OLOPATADINE HYDROCHLORIDE solution/ drops

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Apotex Corp.

Pot uporabe:

OPHTHALMIC

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Olopatadine hydrochloride ophthalmic solution, 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%.

Povzetek izdelek:

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1 % is a clear colorless solution supplied in a white opaque ophthalmic bottle with a white translucent dropper and a white opaque plastic cap in the following size:  5 mL fill in 11 mL bottle:  NDC 60505-0575-1 Storage  Store at 4ºC - 25°C (39ºF - 77°F). Keep bottle tightly closed when not in use.   Keep out of reach of children.  Manufactured by:                 Manufactured for: Apotex Inc.                          Apotex Corp. Toronto, Ontario                   Weston, FL Canada  M9L 1T9                33326                                                                                                                      June 2017

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

OLOPATADINE HYDROCHLORIDE- OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS
APOTEX CORP.
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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 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: 1.11
mg olopatadine hydrochloride equivalent to 1 mg olopatadine with
benzalkonium chloride
0.01%, sodium chloride, sodium phosphate dibasic (anhydrous), water
for injection,
hydrochloric acid and/or sodium hydroxide (to adjust pH). It has a pH
range of 6.5 – 7.5
and an osmolality range of 285 - 315 mOsmols/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
1
1
was