NATACYN Ophthalmic suspension, drops Ref.[10144] Active ingredients: Natamycin

Source: FDA, National Drug Code (US)  Revision Year: 2019 

2. Clinical Pharmacology

Natamycin is a tetraene polyene antibiotic derived from Streptomyces natalensis. It possesses in vitro activity against a variety of yeast and filamentous fungi, including Candida, 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.

Topical administration appears to produce effective concentrations of natamycin within the corneal stroma but not in intraocular fluid. Systemic absorption should not be expected following topical administration of NATACYN (natamycin ophthalmic suspension) 5%. As with other polyene antibiotics, absorption from the gastrointestinal tract is very poor. Studies in rabbits receiving topical natamycin revealed no measurable compound in the aqueous humor or sera, but the sensitivity of the measurement was no greater than 2 mg/mL.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no long term studies done using natamycin in animals to evaluate carcinogenesis, mutagenesis, or impairment of fertility.

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