MAXIDEX- dexamethasone suspension/ drops

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Доступно од:

Novartis Pharmaceuticals Corporation

Пут администрације:

OPHTHALMIC

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. Contraindicated in acute, untreated bacterial infections; mycobacterial ocular infections; epithelial herpes simplex (dendritic keratitis); vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva; fungal disease of ocular structures; and in those persons who have shown hypersensitivity to any component of this preparation.

Резиме производа:

MAXIDEX® (dexamethasone ophthalmic suspension) 0.1% in plastic dispensers: 5 mL NDC 0078-0925-25 STORAGE: Store upright at 8°C to 27°C (46°F to 80°F). After opening, MAXIDEX can be used until the expiration date on the bottle. © Novartis Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 Revised: January 2022 T2022-01

Статус ауторизације:

New Drug Application

Карактеристике производа

MAXIDEX- DEXAMETHASONE SUSPENSION/ DROPS
NOVARTIS PHARMACEUTICALS CORPORATION
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MAXIDEX
(DEXAMETHASONE OPHTHALMIC SUSPENSION) 0.1%
STERILE
DESCRIPTION
MAXIDEX (dexamethasone ophthalmic suspension) 0.1% is an
adrenocortical steroid
prepared as a sterile topical ophthalmic suspension. The active
ingredient is represented
by the chemical structure:
Chemical name:
Pregna-1,4-diene-3,20-dione,9-fluoro-11,17,21-trihydroxy-16-methyl-
,(11β,16α)-.
EACH ML OF MAXIDEX (DEXAMETHASONE OPHTHALMIC SUSPENSION) 0.1%
CONTAINS:
ACTIVE: dexamethasone 0.1%. PRESERVATIVE: benzalkonium chloride 0.01%.
VEHICLE:
hypromellose 0.5%. INACTIVES: citric acid and/or sodium hydroxide (to
adjust pH),
dibasic sodium phosphate, edetate disodium, polysorbate 80, purified
water, and sodium
chloride.
CLINICAL PHARMACOLOGY
Dexamethasone suppresses the inflammatory response to a variety of
agents and it
probably delays or slows healing.
INDICATIONS AND USAGE
®
Steroid responsive inflammatory conditions of the palpebral and bulbar
conjunctiva,
cornea, and anterior segment of the globe, such as allergic
conjunctivitis, acne rosacea,
superficial punctate keratitis, herpes zoster keratitis, iritis,
cyclitis, selected infective
conjunctivitides when the inherent hazard of steroid use is accepted
to obtain an
advisable diminution in edema and inflammation; corneal injury from
chemical, radiation,
or thermal burns, or penetration of foreign bodies.
CONTRAINDICATIONS
Contraindicated in acute, untreated bacterial infections;
mycobacterial ocular infections;
epithelial herpes simplex (dendritic keratitis); vaccinia, varicella,
and most other viral
diseases of the cornea and conjunctiva; fungal disease of ocular
structures; and in
those persons who have shown hypersensitivity to any component of this
preparation.
WARNINGS
Prolonged use may result in ocular hypertension and/or glaucoma, with
damage to the
optic nerve, defects in visual acuity and fields of vision, and
posterior subcapsular
cataract formation. Prolonged use may suppress the host respon