Medicine guide

Vigamox

5 mg/mL · Solution/ Drops

Prescription only
Fluoroquinolone Antibacterial

Active substance: Moxifloxacin Hydrochloride
Used in: Antibiotics, antivirals and antifungals taken into the body
Made by: Harrow Eye, LLC
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-01-22

What it is

Fluoroquinolone Antibacterial

Used for

Corynebacterium species* Micrococcus luteus* Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus warneri* Streptococcus pneumoniae Streptococcus…

Do not take it if

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

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

18other products contain Moxifloxacin Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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 )

From the official label · 2026-01-22 · DailyMed

How it works

From this product’s own US prescribing label.

Moxifloxacin is a member of the fluoroquinolone class of anti-infective drugs [see Microbiology ( 12.4 )].

Half-life13 h

Mostly cleared after≈ 3 daysfive half-lives — our arithmetic

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-22

Do not take it if

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 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

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 )

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Hypersensitivity Reactions :
Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin.
( 5.1 ) Prolonged Use :
May result in overgrowth of non-susceptible organisms, including fungi.
If superinfection occurs, discontinue use and institute alternative therapy.
( 5.2 )
Avoid Contact Lens Wear :
Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
( 5.3 )
5.1 Hypersensitivity Reactions 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.
5.2 Growth of Resistant Organisms With Prolonged Use 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.
5.3 Avoidance of Contact Lens Wear Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary There are no adequate and well-controlled studies with VIGAMOX ® in pregnant women to inform any drug-associated risks.
Oral administration of moxifloxacin to pregnant rats and monkeys and intravenously to pregnant rabbits during the period of organogenesis did not produce adverse maternal or fetal effects at clinically relevant doses.
Oral administration of moxifloxacin to pregnant rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses (see Data) .
Data Animal Data Embryo-fetal studies were conducted in pregnant rats administered with 20, 100, or 500 mg/kg/day moxifloxacin by oral gavage on Gestation Days 6 to 17, to target the period of organogenesis.
Decreased fetal body weight and delayed skeletal development were observed at 500 mg/kg/day [277 times the human area under the curve (AUC) at the recommended human ophthalmic dose].
The No-Observed-Adverse-Effect-Level (NOAEL) for developmental toxicity was 100 mg/kg/day (30 times the human AUC at the recommended human ophthalmic dose).
Embryo-fetal studies were conducted in pregnant rabbits administered with 2, 6.5, or 20 mg/kg/day moxifloxacin by intravenous administration on Gestation Days 6 to 20, to target the period of organogenesis.
Abortions, increased incidence of fetal malformations, delayed fetal skeletal ossification, and reduced placental and fetal body weights were observed at 20 mg/kg/day (1086 times the human AUC at the recommended human ophthalmic dose), a dose that produced maternal body weight loss and death.
The NOAEL for developmental toxicity was 6.5 mg/kg/day (246 times the human AUC at the recommended human ophthalmic dose).
Pregnant cynomolgus monkeys were administered moxifloxacin at doses of 10, 30, or 100 mg/kg/day by intragastric intubation between Gestation Days 20 and 50, targeting the period of organogenesis.
At the maternal toxic doses of ≥ 30 mg/kg/day, increased abortion, vomiting, and diarrhea were observed.
Smaller fetuses/reduced fetal body weights were observed at 100 mg/kg/day (2864 times the human AUC at the recommended human ophthalmic dose).
The NOAEL for fetal toxicity was 10 mg/kg/day (174 times the human AUC at the recommended human ophthalmic dose).
In a pre- and postnatal study, rats were administered moxifloxacin by oral gavage at doses of 20, 100, and 500 mg/kg/day from Gestation Day 6 until the end of lactation.
Maternal death occurred during gestation at 500 mg/kg/day.
Slight increases in the duration of pregnancy, reduced pup birth weight, and decreased prenatal and neonatal survival were observed at 500 mg/kg/day (estimated 277 times the human AUC at the recommended human ophthalmic dose).
The NOAEL for pre- and postnatal development was 100 mg/kg/day (estimated 30 times the human AUC at the recommended human ophthalmic dose).
IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with VIGAMOX ® in pregnant women to inform any drug-associated risks.
Oral administration of moxifloxacin to pregnant rats and monkeys and intravenously to pregnant rabbits during the period of organogenesis did not produce adverse maternal or fetal effects at clinically relevant doses.
Oral administration of moxifloxacin to pregnant rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses (see Data) .
Data Animal Data Embryo-fetal studies were conducted in pregnant rats administered with 20, 100, or 500 mg/kg/day moxifloxacin by oral gavage on Gestation Days 6 to 17, to target the period of organogenesis.
Decreased fetal body weight and delayed skeletal development were observed at 500 mg/kg/day [277 times the human area under the curve (AUC) at the recommended human ophthalmic dose].
The No-Observed-Adverse-Effect-Level (NOAEL) for developmental toxicity was 100 mg/kg/day (30 times the human AUC at the recommended human ophthalmic dose).
Embryo-fetal studies were conducted in pregnant rabbits administered with 2, 6.5, or 20 mg/kg/day moxifloxacin by intravenous administration on Gestation Days 6 to 20, to target the period of organogenesis.
Abortions, increased incidence of fetal malformations, delayed fetal skeletal ossification, and reduced placental and fetal body weights were observed at 20 mg/kg/day (1086 times the human AUC at the recommended human ophthalmic dose), a dose that produced maternal body weight loss and death.
The NOAEL for developmental toxicity was 6.5 mg/kg/day (246 times the human AUC at the recommended human ophthalmic dose).
Pregnant cynomolgus monkeys were administered moxifloxacin at doses of 10, 30, or 100 mg/kg/day by intragastric intubation between Gestation Days 20 and 50, targeting the period of organogenesis.
At the maternal toxic doses of ≥ 30 mg/kg/day, increased abortion, vomiting, and diarrhea were observed.
Smaller fetuses/reduced fetal body weights were observed at 100 mg/kg/day (2864 times the human AUC at the recommended human ophthalmic dose).
The NOAEL for fetal toxicity was 10 mg/kg/day (174 times the human AUC at the recommended human ophthalmic dose).
In a pre- and postnatal study, rats were administered moxifloxacin by oral gavage at doses of 20, 100, and 500 mg/kg/day from Gestation Day 6 until the end of lactation.
Maternal death occurred during gestation at 500 mg/kg/day.
Slight increases in the duration of pregnancy, reduced pup birth weight, and decreased prenatal and neonatal survival were observed at 500 mg/kg/day (estimated 277 times the human AUC at the recommended human ophthalmic dose).
The NOAEL for pre- and postnatal development was 100 mg/kg/day (estimated 30 times the human AUC at the recommended human ophthalmic dose).
8.2 Lactation Risk Summary There is no data regarding the presence of VIGAMOX ® in human milk, the effects on the breastfed infants, or the effects on milk production/excretion to inform risk of VIGAMOX ® to an infant during lactation.
A study in lactating rats has shown transfer of moxifloxacin into milk following oral administration.
Systemic levels of moxifloxacin following topical ocular administration are low [see Clinical Pharmacology ( 12.3 )] , and it is not known whether measurable levels of moxifloxacin would be present in maternal milk following topical ocular administration.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VIGAMOX and any potential adverse effects on the breastfed child from VIGAMOX ® .
8.4 Pediatric Use The safety and effectiveness of VIGAMOX have been established in all ages.
Use of VIGAMOX is supported by evidence from adequate and well controlled studies of VIGAMOX in
adults, children, and neonates [see Clinical Studies ( 14 )] .
There is no evidence that the ophthalmic administration of VIGAMOX has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.
8.5 Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

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.

Quoted from the official label, section “Drug Interactions”.

Use in children

The safety and effectiveness of VIGAMOX have been established in all ages.
Use of VIGAMOX is supported by evidence from adequate and well controlled studies of VIGAMOX in
adults, children, and neonates [see Clinical Studies ( 14 )] .
There is no evidence that the ophthalmic administration of VIGAMOX has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.

Quoted from the official label, section “Pediatric Use”.

Use in older people

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

Quoted from the official label, section “Geriatric Use”.

Side effects

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 .

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Avoid Contamination of the Product Advise patients not to touch the dropper tip to any surface to
avoid contaminating the contents.
Avoid Contact Lens Wear Advise patients not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis [see Warnings and Precautions (5.3) ] .
Hypersensitivity Reactions Systemically administered quinolones including moxifloxacin have been associated with hypersensitivity reactions, even following a single dose.
Instruct patients to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction [see Warnings and Precautions (5.1) ] .

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Ophthalmic solution containing moxifloxacin 0.5%. Ophthalmic solution containing moxifloxacin 0.5%. ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

VIGAMOX ® is supplied as a sterile ophthalmic solution in a dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. 3 mL in a 4 mL bottle NDC 82667-700-03 Storage:
Store at 2°C to 25°C (36°F to 77°F).

Quoted from the official label, section “How Supplied”.

What is in it

VIGAMOX (moxifloxacin 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. The chemical name for moxifloxacin hydrochloride is 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. The molecular formula for moxifloxacin hydrochloride is C 21 H 24 FN 3 O 4
HCl and its molecular weight is 437.9 g/mol. The chemical structure is presented below:
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. VIGAMOX contains Active:
Moxifloxacin 0.5% (5 mg/mL); Inactives:
Boric acid, purified water, and sodium chloride. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8. VIGAMOX ® is an isotonic solution with an osmolality of approximately 290 mOsm/kg. chemical

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (20)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

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Details

Made by	Harrow Eye, LLC
Active substance	Moxifloxacin Hydrochloride
Used in	Antibiotics, antivirals and antifungals taken into the body
Strength	5 mg/mL
Form	Solution/ Drops
Route	Ophthalmic
Packs	1 BOTTLE in 1 CARTON / 3 mL in 1 BOTTLE
NDC	82667-700

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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