Ofloxacin (oral): Difference between revisions

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__NOTOC__
{{DrugProjectFormSinglePage
{{Ofloxacin}}
|authorTag=
'''''For patient information of Ofloxacin injection, click <u>[[Ofloxacin injection (patient information)|here]]</u>'''''.


'''''For patient information of Ofloxacin ophthalmic, click <u>[[Ofloxacin ophthalmic (patient information)|here]]</u>'''''.


'''''For patient information of Ofloxacin oral, click <u>[[Ofloxacin oral (patient information)|here]]</u>'''''.
<!--Overview-->


'''''For patient information of Ofloxacin otic, click <u>[[Ofloxacin otic (patient information)|here]]</u>'''''.
|genericName=


{{CMG}}; {{AE}} {{SS}}


==Overview==
'''Ofloxacin''' (sold under the brand name '''Floxin&reg;''' in the [[United States]], '''Tarivid®''' in Europe and some other countries) is a[[fluoroquinolone]] [[antibiotic]]. Ofloxacin is the [[racemate|racemic]] mixture of the [[Chirality (chemistry)|chiral]] compound. The biologically active [[enantiomer]] is sold separately under the name of [[levofloxacin]].  It is used as a treatment for [[Gonorrhoea#Treatment|gonorrhoea]] and is an alternative treatment to [[ciprofloxacin]] for [[anthrax]].
==Category==
Fluoroquinolone
==US Brand Names==
Ocuflox<sup>®</sup>


==FDA Package Insert==
|aOrAn=


'''  [[Ofloxacin description|Description]]'''
a
'''| [[Ofloxacin clinical pharmacology|Clinical Pharmacology]]'''
'''| [[Ofloxacin microbiology|Microbiology]]'''
'''| [[Ofloxacin indications and usage|Indications and Usage]]'''
'''| [[Ofloxacin contraindications|Contraindications]]'''
'''| [[Ofloxacin warnings and precautions|Warnings and Precautions]]'''
'''| [[Ofloxacin adverse reactions|Adverse Reactions]]'''
'''| [[Ofloxacin drug interactions|Drug Interactions]]'''
'''| [[Ofloxacin clinical studies|Clinical Studies]]'''
'''| [[Ofloxacin dosage and administration|Dosage and Administration]]'''
'''| [[Ofloxacin how supplied|How Supplied]]'''
'''| [[Ofloxacin labels and packages|Labels and Packages]]'''


==Mechanism of Action==
|drugClass=


==Mode of action==
Ofloxacin is a [[broad-spectrum antibiotic]] that is active against both
[[Gram-positive]] and [[Gram-negative]] bacteria.  It functions by inhibiting [[DNA gyrase]], a type II [[topoisomerase]], and topoisomerase IV,<ref>{{cite journal |author=Drlica K, Zhao X |title=DNA gyrase, topoisomerase IV, and the 4-quinolones |journal=Microbiol Mol Biol Rev. |volume=61 |issue=3 |pages=377–92 |date=1 September 1997|pmid=9293187 |pmc=232616 |url=http://mmbr.asm.org/cgi/pmidlookup?view=long&pmid=9293187 }}</ref> which is an enzyme necessary to separate (mostly in prokaryotes, in bacteria in particular) replicated DNA, thereby inhibiting bacterial cell division.


The fluoroquinolones interfere with DNA replication by inhibiting an enzyme complex called DNA gyrase. This can also affect mammalian cell replication. In particular, some [[Congener (chemistry)|congeners]] of this drug family display high activity not only against bacterial topoisomerases, but also against eukaryotic topoisomerases and are toxic to cultured mammalian cells and ''[[in vivo]]'' tumor models. Although the quinolone is highly toxic to mammalian cells in culture, its mechanism of [[cytotoxic]] action is not known. Quinolone induced DNA damage was first reported in 1986.<ref>{{cite journal |author=Hussy P, Maass G, Tümmler B, Grosse F, Schomburg U |title=Effect of 4-quinolones and novobiocin on calf thymus DNA polymerase alpha primase complex, topoisomerases I and II, and growth of mammalian lymphoblasts |journal=Antimicrob. Agents Chemother. |volume=29 |issue=6 |pages=1073–8 |year=1986 |month=June |pmid=3015015 |pmc=180502 |doi= 10.1128/AAC.29.6.1073|url=http://aac.asm.org/cgi/reprint/29/6/1073.pdf}}</ref>


Recent studies have demonstrated a correlation between mammalian cell cytotoxicity of the quinolones and the induction of [[micronuclei]].<ref>Hosomi JA. Maeda Y. Oomori T. Irikura and T. Yokota (1988). "Mutagenicity of norfloxacin and AM-833 in bacteria and mammalian cells". Rev. Infect. Dis 10 (Suppl. 1): S148–S149.</ref><ref>{{cite journal |author=Forsgren A, Bredberg A, Pardee AB, Schlossman SF, Tedder TF |title=Effects of ciprofloxacin on eucaryotic pyrimidine nucleotide biosynthesis and cell growth |journal=Antimicrob. Agents Chemother. |volume=31 |issue=5 |pages=774–9 |year=1987 |month=May |pmid=3606077 |pmc=174831 |doi= 10.1128/AAC.31.5.774|url=http://aac.asm.org/cgi/reprint/31/5/774.pdf |format=PDF |first1=A |first2=A |first3=AB |first4=SF |first5=TF |issn=0066-4804}}</ref><ref>{{cite journal |author=Gootz TD, Barrett JF, Sutcliffe JA |title=Inhibitory effects of quinolone antibacterial agents on eucaryotic topoisomerases and related test systems |journal=Antimicrob. Agents Chemother. |volume=34 |issue=1 |pages=8–12 |year=1990 |month=January |pmid=2158274 |pmc=171510 |doi= 10.1128/AAC.34.1.8|first1=TD |first2=JF |first3=JA |issn=0066-4804}}</ref>
|indication=
As such some fluoroquinolones may cause injury to the chromosome of eukaryotic cells.<ref>{{cite journal |author=Elsea SH, Osheroff N, Nitiss JL |title=Cytotoxicity of quinolones toward eukaryotic cells. Identification of topoisomerase II as the primary cellular target for the quinolone CP-115,953 in yeast |journal=J. Biol. Chem. |volume=267 |issue=19 |pages=13150–3 |year=1992 |month=July |pmid=1320012 |doi= |url=http://www.jbc.org/cgi/reprint/267/19/13150 |first1=SH |first2=N |first3=JL |issn=0021-9258}}</ref><ref>{{cite journal |author=Enzmann H, Wiemann C, Ahr HJ, Schlüter G |title=Damage to mitochondrial DNA induced by the quinolone Bay y 3118 in embryonic turkey liver |journal=Mutat. Res. |volume=425 |issue=2 |pages=213–24 |year=1999 |month=April |pmid=10216214 |doi= 10.1016/S0027-5107(99)00044-5|url= |first1=H |first2=C |first3=HJ |first4=G |issn=0027-5107}}</ref><ref>{{cite journal |author=Kashida Y, Sasaki YF, Ohsawa K |title=Mechanistic study on flumequine hepatocarcinogenicity focusing on DNA damage in mice |journal=Toxicol. Sci. |volume=69 |issue=2 |pages=317–21 |year=2002 |month=October |pmid=12377980 |doi= 10.1093/toxsci/69.2.317|url=http://toxsci.oxfordjournals.org/cgi/pmidlookup?view=long&pmid=12377980 |first1=Y |first2=YF |first3=K |first4=N |first5=A |first6=T |first7=K |issn=1096-6080}}</ref><ref>{{cite journal |author=Thomas A, Tocher J, Edwards DI |title=Electrochemical characteristics of five quinolone drugs and their effect on DNA damage and repair in Escherichia coli |journal=[[J. Antimicrob. Chemother.]] |volume=25 |issue=5 |pages=733–44 |year=1990 |month=May |pmid=2165050 |doi= 10.1093/jac/25.5.733|url=http://jac.oxfordjournals.org/cgi/reprint/25/5/733 |first1=A |first2=J |first3=DI |issn=0305-7453}}</ref><ref>{{cite web | url = http://www.academy.org.uk/pharmacy/fluoroq.htm| title = Fluoroquinolones and Quinolones| accessdate = January 29, 2009| publisher = The American Academy of Optometry (British Chapter) }}</ref>


There is debate as to whether or not this DNA damage is to be considered one of the mechanisms of action concerning the severe and non abating adverse reactions experienced by some patients following fluoroquinolone therapy.<ref>{{cite journal |title=A new class of dihaloquinolones bearing N'-aldehydoglycosylhydrazides, mercapto-1,2,4-triazole, oxadiazoline and a-amino ester precursors: synthesis and antimicrobial activity |journal=J. Braz. Chem. Soc |volume=14 |issue=5 |pages= 790|year=2003 |doi=10.1590/S0103-50532003000500014 |url=http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0103-50532003000500014&lng=es&nrm=iso&tlng=es |quote=Nevertheless, some quinolones cause injury to the chromosome of eukaryotic cells.21,22 These findings prompted us to optimize the substituent at C-3, by... |author1=Al-soud, Yaseen A |author2=Al-masoudi, Najim A |last1=Al-Soud |first1=Yaseen A.}}</ref><ref>{{cite journal |author=Yaseen A. Al-Soud a and Najim A. Al-Masoudi |title=A New Class of Dihaloquinolones Bearing N'-Aldehydoglycosylhydrazides, Mercapto-1,2,4-triazole, Oxadiazoline and α-Amino Ester Precursors: Synthesis and Antimicrobial Activity |journal=J. Braz. Chem. Soc |volume=14 |issue=5 |pages=790–796 |year=2003 |url=http://jbcs.sbq.org.br/jbcs/2003/v14_n5/13-048-02.pdf |quote=Although the current quinolones are not considered to be potent inhibitors of eucaryotic topoisomerases, some effects on these and other enzymes involved with DNA replication have been observed |doi=10.1590/S0103-50532003000500014}}</ref><ref name="pmid14529452">{{cite journal |author=Sissi C, Palumbo M |title=The quinolone family: from antibacterial to anticancer agents |journal=Curr Med Chem Anticancer Agents |volume=3 |issue=6 |pages=439–50 |year=2003 |month=November |pmid=14529452 |doi= 10.2174/1568011033482279|url=http://openurl.ingenta.com/content/nlm?genre=article&issn=1568-0118&volume=3&issue=6&spage=439&aulast=Sissi |quote=The present review focuses on the structural modifications responsible for the transformation of an antibacterial into an anticancer agent. Indeed, a distinctive feature of drugs based on the quinolone structure is their remarkable ability to target different type II topoisomerase enzymes. In particular, some congeners of this drug family display high activity not only against bacterial topoisomerases, but also against eukaryotic topoisomerases and are toxic to cultured mammalian cells and in vivo tumor models. |first1=C |first2=M |issn=1568-0118}}</ref>


==References==
{{Reflist|2}}


[[Category:Antibiotics]]
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Revision as of 14:39, 17 November 2014

Ofloxacin (oral)
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];

Disclaimer

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Ofloxacin (oral) is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

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

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Ofloxacin (oral) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

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 Ofloxacin (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ofloxacin (oral) during labor and delivery.

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Ofloxacin (oral) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Ofloxacin (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Ofloxacin (oral) in the drug label.

Pharmacology

There is limited information regarding Ofloxacin (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

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

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Ofloxacin (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Ofloxacin (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Ofloxacin (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Ofloxacin (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Ofloxacin (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Ofloxacin (oral) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Ofloxacin (oral) 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. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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