Moxifloxacin Hydrochloride
MOXIFLOXACIN HYDROCHLORIDE- moxifloxacin hydrochloride tablet
A-S Medication Solutions
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS
- Fluoroquinolones, including Moxifloxacin Tablets, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together
[see
Warnings and Precautions (5.1)]
, including:
- Tendinitis and tendon rupture [see Warnings and Precautions (5.2)]
- Peripheral neuropathy [see Warnings and Precautions (5.3)]
- Central nervous system effects [see Warnings and Precautions (5.4)]
- Fluoroquinolones, including Moxifloxacin Tablets, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid Moxifloxacin Tablets in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5)].
- Because fluoroquinolones, including Moxifloxacin Tablets, have been associated with serious adverse reactions
[see
Warnings and Precautions (5.1-5.14)]
, reserve Moxifloxacin Tablets for use in patients who have no alternative treatment options for the following indications:
- Acute bacterial sinusitis [see Indications and Usage (1.6)]
- Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage (1.7)]
1 INDICATIONS AND USAGE
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 (5.1-5.14)] and for some patients ABS is self-limiting, reserve Moxifloxacin Tablets for treatment of ABS in patients who have no alternative treatment options.
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