CILOXAN Ointment (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Alcon Laboratories, Inc.
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1. Description
CILOXAN (ciprofloxacin ophthalmic ointment) 0.3% is a synthetic, sterile, multiple dose, antimicrobial for topical use. Ciprofloxacin is a fluoroquinolone antibacterial. It is available as the monohydrochloride ...
2. Clinical Pharmacology
Systemic Absorption Absorption studies in humans with the ciprofloxacin ointment have not been conducted, however, based on studies with ciprofloxacin solution, 0.3%, mean maximal concentrations are expected ...
3. Indications and Usage
CILOXAN (ciprofloxacin ophthalmic ointment) 0.3% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the microorganisms listed below: <u>Gram-Positive:</u> <em> ...
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
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients ...
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 tip to any surface as this may contaminate the ointment. <b>Do not use the product if the imprinted carton seals have been damaged, or removed.</b>
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 <em>in vitro</em> mutagenicity tests have been conducted with ciprofloxacin and the test results are listed below: <em>Salmonella</em>/Microsome Test (Negative) <em>E. coli</em> 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
Safety and effectiveness of CILOXAN (ciprofloxacin ophthalmic ointment) 0.3% in pediatric patients below the age of two years have not been established. Although ciprofloxacin and other quinolones may ...
6.11. Geriatric Use
No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.
7. Adverse Reactions
The following adverse reactions (incidences) were reported in 2% of the patients in clinical studies for CILOXAN (ciprofloxacin ophthalmic ointment) 0.3%: discomfort and keratopathy. Other reactions associated ...
10. Dosage and Administration
Apply a ½ inch ribbon into the conjunctival sac three times a day on the first two days, then apply a ½ inch ribbon two times a day for the next five days.
11. How Supplied
3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. 3.5 g NDC 0065-0654-35 Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134
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 ...
12. Storage and Handling
Store at 2°C to 25°C (36°F-77°F).