OLOPATADINE HYDROCHLORIDE solution/ drops

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Cipla USA Inc.

Vía de administración:

OPHTHALMIC

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is supplied as follows: 5 mL in white opaque low density polyethylene bottle with translucent low density polyethylene dropper and white opaque high density polyethylene cap. 5 mL: NDC 69097-275-35 Storage: Store between 4°C-25°C (39°F-77°F), Protect from light. Rx Only Manufactured by: Cipla Ltd., India Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059 Revised Date: 6/2020

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

OLOPATADINE HYDROCHLORIDE- OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS
CIPLA 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, 0.1%
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 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