pharmacopeia
GET
/api/v1/drug/moxifloxacin

Boxed warning

SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including moxifloxacin hydrochloride, 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 hydrochloride immediately and avoid the use of fluoroquinolones, including moxifloxacin hydrochloride, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1) ]. Fluoroquinolones, including moxifloxacin hydrochloride, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid moxifloxacin hydrochloride in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5) ].

2D structure
7-[(4aS,7aS)-1,2,3,4,4a,5,7,7a-octahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic acid
SMILES COC1=C2C(=CC(=C1N3C[C@@H]4CCCN[C@@H]4C3)F)C(=O)C(=CN2C5CC5)C(=O)O
InChIKey FABPRXSRWADJSP-MEDUHNTESA-N

Mechanism of action

Sourced from openFDA

Moxifloxacin hydrochloride is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4) ] .

DNA GyraseTopoisomerase 4

Indications

Sourced from openFDA
  • 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.ICD-10: J18.9, J20.9, J32.9

Contraindications

Sourced from openFDA
  • Moxifloxacin tablets are contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [see Warnings and Precautions (5.8) ] .contraindicated

Dosage & administration

Sourced from openFDA

Type of Infection Dose Every 24 hours Duration (days) Community Acquired Pneumonia ( 1.1 ) 400 mg 7 to 14 Uncomplicated Skin and Skin Structure Infections (SSSI) ( 1.2 ) 400 mg 7 Complicated SSSI ( 1.3 ) 400 mg 7 to 21 Complicated Intra-Abdominal Infections ( 1.4 ) 400 mg 5 to 14 Plague ( 1.5 ) 400 mg 10 to 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 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 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 .

Warnings & precautions

Sourced from openFDA

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 hydrochloride. Discontinue moxifloxacin hydrochloride at first sign of skin rash, jaundice or any other sign of hypersensitivity. ( 5.7 , 5.8 ) Clostridioides difficile -Associated Diarrhea: Evaluate if diarrhea occurs. ( 5.10 ) 5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting moxifloxacin hydrochloride. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions (5.2, 5.3, 5.4) ] .

Adverse reactions

Sourced from openFDA

The following serious and otherwise important adverse reactions are discussed in greater detail in the warnings and precautions section of the label: Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects [see Warnings and Precautions (5.1) ] 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) ] Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.5) ] QT Prolongation [see Warnings and Precautions (5.6) ] Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions (5.7) ] Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions (5.9) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.10) ] Blood Glucose Disturbances [see Warnings and Precautions (5.12) ] Photosensitivity/Phototoxicity [see Warnings and Precautions (5.13) ] Development of Drug Resistant Bacteria [see Warnings and Precautions (5.14) ] Most common reactions (3% or greater) were nausea, diarrhea, headache, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Use in specific populations

Sourced from openFDA

Pregnancy: Based on animal data may cause fetal harm. (8.1) Geriatrics: Increased risk for severe tendon disorders further increased by concomitant corticosteroid therapy and increased risk of prolongation of the QT interval. (5.1 , 5.6 , 8.5) 8.1 Pregnancy Risk Summary There are no available human data establishing a drug associated risk with the use of moxifloxacin. Based on animal studies with moxifloxacin, moxifloxacin hydrochloride may cause fetal harm. Moxifloxacin did not cause fetal malformations when administered to pregnant rats (IV and oral), rabbits (IV), and monkeys (oral) at exposures that were 0.24 to 2.5 times of those at the human clinical dose (400 mg/day moxifloxacin hydrochloride). However, when moxifloxacin was administered to rats and rabbits during pregnancy and throughout lactation (rats only) at doses associated with maternal toxicity, decreased neonatal body weights, increased incidence of skeletal variations (rib and vertebra combined), and increased fetal loss were observed (see Data). Advise pregnant women of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption Moxifloxacin, given as an oral tablet, is well absorbed from the gastrointestinal tract. The absolute bioavailability of moxifloxacin is approximately 90 percent.

Overdosage

Sourced from openFDA

Single oral overdoses up to 2.8 g were not associated with any serious adverse events. In the event of acute overdose, empty the stomach and maintain adequate hydration. Monitor ECG due to the possibility of QT interval prolongation. Carefully observe the patient and give supportive treatment. The administration of activated charcoal as soon as possible after oral overdose may prevent excessive increase of systemic moxifloxacin exposure. About 3% and 9% of the dose of moxifloxacin, as well as about 2% and 4.5% of its glucuronide metabolite are removed by continuous ambulatory peritoneal dialysis and hemodialysis, respectively.

Approval history

Sourced from openFDA
  • Apr 15, 2003NDANDA021598Harrow Eye
  • Mar 4, 2014ANDAANDA202632Aurobindo Pharma Ltd
  • Mar 4, 2014ANDAANDA076938Dr Reddys
  • Sep 4, 2014ANDAANDA202867Lupin
  • Apr 3, 2015NDANDA205572Fresenius Kabi Usa
  • May 28, 2015ANDAANDA204079Lupin
  • May 5, 2017ANDAANDA205833Mylan Labs Ltd
  • Jun 30, 2017ANDAANDA090080Apotex

FDA shortages

View JSON

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Moxifloxacin, Injection, 400mg per 250mL (NDC 63323-850-74)To be discontinued
    Sponsor: Fresenius Kabi USA, LLC
    Updated

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
19,660 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use2,33512%
  2. 2Dyspnoea2,12511%
  3. 3Drug Ineffective2,05810%
  4. 4Asthma1,98810%
  5. 5Drug Hypersensitivity1,97810%
  6. 6Pneumonia1,9109.7%
  7. 7Vomiting1,7739.0%
  8. 8Pain1,6888.6%
  9. 9Wheezing1,5898.1%
  10. 10Rash1,5257.8%
  11. 11Fatigue1,4257.2%
  12. 12Malaise1,2776.5%
  13. 13Pyrexia1,2406.3%
  14. 14Nausea1,2196.2%
  15. 15Condition Aggravated1,1896.0%

Literature

View JSON

Recent PubMed references pinned to Moxifloxacin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 691 ClinicalTrials.gov registrations naming Moxifloxacin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

View JSON

CPIC-curated drug–gene pairs for Moxifloxacin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Moxifloxacin work?
Moxifloxacin hydrochloride is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4) ] .
What is Moxifloxacin used for?
According to FDA labeling, Moxifloxacin carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Moxifloxacin?
Moxifloxacin is classified as Fluoroquinolones, Fluoroquinolone Antibacterial, DNA Gyrase Inhibitors, Topoisomerase 4 Inhibitors, Decreased DNA Integrity, Decreased DNA Replication, Decreased Protein Synthesis, Decreased Transcription to RNA.
What are the brand names for Moxifloxacin?
Moxifloxacin is marketed under brand names including Avelox, Vigamox.
What are the contraindications for Moxifloxacin?
Moxifloxacin labeling lists contraindications including: Moxifloxacin tablets are contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [see Warnings and Precautions (5.8) ] .. Always consult the full prescribing information and a clinician.
Note. Data for moxifloxacin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients