Natacyn

Ophthalmological Anti-infectives

Natamycin is for topical administration to the eyes only; do NOT inject parenterally.
Instruct patient on proper instillation of eye suspension (see Patient Information).
Instruct patient not to wear contact lenses if signs or symptoms of an ocular infection are present.
To prevent contamination, do not touch the tip of the dropper to the eye, fingertips, or other surface.
Shake well before using.
Wash hands before and after use.
Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch. Close eyes to spread drops.
To avoid contamination or the spread of infection, do not use dropper for more than one person.

corneal opacification / Delayed / Incidence not known

dyspnea / Early / 0-1.0
chest pain (unspecified) / Early / 0-1.0
superinfection / Delayed / 0-1.0
ocular infection / Delayed / 0-1.0
blurred vision / Early / 10.0
hyperemia / Delayed / Incidence not known

ocular irritation / Rapid / 1.0-10.0
lacrimation / Early / 1.0-10.0
foreign body sensation / Rapid / 1.0-10.0
paresthesias / Delayed / 0-1.0
ocular pain / Early / Incidence not known

Natacyn

Rx

Ophthalmic antifungal agent.
Used to treat fungal blepharitis, conjunctivitis, and keratitis.
Fungicidal against Candida, Aspergillus, Fusarium, Acremonium, and Penicillium species.

Initially instill 1 drop topically into the conjunctival sac every 1—2 hours. Application frequency may be reduced to 1 drop topically every 3—4 hours after the first 3—4 days of treatment; however in some cases, application frequency should be gradually reduced at 4—7 day intervals to ensure treatment success. Duration of therapy is 14—21 days or until resolution of active fungal keratitis. Reevaluate patient if improvement is not evident after 7—10 days of treatment.

Instill 1 drop topically into conjunctival sac every 4—6 hours. Duration of therapy should be based on clinical reevaluation and additional laboratory results.

No dosage adjustments are needed.

No dosage adjustments are needed.

There are no drug interactions associated with Natamycin products.

Natacyn/Natamycin Ophthalmic Susp: 5%

24 drops/day per affected eye.

24 drops/day per affected eye.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Natamycin binds to ergosterol, a sterol essential for the stability of fungal cell membranes. As a result of this binding, cell membrane integrity is impaired, causing loss of intracellular potassium and other cellular contents. Natamycin possess dose-related fungicidal activity against a variety of yeast and filamentous fungi. The in vitro antifungal activity of natamycin includes Candida, Aspergillus, Fusarium, Acremonium (previously known as Cephalosporium), and Penicillium species.

Natamycin is administered topically to the eyes. Systemic absorption is not expected following topical administration of natamycin.

Natamycin is not indicated for oral administration; however if accidentally ingested, absorption of natamycin from the gastrointestinal tract is limited.

Ophthalmic Route
Following topical administration to the eyes, natamycin produces therapeutic concentrations within the corneal stoma; however, absorption into the intraocular fluid is limited. In animal studies involving rabbits, natamycin concentrations in the aqueous humor and sera were not measurable (sensitivity of no greater than 2 mg/ml). Furthermore, topically administered natamycin is not expected to be absorbed systemically.

No data are available to determine whether the use of natamycin during pregnancy can cause fetal harm or affect reproduction capacity; however, systemic absorption is not expected following topical ophthalmic administration. Administer natamycin during pregnancy only if clearly needed.

According to the manufacturer, it is not known if natamycin is excreted in human milk; however, systemic absorption is not expected following topical ophthalmic administration. Caution is advised when administering natamycin to a nursing woman. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to maternally administered natamycin, health care providers are encouraged to report the adverse effect to the FDA.