Vigamox eent

Pronunciation

Generic Name: Moxifloxacin Hydrochloride eent
Class: Antibacterials
VA Class: AM900
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

Warning(s)

REMS:

FDA approved a REMS for moxifloxacin to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Antibacterial; 8-methoxy fluoroquinolone.1 5 10 11

Uses for Vigamox

Bacterial Ophthalmic Infections

Treatment of conjunctivitis caused by susceptible Corynebacterium, Micrococcus luteus, Staphylococcus aureus, S. epidermidis, S. haemolyticus, S. hominis, S. warneri, Streptococcus pneumoniae, viridans streptococci, Acinetobacter lwoffii, Haemophilus influenzae, H. parainfluenzae, or Chlamydia trachomatis.1

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

Role of topical fluoroquinolones in management of uncomplicated bacterial conjunctivitis not fully elucidated; some clinicians suggest that the drugs be reserved principally for severe bacterial conjunctivitis because of potential development of quinolone resistance, and possibly, cost considerations.4 6 7 8

Vigamox Dosage and Administration

Administration

For topical use only.1 Not for injection.1 Not for subconjunctival injection or introduction directly into anterior chamber of the eye.1

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.1

Avoid contamination of applicator tip.1

Dosage

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

Pediatric Patients

Bacterial Ophthalmic Infections
Conjunctivitis
Ophthalmic

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

Adults

Bacterial Ophthalmic Infections
Conjunctivitis
Ophthalmic

1 drop of 0.5% solution 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, potentially fatal hypersensitivity reactions reported following systemic administration of fluoroquinolones; has occurred with the initial dose.1

If allergic reaction occurs, discontinue use and institute appropriate therapy if indicated.1

General Precautions

Superinfection

Possible overgrowth of nonsusceptible organisms (e.g., fungi) with prolonged use; if superinfection occurs, discontinue moxifloxacin and institute other appropriate therapy.1

Patient Monitoring

Careful monitoring, including slit-lamp biomicroscopy and fluorescein staining when appropriate, may be necessary in some patients.1

Specific Populations

Pregnancy

Category C.1

Lactation

Some fluoroquinolones are distributed into milk following systemic administration. Use moxifloxacin ophthalmic preparation with caution.1

Pediatric Use

Safety and efficacy not established in children <1 year of age.1

Geriatric Use

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

Common Adverse Effects

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

Vigamox Pharmacokinetics

Absorption

Bioavailability

Mean steady-state peak plasma concentrations and estimated daily exposure AUC were 1600 and 1000 times lower, respectively, after topical application to both eyes (0.5% ophthalmic solution 3 times daily for 5 days) than after oral administration (400 mg daily for 10 days).1

Elimination

Half-life

Approximately 13 hours.1

Stability

Storage

Ophthalmic

Solution

2–25°C.1

Actions and Spectrum

  • Usually bactericidal.1

  • Like other fluoroquinolones, moxifloxacin inhibits bacterial DNA gyrase and 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 against Corynebacterium, M. luteus, S. aureus, S. epidermidis, S. haemolyticus, S. hominis, S. warneri, S. pneumoniae, viridans streptococci, A. lwoffii, H. influenzae, H. parainfluenzae, and C. trachomatis.1

Advice to Patients

  • Importance of discontinuing drug and informing clinician at first sign of rash or other sign of hypersensitivity.1

  • Importance of learning and adhering to proper administration techniques to avoid contamination of the product.1

  • Importance of not wearing contact lenses in the presence of signs and symptoms of bacterial conjunctivitis.1

  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.1

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

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

Preparations

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

Moxifloxacin Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.5% (of moxifloxacin)

Vigamox (with boric acid)

Alcon

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Vigamox 0.5% Solution (ALCON VISION): 3/$96.46 or 9/$271.38

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Alcon Laboratories, Inc. Vigamox (moxifloxacin hydrochloride) ophthalmic solution 0.5% prescribing information. Fort Worth, TX; 2005 May.

2. O’Brien T. Conjunctivitis. In: Mandell GL, Bennett JE, Dolin R eds. Principles and practices of infectious diseases. 5th ed. New York: Churchill Livingstone; 2000:1251-6.

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. [IDIS 439875] [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. Yolton DP. New antibacterial drugs for topical ophthalmic use. Optom Clin. 1992; 2:59-72. [PubMed 1286241]

7. Gwon A for the Ofloxacin Study Group II. Ofloxacin vs tobramycin for the treatment of external ocular infection. Arch Ophthalmol. 1992; 110:1234-7. [IDIS 301536] [PubMed 1520109]

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. [IDIS 472236] [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.

Hide
(web5)