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:

Wockhardt USA LLC.

INN (International Name):

OLOPATADINE HYDROCHLORIDE

Composition:

OLOPATADINE 1 mg in 1 mL

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

Product summary:

Olopatadine hydrochloride ophthalmic solution USP, 0.1% is supplied in natural low density polyethylene bottle and dispensing plug and tamper evident high density polyethylene closure as follows: 5 mL Bottle Pack: NDC 64679-363-01 Storage: Store at 4°-25°C (39°-77°F) Rx Only Manufactured by: Jubilant HollisterStier General Partnership Kirkland, Quebec, H9H 4J4, Canada. Distributed by: Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA. Iss.020415

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OLOPATADINE HYDROCHLORIDE- OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS
WOCKHARDT USA LLC.
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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 to off 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 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 hour