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Moxifloxacin

MOXIFLOXACIN

Standard Dose
2 DOSAGE AND ADMINISTRATION Type of Infection Dose Every 24 hours Duration (days) Community Acquired Pneumonia ( 1.1 ) 400 mg 7–14 Uncomplicated Skin and Skin Structure Infections (SSSI) ( 1.2 ) 400 mg 7 Complicated SSSI ( 1.3 ) 400 mg 7–21 Complicated Intra-Abdominal Infections ( 1.4) 400 mg 5–14 Plague ( 1.5 ) 400 mg 10–14 Acute Bacterial Sinusitis ( 1.6 ) 400 mg 10 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.7 ) 400 mg 5 • No dosage adjustment in patients with renal or hepatic impairment. ( 8.6 , 8.7 ) 2.1 Dosage in Adult Patients The dose of moxifloxacin tablets 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) Community Acquired Pneumonia ( 1.1 ) 400 mg 7-14 Uncomplicated Skin and Skin Structure Infections (SSSI) ( 1.2 ) 400 mg 7 Complicated SSSI ( 1.3 ) 400 mg 7–21 Complicated Intra-Abdominal Infections ( 1.4 ) 400 mg 5-14 Plague ( 1.5) C 400 mg 10-14 Acute Bacterial Sinusitis (ABS) ( 1.6 ) 400 mg 10 Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) ( 1.7 ) 400 mg 5 a) Due to the designated pathogens [see Indications and Usage ( 1 )]. b) Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician c) Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Conversion of Intravenous to Oral Dosing in Adults 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 Injection may be switched to moxifloxacin tablets when clinically indicated at the discretion of the physician. 2.2 Important Administration Instructions M oxifloxacin Tablets With Multivalent Cations Administer moxifloxacin tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )]. With Food Moxifloxacin tablets can be taken with or without food, drink fluids liberally. Missed Doses If a dose is missed, it should be taken anytime but not later than 8 hours prior to the next scheduled dose. If less than 8 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose. Double doses should not be taken to compensate for a missed dose.
Max Dose
See official label
Primary Use
1 INDICATIONS AND USAGE Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 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.
Summary

Indications and usage 1 INDICATIONS AND USAGE Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 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 )] .

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 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 - 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 - 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

Boxed Warning

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS andEXACERBATION 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 )] Discontinue moxifloxacin tablets immediately and avoid the use of fluoroquinolones, including moxifloxacin tablets, in patients who experience any of these serious adverse reactions [see Warnings and Precautions ( 5.1 )]. 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 - 5.13 )] , 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 )] WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning Fluoroquinolones, including moxifloxacin tablets, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1 ) including: Tendinitis and tendon rupture ( 5.2 ) Peripheral Neuropathy ( 5.3 ) Central nervous system effects ( 5.4 ) Discontinue moxifloxacin tablets immediately and avoid the use of fluoroquinolones, including moxifloxacin tablets, in patients who experience any of these serious adverse reactions ( 5.1 ) Fluoroquinolones, including moxifloxacin tablets, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid moxifloxacin tablets in patients with known history of myasthenia gravis ( 5.5 ). Because fluoroquinolones, including moxifloxacin tablets, have been associated with serious adverse reactions ( 5.1 – 5.14 ), reserve moxifloxacin tablets for use in patients who have no alternative treatment options for the following indications: Acute bacterial sinusitis ( 1.6 ) Acute bacterial exacerbation of chronic bronchitis ( 1.7 )

Monitoring

  • • 5 WARNINGS AND PRECAUTIONS Prolongation of the QT interval and isolated cases of torsade de pointes has been reported.
  • • Avoid use in patients with known prolongation, proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia, hypokalemia, hypomagnesemia, and with drugs that prolong the QT interval.
  • • ( 5.6 , 7.5 , 8.5 ) Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions, including anaphylactic reactions, may occur after first or subsequent doses of moxifloxacin tablets.
  • • Discontinue moxifloxacin tablets at first sign of skin rash, jaundice or any other sign of hypersensitivity.

Interaction Notes

  • • 7 DRUG INTERACTIONS Interacting Drug Interaction Multivalent cation-containing products including: antacids, sucralfate, multivitamins Decreased moxifloxacin tablets absorption.
  • • Take moxifloxacin tablets at least 4 hours before or 8 hours after these products.
  • • ( 2.2 , 7.1 , 12.3 ) Warfarin Anticoagulant effect enhanced.
  • • Monitor prothrombin time/INR, and bleeding.