VIGAMOX 5 mg/mL

moxifloxacin hydrochloride · SOLUTION/ DROPS · Harrow Eye, LLC

2 Recalls on RecordCurrently in Shortage

Plain English

VIGAMOX is a solution/ drops containing moxifloxacin hydrochloride at 5 mg/mL, taken ophthalmic. Manufactured by Harrow Eye, LLC.

Key Facts

Brand Name: VIGAMOX
Generic Name: moxifloxacin hydrochloride
NDC Code (Product): 82667-700
Manufacturer: Harrow Eye, LLC
Strength: 5 mg/mL
Dosage Form: SOLUTION/ DROPS
Route: OPHTHALMIC
Marketing Status
Application #: NDA021598
Marketing Start: 07/01/2024

Recall History

2 Recalls on Record

Class II10/19/2013

Specialty Medicine Compounding Pharmacy

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

TerminatedVoluntary: Firm initiated

Class II09/10/2018

Pharm D Solutions, LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

asthma1,196 reports

drug hypersensitivity1,046 reports

off label use1,020 reports

dyspnoea1,011 reports

pain982 reports

wheezing900 reports

rash868 reports

pneumonia847 reports

drug ineffective797 reports

vomiting771 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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 *Efficacy for this organism was studied in fewer than 10 infections. VIGAMOX is a topical fluoroquinolone anti-infective 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 influenzae, Haemophilus parainfluenzae*, Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Instill one drop in the affected eye 3 times a day for 7 days. VIGAMOX is for topical ophthalmic use. Instill one drop in the affected eye 3 times a day for 7 days. ( 2 )

Contraindications

4 CONTRAINDICATIONS VIGAMOX is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. VIGAMOX is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Drug-drug interaction studies have not been conducted with VIGAMOX ® . 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.

Adverse Reactions

6 ADVERSE REACTIONS 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. 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% to 6% of patients. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow Eye, LLC at 844-446-6979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Frequently Asked Questions

What is VIGAMOX used for?

VIGAMOX contains moxifloxacin hydrochloride. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is VIGAMOX a controlled substance?

VIGAMOX is not classified as a controlled substance by the DEA.

What is the generic name for VIGAMOX?

The generic name for VIGAMOX is moxifloxacin hydrochloride. There are 12 other brand versions of moxifloxacin hydrochloride.

What is the NDC code for VIGAMOX 5 mg/mL?

The NDC (National Drug Code) for VIGAMOX 5 mg/mL is 82667-700, listed by Harrow Eye, LLC.

Product NDC

82667-700

Package NDC

82667-700-03

Other Moxifloxacin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)