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Moxifloxacin (ophthalmic): Drug information

Moxifloxacin (ophthalmic): Drug information
(For additional information see "Moxifloxacin (ophthalmic): Patient drug information" and see "Moxifloxacin (ophthalmic): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Moxeza [DSC];
  • Vigamox
Brand Names: Canada
  • ACT Moxifloxacin [DSC];
  • AG-Moxifloxacin;
  • APO-Moxifloxacin;
  • JAMP-Moxifloxacin;
  • PMS-Moxifloxacin;
  • SANDOZ Moxifloxacin;
  • Vigamox
Pharmacologic Category
  • Antibiotic, Fluoroquinolone;
  • Antibiotic, Ophthalmic
Dosing: Adult
Bacterial conjunctivitis

Bacterial conjunctivitis: Ophthalmic:

Moxeza: Instill 1 drop into affected eye(s) 2 times daily for 7 days.

Vigamox: Instill 1 drop into affected eye(s) 3 times daily for 7 days.

Surgical prophylaxis

Surgical prophylaxis (off-label use): Instill 1 drop into operative eye every 5 to 15 minutes for five doses within the hour prior to the start of the procedure (Ref). Note: Prophylactic administration has ranged from preoperatively (including day of surgery only to 1 to 3 days preoperatively), intraoperatively, at end of procedure, and postoperatively. However, no specific recommendations beyond immediate preoperative use, including duration of prophylaxis, can be made due to insufficient evidence. A total duration (pre- and postoperatively) of up to 15 days has been reported (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Moxifloxacin (ophthalmic): Pediatric drug information")

Bacterial conjunctivitis

Bacterial conjunctivitis:

Moxeza: Infants ≥4 months, Children, and Adolescents: Ophthalmic: Instill 1 drop into affected eye(s) 2 times daily for 7 days.

Vigamox: Infants, Children, and Adolescents: Ophthalmic: Instill 1 drop into affected eye(s) 3 times daily for 7 days.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, adjustment unlikely needed due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, adjustment unlikely needed due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Dermatologic: Skin rash (1% to 4%)

Infection: Infection (1% to 4%)

Ophthalmic: Conjunctivitis (1% to 6%), decreased visual acuity (1% to 6%), dry eye syndrome (1% to 6%), eye discomfort (1% to 6%), eye irritation (1% to 2%), eye pain (1% to 6%), eye pruritus (1% to 6%), keratitis (1% to 6%), lacrimation (1% to 6%), ocular hyperemia (1% to 6%), subconjunctival hemorrhage (1% to 6%)

Otic: Otitis media (1% to 4%)

Respiratory: Increased cough (1% to 4%), pharyngitis (1% to 4%), rhinitis (1% to 4%)

Miscellaneous: Fever (1% to 4%)

Contraindications

Moxeza ophthalmic solution: There are no contraindications listed in manufacturer's labeling

Vigamox: Hypersensitivity to moxifloxacin, other quinolone antibiotics, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, angioedema, and dermatologic reactions, have been reported with systemic use of moxifloxacin. Discontinue use if an allergic reaction occurs.

• Superinfection: Prolonged use may lead to overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute appropriate alternative therapy.

• Toxic anterior segment syndrome: Toxic anterior segment syndrome, which may consist of corneal edema, fibrin, cell or flare, hypopyon, keratic precipitates, or vitreous opacities, has occurred with intraocular administration.

Dosage form specific issues:

• Ophthalmic solution: For topical ophthalmic use only. Not for subconjunctival injection or for direct introduction into the anterior chamber of the eye. Contact lenses should not be worn during therapy.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Ophthalmic:

Moxeza: 0.5% (3 mL [DSC])

Vigamox: 0.5% (3 mL)

Generic: 0.5% (3 mL)

Solution, Ophthalmic [preservative free]:

Generic: 0.5% (3 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Moxifloxacin HCl (2X Day) Ophthalmic)

0.5% (per mL): $61.09

Solution (Moxifloxacin HCl Ophthalmic)

0.5% (per mL): $4.64 - $58.11

Solution (Vigamox Ophthalmic)

0.5% (per mL): $80.37

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

Vigamox: 0.5% (1 mL, 3 mL)

Generic: 0.5% (3 mL)

Administration: Adult

For topical ophthalmic use only; not for injection. Avoid touching tip of applicator to eye or other surfaces.

Administration: Pediatric

For topical ophthalmic use only; not for injection. Avoid touching tip of applicator to eye, finger, or other surfaces. Apply gentle pressure to lacrimal sac during and immediately following instillation (1 minute) or instruct patient to gently close eyelid after administration, to decrease systemic absorption of ophthalmic drops (Ref).

Use: Labeled Indications

Bacterial conjunctivitis: Treatment of bacterial conjunctivitis caused by susceptible organisms: Acinetobacter lwoffii, Aerococcus viridams, Chlamydia trachomatis, Corynebacterium spp, Cutibacterium (formerly Propionibacterium) acnes, Enterococcus faecalis, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Micrococcus luteus, Staphylococcus arlettae, Staphylococcus aureus, Staphylococcus capitis, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus warneri, Streptococcus mitis, Streptococcus parasanguinis, Streptococcus pneumoniae, Viridans group streptococci.

Use: Off-Label: Adult

Surgical (ophthalmic) prophylaxis

Medication Safety Issues
International issues:

Vigamox [U.S., Canada, and multiple international markets] may be confused with Fisamox brand name for amoxicillin [Australia]

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

When administered orally or IV, moxifloxacin crosses the placenta (Ozyüncü 2010a; Ozyüncü 2010b). The amount of moxifloxacin available systemically following topical application of the ophthalmic drops is limited and significantly less in comparison to oral or IV doses.

If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion for 3 to 5 minutes after application to decrease potential exposure to the fetus (Samples 1988).

Breastfeeding Considerations

It is not known if moxifloxacin is present in breast milk following ophthalmic administration.

The amount of moxifloxacin available systemically following topical application is limited. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Mechanism of Action

Moxifloxacin is a DNA gyrase inhibitor, and also inhibits topoisomerase IV. DNA gyrase (topoisomerase II) is an essential bacterial enzyme that maintains the superhelical structure of DNA. DNA gyrase is required for DNA replication and transcription, DNA repair, recombination, and transposition; inhibition is bactericidal.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Minimal systemic absorption; resulting serum concentration was 0.02% of that achieved with oral formulation

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Imox | Moxigram | Vigamox;
  • (AR) Argentina: Flomox | Moflag | Moxidrop | Vigamox;
  • (BD) Bangladesh: Cinagen xg | Flomox | Floromox | Floxalone | Floximox | Iventi | Mfc | Moxif | Moxigen | Moxigen xg | Moxigram | Moxikem | Moxivin | Moxquin | Odycin | Optimox | Optimox xg | Visomox;
  • (BE) Belgium: Kanavig;
  • (BF) Burkina Faso: Apdrops | Mo floren;
  • (BG) Bulgaria: Moxifloxan | Vigamox | Xiflodrop;
  • (BR) Brazil: Vigamox;
  • (CH) Switzerland: Vigamox;
  • (CI) Côte d'Ivoire: Apdrops | Mo floren | Moxiflal;
  • (CL) Chile: Megrelan | Moxof | Quimox | Vigamox;
  • (CO) Colombia: Floxma | Moxflodel | Moxifloxacino | Moxilab | Moxipharm | Oftalmotrimox | Oftamox | Quimox | Vigamox | Vitalmox | Willmox;
  • (CZ) Czech Republic: Moxifloxacin olikla | Vigamox;
  • (DE) Germany: Moxifloxacin Micro Labs | Vigamox;
  • (DK) Denmark: Monafox;
  • (DO) Dominican Republic: Azon | Ixmu | Micoftal | Moxiquinol | Moxof | Siccina | Vigamox;
  • (EC) Ecuador: Lamoflox | Moflag | Moxof;
  • (EE) Estonia: Lifodrox | Vigamox;
  • (EG) Egypt: Depzabid | Eliocuban | Fluroquinomox | Fortymox | Mograflox | Moxiflox | Moxyseyaro | Vigamox;
  • (ES) Spain: Abimox | Moxifloxacino kern pharma | Vigamox;
  • (ET) Ethiopia: Eyemox | Fortymox | Mosi | Moxifloxacin | Moxifloxan | Moxigram | Moxista;
  • (FI) Finland: Vigamox;
  • (GB) United Kingdom: Moxivig;
  • (GR) Greece: Vigamox;
  • (HK) Hong Kong: Vigamox;
  • (HR) Croatia: Moksacin;
  • (HU) Hungary: Vigamox;
  • (ID) Indonesia: Molcin | Moxidrop | Moxifloxacin HCL | Vigamox;
  • (IE) Ireland: Moxivig;
  • (IN) India: 4 Quin | Akuvitis | Apdrops | Apdrops xg | Aromoxi | Centaflox | Congimox | Emfozen | Eye Quin | Floxview | Gb Mox | K moxi | Lupin's mxg | Mahaflox | Maxim | Mfc | Mflotas | Milflox | Mlobe | Mo 4 | Mo floren | Mosi | Moxiblu | Moxicip | Moxieye | Moxifax | Moxigram | Moxilone | Moximac | Moximum | Moxiset | Moxisurge | Moxitak | Moxiview | Moxluv | Moxoft | Moxyma | Mxc | Mxy | Occumox | Qpflox | Raymoxi | Senzmox | Tagamox | Thomoxx | Vigamox | Vigoquin;
  • (IT) Italy: Oxa | Vigamox;
  • (JO) Jordan: Fortymox | Imox | Vigamox;
  • (JP) Japan: Moxifloxacin sandoz | Vegamox;
  • (KE) Kenya: Apdrops | Mflox | Milflox | Mo floren | Moxoft | Oxin | Vigamox;
  • (KR) Korea, Republic of: Aucomox | Bimox | Eye moxi | Eyemox | Eymox | Flonacin | Huons moxyfloxacin | K moxi | Lightmoxi | Litemoxi | Moroxacin | Moxi i | Moxiain | Moxibella | Moxibit | Moxibru | Moxiflan | Moxifle | Moxiflem | Moxiflo | Moxiforce | Moxihue | Moxikacin | Moxista | Moxitacin | Moxitan | Moxitra | Moxitwo | Ophthalocin | Optimox | Unifle | Vigaflo | Vigamox;
  • (KW) Kuwait: Vigamox;
  • (LB) Lebanon: Fortymox | Vigamox;
  • (LT) Lithuania: Ekara | Lifodrox | Vigamox;
  • (LU) Luxembourg: Kanavig;
  • (LV) Latvia: Ekara | Lifodrox | Vigamox;
  • (MA) Morocco: Vigamox;
  • (MX) Mexico: Avelux | Mifloko | Vigamoxi;
  • (MY) Malaysia: Mosi | Moxifcin | Vigamox | Zanaflox;
  • (NG) Nigeria: Micromox | Moxifloxacin;
  • (NL) Netherlands: Vigamox;
  • (NO) Norway: Vigamox;
  • (NZ) New Zealand: Vigamox;
  • (PE) Peru: Akamoxx | Citol moxifloxacin | Cubris | Lamoflox | Moxof | Unimox | Vigamox;
  • (PH) Philippines: Amoxiflox | Occumox | Vigamox | Vistamox;
  • (PK) Pakistan: Cemox | Fotiflox | Inmox | Izilon | Maxcare | Medimox | Megamox | Mexoflox | Mionex | Moxear | Moxicin | Moxifloxacin | Moxilab | Moxiopt | Moxirains | Moxiral | Moxopt | Moxotic | Narmox | Ocumox | Opmox | Oxcin | Q mox | Raymox | Selmoxi | Valamox | Vigamox | X gen | Xemox | Xomelox;
  • (PL) Poland: Floxamic | Floxamic Neo | Monafox | Vigamox;
  • (PR) Puerto Rico: Moxeza | Moxifloxacin | Moxifloxacin ophthalmic | Vigamox;
  • (PT) Portugal: Moflok | Vigamox;
  • (PY) Paraguay: Moflag | Moxi oftalmol | Moxipron | Moxof | Vigamox;
  • (QA) Qatar: iMox | MO-Floren | Moxitec | Vigamox;
  • (RO) Romania: Moxifloxacina rompharm | Vigamox;
  • (RU) Russian Federation: Bivoxa | Floxepol | Maxiflox | Moxifloxacine Optik | Moxifur | Timilox | Vigamox;
  • (SA) Saudi Arabia: Arox;
  • (SE) Sweden: Vigamox;
  • (SG) Singapore: Mo floren | Vigamox;
  • (SI) Slovenia: Vigamox;
  • (SK) Slovakia: Moxifloxacin olikla | Vigamox;
  • (TH) Thailand: Moximac | Svoz | Vigamox;
  • (TN) Tunisia: Odycin;
  • (TR) Turkey: Bivoxa | Demoxif | Moxaflox | Moxai | Vigamox;
  • (TW) Taiwan: Vigamox;
  • (UA) Ukraine: Cytomoxan | Monafox | Moxifloxacin pharmex | Tamvelier;
  • (UG) Uganda: Mofloren ed;
  • (UY) Uruguay: Akamoxx | Vigamox;
  • (VE) Venezuela, Bolivarian Republic of: Floromox | Vigamox;
  • (VN) Viet Nam: Flomoxad | Motarvi | Moxideka | Quimoxi;
  • (ZA) South Africa: Genfloc | Moxifloxacin ascendis;
  • (ZM) Zambia: Moxoft
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