NATACYN- natamycin suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NATAMYCIN (UNII: 8O0C852CPO) (NATAMYCIN - UNII:8O0C852CPO)

Available from:

Eyevance Pharmaceuticals, LLC

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. NATACYN ® (natamycin ophthalmic suspension) 5% is contraindicated in individuals with a history of hypersensitivity to any of its components. Safety and effectiveness in pediatric patients have not been established. No overall differences in safety or effectiveness have been observed be

Product summary:

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 separately in a clear plastic blister with Tyvek backing. 15 mL NDC 71776-005-15 STORAGE: Store between 2°C to 24°C (36°F-75°F). Do not freeze . Avoid exposure to light and excessive heat. Rx Only Distributed by: Eyevance Pharmceuticals, LLC Fort Worth, Texas 76134 Revised: 05/2020

Authorization status:

New Drug Application

Summary of Product characteristics

NATACYN- NATAMYCIN SUSPENSION/ DROPS
EYEVANCE PHARMACEUTICALS, LLC
----------
NATACYN (NATAMYCIN OPHTHALMIC SUSPENSION) 5%
STERILE
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 5% (50 mg). PRESERVATIVE:
benzalkonium
chloride 0.02%. INACTIVE: sodium hydroxide and/or hydrochloric acid
(neutralized to
adjust the pH), purified water.
The active ingredient is represented by the chemical structure:
ESTABLISHED NAME:
Natamycin
MOLECULAR FORMULA: C
H
NO
MOLECULAR WEIGHT: 665.73 g/mol
CHEMICAL NAME: Stereoisomer of 22-[(3-amino-3,6-dideoxy- β-D-
mannopyranosyl)oxy]-1,3,26- trihydroxy-12- methyl-10-oxo-6,11,28-
trioxatricyclo[22.3.1.05,7] octacosa-8,14,16,18,20-pentaene-25-
carboxylic acid.
®
®
®
33
47
13
OTHER: Pimaricin
The pH range is 5.0-7.5.
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, Aspergillus, Cephalosporium, Fusarium _and _Penicillium_.
The mechanism of
action appears to be through binding of the molecule to the sterol
moiety of the fungal
cell membrane. The polyenesterol complex alters the permeability of
the membrane to
produce depletion of essential cellular constituents. Although the
activity against fungi is
dose-related, natamycin is predominantly fungicidal. Natamycin is not
effective _in vitro_
against gram-positive or gram-negative bacteria. Topical
administration appears to
produce effective concentrations of natamycin within the corneal
stroma but not in
intraocular fluid. Systemic absorption should not be expected
following topical
administration of NATACYN
(natamycin ophthalmic suspension) 5%. As with other
polyene antibiotics, absorption from the gastrointestinal tract is
very poor. Studies in
rabbits receiving topical natamycin revealed no measurable compound in
the aqueous