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Cations in the didanosine tablet reduce ciprofloxacin bioavailability
Author(s) -
Sahai Jan,
Gallicano Keith,
Oliveras Linda,
Khaliq Shireen,
HawleyFoss Nanci,
Garber Gary
Publication year - 1993
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.1993.24
Subject(s) - didanosine , ciprofloxacin , crossover study , pharmacokinetics , placebo , pharmacology , bioavailability , medicine , bioequivalence , oral administration , antibacterial agent , zidovudine , antibiotics , chemistry , human immunodeficiency virus (hiv) , immunology , biochemistry , alternative medicine , pathology , viral disease
The effect of the magnesium‐aluminum cations contained in didanosine chewable tablets on ciprofloxacin pharmacokinetics was evaluated in 12 healthy volunteers. The study was designed as a randomized, balanced, open, two‐period, two‐treatment crossover trial with a 7‐day washout period between treatments. In one phase, subjects received a single 750 mg ciprofloxacin tablet alone. In the didanosine‐cation regimen, subjects received two didanosine‐placebo tablets every 12 hours for two doses. On day 2, they received two didanosine‐placebo tablets immediately followed by a single 750 mg ciprofloxacin tablet. Serial blood samples were collected for 24 hours after administration of each ciprofloxacin dose. The average maximum concentration of ciprofloxacin alone was 3.38 ± 0.63 (SD) µg/ml compared with 0.25 ± 0.21 (SD) µg/ml when ciprofloxacin was administered with the didanosine placebo (p < 0.0001). The mean (± SD) area under the plasma drug concentration–time curve from time 0 to the last measurable concentration for ciprofloxacin alone was 15.50 ± 2.69 µg · hr/ml compared with 0.26 ± 0.21 µg · hr/ml when ciprofloxacin was coadministered with the didanosine‐placebo (p < 0.0001). The mean time to maximum concentration of ciprofloxacin alone decreased from 1.56 ± 0.62 to 0.75 ± 0.38 hours with buffer administration (p = 0.0012). The simultaneous administration of ciprofloxacin and didanosine should be avoided. Clinical Pharmacology and Therapeutics (1993) 53, 292–297; doi: 10.1038/clpt.1993.24