BLEPHAMIDE- sulfacetamide sodium and prednisolone acetate suspension/ drops

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5), prednisolone acetate (UNII: 8B2807733D) (prednisolone - UNII:9PHQ9Y1OLM)

थमां उपलब्ध:

Allergan, Inc.

प्रशासन का मार्ग:

OPHTHALMIC

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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

उत्पाद समीक्षा:

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.

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

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