Moxifloxacin (injection)

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Moxifloxacin (injection)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Black Box Warning

WARNING: TENDON EFFECTS AND MYASTHENIA GRAVIS
See full prescribing information for complete Boxed Warning.
* Fluoroquinolones, including AVELOX®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
  • Fluoroquinolones, including AVELOX, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid AVELOX in patients with known history of myasthenia gravis.

Overview

Moxifloxacin (injection) is an antibiotic that is FDA approved for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia, skin and skin structure infections: uncomplicated and complicated, complicated intra-abdominal infections. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, diarrhea, headache, and dizziness.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • For treating infections in adults ≥ 18 years of age caused by designated, susceptible bacteria.
  • Acute Bacterial Sinusitis
  • Acute Bacterial Exacerbation of Chronic Bronchitis
  • Community Acquired Pneumonia
  • Skin and Skin Structure Infections: Uncomplicated and Complicated

Complicated Intra-Abdominal Infections

Dosage

  • The dose of AVELOX 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.
This image is provided by the National Library of Medicine.
  • 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 AVELOX IV may be switched to AVELOX Tablets when clinically indicated at the discretion of the physician.

AVELOX IV Solution for Infusion

  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • AVELOX IV should be administered by INTRAVENOUS infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
  • AVELOX IV 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 AVELOX intravenous injection with other intravenous substances, additives or other medications should not be added to AVELOX IV 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 AVELOX IV with an infusion solution compatible with AVELOX IV as well as with other drug(s) administered via this common line.
This image is provided by the National Library of Medicine.

Preparation for Administration of AVELOX IV

  • To prepare AVELOX IV 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.

NOTE: Refer to complete directions that have been provided with the administration set.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Moxifloxacin (injection) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Moxifloxacin (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Moxifloxacin (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Moxifloxacin (injection) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Moxifloxacin (injection) in pediatric patients.

Contraindications

There is limited information regarding Moxifloxacin (injection) Contraindications in the drug label.

Warnings

WARNING: TENDON EFFECTS AND MYASTHENIA GRAVIS
See full prescribing information for complete Boxed Warning.
* Fluoroquinolones, including AVELOX®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
  • Fluoroquinolones, including AVELOX, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid AVELOX in patients with known history of myasthenia gravis.

There is limited information regarding Moxifloxacin (injection) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Moxifloxacin (injection) in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Moxifloxacin (injection) in the drug label.

Drug Interactions

There is limited information regarding Moxifloxacin (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Moxifloxacin (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Moxifloxacin (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Moxifloxacin (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Moxifloxacin (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Moxifloxacin (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Moxifloxacin (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Moxifloxacin (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Moxifloxacin (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Moxifloxacin (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Moxifloxacin (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Moxifloxacin (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Moxifloxacin (injection) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Moxifloxacin (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Moxifloxacin (injection) in the drug label.

Pharmacology

Template:Px
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Moxifloxacin (injection)
Systematic (IUPAC) name
1-cyclopropyl-7-[(1S,6S)-2,8-diazabicyclo

[4.3.0]non-8-yl]-6-fluoro-8-methoxy-4-oxo- quinoline-3-carboxylic acid

Identifiers
CAS number 354812-41-2
ATC code J01MA14 S01AE07 (WHO)
PubChem 152946
DrugBank DB00218
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 401.431 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability 86 to 92%
Protein binding 30 to 50%
Metabolism Glucuronide and sulfate conjugation
Cytochrome P450 system not involved
Half life 12 hours
Excretion hepatic
Therapeutic considerations
Licence data

US

Pregnancy cat.

B3(AU) C(US)

Legal status

[[Prescription drug|Template:Unicode-only]](US)

Routes Oral, IV, local (eyedrops)

Mechanism of Action

Structure

File:Moxifloxacin (injection)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Moxifloxacin (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Moxifloxacin (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Moxifloxacin (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Moxifloxacin (injection) in the drug label.

How Supplied

Storage

There is limited information regarding Moxifloxacin (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Moxifloxacin (injection) in the drug label.

Precautions with Alcohol

  • Alcohol-Moxifloxacin (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "moxifloxacin hydrochloride injection, solution".
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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