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:

Mylan Pharmaceuticals 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%. Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% Before you use Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% for the first time: This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Micro Labs Limited Bangalore – 560 099, INDIA M.L. No.: KTK/28/357/2006 Revised: 7/2017 MCR:OLOPHOS1:R2

Product summary:

Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% is supplied in a 5 mL sterile white opaque LDPE bottle with sterile open white opaque LDPE nozzle and sterile HDPE white cap. 5 mL fill NDC 0378-8023-35 carton of one bottle Storage Store at 4° to 25°C (39° to 77°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OLOPATADINE HYDROCHLORIDE- OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS
MYLAN PHARMACEUTICALS INC.
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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 USP is a white to yellowish,
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 USP equivalent to 1 mg olopatadine.
PRESERVATIVE: benzalkonium chloride 0.01%. INACTIVES: dibasic sodium
phosphate anhydrous, sodium
chloride, hydrochloric acid and/or sodium hydroxide (to 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 hours, and elimina