AVELOX- moxifloxacin hydrochloride injection, solution
WARNING: TENDON EFFECTS and MYASTHENIA GRAVIS
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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 ].
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 ].
DESCRIPTION
AVELOX (moxifloxacin) hydrochloride is synthetic antibacterial agent for oral and intravenous administration. Moxifloxacin, 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 slightly yellow to yellow crystalline substance with molecular weight of 437.9
VELOX Tablets
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AVELOX Tablets are available as film-coated tablets containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin).
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The inactive ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and ferric oxide.
11.2 AVELOX Injection
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AVELOX Injection for intravenous use is available in ready-to-use 250 mL flexibags as sterile, preservative free, 0.8% sodium chloride aqueous solution of moxifloxacin hydrochloride (containing 400 mg moxifloxacin) with pH ranging from 4.1 to 4.6. The flexibag is not made with natural rubber latex.
Mechanism of Action
AVELOX is member of the fluoroquinolone class of antibacterial agents.The bactericidal action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV required for bacterial DNA replication, transcription, repair, and recombination
INDICATIONS AND USAGE
1.1 Acute Bacterial Sinusitis
AVELOX is indicated in adult patients (18 years of age and older) for the treatment of Acute Bacterial Sinusitis caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis [see Clinical Studies ].
1.2 Acute Bacterial Exacerbation of Chronic Bronchitis
AVELOX is indicated in adult patients for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis [see Clinical Studies ].
1.3 Community Acquired Pneumonia
AVELOX is indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Clinical Studies ].
MDRSP isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [MIC] 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
1.4 Uncomplicated Skin and Skin Structure Infections
AVELOX is indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes [see Clinical Studies ].
1.5 Complicated Skin and Skin Structure Infections
AVELOX is indicated in adult patients for the treatment of Complicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae [see Clinical Studies ].
1.6 Complicated Intra-Abdominal Infections
AVELOX is indicated in adult patients for the treatment of Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by susceptible isolates of Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species [see Clinical Studies ].
1.7Plague
? AVELOX is indicated in adult patients for the treatment of plague, including pneumonic and septicemic plague, due to susceptible isolates of Yersinia pestis and prophylaxis of plague in adult patients. Efficacy studies of moxifloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see Clinical Studies 14.7 )] .
1.8 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 info. 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.
Dosage in Adult Patients
The dose of AVELOX is 400 mg (orally or as an intravenous infusion) once every 24 hours.
Conversion of Intravenous to Oral Dosing in Adults
Intravenous formulation is indicated when it offers route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with AVELOXInjection may be switched to AVELOX Tablets when clinically indicated at the discretion of the physician.
AVELOX Tablets
With Multivalent Cations
Administer AVELOX Tablets at least hours before or hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution [see Drug Interactions and Clinical Pharmacology (12.3)].
With Food
AVELOX Tablets can be taken with or without food, drink fluids liberally.
AVELOX Injection
Administer by Intravenous infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
DOSAGE FORMS AND STRENGTHS
3.1 AVELOX Tablets
Oblong, dull red, film-coated tablets imprinted with ?BAYER? on one side and ?M400? on the other containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin).
3.2 AVELOX Injection
Ready-to-use 250 mL flexibags containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin) in 0.8% sodium chloride aqueous solution. The appearance of the intravenous solution is yellow.
ADVERSE REACTIONS
The following serious and otherwise important adverse reactions are discussed in greater detail in the warnings and precautions section of the label:
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Tendinopathy and Tendon Rupture
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Exacerbation of Myasthenia Gravis
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QT Prolongation
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Hypersensitivity Reactions
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Other Serious and Sometimes Fatal Reactions
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Central Nervous System Effects
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Clostridium difficile-Associated Diarrhea
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Peripheral Neuropathy that may be irreversible
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Blood Glucose Disturbances
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Photosensitivity/Phototoxicity
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Development of Drug Resistant Bacteria
