ZONAT Natamycin 5 % Eye Drops

Composition     

Natamycin USP 5% w/v

Benzalkonium Chloride Solution NF 0.0001 ml

(as preservative)             

Sterile Aqueous Buffered Vehicle              q.s.

Dosage form

Ophthalmic Suspension (Eye Drops)

Category

Antifungal

Description

Natamycin is a tetraene polyene antibiotic derived from Streptomyces natalensis. It possesses in vitro activity against a variety of yeast and filamentous fungi, includingCandida, Aspergillus, Cephalosporium, Fusarium and Penicillium. The mechanism of action appears to be through binding of the molecule to the sterol moiety of the fungal cell membrane. The polyenesterol complex alters the permeability of the membrane to produce depletion of essential cellular constituents. Although the activity against fungi is dose-related, natamycin is predominantly fungicidal. Natamycin is not effective in vitro against gram-positive or gram-negative bacteria.

Indications

Natamycin ophthalmic suspension 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solani keratitis. As in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response.

Dosage

The preferred initial dosage in fungal keratitis is one drop of natamycin ophthalmic suspension, 5% instilled in the conjunctival sac at hourly or two-hourly intervals. The frequency of application can usually be reduced to one drop 6 to 8 times daily after the first 3 to 4 days. Therapy should generally be continued for 14 to 21 days or until there is resolution of active fungal keratitis. In many cases, it may be helpful to reduce the dosage gradually at 4 to 7-day intervals to assure that the replicating organism has been eliminated. Less frequent initial dosage (4 to 6 daily applications) may be sufficient in fungal blepharitis and conjunctivitis.

Contraindications

Natamycin ophthalmic suspension, 5% is contraindicated in individuals with a history of hypersensitivity to any of its components.

Warnings & Precautions

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives and other non-steroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

Adverse Effects

Conjunctival chemosis and hyperemia has been reported.

Storage

Store in a cool dry place. Protect from light.

Presentation

ZONAT Eye Drop is available in sterile FFS PACK of 5ml.