OLOPATADINE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

FDC Limited

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 as follows: 5 mL solution filled in a 5 mL translucent low density polyethylene bottle with insert cap assembly comprising of a white colored, High density Polyethylene screw cap over a Low density Polyethylene nozzle with tamper evident Low density polyethylene dust cover sealing the bottle cap.  5 mL: NDC 55545-1009-1 Storage: Store at 39°F-77°F (4°C-25°C). Protect from light. Rx Only Made in India by: FDC Limited B-8, MIDC Industrial Area, Waluj, Aurangabad 431 136, Maharashtra India. Distributed by: Leading Pharma LLC Fairfield, NJ07004 Revised: October 2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OLOPATADINE- OLOPATADINE SOLUTION
FDC LIMITED
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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
– receptor 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
predominantl