Vigamox

— THERAPEUTIC CATEGORIES —
  • Ocular infections
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Vigamox Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Moxifloxacin (as HCl) 0.5%; oph soln.

    Pharmacological Class

    Quinolone.

    How Supplied

    Soln—3mL

    Storage

    Store at 2°C to 25°C (36°F to 77°F). 

    Manufacturer

    Harrow, Inc

    Mechanism of Action

    The antibacterial action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV.

    Vigamox Indications

    Indications

    Susceptible bacterial conjunctivitis.

    Indications

    Vigamox is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

    Corynebacterium species

    Micrococcus luteus

    Staphylococcus aureus

    Staphylococcus epidermidis

    Staphylococcus haemolyticus

    Staphylococcus hominis

    Staphylococcus warneri

    Streptococcus pneumoniae

    Streptococcus viridans group

    Acinetobacter lwoffii

    Haemophilus influenza

    Haemophilus parainfluenzae

    Chlamydia trachomatis

    Vigamox Dosage and Administration

    Adults and Children

    Instill 1 drop 3 times daily for 7 days.

    Vigamox Contraindications

    Not Applicable

    Vigamox Boxed Warnings

    Not Applicable

    Vigamox Warnings/Precautions

    Warnings/Precautions

    For topical ophthalmic use only. Discontinue if superinfection or hypersensitivity occurs. Avoid contact lenses if symptomatic. Pregnancy. Nursing mothers.

    Pregnancy Considerations

    No adequate and well-controlled studies in pregnant women to inform any drug-associated risks.

    Nursing Mother Considerations

    Systemic levels of moxifloxacin following topical ocular administration are low; it is not known whether measurable levels of moxifloxacin would be present in breastmilk. Consider the benefits to the mother vs the potential adverse effects on the breastfed child.

    Pediatric Considerations

    The safety and effectiveness of Vigamox have been established in all ages and is supported by controlled studies in children and neonates.

    Geriatric Considerations

    No overall differences in safety and effectiveness have been observed between elderly and younger patients.

    Vigamox Pharmacokinetics

    Elimination

    Half-life: 13 hours.

    Vigamox Interactions

    Not Applicable

    Vigamox Adverse Reactions

    Adverse Reactions

    Conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, hyperemia, pain, pruritus, subconjunctival hemorrhage, tearing.

    Vigamox Clinical Trials

    Clinical Trials

    In 2 randomized controlled trials, Vigamox produced clinical cures on day 5-6 in 66-69%  of patients with bacterial conjunctivitis; microbiological success rates (eradication of baseline pathogens) ranged from 84-94%.

    Vigamox was evaluated in a randomized, double-masked, parallel group study of pediatric patients with bacterial conjunctivitis between birth and 31 days of age. Patients were randomly assigned to receive Vigamox or another anti-infective agent. At day 9, results showed a clinical cure rate of 80% and a microbiological eradication success rate of 92%.

    Vigamox Note

    Not Applicable

    Vigamox Patient Counseling

    Patient Counseling

    Do not touch the dropper tip to any surface to avoid contamination.

    Avoid contact lens wear with bacterial conjunctivitis.

    Discontinue use at the first sign of rash or allergic reaction. 

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