Ofloxacin eent

Name: Ofloxacin eent

Stability

Storage

Ophthalmic

Solution

15–25°C.1

Otic

Solution

25°C (may be exposed to 15–30°C).a

Actions and Spectrum

  • Usually bactericidal.1 3 8 14 26 27 29 32 33 34 35 36 44 64 65 66 71 84 85

  • Like other fluoroquinolones, ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV.1 3 4 5 8 9 27 30 33 44 64 65 85

  • Spectrum of activity includes gram-positive aerobic bacteria and some gram-negative aerobic bacteria.1 Inactive against fungi8 44 and viruses.8

  • Active in vitro against most gram-negative aerobic bacteria, including Enterobacteriaceae and Ps. aeruginosa.1 3 8 21 22 25 26 27 44 64 65 66 67 68 72 84 85 Active in vitro against many gram-positive aerobic bacteria, including penicillinase-producing, nonpenicillinase-producing, and some oxacillin-resistant staphylococci (previously known as methicillin-resistant staphylococci).1 3 8 21 22 25 26 27 44 64 65 66 67 68 72 84 85 Less active against gram-positive than -negative bacteria.3 8 25 26

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ofloxacin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.3%*

Ocuflox (with benzalkonium chloride)

Allergan

Ofloxacin Ophthalmic Solution

Bausch & Lomb

Otic

Solution

0.3%

Floxin Otic (with benzalkonium chloride)

Daiichi

For Healthcare Professionals

Applies to ofloxacin ophthalmic: ophthalmic solution

Ocular

Burning/stinging, tearing, and eye pain were reported in up to 14%, up to 11%, and up to 5% of treated eyes, respectively.

Burning/stinging, tearing, photophobia, and foreign body sensation were reported more often in patients treated for corneal ulcer.[Ref]

Common (1% to 10%): Eye irritation, ocular discomfort
Frequency not reported: Transient ocular burning/discomfort, keratitis, conjunctivitis, eye edema, periorbital edema, foreign body sensation in eyes, dry eyes, ocular hyperemia, eye pruritus, eyelid pruritus, burning/stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, eye pain, photophobia, tearing, blurred vision, dryness
Postmarketing reports: Hypersensitivity, increased lacrimation[Ref]

Hypersensitivity

Very rare (less than 0.01%)/Postmarketing reports: Hypersensitivity (including angioedema, dyspnea, anaphylactic reaction/shock, oropharyngeal swelling, swollen tongue)

Systemic ofloxacin:
-Frequency not reported: Hypersensitivity (anaphylactic/anaphylactoid) reactions

Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions (some after first dose) have been reported with systemic ofloxacin.

Cardiovascular

Ventricular arrhythmia and torsades de pointes were reported mainly in patients with risk factors for QT prolongation.

Frequency not reported: Ventricular arrhythmia, torsades de pointes, prolonged ECG QT

Nervous system

Frequency not reported: Dizziness[Ref]

Gastrointestinal

Frequency not reported: Nausea[Ref]

Other

Frequency not reported: Facial edema

Some side effects of ofloxacin ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Pediatric Dose for Bacterial Conjunctivitis

1 year or older:
-Days 1 and 2: Instill 1 to 2 drops in the affected eye(s) every 2 to 4 hours.
-Days 3 through 7: Instill 1 to 2 drops in the affected eye(s) 4 times a day.

Use: For the treatment of bacterial conjunctivitis due to susceptible strains of S aureus, S epidermidis, S pneumoniae, E cloacae, H influenzae, P mirabilis, P aeruginosa

Precautions

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.

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