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General MedicationsINTRAVENOUSBlack Box

MOXIFLOXACIN HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE

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 ) • Moxifloxacin Hydrochloride in Sodium Chloride Injection: Slow intravenous infusion over 60 minutes. Avoid rapid or bolus intravenous injection. ( 2.2 ) • Do not mix with other medications in intravenous bag or in an intravenous line. ( 2.3 ) 2.1 Dosage in Adult Patients The dose of moxifloxacin is 400 mg (orally or as an intravenous infusion) 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 Due to the designated pathogens [see Indications and Usage (1) ]. Dose Every 24 hours Duration Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician (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 ) Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis . 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 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 hydrochloride in sodium chloride injection may be switched to moxifloxacin tablets when clinically indicated at the discretion of the physician. 2.2 Important Administration Instructions Moxifloxacin Hydrochloride in Sodium Chloride Injection Administer by intravenous infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. Administer by intravenous infusion over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place. Avoid rapid or bolus intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer moxifloxacin hydrochloride in sodium chloride injection if particulate matter and/or discoloration is observed. Discard any unused portion because the premix flexible containers are for single-dose only. 2.3 Drug and Diluent Compatibilities Because only limited data are available on the compatibility of moxifloxacin intravenous injection with other intravenous substances, additives or other medications should not be added to moxifloxacin hydrochloride in sodium chloride injection or infused simultaneously through the same intravenous line. If the same intravenous line or a Y-type line is used for sequential infusion of other drugs, or if the “piggyback” method of administration is used, the line should be flushed before and after infusion of moxifloxacin hydrochloride in sodium chloride injection with an infusion solution compatible with moxifloxacin hydrochloride in sodium chloride injection as well as with other drug(s) administered via this common line. Compatible Intravenous Solutions : Moxifloxacin hydrochloride in sodium chloride injection is compatible with the following intravenous solutions at ratios from 1:10 to 10:1: 0.9% Sodium Chloride Injection, USP 1 Molar Sodium Chloride Injection 5% Dextrose Injection, USP Sterile Water for Injection, USP 10% Dextrose for Injection, USP Lactated Ringer’s for Injection 2.4 Preparation for Administration of Moxifloxacin Hydrochloride in Sodium Chloride Injection Refer to complete directions that have been provided with the administration set. To prepare moxifloxacin hydrochloride in sodium chloride injection premix in flexible containers: Close flow control clamp of administration set. Remove cover from port at bottom of container. Insert piercing pin from an appropriate transfer set (for example, one that does not require excessive force, such as ISO compatible administration set) into port with a gentle twisting motion until pin is firmly seated.
Max Dose
See official label
Primary Use
1 INDICATIONS AND USAGE Moxifloxacin is 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 and other antibacterial drugs.
Summary

Indications and usage 1 INDICATIONS AND USAGE Moxifloxacin is 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 and other antibacterial drugs.

Moxifloxacin 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 hydrochloride in sodium chloride injection 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) ] .

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Moxifloxacin is 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 and other antibacterial drugs. Moxifloxacin 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 hydrochloride in sodium chloride injection 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), 2 nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. 1.2 Uncomplicated Skin and Skin Structure Infections Moxifloxacin hydrochloride in sodium chloride injection 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 in sodium chloride injection 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 in sodium chloride injection 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 in sodium chloride injection 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 in sodium chloride injection is 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, 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 for treatment of ABS in patients who have no alternative treatment options. 1.7 Acute Bacterial Exacerbation of Chronic Bronchitis Moxifloxacin hydrochloride in sodium chloride injection 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, 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 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 and other antibacterial drugs, moxifloxacin hydrochloride in sodium chloride injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Boxed Warning

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including moxifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1) ] , including: o Tendinitis and tendon rupture [see Warnings and Precautions (5.2) ] o Peripheral neuropathy [see Warnings and Precautions (5.3) ] o Central nervous system effects [see Warnings and Precautions (5.4) ] Discontinue moxifloxacin immediately and avoid the use of fluoroquinolones, including moxifloxacin, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1) ]. • Fluoroquinolones, including moxifloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid moxifloxacin in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5) ]. • Because fluoroquinolones, including moxifloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.14) ] , reserve moxifloxacin for use in patients who have no alternative treatment options for the following indications: o Acute bacterial sinusitis [see Indications and Usage (1.6) ] o 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, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1 ) including: o Tendinitis and tendon rupture ( 5.2 ) o Peripheral Neuropathy ( 5.3 ) o Central nervous system effects ( 5.4 ) Discontinue moxifloxacin immediately and avoid the use of fluoroquinolones, including moxifloxacin, in patients who experience any of these serious adverse reactions ( 5.1 ) • Fluoroquinolones, including moxifloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid moxifloxacin in patients with known history of myasthenia gravis ( 5.5 ). • Because fluoroquinolones, including moxifloxacin, have been associated with serious adverse reactions ( 5.1 - 5.14 ), reserve moxifloxacin for use in patients who have no alternative treatment options for the following indications: o Acute bacterial sinusitis ( 1.6 ) o 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.
  • • Discontinue moxifloxacin 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 absorption.
  • • Take moxifloxacin tablet at least 4 hours before or 8 hours after these products.
  • • ( 7.1 , 12.3 ) Warfarin Anticoagulant effect enhanced.
  • • Monitor prothrombin time/INR, and bleeding.