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:

Direct Rx

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 0.1 % is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution.

Resumen del producto:

Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% is a clear, colorless solution. Practically free from visible particles packed in 5 mL opaque LDPE container with LDPE nozzle and white colored HDPE cap.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

OLOPATADINE HYDROCHLORIDE- OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS
DIRECT RX
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OLAPATADINE HYDROCHLORIDE
Olopatadine hydrochloride ophthalmic solution USP 0.1 % is a sterile
ophthalmic solution containing
olopatadine, a relatively selective H1-receptor antagonist and
inhibitor of histamine release from the
mast cell for topical administration to the eyes. Olopatadine
hydrochloride USP is a white to off-white
crystalline powder, odorless with a molecular weight of 373.88. The
chemical structure is presented
below:
[Chemical Structure]
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.
Olopatadine is an inhibitor of the release of histamine from the mast
cell and a relatively selective
histamine H1-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
excre