|
|
| (6 intermediate revisions by one other user not shown) |
| Line 1: |
Line 1: |
| {{DrugProjectFormSinglePage
| | #REDIRECT[[Moxifloxacin (ophthalmic)]] |
| |authorTag=
| |
| | |
| {{VP}}
| |
| <!--Overview-->
| |
| | |
| |genericName=
| |
| | |
| | |
| | |
| |aOrAn=
| |
| | |
| a
| |
| | |
| |drugClass=
| |
| | |
| fluoroquinolone
| |
| | |
| |indication=
| |
| | |
| [[bacterial conjunctivitis]]
| |
| | |
| |hasBlackBoxWarning=
| |
| | |
| |adverseReactions=
| |
| | |
| [[conjunctivitis]], decreased [[visual acuity]], dry eye, [[keratitis]], ocular discomfort, ocular [[hyperemia]], ocular pain, ocular [[pruritus]], [[subconjunctival hemorrhage]], and tearing
| |
| | |
| <!--Black Box Warning-->
| |
| | |
| |blackBoxWarningTitle=
| |
| Title
| |
| | |
| |blackBoxWarningBody=
| |
| <i><span style="color:#FF0000;">ConditionName: </span></i>
| |
| | |
| * Content
| |
| | |
| <!--Adult Indications and Dosage-->
| |
| | |
| <!--FDA-Labeled Indications and Dosage (Adult)-->
| |
| | |
| |fdaLIADAdult=
| |
| | |
| =====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 (Adult)-->
| |
| | |
| |offLabelAdultGuideSupport=
| |
| | |
| =====Condition1=====
| |
| | |
| * Developed by:
| |
| | |
| * Class of Recommendation:
| |
| | |
| * Strength of Evidence:
| |
| | |
| * Dosing Information
| |
| | |
| :* Dosage
| |
| | |
| =====Condition2=====
| |
| | |
| There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
| |
| | |
| <!--Non–Guideline-Supported Use (Adult)-->
| |
| | |
| |offLabelAdultNoGuideSupport=
| |
| | |
| =====Condition1=====
| |
| | |
| * Dosing Information
| |
| | |
| :* Dosage
| |
| | |
| =====Condition2=====
| |
| | |
| There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
| |
| | |
| <!--Pediatric Indications and Dosage-->
| |
| | |
| <!--FDA-Labeled Indications and Dosage (Pediatric)-->
| |
| | |
| |fdaLIADPed=
| |
| | |
| =====Condition1=====
| |
| | |
| * Dosing Information
| |
| | |
| :* Dosage
| |
| | |
| =====Condition2=====
| |
| | |
| There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
| |
| | |
| <!--Off-Label Use and Dosage (Pediatric)-->
| |
| | |
| <!--Guideline-Supported Use (Pediatric)-->
| |
| | |
| |offLabelPedGuideSupport=
| |
| | |
| =====Condition1=====
| |
| | |
| * Developed by:
| |
| | |
| * Class of Recommendation:
| |
| | |
| * Strength of Evidence:
| |
| | |
| * Dosing Information
| |
| | |
| :* Dosage
| |
| | |
| =====Condition2=====
| |
| | |
| There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
| |
| | |
| <!--Non–Guideline-Supported Use (Pediatric)-->
| |
| | |
| |offLabelPedNoGuideSupport=
| |
| | |
| =====Condition1=====
| |
| | |
| * Dosing Information
| |
| | |
| :* Dosage
| |
| | |
| =====Condition2=====
| |
| | |
| There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
| |
| | |
| <!--Contraindications-->
| |
| | |
| |contraindications=
| |
| | |
| *VIGAMOX® solution is contraindicated in patients with a history of [[hypersensitivity]] to moxifloxacin, to other quinolones, or to any of the components in this medication.
| |
| | |
| <!--Warnings-->
| |
| | |
| |warnings=
| |
| | |
| ====Precautions====
| |
| | |
| *NOT FOR INJECTION. VIGAMOX® solution is for topical ophthalmic use only and should not be injected [[subconjunctivally]] or introduced directly into the anterior chamber of the eye.
| |
| | |
| *In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal [[hypersensitivity]] (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by [[cardiovascular]] collapse, [[loss of consciousness]], [[angioedema]] (including laryngeal, pharyngeal or facial edema), airway obstruction, [[dyspnea]], [[urticaria]], and [[itching]]. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute [[hypersensitivity]] reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.
| |
| | |
| *As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.
| |
| | |
| *Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial [[conjunctivitis]].
| |
| | |
| <!--Adverse Reactions-->
| |
| | |
| <!--Clinical Trials Experience-->
| |
| | |
| |clinicalTrials=
| |
| | |
| *Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
| |
| | |
| *The most frequently reported ocular adverse events were [[conjunctivitis]], decreased visual acuity, dry eye, [[keratitis]], ocular discomfort, ocular [[hyperemia]], ocular pain, ocular [[pruritus]], [[subconjunctival hemorrhage]], and [[tearing]]. These events occurred in approximately 1-6% of patients.
| |
| | |
| *Nonocular adverse events reported at a rate of 1-4% were [[fever]], increased [[cough]], [[infection]], [[otitis media]], [[pharyngitis]], [[rash]], and [[rhinitis]].
| |
| | |
| <!--Postmarketing Experience-->
| |
| | |
| |postmarketing=
| |
| | |
| There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--Drug Interactions-->
| |
| | |
| |drugInteractions=
| |
| | |
| *Drug-drug interaction studies have not been conducted with VIGAMOX® solution. In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2, indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these [[cytochrome P450]] isozymes.
| |
| | |
| <!--Use in Specific Populations-->
| |
| | |
| |useInPregnancyFDA=
| |
| * '''Pregnancy Category C'''
| |
| | |
| *Teratogenic Effects
| |
| :*Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose); however, decreased fetal body weights and slightly delayed fetal skeletal development were observed. There was no evidence of teratogenicity when pregnant Cynomolgus monkeys were given oral doses as high as 100 mg/kg/day (approximately 4,300 times the highest recommended total daily human ophthalmic dose). An increased incidence of smaller fetuses was observed at 100 mg/kg/day.
| |
| :*Since there are no adequate and well-controlled studies in pregnant women, VIGAMOX® solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
| |
| | |
| |useInPregnancyAUS=
| |
| * '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
| |
| | |
| There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
| |
| | |
| |useInLaborDelivery=
| |
| There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
| |
| | |
| |useInNursing=
| |
| | |
| *Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when VIGAMOX® solution is administered to a nursing mother.
| |
| | |
| |useInPed=
| |
| | |
| *The safety and effectiveness of VIGAMOX® solution in infants below 1 year of age have not been established.
| |
| | |
| |useInGeri=
| |
| | |
| *No overall differences in safety and effectiveness have been observed between elderly and younger patients.
| |
| | |
| |useInGender=
| |
| There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
| |
| | |
| |useInRace=
| |
| There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
| |
| | |
| |useInRenalImpair=
| |
| There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
| |
| | |
| |useInHepaticImpair=
| |
| There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
| |
| | |
| |useInReproPotential=
| |
| There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
| |
| | |
| |useInImmunocomp=
| |
| There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
| |
| | |
| <!--Administration and Monitoring-->
| |
| | |
| |administration=
| |
| | |
| * Topical
| |
| | |
| |monitoring=
| |
| | |
| There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--IV Compatibility-->
| |
| | |
| |IVCompat=
| |
| | |
| There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--Overdosage-->
| |
| | |
| |overdose=
| |
| | |
| ===Acute Overdose===
| |
| | |
| ====Signs and Symptoms====
| |
| | |
| * Description
| |
| | |
| ====Management====
| |
| | |
| * Description
| |
| | |
| ===Chronic Overdose===
| |
| | |
| There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--Pharmacology-->
| |
| | |
| <!--Drug box 2-->
| |
| | |
| |drugBox=
| |
| | |
| | |
| | |
| <!--Mechanism of Action-->
| |
| | |
| |mechAction=
| |
| | |
| *
| |
| | |
| <!--Structure-->
| |
| | |
| |structure=
| |
| | |
| * VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position.
| |
| | |
| : [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
| |
| | |
| *1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4-b]pyridin-6-yl]-4-oxo-3-quinoline carboxylic acid, monohydrochloride. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of VIGAMOX® solution contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base.
| |
| | |
| *Contains: Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and purified water. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8.
| |
| | |
| *VIGAMOX® solution is an isotonic solution with an osmolality of approximately 290 mOsm/kg.
| |
| | |
| <!--Pharmacodynamics-->
| |
| | |
| |PD=
| |
| | |
| There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--Pharmacokinetics-->
| |
| | |
| |PK=
| |
| | |
| There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--Nonclinical Toxicology-->
| |
| | |
| |nonClinToxic=
| |
| | |
| *Long-term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. However, in an accelerated study with initiators and promoters, moxifloxacin was not carcinogenic in rats following up to 38 weeks of oral dosing at 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose for a 50 kg person, on a mg/kg basis).
| |
| | |
| *Moxifloxacin was not mutagenic in four bacterial strains used in the Ames Salmonella reversion assay. As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when v79 cells were used. Moxifloxacin was clastogenic in the v79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence of genotoxicity in vivo in a micronucleus test or a dominant lethal test in mice.
| |
| | |
| *Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 21,700 times the highest recommended total daily human ophthalmic dose. At 500 mg/kg orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats.
| |
| | |
| <!--Clinical Studies-->
| |
| | |
| |clinicalStudies=
| |
| | |
| There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--How Supplied-->
| |
| | |
| |howSupplied=
| |
| | |
| *
| |
| | |
| <!--Patient Counseling Information-->
| |
| | |
| |fdaPatientInfo=
| |
| | |
| There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
| |
| | |
| <!--Precautions with Alcohol-->
| |
| | |
| |alcohol=
| |
| | |
| * Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
| |
| | |
| <!--Brand Names-->
| |
| | |
| |brandNames=
| |
| | |
| * ®<ref>{{Cite web | title = | url = }}</ref>
| |
| | |
| <!--Look-Alike Drug Names-->
| |
| | |
| |lookAlike=
| |
| | |
| * A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
| |
| | |
| <!--Drug Shortage Status-->
| |
| | |
| |drugShortage=
| |
| }}
| |
| | |
| <!--Pill Image-->
| |
| | |
| {{PillImage
| |
| |fileName=No image.jpg|This image is provided by the National Library of Medicine.
| |
| |drugName=
| |
| |NDC=
| |
| |drugAuthor=
| |
| |ingredients=
| |
| |pillImprint=
| |
| |dosageValue=
| |
| |dosageUnit=
| |
| |pillColor=
| |
| |pillShape=
| |
| |pillSize=
| |
| |pillScore=
| |
| }}
| |
| | |
| <!--Label Display Image-->
| |
| | |
| {{LabelImage
| |
| |fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
| |
| }}
| |
| | |
| {{LabelImage
| |
| |fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
| |
| }}
| |
| | |
| <!--Category-->
| |
| | |
| [[Category:Drug]]
| |