OLOPATADINE HYDROCHLORIDE solution/ drops

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Asclemed USA, Inc.

طريقة التعاطي:

OPHTHALMIC

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Olopatadine hydrochloride ophthalmic solution USP, 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%. Olopatadine hydrochloride ophthalmic solution, 0.1% is for topical use only and not for injection or oral use.

ملخص المنتج:

Olopatadine hydrochloride ophthalmic solution USP, 0.1% is supplied as follows: 5 mL in LDPE Bottle. 5 mL:  NDC 76420-089-05 (relabeled from NDC 70069-007-01) Storage: Store at 39°F-77°F (4°C-25°C). Rx Only Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

OLOPATADINE HYDROCHLORIDE- OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS
ASCLEMED USA, INC.
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OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.1%
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, USP
contains:
ACTIVE: 1.11 mg olopatadine hydrochloride, USP equivalent to 1 mg
olopatadine.
PRESERVATIVE: benzalkonium chloride 0.01%. INACTIVES: dibasic sodium
phosphate; sodium chloride;
hydrochloric acid/sodium hydroxide (adjust pH); and water for
injection. 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 e