Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5), prednisolone acetate (UNII: 8B2807733D) (prednisolone - UNII:9PHQ9Y1OLM)
Allergan, Inc.
OPHTHALMIC
PRESCRIPTION DRUG
BLEPHAMIDE ® ophthalmic suspension is a steroid/anti-infective combination drug indicated for steroid- responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular antibacterial drug in this product is active ag
BLEPHAMIDE ® (sulfacetamide sodium-prednisolone acetate ophthalmic suspension, USP) is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with white high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle — NDC 11980-022-05 10 mL in 15 mL bottle — NDC 11980-022-10 Note: Shake well before using. Storage: Store at 8°-24°C (46°-75°F) in an upright position. PROTECT FROM LIGHT. Protect from freezing. Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity. KEEP OUT OF REACH OF CHILDREN. Revised: 07/2017 © 2017 Allergan. All rights reserved. All trademarks are the property of their respective owners. Irvine, CA 92612 Made in the U.S.A.
New Drug Application
BLEPHAMIDE- SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE SUSPENSION/ DROPS ALLERGAN, INC. ---------- BLEPHAMIDE (SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION, USP) 10%/0.2% DESCRIPTION BLEPHAMIDE ophthalmic suspension is a sterile, topical anti-inflammatory/anti- infective combination product for ophthalmic use. STRUCTURAL FORMULAS MW=254.24 C H N NaO S·H O MW=402.49 C H O CHEMICAL NAMES Sulfacetamide sodium: N-sulfanilylacetamide monosodium salt monohydrate. Prednisolone acetate: 11ß, 17, 21-trihydroxypregna-1, 4-diene-3, 20-dione 21-acetate. Each mL of BLEPHAMIDE ophthalmic suspension contains: ACTIVES: sulfacetamide sodium 10%, prednisolone acetate (microfine suspension) 0.2%. INACTIVES: benzalkonium chloride (0.004%); edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; potassium phosphate, monobasic; purified water; sodium phosphate, dibasic; sodium thiosulfate; hydrochloric acid and/or sodium hydroxide to adjust pH (6.6 to 7.2). CLINICAL PHARMACOLOGY Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antibacterial drug may be used when this inhibition is considered to be clinically significant in a particular case. When a decision to administer both a corticosteroid and an antibacterial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered. When both types of drugs are in the same formulation, ® ® 8 9 2 3 2 23 30 6 ® compatibility of ingredients is assured and the correct volume of drug is delivered and retained. The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle. MICROBIOLOGY Sulfacetamide sodium exerts a bacteriostatic effect against susceptible bacteria by restricting the synthesis of folic acid req Lire le document complet