NATACYN 5% STERILE OPHTHALMIC SUSPENSION

Quốc gia: Singapore

Ngôn ngữ: Tiếng Anh

Nguồn: HSA (Health Sciences Authority)

Thành phần hoạt chất:

NATAMYCIN

Sẵn có từ:

LINK HEALTHCARE SINGAPORE PTE LTD

Mã ATC:

S01AA10

Liều dùng:

5.00%

Dạng dược phẩm:

SOLUTION

Thành phần:

NATAMYCIN 5%

Tuyến hành chính:

OPHTHALMIC

Loại thuốc theo toa:

Prescription Only

Sản xuất bởi:

ALCON RESEARCH LLC

Tình trạng ủy quyền:

ACTIVE

Ngày ủy quyền:

1991-12-09

Tờ rơi thông tin

DESCRIPTION: NATACYN® (natamycin 
ophthalmic suspension) 5% is a sterile, 
antifungal drug for topical ophthalmic 
administration. Each mL of the suspension 
contains: ACTIVE: natamycin 5% (50mg). 
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
33
H
47
NO
13
Molecular Weight: 665.73
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.
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 humor or sera, but the sensitivity 
of the mea

Đặc tính sản phẩm

(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
33
H
47
NO
13
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.
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
humor or sera, but the sensitivity of the
measurement was no greater than 2 mg/mL.