1 INDICATIONS AND USAGE
Moxifloxacin injection is a fluoroquinolone antibacterial drug indicated for treating infections in adults
18 years of age caused by designated, susceptible bacteria. (
1,
12.4)
Community Acquired Pneumonia (
1.1)
Skin and Skin Structure Infections: Uncomplicated (
1.2) and Complicated (
1.3)
Complicated Intra-Abdominal Infections (
1.4)
Acute Bacterial Sinusitis (
1.5)
Acute Bacterial Exacerbation of Chronic Bronchitis (
1.6)
1.1 Community Acquired Pneumonia
Moxifloxacin Injection is indicated in adults (18 years of age or older) for the treatment of Community Acquired Pneumonia caused by susceptible isolates of
Streptococcus pneumoniae (including multi-drug resistant isolates*),
Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible
Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or
Chlamydophila pneumoniae.
* MDRSP, Multi-drug resistant
Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillin-resistant
S. pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin (minimum inhibitory concentrations [MIC]
2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole
[see
Clinical Studies (14.2)]
.
1.2 Uncomplicated Skin and Skin Structure Infections
Moxifloxacin Injection is indicated in adults (18 years of age or older) 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 (14.5)].
1.3 Complicated Skin and Skin Structure Infections
Moxifloxacin Injection is indicated in adults (18 years of age or older) 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 (14.6)].
1.4 Complicated Intra-Abdominal Infections
Moxifloxacin Injection is indicated in adults (18 years of age or older) 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 (14.7)]
.
1.5 Acute Bacterial Sinusitis
Moxifloxacin Injection is indicated in adults (18 years of age or older) for the treatment of Acute Bacterial Sinusitis (ABS) caused by susceptible isolates of
Streptococcus pneumoniae, Haemophilus influenzae, or
Moraxella catarrhalis [see
Clinical Studies (14.4)]
.
Because fluoroquinolones, including Moxifloxacin Injection, have been associated with serious adverse reactions
[see
Warnings and Precautions (5.1 to 5.13)]
and for some patients ABS is self-limiting, reserve Moxifloxacin Injection for treatment of ABS in patients who have no alternative treatment options.
1.6 Acute Bacterial Exacerbation of Chronic Bronchitis
Moxifloxacin Injection is indicated in adults (18 years of age or older) for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) caused by susceptible isolates of
Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible
Staphylococcus aureus, or
Moraxella catarrhalis [see
Clinical Studies (14.1)].
Because fluoroquinolones, including Moxifloxacin Injection, have been associated with serious adverse reactions
[see
Warnings and Precautions (5.1 to 5.13)]
and for some patients ABECB is self-limiting, reserve Moxifloxacin Injection for treatment of ABECB in patients who have no alternative treatment options.
1.7 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin injection and other antibacterial drugs, moxifloxacin injection 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.
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 moxifloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.