地塞米松眼用混悬液说明书(英文)

更新时间:2023-05-27 12:20:58 阅读: 评论:0

Package Inrt
贸易的英文Maxidex
0.1 % (dexamethasone ophthalmic suspension)
Sterile
形容帅的成语
DESCRIPTION: MAXIDEX® 0.1 % (dexamethasone ophthalmic suspension) is an adrenocortical steroid prepared as a sterile topical ophthalmic suspension. The active ingredient is reprented by the chemical structure:
[Structure]
Chemical name: Pregna-1,4-diene-3,20-dione,9-fluoro-11,17,21-trihydroxy-16-methyl-,(11β,16α)-.
树的英文Each mL contains: Active: dexamethasone 0.1 %. Prervative: benzalkonium chloride 0.01 %. Vehicle: hydroxypropyl methylcellulo 0.5%. Inactives: sodium chloride, dibasic sodium phosphate, polysorbate 80, edetate disodium, citric acid and/or sodium hydroxide (to adjust pH), purified water.
我的老师小说
CLINICAL PHARMACOLOGY: Dexamethasone suppress the inflammatory respon 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 gment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, lected infective conjunctivitides when the inherent hazard of steroid u is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal bums, or penetration of foreign bodies.
CONTRAINDICATIONS: Contraindicated in epithelial herpes simplex (dendritic keratitis), vaccinia, varicella, and most other viral dias of the cornea and conjunctiva; tuberculosis of the eye; fungal dia of ocular structures; and in tho persons who have shown hypernsitivity to any component of this preparation.
WARNINGS: Prolonged u 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 u may suppress the host respon and thus increa the hazard of conda
ry ocular infections. In tho dias causing thinning of the cornea or sclera, perforations have been known to occur with the u of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection. If the products are ud for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.
Employment of corticosteroid medication in the treatment of herpes simplex other than epithelial herpes simplex keratitis, in which it is contraindicated, requires great caution; periodic slit-lamp microscopy is esntial.
PRECAUTIONS:
General. FOR TOPICAL OPHTHALMIC USE ONLY. The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing.
Information for Patients.
Do not touch dropper tip to any surface, as this may contaminate the contents. The prervative in MAXIDEX® (dexamethasone ophthalmic suspension), benzalkonium chloride, may be absorbed by
soft contact lens. MAXIDEX® (dexamethasone ophthalmic suspension) should not be administered while wearing soft contact lens.
Carcinogenesis, Mutagenesis, Impairment of Fertility.
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of MAXIDEX® (dexamethasone ophthalmic suspension).
Pregnancy.
冷库出租收费标准Pregnancy Category C. Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic do.
菊花的习性In the mou, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc.
There are no adequate or well-controlled studies in pregnant women. MAXIDEX® (dexamethasone ophthalmic suspension) should be ud during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Infants born of mothers who have received substant
ial dos of corticosteroids during pregnancy should be obrved carefully for signs of hypoadrenalism.
Nursing Mothers.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cau other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Becau many drugs are excreted in human milk, caution should be exercid when MAXIDEX® (dexamethasone ophthalmic suspension) is administered to a nursing woman.
Pediatric U. Safety and effectiveness in pediatric patients have not been established.
Geriatric U: No overall differences in safety or effectiveness have been obrved between elderly and younger patients.
苦丁茶树图片ADVERSE REACTIONS: Glaucoma with optic nerve damage, visual acuity and field defects; cataract formation; condary ocular infection following suppression of host respon; and perforation of the globe may occur.
DOSAGE AND ADMINISTRATION:
SHAKE WELL BEFORE USING. One or two drops topically in the conjunctival sac(s). In vere dia, drops may be ud hourly, being tapered to discontinuation as the inflammation subsides. In mild dia, drops may be ud up to four to six times daily.
HOW SUPPLIED: MAXIDEX® (dexamethasone ophthalmic suspension) in plastic DROP-TAINER® dispenrs:王夫子
5 mL NDC 0998-0615-05
15 mL NDC 0998-0615-15
STORAGE: Store upright at 8°-27°C (46°-80°F).
Rx Only Alcon
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Printed in USA  2002 Alcon Laboratories, Inc.
MAXSGER-0802
Revid: August 2002

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