NATACYN Ophthalmic suspension, drops (2019)

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Alcon Laboratories, Inc.

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1. Description

NATACYN (natamycin ophthalmic suspension) 5% is a sterile, antifungal drug for topical ophthalmic administration. Each mL of NATACYN (natamycin ophthalmic suspension) contains: Active: natamycin ...

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, ...

3. Indications and Usage

NATACYN (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solani keratitis. ...

4. Contraindications

NATACYN (natamycin ophthalmic suspension) 5% is contraindicated in individuals with a history of hypersensitivity to any of its components.

6.1. General

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 ...

6.2. Information for Patients

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, ...

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.

6.7. Pregnancy

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. ...

6.9. 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.

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

6.11. Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

7. Adverse Reactions

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 ...

10. Dosage and Administration

SHAKE WELL BEFORE USING. The preferred initial dosage in fungal keratitis is one drop of NATACYN (natamycin ophthalmic suspension) 5% instilled in the conjunctival sac at hourly or two-hourly intervals. ...

11. How Supplied

NATACYN (natamycin ophthalmic suspension) 5% is a 15 mL fill packaged in a 15 mL amber glass bottle with a black closure. A flint glass dropper with a red plastic closure and a black rubber bulb are packaged ...

12. Storage and Handling

Store between 2°C to 24°C (36°F-75°F). Do not freeze. Avoid exposure to light and excessive heat.