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Vigamox eent

Pronunciation

Generic Name: Moxifloxacin Hydrochloride eent
Class: Antibacterials
VA Class: OP210
Chemical Name: (4aS-cis)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(octahydro-6H-pyrrolol[3,4-b]pyridin-6-yl)-4-oxo-3-quinolinecarboxylic acid monohydrochloride
Molecular Formula: C21H24FN3O4
CAS Number: 186826-86-8

Introduction

Antibacterial; 8-methoxy fluoroquinolone.1 2 5 10 11 20

Uses for Vigamox

Bacterial Ophthalmic Infections

Topical treatment of bacterial conjunctivitis caused by susceptible gram-positive bacteria, including Staphylococcus (S. aureus,1 2 S. arlettae,2 S. capitis,2 S. epidermidis,1 2 S. haemolyticus,1 2 S. hominis,1 2 S. saprophyticus,2 S. warneri1 2 ), Streptococcus (S. mitis,2 S. parasanguinis,2 S. pneumoniae,1 2 viridans streptococci1 ), Enterococcus faecalis,2 Aerococcus viridans,2 Corynebacterium1 (C. macginleyi),2 Micrococcus luteus,1 2 or Propionibacterium acnes.2

Topical treatment of bacterial conjunctivitis caused by susceptible gram-negative bacteria, including Acinetobacter lwoffii,1 Escherichia coli,2 Haemophilus influenzae,1 2 H. parainfluenzae,1 or Klebsiella pneumoniae.2

Many cases of mild, acute bacterial conjunctivitis resolve spontaneously without anti-infective therapy.6 17 18 19 Although topical ophthalmic anti-infectives may shorten time to resolution and reduce severity and risk of complications,6 17 18 19 avoid indiscriminate use of topical anti-infectives.6 17

Treatment of acute bacterial conjunctivitis generally is empiric;6 17 18 use of a broad-spectrum topical antibacterial usually recommended.6 17 18 In vitro staining and/or cultures of conjunctival material may be indicated in diagnosis and management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment.6 17 18

Chlamydial Ophthalmic Infections

Has been used for topical treatment of conjunctivitis caused by Chlamydia trachomatis.1 2

Systemic anti-infectives are recommended for treatment of conjunctivitis caused by C. trachomatis.17 Although topical anti-infectives have been used concomitantly,17 18 concomitant use of topical anti-infectives not considered necessary.17 18

Vigamox Dosage and Administration

Administration

Ophthalmic Administration

Apply 0.5% ophthalmic solution topically to the eye.1 2

For topical ophthalmic use only;1 2 do not inject subconjunctivally and do not introduce directly into anterior chamber of the eye.1 2

Avoid contaminating applicator tip with material from eye, fingers, or other source.1 2

Dosage

Available as moxifloxacin hydrochloride;1 2 dosage expressed in terms of moxifloxacin.1 2

Pediatric Patients

Bacterial Ophthalmic Infections
Conjunctivitis
Ophthalmic

Moxeza 0.5% ophthalmic solution in pediatric patients ≥4 months of age: Instill 1 drop in the affected eye(s) 2 times daily for 7 days.2

Vigamox 0.5% ophthalmic solution in pediatric patients ≥1 year of age: Instill 1 drop in the affected eye(s) 3 times daily for 7 days.1

Chlamydial Ophthalmic Infections
Conjunctivitis
Ophthalmic

Moxeza 0.5% ophthalmic solution in pediatric patients ≥4 months of age: Instill 1 drop in the affected eye(s) 2 times daily for 7 days.2

Vigamox 0.5% ophthalmic solution in pediatric patients ≥1 year of age: Instill 1 drop in the affected eye(s) 3 times daily for 7 days.1

Adults

Bacterial Ophthalmic Infections
Conjunctivitis
Ophthalmic

Moxeza 0.5% ophthalmic solution: Instill 1 drop in the affected eye(s) 2 times daily for 7 days.2

Vigamox 0.5% ophthalmic solution: Instill 1 drop in the affected eye(s) 3 times daily for 7 days.1

Chlamydial Ophthalmic Infections
Conjunctivitis
Ophthalmic

Moxeza 0.5% ophthalmic solution: Instill 1 drop in the affected eye(s) 2 times daily for 7 days.2

Vigamox 0.5% ophthalmic solution: Instill 1 drop in the affected eye(s) 3 times daily for 7 days.1

Cautions for Vigamox

Contraindications

  • Hypersensitivity to moxifloxacin, other quinolones, or any ingredient in the formulation.1

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions reported in patients receiving systemic fluoroquinolones, including systemic moxifloxacin;1 2 21 these reactions may occur with first dose.1 2 21 Some hypersensitivity reactions reported with systemic fluoroquinolones have been accompanied by cardiovascular collapse, loss of consciousness, tingling, angioedema (e.g., laryngeal, pharyngeal, facial), airway obstruction, dyspnea, urticaria, and itching.1 2 21

Immediately discontinue moxifloxacin ophthalmic solution at first sign of rash or hypersensitivity reaction.1 2

Serious acute hypersensitivity reactions may require immediate emergency treatment;1 2 administer oxygen and airway management as clinically indicated.1 2

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.1 2

If superinfection occurs, discontinue moxifloxacin ophthalmic solution and institute appropriate therapy.1 2

Patient Monitoring

Whenever clinical judgment dictates, examine patient with the aid of magnification (e.g., slit lamp biomicroscopy) and, if appropriate, fluorescein staining.1 2

Contact Lenses

Do not wear contact lenses if any signs or symptoms of bacterial conjunctivitis are present.1 2

Specific Populations

Pregnancy

Category C.1 2

Data not available regarding use of moxifloxacin 0.5% ophthalmic solution in pregnant women;1 2 use only if potential benefits to the woman justify potential risks to fetus.1 2

Lactation

Distribution into human milk following topical application to the eye not studied;1 2 presumed to be distributed into human milk.1 2

Use with caution in nursing women.1 2

Pediatric Use

Moxeza 0.5% ophthalmic solution: Safety and efficacy not established in pediatric patients <4 months of age.2

Vigamox 0.5% ophthalmic solution: Safety and efficacy not established in pediatric patients <1 year of age.1

Geriatric Use

No overall differences in safety and efficacy relative to younger adults.1 2

Common Adverse Effects

Moxeza 0.5% ophthalmic solution: Eye irritation, pyrexia, conjunctivitis.2

Vigamox 0.5% ophthalmic solution: Conjunctivitis, decreased visual acuity, ocular dryness, keratitis, ocular discomfort/pain/pruritus, ocular hyperemia, subconjunctival hemorrhage, tearing, fever, increased cough, infection, otitis media, pharyngitis, rash, rhinitis.1

Interactions for Vigamox

No formal drug interaction studies using moxifloxacin 0.5% ophthalmic solution.1

Does not inhibit CYP isoenzymes 1A2, 2C9, C19, 2D6, or 3A4;1 unlikely to alter pharmacokinetics of drugs metabolized by these CYP isoenzymes.1

Vigamox Pharmacokinetics

Absorption

Bioavailability

Following topical application of moxifloxacin 0.5% ophthalmic solution to the eye, the drug is absorbed systemically and low moxifloxacin concentrations are attained in plasma.1 2

Moxeza 0.5% ophthalmic solution: Multiple, bilateral, topical ocular doses applied twice daily for 4 days resulted in peak plasma concentrations of moxifloxacin that were approximately 0.02% of those reported with usual oral dosages of moxifloxacin.2

Vigamox 0.5% ophthalmic solution: Bilateral topical doses applied 3 times daily for 5 days resulted in mean steady-state peak plasma concentrations and estimated daily exposures (AUCs) that were 1600 and 1000 times lower, respectively, than those reported with usual oral dosages of moxifloxacin.1

Elimination

Half-life

Half-life of systemically absorbed moxifloxacin is approximately 13 hours.1

Stability

Storage

Ophthalmic

Solution

2–25°C.1 2

Actions and Spectrum

  • Fluoroquinolone anti-infective.1 2

  • Like other fluoroquinolones, inhibits bacterial DNA synthesis in susceptible bacteria via inhibition of type II DNA topoisomerases (DNA gyrase, topoisomerase IV).1 10 11

  • Spectrum of activity includes gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and some other organisms (e.g., Chlamydia).1

  • Active in vitro and in vivo in conjunctival infections against some gram-positive bacteria, including Staphylococcus (S. aureus,1 2 S. arlettae,2 S. capitis,2 S. epidermidis,1 2 S. haemolyticus,1 2 S. hominis,1 2 S. saprophyticus,2 S. warneri1 2 ), Streptococcus (S. mitis,2 S. parasanguinis,2 S. pneumoniae,1 2 viridans streptococci1 ), Enterococcus faecalis,2 Aerococcus viridans,2 Corynebacterium1 (C. macginleyi),2 Micrococcus luteus,1 2 and Propionibacterium acnes.2

  • Active in vitro and in vivo in conjunctival infections against some gram-negative bacteria, including Acinetobacter lwoffii,1 Escherichia coli,2 Haemophilus influenzae,1 2 H. parainfluenzae,1 and Klebsiella pneumoniae.2 Also active against Chlamydia trachomatis.1 2

  • Cross-resistance can occur between moxifloxacin and other fluoroquinolones.1 2

Advice to Patients

  • Advise patients to avoid contaminating applicator tip with material from the eye, fingers, or other source.1 2

  • Advise patients not to wear contact lenses if signs or symptoms of bacterial conjunctivitis are present.1 2

  • Inform patients that systemic fluoroquinolones, including moxifloxacin, have been associated with hypersensitivity reactions, even following a single dose.1 2 Advise patients to immediately discontinue moxifloxacin ophthalmic solution and contact a clinician at first sign of rash or hypersensitivity reaction.1 2

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 2

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2

  • Importance of informing patients of other important precautionary information.1 2 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Moxifloxacin Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.5% (of moxifloxacin)

Moxeza

Alcon

Vigamox

Alcon

AHFS DI Essentials. © Copyright 2017, Selected Revisions May 22, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Alcon Laboratories, Inc. Vigamox (moxifloxacin hydrochloride) ophthalmic solution 0.5% prescribing information. Fort Worth, TX; 2015 Apr.

2. Alcon Laboratories, Inc. Moxeza (moxifloxacin hydrochloride) ophthalmic solution 0.5% prescribing information. Fort Worth, TX; 2013 May.

3. Limberg MB. A review of bacterial keratitis and bacterial conjunctivitis. Am J Ophthalmol. 1991; 112::2-9S. [PubMed 1928269]

4. Thielen TL, Castle SS, Terry JE. Anterior ocular infections: an overview of pathophysiology and treatment. Ann Pharmacother. 2000; 34:235-46. [PubMed 10676832]

5. Zhanel GC, Ennis K, Vercaigne L et al. A critical review of the fluoroquinolones: focus on respiratory tract infections. Drugs. 2002; 62:13-59. [PubMed 11790155]

6. Barnes SD, Kumar NM, Pavin-Langston D et al. Microbial Conjunctivitis. In: Bennett JE, Dolin R, and Blaser MJ, eds. Mandell, Douglas, and Bennett's principles and practices of infectious diseases. 8th ed. Philadelphia, PA: Elsevier Saunders; 2015:1392-1401.

8. Robert PY, Adenis JP. Comparative review of topical ophthalmic antibacterial preparations. Drugs. 2001; 61:175-85. [PubMed 11270936]

9. Alcon Laboratories, Inc. Managed Care Dossier: Vigamox (moxifloxacin hydrochloride ophthalmic solution 0.5%) as base. Fort Worth, TX; 2003 May.

10. Bearden DT, Danziger LH. Mechanism of action of and resistance to quinolones. Pharmacotherapy. 2001; 21:224S-32S. [PubMed 11642689]

11. Mah FS. New antibiotics for bacterial infections. Ophthalmol Clin North Am. 2003; 16:11-27. [PubMed 12683245]

12. Alcon, Forth Worth, TX: Personal communication.

17. American Academy of Ophthalmology. Preferred practice pattern (PPP) guidelines: conjunctivitis PPP - 2013. From American Academy of Ophthalmology website. Accessed 17 Oct 2016.

18. Azari AA, Barney NP. Conjunctivitis: a systematic review of diagnosis and treatment. JAMA. 2013; 310:1721-9. [PubMed 24150468]

19. Sheikh A, Hurwitz B, van Schayck CP et al. Antibiotics versus placebo for acute bacterial conjunctivitis. Cochrane Database Syst Rev. 2012; :CD001211. [PubMed 22972049]

20. Hooper DC, Strhilevitaz J. Quinolones. In: Bennett JE, Dolin R, and Blaser MJ, eds. Mandell, Douglas, and Bennett's principles and practices of infectious diseases. 8th ed. Philadelphia, PA: Elsevier Saunders; 2015:419-39.

21. Bayer. Avelox (moxifloxacin hydrochloride) tablets and injection for IV use prescribing information. Wayne, NJ; 2016 Jul.

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