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Sulfacetamide Sodium And Prednisolone Acetate (Blephamide)

Trade Name : BLEPHAMIDE

Allergan, Inc.

OINTMENT

Strength 1002 mg/gmg/g

SULFACETAMIDE SODIUM; PREDNISOLONE ACETATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Sulfonamide Antibacterial [EPC],Sulfonamides [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sulfacetamide Sodium And Prednisolone Acetate (Blephamide) which is also known as BLEPHAMIDE and Manufactured by Allergan, Inc.. It is available in strength of 100; 2 mg/g; mg/g per ml. Read more

Sulfacetamide Sodium And Prednisolone Acetate (Blephamide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • BLEPHAMIDE
  • nttu00a0u00a0u00a0u00a0u00a0nt
  • nttu00a0u00a0u00a0u00a0u00a0ntSulfacetamide sodiumnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntPrednisolone acetate
  • nttu00a0u00a0u00a0u00a0u00a0ntMW = 254.24nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntMW = 402.49
  • nttu00a0u00a0u00a0u00a0u00a0ntCHNNaOSu2022HOnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntCHOn
  • Chemical Names:
  • Each mL of n n contains:sulfacetamide sodium 10% and prednisolone acetate 0.2%;n n phenylmercuric acetate 0.0008%;mineral oil; petrolatum and lanolin alcohol; and white petrolatum.
  • Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the bodyu2019s 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, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that 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 exerts a bacteriostatic effect against susceptible bacteria by restricting the synthesis of folic acid required for growth through competition with p-aminobenzoic acid.
  • Some strains of these bacteria may be resistant to sulfacetamide or resistant strains may emerge .
  • The anti-infective component in n ointment is included to provide action against specific organisms susceptible to it. Sulfacetamide sodium is active against susceptible strains of the following microorganisms: n (n group). speciesandn n species. This product does not provide adequate coverage against:u00a0 species, species, and (see ).
  • BLEPHAMIDE
  • 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 against the following common bacterial eye pathogens: n group), species, and species.
  • The product does not provide adequate coverage against: species, species, and .
  • A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
  • BLEPHAMIDE
  • BLEPHAMIDE
  • NOT FOR INJECTION INTO THE EYE.
  • Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in ocular hypertension/glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision.
  • If the product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.
  • The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
  • In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical corticosteroids.
  • In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.
  • The use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.
  • Prolonged use of n ophthalmic ointment may suppress the host response and thus increase the hazard of secondary ocular infections.
  • Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi.
  • A significant percentage of staphylococcal isolates are completely resistant to sulfonamides.
  • Acute anterior uveitis may occur in susceptible individuals, primarily Blacks.
  • Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias. Sensitization may recur when au00a0sulfonamide is readministered, irrespective of the route of administration.
  • If signs of hypersensitivity, skin rash, or other serious reaction occur, discontinue use of this preparation. Cross-sensitivity among corticosteroids has been demonstrated (see ).u00a0n ophthalmic ointment contains the preservative phenylmercuric acetate, which may cause allergic-type reactions in susceptible patients.
  • No data
  • The following adverse reactions have been identified during use of n ophthalmic ointment. Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Adverse reactions have occurred with corticosteroid/antibacterial combination drugs which can be attributed to the corticosteroid component, the antibacterial component, or the combination.
  • Reactions occurring with BLEPHAMIDEu00ae ophthalmic ointment include: cataract, dizziness, eye discharge, eyelid edema, eyelid erythema, eye irritation, eye pain, eye pruritus, and hypersensitivity including rash, skin pruritus, urticaria, ocular hyperemia, and visual disturbance (blurry vision).
  • Reactions occurring most often from the presence of the antibacterial ingredient are allergic sensitizations. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (see ).
  • The reactions due to the corticosteroid component in decreasing order of frequency are: delayed wound healing, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, and posterior subcapsular cataract formation.
  • Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical corticosteroids.
  • Corticosteroid-containing preparations can also cause acute anterior uveitis or perforation of the globe. Mydriasis, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.
  • Secondary Infection
  • The development of secondary infection has occurred after use of combinations containing corticosteroids and antibacterials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.
  • Secondary bacterial ocular infection following suppression of host responses also occurs.
  • A small amount, approximately 1/2 inch ribbon of ointment, should be applied in the conjunctival sac three or four times daily and once or twice at night.
  • Not more than 8 g should be prescribed initially.
  • The dosing of n ophthalmic ointment may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of application.
  • If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see ).
  • BLEPHAMIDE
  • 3.5 g - NDC 0023-0313-04
  • Store at 15u00b0-25u00b0C (59u00b0-77u00b0F).
  • Revised:
  • 6
  • /2018
  • Distributed by: Allergan USA, Inc.Madison, NJ 07940
  • u00a9 2018u00a0Allergan. All rights reserved. All trademarks are the property of their respective owners.
  • NDC 0023-0313-043.5 gBLEPHAMIDEu00ae(sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%sterileRx Only

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