Moxifloxacin Hydrochloride

MOXIFLOXACIN HYDROCHLORIDE- moxifloxacin hydrochloride tablet, film coated
PD-Rx Pharmaceuticals, Inc.

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAI NERVOUS SYTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including Moxifloxacin Hydrochloride, 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)]
  • Discontinue Moxifloxacin Hydrochloride immediately and avoid the use of fluoroquinolones, including Moxifloxacin Hydrochloride, in patients who experience any of these serious adverse reactions [see Warnings and Precautions ( 5.1)] .
  • Fluoroquinolones, including Moxifloxacin Hydrochloride, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid Moxifloxacin Hydrochloride in patients with known history of myasthenia gravis [see Warnings and Precautions ( 5.5)].
  • Because fluoroquinolones, including Moxifloxacin Hydrochloride, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.13)] , reserve Moxifloxacin Hydrochloride 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 Hydrochloride is 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 Hydrochloride is 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 Hydrochloride is 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 Hydrochloride is 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 Hydrochloride is 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 Hydrochloride is indicated in adult patients (18 years of age and older) for the treatment of acute bacterial sinusitis (ABS) caused by susceptible isolates of , or . Moxifloxacin Hydrochloride is indicated in adult patients (18 years of age and older) for the treatment of acute bacterial sinusitis (ABS) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae , or Moraxella catarrhalis [see Clinical Studies ( 14.1)] .

. Because fluoroquinolones, including Moxifloxacin Hydrochloride, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1-5.13)] and for some patients ABS is self-limiting, reserve Moxifloxacin Hydrochloride for treatment of ABS in patients who have no alternative treatment options .

1.7 Acute Bacterial Exacerbation of Chronic Bronchitis

Moxifloxacin Hydrochloride is indicated in adult patients for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) caused by susceptible isolates of methicillin-susceptible or Moxifloxacin Hydrochloride is 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 Hydrochloride, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.13)] and for some patients ABECB is self-limiting, reserve Moxifloxacin Hydrochloride for treatment of ABECB in patients who have no alternative treatment options.

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