Moxifloxacin (injection)

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)

There is limited information regarding Moxifloxacin (injection) FDA-Labeled Indications and Dosage (Adult) in the drug label.

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

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

• AVELOX®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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