1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride tablets and other antibacterial drugs, moxifloxacin hydrochloride 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.
Moxifloxacin hydrochloride tablets are indicated for the treatment of adults ( 18 years of age) with infections caused by susceptible isolates 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 moxifloxacin hydrochloride tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
Moxifloxacin hydrochloride tablets are a fluoroquinolone antibacterial indicated for treating infections in adults
18 years of age caused by designated, susceptible bacteria.
(1,
12.4)
Acute Bacterial Sinusitis
(1.1)
Acute Bacterial Exacerbation of Chronic Bronchitis
(1.2)
Community Acquired Pneumonia
(1.3)
Skin and Skin Structure Infections: Uncomplicated
(1.4) and Complicated
(1.5)
Complicated Intra-Abdominal Infections
(1.6)
1.1 Acute Bacterial Sinusitis
Moxifloxacin hydrochloride tablets are indicated for the treatment of Acute Bacterial Sinusitis caused by
Streptococcus pneumoniae, Haemophilus influenzae, or
Moraxella catarrhalis [see
Clinical Studies (14.4)]
.
1.2 Acute Bacterial Exacerbation of Chronic Bronchitis
Moxifloxacin hydrochloride tablets are indicated for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis caused by
Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible
Staphylococcus aureus, or
Moraxella catarrhalis [see
Clinical Studies (14.1)]
.
1.3 Community Acquired Pneumonia
Moxifloxacin hydrochloride tablets are indicated for the treatment of Community Acquired Pneumonia caused by
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 areisolates resistant to two or more of the following antibiotics: penicillin (minimum inhibitory concentrations [MIC] 2 mcg/mL), 2
nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole
[see
Clinical Studies (14.2)]
.
1.4 Uncomplicated Skin and Skin Structure Infections
Moxifloxacin hydrochloride tablets are indicated for the treatment of Uncomplicated Skin and Skin Structure Infections caused by methicillin-susceptible
Staphylococcus aureus or
Streptococcus pyogenes [see
Clinical Studies (14.5)]
.
1.5 Complicated Skin and Skin Structure Infections
Moxifloxacin hydrochloride tablets are indicated for the treatment of Complicated Skin and Skin Structure Infections caused by methicillin-susceptible
Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or
Enterobacter cloacae [see
Clinical Studies (14.6)]
.
1.6 Complicated Intra-Abdominal Infections
Moxifloxacin hydrochloride tablets are indicated for the treatment of Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by
Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or
Peptostreptococcus species
[see
Clinical Studies (14.7)]
.