temporally related to ofloxacin; spitting, profuse swearing, echolalia, echopraxia, orofacial and limb automatisms, and hypersalivation all resolved completely after withdrawal.

Sensory systems

Compared with aminoglycosides, which caused significant loss of hair cells in the basal turn of the cochlea, ofloxacin caused no loss of hair cells in rats, even at concentrations higher than are achieved clinically. Moreover, auditory brainstem testing showed no change in auditory thresholds in the ofloxacin-treated animals, whereas neomycin-treated animals showed substantial threshold shifts. In human studies, topical ofloxacin 0.3% had no demonstrable adverse effects on middle ear or cochlear function and was not associated with any changes in hearing.

Endocrine

Ofloxacin 200 mg bd caused diabetes insipidus in a 25-year-old man.

Mouth

Ofloxacin can impair salivary gland function. In rat parotid and submandibular glands intraperitoneal ofloxacin (20,40, and 80 mg/kg) reduced flow rate, amylase activity, total protein and calcium concentrations; in parotid saliva, sodium and potassium were increased. Sodium and potassium concentrations were also increased by a dose of 80 mg/kg in submandibular saliva. Possible mechanisms of these effects include altered intracellular cAMP and calcium concentrations and suppression of DNA, RNA, and protein synthesis in acinar cells.

Liver

Ofloxacin can cause fatal hepatic failure.

Urinary tract

Acute renal insufficiency has been caused by ofloxacin. Antimicrobial chemotherapy against diseases caused by Escherichia coli producing Shiga toxin has been implicated as a risk factor for progression to the hemolytic-uremic syndrome.

A 75-year-old woman took ofloxacin and developed the hemolytic-uremic syndrome.

In an in vitro study the addition of ofloxacin to a cell culture increased toxin activity by more than 200-fold.

Skin

Ofloxacin has been implicated in a case of toxic epidermal necrolysis.

A 75-year-old white man took 24 g of ofloxacin over 51 days for epididymitis. He had a severe skin reaction, diagnosed as toxic epidermal necrolysis, and died from complications.

Drug Administration

Drug formulations

Chitosan, a positively charged polysaccharide, increases the precorneal residence time of ophthalmic formulations that contain active compounds. Two chitosan products of high molecular weights (1350 and 1930 kDa) and low degrees of deacetylation (50%) significantly increased antibiotic availability compared with controls. The duration of efficacy of ofloxacin was significantly increased from about 25 minutes to 46 minutes by the chitosan of higher molecular weight.

Drug-Drug Interactions

Antacids

The systemic availability of ofloxacin is reduced by aluminium-containing antacids, but not by antacids containing magnesium or calcium.

Glucocorticoids

The antibacterial activity of polymorphonuclear leukocytes is based on the production of superoxide anions and H202 in the respiratory burst. Combinations of an antibacterial agent and an anti-inflammatory drug are commonly used in immunosuppressed patients whose respiratory burst of polymorphonuclear leukocytes is impaired. An in vitro study has shown that the combination of a glucocorticoid (dexamethasone, methylprednisolone, betamethasone, hydrocortisone) with ofloxacin 10 mg/ml neutralizes the inhibitory effect of the former on the respiratory burst.

Non-steroidal anti-inflammatory drugs

The antibacterial activity of polymorphonuclear leukocytes is based on the production of superoxide anions and H202 in the respiratory burst. Combinations of an antibacterial agent and an anti-inflammatory drug are commonly used in immu-nosuppressed patients whose respiratory burst of polymorphonuclear leukocytes is impaired. An in vitro study has shown that the combination of an anti-inflammatory drug (phenylbutazone or acetylsalicylic acid) with ofloxacin 10 mg/ml neutralizes the inhibitory effect of the former on the respiratory burst.

Oral contraceptives

Plasma concentrations of oral contraceptive steroids were unchanged by ofloxacin.

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