Moxifloxacin
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Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin injection and other antibacterial drugs, moxifloxacin injection 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 injection is indicated for the treatment of adults (18 years of age or older) 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 may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
Moxifloxacin is indicated for the treatment of Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)].
Moxifloxacin is 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)].
Moxifloxacin is 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), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole [see Clinical Studies (14.2)].
Moxifloxacin is 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)].
Moxifloxacin is 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)].
Moxifloxacin is 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)].
Moxifloxacin is 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 BronchitisMoxifloxacin is 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)].
History
There is currently no drug history available for this drug.
Other Information
Moxifloxacin is a synthetic broad spectrum antibacterial agent for intravenous administration. Moxifloxacin, a fluoroquinolone, is available as a buffered salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow crystalline substance. Its chemical structure is as follows:
Moxifloxacin injection is sterile solution for infusion in a ready-to-use flexible plastic container.
Moxifloxacin injection
| Component |
Function |
Dosage Formulation |
| Moxifloxacin* |
Active ingredient |
400 mg* |
| Sodium acetate (added as a trihydrate) |
Tonicity adjuster |
1,702.5 mg |
| Disodium sulfate |
Tonicity adjuster |
2,840 mg |
| Sulfuric acid ** |
pH adjustment |
As needed |
| Water for injection |
vehicle |
q.s. 250 mL |
* 400 mg moxifloxacin equivalent to 437.5 mg of moxifloxacin hydrochloride.
**The pH may have been adjusted with sulfuric acid. The pH is 5.0 to 6.0.
Each mL contains 1.6 mg of moxifloxacin.
The appearance of the intravenous solution is clear. The plastic container is fabricated from a specially designed multilayer plastic (freeflex®). Solution is in contact with the polypropylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The leachable compounds were all within acceptable limits based on animal toxicology studies.
Moxifloxacin injection contains approximately 52.5 mEq (1,207 mg) of sodium in 250 mL.
Sources
Moxifloxacin Manufacturers
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Fresenius Kabi Usa, Llc
![Moxifloxacin (Moxifloxacin Hydrochloride) Injection, Solution [Fresenius Kabi Usa, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Moxifloxacin | Fresenius Kabi Usa, Llc
2.1 Dosage in Adult PatientsThe dose of moxifloxacin injection is 400 mg intravenously 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 Infectiona
Dose Every 24 hours
Durationb (days)
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 to 14
Uncomplicated Skin and Skin Structure Infections (SSSI) (1.4)
400 mg
7
Complicated SSSI (1.5)
400 mg
7 to 21
Complicated Intra-Abdominal Infections (1.6)
400 mg
5 to 14
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.
When switching from intravenous to oral formulation, no dosage adjustment is necessary [see Clinical Pharmacology (12.4)]. 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 Administration InstructionsMoxifloxacin Injection Solution for Infusion
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Moxifloxacin injection should be administered by intravenous infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Moxifloxacin injection should be administered 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. Caution: rapid or bolus intravenous infusion must be avoided.
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 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 injection with an infusion solution compatible with moxifloxacin injection as well as with other drug(s) administered via this common line.
Moxifloxacin Injection is compatible with the following intravenous solutions at ratios from 1:10 to 10:1
0.9% Sodium Chloride Injection, USP Sterile Water for Injection, USP
1 molar Sodium Chloride Injection 10% Dextrose for Injection, USP
5% Dextrose Injection, USP Lactated Ringer’s for Injection
2.3 Preparation for Administration of Moxifloxacin InjectionTo prepare moxifloxacin injection premix in flexible plastic containers:
1. Close flow control clamp of administration set.
2. Remove cover from port at bottom of container.
3. 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.
NOTE: Refer to complete directions that have been provided with the administration set.
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Dr. Reddy’s Laboratories Limited
Moxifloxacin | Dr. Reddy's Laboratories Limited
2.1 Dosage in Adult PatientsThe dose of moxifloxacin hydrochloride tablet 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 Infectiona Dose Every 24 hours Durationb (days) 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 to 14 Uncomplicated Skin and Skin Structure Infections (SSSI ) (1.4) 400 mg 7 Complicated SSSI (1.5) 400 mg 7 to 21 Complicated Intra-Abdominal Infections (1.6) 400 mg 5 to 14a 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
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.
2.2 Drug interactions with Multivalent CationsOral doses of moxifloxacin hydrochloride tablets should be administered at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and VIDEX® (didanosine) chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1 ) and Clinical Pharmacology (12.3)].
2.3 Administration InstructionsMoxifloxacin Hydrochloride Film-Coated Tablets
Moxifloxacin hydrochloride tablets can be taken with or without food, drink fluids liberally.
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Major Pharmaceuticals
Moxifloxacin | Major Pharmaceuticals
2.1 Dosage in Adult PatientsThe dose of moxifloxacin hydrochloride tablet 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 Infectiona Dose Every 24 hours Durationb (days) 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 to 14 Uncomplicated Skin and Skin Structure Infections (SSSI ) (1.4) 400 mg 7 Complicated SSSI (1.5) 400 mg 7 to 21 Complicated Intra-Abdominal Infections (1.6) 400 mg 5 to 14a 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
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.
2.2 Drug interactions with Multivalent CationsOral doses of moxifloxacin hydrochloride tablets should be administered at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and VIDEX® (didanosine) chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1 ) and Clinical Pharmacology (12.3)].
2.3 Administration InstructionsMoxifloxacin Hydrochloride Film-Coated Tablets
Moxifloxacin hydrochloride tablets can be taken with or without food, drink fluids liberally.
![Moxifloxacin (Moxifloxacin) Tablet, Film Coated [Dr. Reddy’s Laboratories Limited]](http://www.recallguide.org/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Moxifloxacin Tablet, Film Coated [Major Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7b481eda-7e7a-41b5-b698-bd7d7fa59cfb&name=moxifloxacin-hydrochloride-tablets-5.jpg)
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