ALPHAGAN P OPHTHALMIC SOLUTION 0.15% wv

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

BRIMONIDINE TARTRATE

Հասանելի է:

ABBVIE PTE. LTD.

ATC կոդը:

S01EA05

Դոզան:

0.15% w/v

Դեղագործական ձեւ:

SOLUTION

Կազմը:

BRIMONIDINE TARTRATE 0.15% w/v

Կառավարման երթուղին:

OPHTHALMIC

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

ALLERGAN SALES LLC

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

2003-06-26

Ապրանքի հատկությունները

* ARTWORK IS ACTUAL SIZE
* DROP NOTES AND TEMPLATE BEFORE PROCESSING
* IF REQUIRED, BARCODE AND CONTROL BAR(S) WILL BE ADDED BY SUPPLIER
* PERFORATION REQUIRED: NO
PART NUMBER:
71816SN12
DRAWING NUMBER:
0196601
V-CODE 128C BARCODE:
4465
PAGE:
1 OF 2
DESCRIPTION
ALPHAGAN®
P
(brimonidine
tartrate
ophthalmic
solution)
0.15%
is
a
relatively
selective
alpha-2
adrenergic
agonist
for
ophthalmic
use. The
chemical
name
of
brimonidine
tartrate
is
5-bromo-
6-
(2-imidazolidinylideneamino) quinoxaline L-tartrate. It is an
off-white to pale yellow powder. It has a
molecular weight of 442.24 as the tartrate salt, and is both soluble
in water (1.5 mg/mL) and in the product
vehicle (3.0 mg/mL) at pH 7.2.
The structural formula is:
Formula: C
11
H
10
BrN
5
•C
4
H
6
O
6
CAS Number: 59803-98-4
In solution, ALPHAGAN® P (brimonidine tartrate ophthalmic solution)
0.15% has a clear, greenish-yellow
color. It has an osmolality of 250-350 mOsmol/kg and a pH of 6.6-7.4.
Each mL of ALPHAGAN® P contains:
ACTIVE INGREDIENT: brimonidine tartrate 0.15% (1.5 mg/mL)
PRESERVATIVE: PURITE® 0.005% (0.05mg/mL)
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
ALPHAGAN® P is an alpha adrenergic receptor agonist. It has a peak
ocular hypotensive effect occurring at
two hours post-dosing. Fluorophotometric studies in animals and humans
suggest that brimonidine tartrate
has a dual mechanism of action by reducing aqueous humor production
and increasing uveoscleral outflow.
PHARMACOKINETICS:
After ocular administration of either a 0.1% or 0.2% solution, plasma
concentrations peaked within 0.5 to
2.5 hours and declined with a systemic half-life of approximately 2
hours. In humans, systemic metabolism
of brimonidine is extensive. It is metabolized primarily by the liver.
Urinary excretion is the major route of
elimination of the drug and its metabolites. Approximately 87% of an
orally-administered radioactive dose
was eliminated within 120 hours, with 74% found in the urine.
CLINICAL EVALUATIONS:
Elevated IOP presents a major risk factor in glaucomatous fiel