OLOPATADINE HYDROCHLORIDE solution/ drops

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

ECI Pharmaceuticals, LLC

Rute administrasi :

OPHTHALMIC

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 %.

Ringkasan produk:

Olopatadine hydrochloride ophthalmic solution, USP 0.1% is supplied as follows: 5 mL in LDPE bottles.            5 mL: NDC 51293-838-85 Storage Store at 39°F to 77°F (4°C to 25°C) Rx Only Manufactured by: USV Private Limited H-13,16,16A,17,18,19,20,21,E-22, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman - 396210, India Manufactured for: ECI Pharmaceuticals, LLC Ft. Lauderdale, FL 33309

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

OLOPATADINE HYDROCHLORIDE - OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS
ECI PHARMACEUTICALS, LLC
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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 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
dodecahydrate;
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
1
1
from 0.5 to 1.3 ng/mL. The half-life in plasma was approximately 3
hours, and elimination
was predominantly