1 INDICATIONSAND USAGE
Moxifloxacin tablets
are a fluoroquinolone antibacterial indicated for treating infections in adults18 years of age and older caused by designated susceptible bacteria, in the conditions listed below:
Community Acquired Pneumonia (
1.1)
Skin and Skin Structure Infections: Uncomplicated (
1.2) and Complicated (
1.3)
Complicated Intra-Abdominal Infections (
1.4)
Plague (
1.5)
Acute Bacterial Sinusitis (
1.6)
Acute Bacterial Exacerbation of Chronic Bronchitis (
1.7)To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin tablets and other antibacterial drugs. Moxifloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (
1.8)
1.1 Community Acquired Pneumonia
Moxifloxacin tablets are 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 (
14.3)].
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.
1.2 Uncomplicated Skin and Skin Structure Infections
Moxifloxacin tablets are 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 (
14.4)].
1.3 Complicated Skin and Skin Structure Infections
Moxifloxacin tablets are 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 (
14.5)].
1.4 Complicated Intra-Abdominal Infections
Moxifloxacin tablets are indicated in adult patients for the treatment of Complicated Intra-Abdominal Infections (cIAI) 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 (
14.6)].
1.5 Plague
Moxifloxacin tablets are 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)].
1.6 Acute Bacterial Sinusitis
Moxifloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) caused by susceptible isolates of
Streptococcus pneumoniae, Haemophilus influenzae, or
Moraxella catarrhalis [see Clinical Studies (
14.1)].
Because fluoroquinolones, including moxifloxacin tablets, have been associated with serious adverse reactions
[see Warnings and Precautions (
5.1 to
5.14)]
and for some patients ABS is self-limiting, reserve moxifloxacin tablets for treatment of ABS in patients who have no alternative treatment options.
1.7 Acute Bacterial Exacerbation of Chronic Bronchitis
Moxifloxacin tablets are indicated in adult patients 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 (
14.2)].
Because fluoroquinolones, including moxifloxacin tablets, have been associated with serious adverse reactions
[see Warnings and Precautions (
5.1 to
5.14)]
and for some patients ABECB is self-limiting, reserve moxifloxacin tablets for treatment of ABECB in patients who have no alternative treatment options.
1.8 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin tablets and other antibacterial drugs, moxifloxacin tablets 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.