Pharmacia & Upjohn
Neomycin Sulfate – Hydrocortisone Acetate
Antibiotic – Corticosteroid
Indications And Clinical Uses: These preparations are indicated in the following conditions when threatened with or complicated by infection due to neomycin sensitive organisms.
Eye Drops: phlyctenular kerato-conjunctivitis, nonspecific superficial keratitis, acne rosacea keratitis, allergic conjunctivitis, sclerokeratitis, episcleritis, traumatic keratitis. In generalized uveitis and inflammatory diseases of the posterior segment, systemic corticosteroid therapy should be employed.
Ointment: allergic, atopic and seborrheic dermatitis, pruritus ani and vulvae, and neurodermatitis.
Contra-Indications: Viral diseases of the cornea, conjunctiva, or skin. Tuberculosis of the eye or skin, fungal diseases of the eye or skin, active purulent untreated infections of the eye, which like other diseases caused by microorganisms may be masked or enhanced by the presence of the steroid. Cutaneous infections which do not respond to neomycin. Individuals with a history of hypersensitivity to any of the components.
Precautions: Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain patients and in those diseases causing thinning of the cornea, perforation has been known to occur. As with any antibiotic containing product, overgrowth by resistant organisms may occur, particularly monilia. If this occurs, discontinue treatment and institute appropriate measures.
Articles in current medical literature indicate an increase in the incidence of patients allergic to neomycin. The possibility of such a reaction should be borne in mind.
Ototoxicity and nephrotoxicity have been reported following absorption of topically applied neomycin.
Although untoward effects associated with the use of topical corticosteroids are uncommon and not to be expected from ordinary use, sensitization, irritation and failure of therapeutic response have been noted in rare instances. Application to extensive areas, too-frequent application, or application under occlusive dressings may result in systemic absorption with symptoms of adrenal suppression, localized atrophy and striae. If secondary bacterial infection exists or supervenes, concomitant antimicrobial therapy is indicated.
Pregnancy: Although topical steroids have not been reported to have an adverse effect on pregnancy, the safety of their use has not absolutely been established. Therefore, use with care during pregnancy.
Adverse Reactions: The following local adverse reactions have been reported with topical corticosteroids, either with or without occlusive dressings: burning sensation, itching, irritation, dryness, folliculitis, secondary infection, skin atrophy, striae, miliaria, hypertrichosis, acneiform eruptions, laceration of the skin and hypopigmentation.
Dosage And Administration: Eye Drops: Ocular-1 or 2 drops in conjunctival sac every hour during day and every 2 hours at night. After improvement occurs this may be reduced to 1 or 2 drops 3 or 4 times daily. Duration of therapy should be determined by the judgment of the physician and the response of the patient to the medication.
Ointment: A small amount rubbed gently into the area 1 to 3 times daily.
Availability And Storage: Eye Drops: Each mL contains: hydrocortisone acetate 15 mg (1.5%), neomycin sulfate 5 mg in sterile, aqueous suspension. Nonmedicinal ingredients: myristyl-gamma-picolinium chloride, polyethylene glycol, povidone and sodium citrate. Sodium hydroxide or hydrochloric acid may be used to adjust pH. Dropper bottles of 5 mL.
Ointment: Each g contains: hydrocortisone acetate 5 mg (0.5%) or 10 mg (1%) and neomycin sulfate 5 mg (equivalent to 3.5 mg neomycin base). Nonmedicinal ingredients: butylparaben and methylparaben in a bland base composed of cholesterol, microcrystalline wax, mineral oil and white petrolatum. Tubes of 25 g.
NEO-CORTEF® Preparations Pharmacia & Upjohn Neomycin Sulfate – Hydrocortisone Acetate Antibiotic – Corticosteroid