Source: FDA, National Drug Code (US) Revision Year: 2019
NATACYN (natamycin ophthalmic suspension) 5% is contraindicated in individuals with a history of hypersensitivity to any of its components.
The following events have been identified during post-marketing use of NATACYN (natamycin ophthalmic suspension) 5% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to their seriousness, frequency of reporting, possible causal connection to NATACYN (natamycin ophthalmic suspension) 5%, or a combination of these factors include: allergic reaction, change in vision, chest pain, corneal opacity, dyspnea, eye discomfort, eye edema, eye hyperemia, eye irritation, eye pain, foreign body sensation, parethesia, and tearing.
FOR TOPICAL OPHTHALMIC USE ONLY — NOT FOR INJECTION. 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 natamycin.
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. Use only if the container is undamaged.
Do not touch dropper tip to any surface, as this may contaminate the suspension. Patients should be advised not to wear contact lenses if they have signs and symptoms of fungal blepharitis, conjunctivitis, and keratitis.
Animal reproduction studies have not been conducted with natamycin. It is also not known whether natamycin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. NATACYN (natamycin ophthalmic suspension) 5% should be given to a pregnant woman only if clearly needed.
It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when natamycin is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
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