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Levofloxacin (ophthalmic): Drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Pharmacologic Category
  • Antibiotic, Fluoroquinolone;
  • Antibiotic, Ophthalmic
Dosing: Adult
Bacterial conjunctivitis

Bacterial conjunctivitis: Ophthalmic: 0.5% solution:

Treatment day 1 and day 2: Instill 1 to 2 drops into affected eye(s) every 2 hours while awake, up to 8 times daily.

Treatment day 3 through day 7: Instill 1 to 2 drops into affected eye(s) every 4 hours while awake, up to 4 times daily.

Corneal ulcer

Corneal ulcer: Ophthalmic: 1.5% solution:

Treatment day 1 through day 3: Instill 1 to 2 drops into affected eye(s) every 30 minutes to 2 hours while awake and ~ 4 to 6 hours after going to bed for the night.

Treatment day 4 through completion of therapy: Instill 1 to 2 drops into affected eye(s) every 1 to 4 hours while awake.

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 "Levofloxacin (ophthalmic): Pediatric drug information")

Bacterial conjunctivitis

Bacterial conjunctivitis: Children and Adolescents: Ophthalmic: 0.5% solution:

Day 1 and 2: Instill 1 to 2 drops into affected eye(s) every 2 hours while awake, up to 8 times/day

Day 3 to 7: Instill 1 to 2 drops into affected eye(s) every 4 hours while awake, up to 4 times/day

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, dosage adjustment unlikely 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%:

Gastrointestinal: Diarrhea (1% to 2%), dysgeusia (8% to 10%), dyspepsia (1% to 2%), nausea (1% to 2%)

Nervous system: Headache (1% to 10%)

Ophthalmic: Blurred vision (1% to 2%), burning sensation of eyes (1% to 3%), eye discomfort (1% to 3%), eye infection (1% to 2%), eye irritation (1% to 2%), eye pain (1% to 3%), foreign body sensation of eye (1% to 3%), photophobia (1% to 3%), temporary vision loss (1% to 3%)

Respiratory: Pharyngitis (1% to 3%), throat irritation (1% to 2%)

Miscellaneous: Fever (1% to 3%)

<1%:

Endocrine & metabolic: Chemosis

Hypersensitivity reaction: Hypersensitivity reaction

Ophthalmic: Corneal erosion, diplopia, dry eye syndrome, erythema of eyelid, eye pruritus, eyelid edema, seeing spots (floaters)

Postmarketing: Ophthalmic: Blepharitis (Kanda 2012), conjunctival hyperemia (Kanda 2012), conjunctivitis (Kanda 2012), episcleritis (Kanda 2012), eyelid pruritus (Kanda 2012), increased lacrimation (Kanda 2012), keratitis (including punctate keratitis) (Kanda 2012)

Contraindications

Hypersensitivity to levofloxacin, other quinolones, or to any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, have been reported with systemic quinolone therapy. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.

• Superinfection: Prolonged use may lead to overgrowth of nonsusceptible organisms, including fungi. Discontinue use and institute appropriate alternative therapy if superinfection is suspected.

Other warnings/precautions:

• Appropriate use: For topical use only. Do not inject subconjunctivally or introduce into anterior chamber of the eye. Contact lenses should not be worn during treatment.

Warnings: Additional Pediatric Considerations

Ophthalmic administration of fluoroquinolones has not been shown to affect weight-bearing joints.

Dosage Forms: US

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

Solution, Ophthalmic:

Generic: 0.5% (5 mL [DSC])

Solution, Ophthalmic [preservative free]:

Generic: 1.5% (5 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (levoFLOXacin Ophthalmic)

1.5% (per mL): $13.00

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.

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: Apply finger pressure to lacrimal sac during and for 1 to 2 minutes after instillation to decrease risk of absorption and systemic effects; avoid contacting bottle tip with skin

Use: Labeled Indications

Bacterial conjunctivitis: 0.5% solution: Treatment of bacterial conjunctivitis caused by susceptible strains of Corynebacterium species, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus groups C/F, Streptococcus group G, Viridans group streptococci, Acinetobacter lwoffii, Haemophilus influenzae, and Serratia marcescens.

Corneal ulcers: 1.5% solution: Treatment of corneal ulcers caused by susceptible strains of Corynebacterium species, Pseudomonas aeruginosa, Serratia marcescens, S. aureus, S. epidermidis, S. pneumoniae, and Viridans group streptococci.

Medication Safety Issues
Sound-alike/look-alike issues:

LevoFLOXacin may be confused with levETIRAcetam, levodopa, levothyroxine

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. When administered orally or IV, levofloxacin crosses the placenta (Ozyüncü and Beksac 2010; Ozyüncü and Nemutlu 2010). The amount of levofloxacin available systemically following topical application of the ophthalmic drops is 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

When administered orally or IV, levofloxacin enters breast milk (Cahill 2005). The amount of levofloxacin available systemically following topical application of the ophthalmic drops is significantly less in comparison to oral or IV doses. The manufacturer recommends that caution be exercised when administering levofloxacin ophthalmic drops to nursing women.

Mechanism of Action

Levofloxacin is the L-isomer of ofloxacin. Levofloxacin inhibits DNA-gyrase and topoisomerase IV in susceptible organisms and thereby inhibits relaxation of supercoiled DNA and promotes breakage of DNA strands. DNA gyrase (topoisomerase II), is an essential bacterial enzyme that maintains the superhelical structure of DNA and is required for DNA replication, transcription, repair, and recombination.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Only small amounts are absorbed systemically after ophthalmic instillation

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

  • (AR) Argentina: Quinomed L | Tisural;
  • (AT) Austria: Oftaquix;
  • (BD) Bangladesh: Evo | Genolev | Genolev ts | Leflox | Leo | Lequin | Levoflox | Levogen | Levomax | Levoquin | Levoquin ts | Levosina | Levosina ts | Levox | Lifcin | Lovicin | Ovel | Resquin | Resquin ts | Revacin;
  • (BG) Bulgaria: Levofloxan | Oftaquix;
  • (CN) China: Cravit | Hai lun | Jie qi | Ke le bi tuo | Lian bang zuo fu kang | Shi bang | Zuo fu kang;
  • (CO) Colombia: Landax | Levomax;
  • (CZ) Czech Republic: Oftaquix;
  • (DE) Germany: Oftaquix;
  • (EE) Estonia: Levofloxacin unimed | Oftaquix;
  • (EG) Egypt: Lee-flox | Levoxin;
  • (ET) Ethiopia: Levofloxan | Levosta | Lexavon;
  • (FI) Finland: Oftaquix;
  • (GB) United Kingdom: Eyflox | Levoximed | Oftaquix | Oxalux;
  • (GR) Greece: Lexacin | Lexavon;
  • (HK) Hong Kong: Cravit | Levocin | Levocle | Levotin;
  • (HU) Hungary: Levofloxacin unimed pharma | Oftaquix;
  • (ID) Indonesia: Cravit | Lfx | Optiflox;
  • (IN) India: Esenflox plus | Glevo | L Cin | Leeflox | Levess forte | Levobact | Levotak | Levotop | Lv Flox | Oftaquix | Otolev;
  • (IQ) Iraq: Levoneer;
  • (IT) Italy: Doclevo | Floxana | Floxistill | Floxsine | Kinofta | Levodrop | Oftaquix | Petas | Socin | Visuflox;
  • (JP) Japan: Cravit | Levofloxacin ffp | Levofloxacin kaken | Levofloxacin Kissei | Levofloxacin nitten | Levofloxacin pfizer | Levofloxacin Teika | Levofloxacin Towa | Levofloxacin Wakamoto;
  • (KE) Kenya: Levobact | Levotop | Levotop pf | Quixin;
  • (KR) Korea, Republic of: Bisnang | Cavastar | Crafroxin | Cravit | Croxacin | Culevox | Daewoong levofloxacin | Elevo | Eyelevo | Eyelevocin | Grabella | Huloxacin | Huons levofloxacin hydrate | Huresin | Hwail levofloxacin | J Flo | J levo | Jaylevo | Lecrox | Lectacin | Lenacin | Lenobri | Letroxin | Levoa | Levoain | Levocacin | Levocle | Levocra | Levofexin | Levoflan | Levoflesh f | Levoflo | Levoflox | Levofresh | Levohi | Levokacin | Levoking | Levosta | Levotin | Levotra | Levotwo | Levox | Levoxacin | Lexacin | Lflox | Lite levo | Luce L | Oculevo | Procin | Provit | Q levox | Revopran | Rilevo;
  • (LB) Lebanon: Levo fresh | Levoxin;
  • (LT) Lithuania: Levofloxacin actavis | Levofloxacin unimed | Oftaquix;
  • (LV) Latvia: Oftaquix;
  • (MY) Malaysia: Cravit;
  • (PH) Philippines: Ilevox | Leeflox | Levosta | Oftaquix;
  • (PK) Pakistan: Leon | Lequix | Opticin | Otovoxin | Qumic | S flox | Xeflox;
  • (PL) Poland: Levofloxacin genoptim | Levoftyal | Levomer | Oftaquix | Oftaquix sine;
  • (PR) Puerto Rico: Quixin;
  • (PT) Portugal: Levofloxacina Optacare | Levofloxacina Rafarm | Levoftal | Oftaquix;
  • (RO) Romania: L optic | Oftaquix;
  • (RU) Russian Federation: Korfecin solopharm | L optic | L-optic rompharm | Levofloxacin | Levofloxacin solopharm | Levofloxacin-optic | Oftaquix | Signicef;
  • (SE) Sweden: Levofloxacin actavis | Oftaquix;
  • (SG) Singapore: Cravit;
  • (SI) Slovenia: Levofloksacin unimed pharma;
  • (SK) Slovakia: Oftaquix;
  • (TH) Thailand: Cravit;
  • (TR) Turkey: Levolon | Levoximed;
  • (UA) Ukraine: Levonext | Oftaquix | Signicef;
  • (UG) Uganda: Levotop;
  • (VE) Venezuela, Bolivarian Republic of: Levosina ts;
  • (ZM) Zambia: Leeflox
  1. Cahill JB Jr, Bailey EM, Chien S, Johnson GM. Levofloxacin secretion in breast milk: a case report. Pharmacotherapy. 2005;25(1):116-118. [PubMed 15767227]
  2. Kanda Y, Kayama T, Okamoto S, et al. Post-marketing surveillance of levofloxacin 0.5% ophthalmic solution for external ocular infections. Drugs R D. 2012;12(4):177-185. doi:10.2165/11636020-000000000-00000 [PubMed 23075336]
  3. Levofloxacin 1.5% ophthalmic solution [prescribing information]. Largo, FL: BPI Labs LLC; February 2022.
  4. Levofloxacin ophthalmic solution [prescribing information]. Lake Forest, IL: Akorn Inc; February 2017.
  5. Ozyüncü O, Beksac MS, Nemutlu E, Katlan D, Kir S. Maternal blood and amniotic fluid levels of moxifloxacin, levofloxacin and cefixime. J Obstet Gynaecol Res. 2010;36(3):484-487. [PubMed 20598025]
  6. Ozyüncü O, Nemutlu E, Katlan D, Kir S, Beksac MS. Maternal and fetal blood levels of moxifloxacin, levofloxacin, cefepime and cefoperazone. Int J Antimicrob Agents. 2010;36(2):175-178. [PubMed 20418070]
  7. Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-623. [PubMed 2903673]
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