Clinical Information
Gen. Code and Des.
43879 moxifloxacin HCl ORAL TABLET 400 MG
GCN and Des.
50767 moxifloxacin HCl ORAL TABLET 400 MG
Strength
400MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
8121800 QUINOLONE ANTIBIOTICS
8160400 ANTITUBERCULOSIS AGENTS
Active Ingredients
7928 moxifloxacin HCl 186826868
Inactive Ingredients
2537 povidone 9003398
AVELOX - moxifloxacin hydrochloride tablet, film coated
RedPharm Drug Inc.
WARNING:
Fluoroquinolones, including AVELOX , are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [see Warnings and Precautions (5.1)].
? Fluoroquinolones, including AVELOX, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid AVELOX in patients with known history of myasthenia gravis [see Warnings and Precautions (5.2)].
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVELOX and other antibacterial drugs, AVELOX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
AVELOX Tablets and IV are indicated for the treatment of adults (? 18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below [see Dosage and Administration (2) and Use In Specific Populations (8.5)].
Culture and Susceptibility Testing
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin [see Clinical Pharmacology (12.4)]. Therapy with AVELOX may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. DOSAGE FORMS AND STRENGTHS
3.1 AVELOX Tablets
Containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin)
Oblong, dull red film-coated tablets
Imprinted with BAYER on one side and M400 on the other
3.2 AVELOX IV
Containing 400 mg moxifloxacin in 0.8% saline (moxifloxacin hydrochloride in sodium chloride injection) with pH ranging from 4.1 to 4.6.
Ready-to-use 250 mL latex-free flexibags. No further dilution is necessary
Sterile, preservative free, 0.8% sodium chloride aqueous solution of moxifloxacin hydrochloride DESCRIPTION
AVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent for oral and intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow crystalline substance with a molecular weight of 437.9. Its empirical formula is C21 H24 FN3 O4 *HCl CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
AVELOX is a member of the flouroquinolone class of antibacterial agents [see Clinical Pharmacology (12.4)].
