OLOPATADINE- olopatadine hydrochloride solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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%.

Product summary:

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is supplied in a 10 mL white, low density polyethylene (LDPE) bottle with a dropper tip, and a white polypropylene cap in the following size: NDC: 60429-957-05 5 mL in 10 mL bottle

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OLOPATADINE- OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS
GOLDEN STATE MEDICAL SUPPLY, INC.
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OLOPATADINE HCL 0.1% SOLUTION 5ML.
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]-6-11dihydrodibenz[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.
Inactives: Dibasic
Sodium Phosphate; Sodium Chloride; Hydrochloric Acid/Sodium Hydroxide
(adjust pH);
and Water for Injection. Preservative: Benzalkonium Chloride 0.01%. 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 predom