CILOXAN Ophthalmic solution (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Alcon Laboratories, Inc.

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1. Description

CILOXAN (ciprofloxacin ophthalmic solution) is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum ...

2. Clinical Pharmacology

Systemic Absorption A systemic absorption study was performed in which CILOXAN (ciprofloxacin ophthalmic solution) 0.3% was administered in each eye every two hours while awake for two days followed by ...

3. Indications and Usage

CILOXAN Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas ...

4. Contraindications

A history of hypersensitivity to ciprofloxacin or any other component of the medication is a contraindication to its use. A history of hypersensitivity to other quinolones may also contraindicate the use ...

5. Warnings

NOT FOR INJECTION INTO THE EYE. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. ...

6.1. General

As with other antibacterial preparations, prolonged use of ciprofloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. ...

6.2. Information for Patients

Do not touch dropper tip to any surface, as this may contaminate the solution.

6.4. Drug Interactions

Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Eight in vitro mutagenicity tests have been conducted with ciprofloxacin and the test results are listed below: Salmonella/Microsome Test (Negative) E. coli DNA Repair Assay ...

6.7. Pregnancy

Reproduction studies have been performed in rats and mice at doses up to six times the usual daily human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to ciprofloxacin. ...

6.9. Nursing Mothers

It is not known whether topically applied ciprofloxacin is excreted in human milk; however, it is known that orally administered ciprofloxacin is excreted in the milk of lactating rats and oral ciprofloxacin ...

6.10. Pediatric Use

The safety and effectiveness of CILOXAN (ciprofloxacin ophthalmic solution) 0.3% have been established in all ages. Use of CILOXAN is supported by evidence from adequate and well controlled studies of ...

6.11. Geriatric Use

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

7. Adverse Reactions

The most frequently reported drug related adverse reaction was local burning or discomfort. In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen in ...

9. Overdosage

A topical overdose of CILOXAN (ciprofloxacin ophthalmic solution) 0.3% may be flushed from the eye(s) with warm tap water.

10. Dosage and Administration

Corneal Ulcers The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every ...

11. How Supplied

As a sterile ophthalmic solution in Alcons DROP-TAINER dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided ...

12. Animal Pharmacology and/or Animal Toxicology

Ciprofloxacin and related drugs have been shown to cause arthropathy in immature animals of most species tested following oral administration. However, a one-month topical ocular study using immature Beagle ...

13. Clinical Studies

Following therapy with CILOXAN (ciprofloxacin ophthalmic solution) 0.3%, 76% of the patients with corneal ulcers and positive bacterial cultures were clinically cured and complete re-epithelialization ...

12. Storage and Handling

Store at 2°C to 25°C (36°F-77°F). Protect from light.