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Avelox (Moxifloxacin Hydrochloride) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Drug Interactions:

Antacids, Sucralfate, Metal Cations, Multivitamins: Quinolones form chelates with alkaline earth and transition metal cations. Oral administration of quinolones with antacids containing aluminum or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as VIDEX® (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, may substantially interfere with the absorption of quinolones, resulting in systemic concentrations considerably lower than desired. Therefore, moxifloxacin should be taken at least 4 hours before or 8 hours after these agents. (See CLINICAL PHARMACOLOGY, Drug Interactions and DOSAGE AND ADMINISTRATION.)

No clinically significant drug-drug interactions between itraconazole, theophylline, warfarin, digoxin, atenolol, oral contraceptives or glyburide have been observed with moxifloxacin. Itraconazole, theophylline, digoxin, probenecid, morphine, ranitidine, and calcium have been shown not to significantly alter the pharmacokinetics of moxifloxacin. (See CLINICAL PHARMACOLOGY.)

Warfarin: No significant effect of moxifloxacin on R- and S-warfarin was detected in a clinical study involving 24 healthy volunteers. No significant changes in prothrombin time were noted in the presence of moxifloxacin. Quinolones, including moxifloxacin, have been reported to enhance the anticoagulant effects of warfarin or its derivatives in the patient population. In addition, infectious disease and its accompanying inflammatory process, age, and general status of the patient are risk factors for increased anticoagulant activity. Therefore the prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if a quinolone is administered concomitantly with warfarin or its derivatives.

Drugs metabolized by Cytochrome P450 enzymes: In vitro studies with cytochrome P450 isoenzymes (CYP) indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2, suggesting that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these enzymes (e.g. midazolam, cyclosporine, warfarin, theophylline).

Nonsteroidal anti-inflammatory drugs (NSAIDs): Although not observed with moxifloxacin in preclinical and clinical trials, the concomitant administration of a nonsteroidal anti-inflammatory drug with a quinolone may increase the risks of CNS stimulation and convulsions. (See WARNINGS.)

OVERDOSAGE

Single oral overdoses up to 2.8 g were not associated with any serious adverse events. In the event of acute overdose, the stomach should be emptied and adequate hydration maintained. ECG monitoring is recommended due to the possibility of QT interval prolongation. The patient should be carefully observed and given supportive treatment. The administration of activated charcoal as soon as possible after oral overdose may prevent excessive increase of systemic moxifloxacin exposure. About 3% and 9% of the dose of moxifloxacin, as well as about 2% and 4.5% of its glucuronide metabolite are removed by continuous ambulatory peritoneal dialysis and hemodialysis, respectively.

Single oral moxifloxacin doses of 2000, 500, and 1500 mg/kg were lethal to rats, mice, and cynomolgus monkeys, respectively. The minimum lethal intravenous dose in mice and rats was 100 mg/kg. Toxic signs after administration of a single high dose of moxifloxacin to these animals included CNS and gastrointestinal effects such as decreased activity, somnolence, tremor, convulsions, vomiting and diarrhea.

CONTRAINDICATIONS

Moxifloxacin is contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.

REFERENCES:

  1. Clinical and Laboratory Standards Institute, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically -Sixth Edition. Approved Standard CLSI Document M7-A6, Vol. 23, No. 2, CLSI, Wayne, PA, January, 2003.
  2. Clinical and Laboratory Standards Institute, Performance Standards for Antimicrobial Disk Susceptibility Tests -Eighth Edition. Approved Standard CLSI Document M2-A8, Vol. 23, No. 1, CLSI, Wayne, PA, January, 2003.
  3. Clinical and Laboratory Standards Institute, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard CLSI Document M11-A6, Vol. 24, No. 2, CLSI, Wayne, PA, 2004.

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