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HSA Approval

NATACYN 5% STERILE OPHTHALMIC SUSPENSION

SIN06719P

NATACYN 5% STERILE OPHTHALMIC SUSPENSION

NATACYN 5% STERILE OPHTHALMIC SUSPENSION

December 9, 1991

LINK HEALTHCARE SINGAPORE PTE LTD

LINK HEALTHCARE SINGAPORE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantLINK HEALTHCARE SINGAPORE PTE LTD
Licence HolderLINK HEALTHCARE SINGAPORE PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

SOLUTION

**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. The frequency of application can usually be reduced to one drop 6 to 8 times daily after the first 3 to 4 days. Therapy should generally be continued for 14 to 21 days or until there is resolution of active fungal keratitis. In many cases, it may be helpful to reduce the dosage gradually at 4 to 7 day intervals to assure that the replicating organism has been eliminated. Less frequent initial dosage (4 to 6 daily applications) may be sufficient in fungal blepharitis and conjunctivitis.

OPHTHALMIC

Medical Information

**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. As in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response. Whenever possible the _in vitro_ activity of natamycin against the responsible fungus should be determined. The effectiveness of natamycin as a single agent in fungal endophthalmitis has not been established.

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

S01AA10

natamycin

Manufacturer Information

LINK HEALTHCARE SINGAPORE PTE. LTD.

ALCON RESEARCH LLC

Active Ingredients

NATAMYCIN

5%

Natamycin

Documents

Package Inserts

1.4.3-package-insert-proposed.pdf

Approved: March 5, 2021

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