Moxifloxacin Hydrochloride

MOXIFLOXACIN HYDROCHLORIDE — moxifloxacin hydrochloride tablet, film coated
AvPAK

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.

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 are isolates 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)] .

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adult Patients

The dose of moxifloxacin is 400 mg (orally) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.

Table 1: Dosage and Duration of Therapy in Adult Patients

Type of Infection a	Dose Every 24 hours	Duration b (days)
a) Due to the designated pathogens [see Indications and Usage (1), for IV use, see Use in Specific Populations (8.5)] . b) Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
Acute Bacterial Sinusitis (1.1)	400 mg	10
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)	400 mg	5
Community Acquired Pneumonia	400 mg	7-14
Uncomplicated Skin and Skin Structure Infections (SSSI ) (1.4)	400 mg	7
Complicated SSSI (1.5)	400 mg	7-21
Complicated Intra-Abdominal Infections (1.6)	400 mg	5-14

Intravenous formulation is indicated when it offers a 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 moxifloxacin hydrochloride IV may be switched to moxifloxacin hydrochloride tablets when clinically indicated at the discretion of the physician.