Natamycin

Natadrop ophthalmic suspension is indicated for the treatment of fungal blepharitis, conjunctivitis and keratitis caused by susceptible organisms including Fusarium solani keratitis.

Natamycin is a tetraene polyene antibiotic derived from Streptomyces natalensis. Natamycin probably exerts its antifungal effects by binding to sterols in the fungal cell membrane to produce a change in membrane permeability that allows loss of essential cellular constituents. It possesses in vitro activity against a variety of yeast and filamentous fungi, including Candida, Aspergillus, Cephalosporium, Fusarium and Penicillium. Although the activity against fungi is dose-related, Natamycin is predominantly fungicidal. Topical administration appears to produce effective concentration of Natamycin within the corneal stroma but not in intraocular fluid.

For fungal keratitis : The preferred initial dosage is 1 drop instilled in the conjuntival sac (s) at 1-2 hours interval. The frequency of application can usually be reduced to 1 drop 6-8 times daily after the first 3-4 days. Therapy should generally be continued for 14 to 21 days or until there is resolution of active fungal keratitis. For fungal blepharitis & conjunctivitis : 1 drop 4-6 times daily may be sufficient. Pediatric use : Safety and effectiveness in paediatric patients have not been established.

May increase spread of fungal eye infection when used with topical corticosteroid.

Natamycin ophthalmic suspension is contraindicated in individuals with a history of hypersensitivity to any of its component.

Eye irritation, eye discomfort, eye edema, conjunctival chemosis and hyperemia has been reported.

Pregnancy category C. Animal reproduction studies have not been conducted with Natamycin. It is also not known whether Natamycin can cause fetal harm when administered to the pregnant women or can affect reproduction capacity. Natamycin ophthalmic suspension should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Natamycin is administered to a nursing woman.

Do not touch dropper tip to any surface, as this may contaminate the suspension. Patient should be advised not to wear contact lenses if they have signs and symptoms of fungal blepharitis, conjunctivitis and keratitis. Failure of improvement of keratitis following 7-10 days of administration of the drug suggests that the infection may be caused by a microorganism not susceptible to Natadrop. Continuation of therapy should be based on clinical re-evaluation and additional laboratory studies. Adherence of the suspension to areas of epithelial ulceration or retention of the suspension in the fornices occurs regularly.

Store in a cool and dry place. Protect from light. Do not freeze. Do not use for longer than one month after first opening of the bottle.