Natacyn Indications, Dosage, Storage, Stability - Natamycin

Natacyn Indications, Dosage, Storage, Stability - Natamycin

INDICATIONS

NATACYN (natamycin ophthalmic suspension, USP) 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.

SHAKE WELL BEFORE USING. 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 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.

15 mL in glass bottles with sterile dropper assembly. NDC 0065-0645-15.

Storage :   May be stored in refrigerator [(36°-46° F) (2°-8°C)] or at room temperature [(46°-75° F) (8°-24°C)]. Do not freeze. Avoid exposure to light and excessive heat.

Rx Only

*Laupen, J.O.; McLellan, W.L.; El Nakeeb, M.A.: "Antibiotics and Fungal Physiology," Antimicrobial Agents and Chemotherapy, 1965:1006, 1965.

References :

1. Barckhausen, B.: Die Behandlung der Probleminfektionen das vorderen Augenabschnittes in der Praxis. Landarzt 46:842, 1970.

2. Cuendet, J.F.; Nouri, A.: Traitement local en ophthalmologie par un nouvel antibiotique fungicide, la "pimaricine". Ophthalmologica 145:297, 1963.

3. Forster, R.K.; Rebell, G.: "The Diagnosis and Management of Keratomycoses", Arch. Ophth. 93:1134, 1975.

4. Francois, J.; de Vos, El: Traitement des mycoses oculaires par la pimaricine. Bull. Soc. Belge Ophthal. 131:382, 1962.

5. Jones, D.B.; Sexton, R.; Rebell, G.: "Mycotic keratitis in South Florida: A Review of Thirty-nine Cases." Transactions ophthal. Soc. U.K. 89:781, 1969.

6. Jones, D.B.; Forster, R.K.; Rebell, G.: "Fusarium solani keratitis treated with Natamycin (pimaricin), 18 consecutive cases." Arch. Ophth. 88:147, 1972.

7. L'Editeur: Traitement des mycoses oculaires. Presse med. 77:147, 1969.

8. Vozza, R.; Bagolini, B.: Su di un caso di grave ulcerazione bilaterale delle palpebra de Candida albicans. Bol. Oculist. 43:433, 1964.

Manufactured Under License From Gist-Brocades, N.V., Delft, Holland