OLOPATADINE HYDROCHLORIDE- olopatadine hydrochloride 0.1% solution/ drops

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)

から入手可能:

Preferred Pharmaceuticals Inc.

投与経路:

OPHTHALMIC

処方タイプ:

PRESCRIPTION DRUG

適応症:

Olopatadine hydrochloride ophthalmic solution 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. Olopatadine hydrochloride ophthalmic solution 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution 0.1%.

製品概要:

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is supplied as follows: 5mL in a 5mL white, round low-density polyethylene (LDPE) bottle, with a natural LDPE dropper tip, and white colored high-density polyethelene (HDPE) eyedropper cap. A white tamper evident overcap is provided.   5 mL: NDC 68788-6317-5 Storage: Store at 20-25°C (68°F-77°F) [See USP Controlled Room Temperature]. Rx Only

認証ステータス:

Abbreviated New Drug Application

製品の特徴

OLOPATADINE HYDROCHLORIDE- OLOPATADINE HYDROCHLORIDE 0.1% SOLUTION/
DROPS
PREFERRED PHARMACEUTICALS INC.
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DESCRIPTION
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is a sterile
ophthalmic solution containing
olopatadine, a relatively selective H – receptor antagonist and
inhibitor of histamine release from the
mast cell for topical administration to the eyes. Olopatadine
hydrochloride is a white, crystalline, water-
soluble powder with a molecular weight of 373.88. The chemical
structure is presented below:
CHEMICAL NAME: 11-[(Z)-3 (Dimethylamino)propylidene]-6-11-
dihydrodibenz[b,e] oxepin-2-acetic
acid hydrochloride
Each mL of olopatadine hydrochloride ophthalmic solution contains:
ACTIVE: 1.11 mg olopatadine
hydrochloride equivalent to 1 mg olopatadine. PRESERVATIVE:
benzalkonium chloride 0.01%. INACTIVES:
dibasic sodium phosphate; sodium chloride; hydrochloric acid/sodium
hydroxide (adjust pH); and
purified water. It has a pH of approximately 7 and an osmolality of
approximately 300 mOsm/kg.
CLINICAL PHARMACOLOGY
Olopatadine is an inhibitor of the release of histamine from the mast
cell and a relatively selective
histamine H – antagonist that inhibits the _in vivo_ and _in vitro_
type 1 immediate hypersensitivity reaction
including inhibition of histamine induced effects on human
conjunctival epithelial cells. Olopatadine is
devoid of effects on alpha-adrenergic, dopamine and muscarinic type 1
and 2 receptors. Following
topical ocular administration in man, olopatadine was shown to have
low systemic exposure. Two
studies in normal volunteers (totaling 24 subjects) dosed bilaterally
with olopatadine 0.15% ophthalmic
solution once every 12 hours for 2 weeks demonstrated plasma
concentrations to be generally below the
quantitation limit of the assay (<0.5 ng/mL). Samples in which
olopatadine was quantifiable were
typically found within 2 hours of dosing and ranged from 0.5 to 1.3
ng/mL. The half-life in plasma was
approximately 3 hours, and elimination was predominantly through renal
excr