NATACYN (NATAMYCIN 5%) OPHTHALMIC SUSPENSION

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

NATAMYCIN

Available from:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

NATAMYCIN

Units in package:

15ml mL

Manufactured by:

ALCON LABS INC

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
NAT ACYN ® OPTHALMIC SUSPENSION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients: 50 mg of natamyci n in one mL of suspension (5%).
Preservative: benzalkonium chloride
For the full list of excipients, see section 6.1.
3. PHARM ACEUTICAL FORM
Eye drops, suspension
White to yellow
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
NATACYN
® 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. W henever possible the in vitro
activity of natamycin against the responsible fungus should be determined.
4.2 Posology and Method of Administration
Posology
The preferred initial dosage in fungal keratitis is one drop of NATACYN
® (natamycin ophthalmic suspension,
USP) 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 days 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.
Method of administration
• For ocular use.
• Shake well before using.
• To prevent contamination of the dropper tip and suspension, care must be taken not to touch the
eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. Keep the bottle tightly
closed when not in use.
• If more than one topical ophthalmic medicinal product is being used, the medicines must be
administered at least 5 minutes apart. Eye oi