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

 
 



DRUG INTERACTIONS

Antacids, Sucralfate, Multivitamins and other products containing Multivalent Cations

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, AVELOX should be taken at least 4 hours before or 8 hours after these agents [see Dosage and Administration Pharmacokinetics (12.3), and Patient Counseling Information].

Warfarin

Quinolones, including AVELOX, 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 [see Adverse Reactions (6.2, 6.3), Pharmacokinetics and Patient Counseling Information].

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Although not observed with AVELOX 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 and Precautions and Patient Counseling Information].

Drugs that Prolong QT

There is limited information available on the potential for a pharmacodynamic interaction in humans between AVELOX and other drugs that prolong the QTc interval of the electrocardiogram. Sotalol, a Class III antiarrhythmic, has been shown to further increase the QTc interval when combined with high doses of intravenous (IV) AVELOX in dogs. Therefore, AVELOX should be avoided with Class IA and Class III antiarrhythmics [see Warnings and Precautions, (5.3), Nonclinical Toxicology and Patient Counseling Information].

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 AVELOX 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. Adverse clinical signs included CNS and gastrointestinal effects such as decreased activity, somnolence, tremor, convulsions, vomiting and diarrhea.

CONTRAINDICATIONS

AVELOX 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 (CLSI), Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically Eighth Edition. Approved Standard CLSI Document M7-A8, Vol. 29, No. 2, CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087, 2009.
  2. CLSI, Performance Standards for Antimicrobial Susceptibility Testing 21st Informational Supplement. CLSI Document M100-S21, 2011.
  3. CLSI, Performance Standards for Antimicrobial Disk Susceptibility Tests Tenth Edition. Approved Standard CLSI Document M2-A9, 2009.
  4. CLSI, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard CLSI Document M11-A7, 2007

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