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Natacyn Warnings, Precautions, Pregnancy, Nursing, Abuse - Natamycin
WARNINGS
No Information Provided.
General. For topical eye 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. There have only been a limited number of cases in which natamycin has been used; therefore, it is possible that adverse reactions of which we have no knowledge at present may occur. For this reason, patients on this drug should be monitored at least twice weekly. Should suspicion of drug toxicity occur, the drug should be discontinued.
Information for Patients : Do not touch dropper tip to any surface, as this may contaminate the suspension.
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.
Pregnancy: 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 a pregnant woman or can affect reproduction capacity. NATACYN (natamycin ophthalmic suspension, USP) 5% should be given to a pregnant woman only if clearly needed.
Nursing Mothers: 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.
Pediatric Use: Safety and effectiveness in pediatric patients have not been establised.
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