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Ofloxacin (ophthalmic): Drug information

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

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

Bacterial conjunctivitis: Ophthalmic: Instill 1 to 2 drops in affected eye(s) every 2 to 4 hours for the first 2 days, then instill 1 to 2 drops 4 times daily for an additional 5 days.

Corneal ulcer

Corneal ulcer: Ophthalmic: Instill 1 to 2 drops in affected eye(s) every 30 minutes while awake and every 4 to 6 hours at night for the first 2 days; beginning on day 3, instill 1 to 2 drops every hour while awake for 4 to 6 additional days; thereafter, 1 to 2 drops 4 times daily until clinical cure.

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 "Ofloxacin (ophthalmic): Pediatric drug information")

Bacterial conjunctivitis

Bacterial conjunctivitis: Children and Adolescents: Ophthalmic: Initial: Instill 1 to 2 drops in affected eye(s) every 2 to 4 hours for the first 2 days (Days 1 and 2); then instill 1 to 2 drops 4 times daily for an additional 5 days (Days 3 through 7)

Corneal ulcer

Corneal ulcer: Children and Adolescents: Ophthalmic: Initial: Instill 1 to 2 drops in affected eye(s) every 30 minutes while awake and every 4 to 6 hours at night for the first 2 days (Days 1 and 2); then instill 1 to 2 drops every hour while awake for 4 to 6 additional days (Days 3 through 7 to 9); thereafter, 1 to 2 drops 4 times daily until clinical cure is achieved

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Adverse Reactions

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

Frequency not defined:

Central nervous system: Dizziness, foreign body sensation of eye

Gastrointestinal: Nausea

Ophthalmic: Blurred vision, burning sensation of eyes, conjunctivitis (chemical), eye discomfort, eye pain, eye pruritus, eye redness, keratitis (chemical), lacrimation, photophobia, stinging of eyes, swelling of eye, xerophthalmia

<1%, postmarketing, and/or case reports: Stevens-Johnson syndrome, toxic epidermal necrolysis

Contraindications

Hypersensitivity to ofloxacin, other quinolones, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Rare severe hypersensitivity reactions (some fatal), including anaphylaxis and anaphylactic shock, have occurred with systemic quinolone therapy (some following the first dose). Some reactions were accompanied by airway obstruction, angioedema (laryngeal, pharyngeal, or facial edema), cardiovascular collapse, dyspnea, loss of consciousness, pruritus, and urticaria. Discontinue treatment if an allergic reaction occurs.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection. If superinfection is suspected, institute appropriate alternative therapy.

• Tendon inflammation/rupture: There have been reports of tendon inflammation and/or rupture with systemic quinolone antibiotics. Exposure following ophthalmic administration is substantially lower than with systemic therapy. Discontinue at first sign of tendon inflammation or pain.

Dosage form specific issues:

• Appropriate use: Not for subconjunctival injection or for introduction into the ocular anterior chamber.

Special populations:

• Contact lens wearers: Contact lenses should not be worn during treatment of ophthalmic infections.

Dosage Forms: US

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

Solution, Ophthalmic:

Ocuflox: 0.3% (5 mL) [contains benzalkonium chloride]

Generic: 0.3% (5 mL, 10 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Ocuflox Ophthalmic)

0.3% (per mL): $29.77

Solution (Ofloxacin Ophthalmic)

0.3% (per mL): $1.38 - $14.07

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:

Ocuflox: 0.3% (5 mL) [contains benzalkonium chloride]

Administration: Adult

For ophthalmic use only; not for subconjunctival or direct injection into the anterior chamber of the eye. Avoid touching tip of applicator to eye, fingers, or other surfaces.

Administration: Pediatric

For ophthalmic use only; not for subconjunctival or direct injection into the anterior chamber of the eye. To avoid excessive systemic absorption, apply gentle pressure to lacrimal sac during and immediately following instillation (1 minute) or instruct patient to gently close eyelid after administration (Ref). Avoid touching tip of applicator to eye, fingers, or other surfaces.

Use: Labeled Indications

Bacterial conjunctivitis: Treatment of bacterial conjunctivitis caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Enterobacter cloacae, Haemophilus influenzae, Proteus mirabilis, and Pseudomonas aeruginosa.

Corneal ulcer: Treatment of corneal ulcers caused by S.aureus, S.epidermidis, S.pneumoniae, P.aeruginosa, Serratia marcescens, and Cutibacterium acnes.

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

Ocuflox may be confused with Occlusal-HP, Ocufen

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, ofloxacin crosses the placenta (Giamarellou 1989). The amount of ofloxacin available systemically following topical application of the ophthalmic drops is significantly less in comparison to oral 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, ofloxacin enters breast milk. It is not known if ofloxacin is excreted into breast milk following ophthalmic application. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother.

Mechanism of Action

Ofloxacin is a DNA gyrase inhibitor. DNA gyrase 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; bactericidal

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Only small amounts are absorbed systemically after ophthalmic instillation.

Excretion: Urine

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

  • (AT) Austria: Ofloxa vision sine | Ofloxacin Stulln;
  • (BE) Belgium: Trafloxal;
  • (DE) Germany: Floxal | Ofloxa vision | Ofloxa vision sine | Ofloxacin Ratiopharm | Ofloxacin Stulln;
  • (ES) Spain: Oculaflox;
  • (FR) France: Monoox | Oflocet | Ofloxacine biogaran | Quinofree;
  • (GR) Greece: Oxatrex;
  • (ID) Indonesia: Floxa;
  • (IT) Italy: Eukinoft | Floxigen | Monofloxofta;
  • (KR) Korea, Republic of: Octacin | Opirocin Free;
  • (LB) Lebanon: Floxigen;
  • (MA) Morocco: Oflocet;
  • (NL) Netherlands: Otiflox | Trafloxal e.d.o;
  • (PT) Portugal: Floxedol | Ottoflox;
  • (QA) Qatar: Ofloren | Optiflox;
  • (TN) Tunisia: Oflocol | Oflomed;
  • (UA) Ukraine: Ofloxacin stuln ud
  1. Giamarellou H, Kolokythas E, Petrikkos G, et al. "Pharmacokinetics of Three Newer Quinolones in Pregnant and Lactating Women," Ciprofloxacin: major advances in intravenous and oral quinolone therapy. Proceedings of a symposium. April 28 to 29, 1989, Naples, Florida. Am J Med. 1989; 87(5A):49S-51S. [PubMed 2589353]
  2. Ocuflox (ofloxacin) [prescribing information]. Irvine, CA: Allergan Inc; April 2017.
  3. Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-623. [PubMed 2903673]
  4. Urtti A, Salminen L. Minimizing systemic absorption of topically administered ophthalmic drugs. Surv Ophthalmol. 1993;37(6):435-456. [PubMed 8100087]
  5. Zimmerman TJ, Kooner KS, Kandarakis AS, Ziegler LP. Improving the therapeutic index of topically applied ocular drugs. Arch Ophthalmol. 1984;102(4):551-553. [PubMed 6704011]
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