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:

Proficient Rx LP

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%. Olopatadine hydrochloride ophthalmic solution, 0.1% is for topical use only and not for injection or oral use.

Product summary:

Olopatadine hydrochloride ophthalmic solution USP, 0.1% is supplied as follows: 5 mL in LDPE Bottle. 5 mL: NDC 71205-345-05 Storage: Store at 39°F-77°F (4°C-25°C). Rx Only For Product Inquiry call 1-800-417-9175. Manufactured for:                            Somerset Therapeutics, LLC Somerset, NJ 08873       Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320                                                          Code No.: KR/DRUGS/KTK/28/289/97                    ST-OLP11/P/01                                                                                     Revised: 09/2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OLOPATADINE HYDROCHLORIDE- OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS
PROFICIENT RX LP
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OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 0.1%
SOMERSET THERAPEUTICS, LLC
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
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.
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 appr