PRED MILD prednisolone acetate suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

prednisolone acetate (UNII: 8B2807733D) (prednisolone - UNII:9PHQ9Y1OLM)

Available from:

Preferred Pharmaceuticals, Inc

INN (International Name):

prednisolone acetate

Composition:

prednisolone acetate 1.2 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

PRED MILD- PREDNISOLONE ACETATE SUSPENSION/ DROPS
PREFERRED PHARMACEUTICALS, INC
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PRED MILD
(PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION, USP) 0.12%
S TERILE
DESCRIPTION
PRED MILD (prednisolone acetate ophthalmic suspension, USP) 0.12% is a
sterile, topical anti-
inflammatory agent for ophthalmic use. Its chemical name is 11ß,17,
21-Trihydroxypregna-1,4-diene-3,
20-dione 21-acetate and it has the following structure:
STRUCTURAL FORMULA:
prednisolone acetate
ACTIVE: prednisolone acetate (microfine suspension) 0.12%.
INACTIVES: benzalkonium chloride as preservative; boric acid; edetate
disodium; hypromellose;
polysorbate 80; purified water; sodium bisulfite; sodium chloride; and
sodium citrate. The pH during its
shelf life ranges from 5.0 - 6.0.
CLINICAL PHARMACOLOGY
Prednisolone acetate is a glucocorticoid that, on the basis of weight,
has 3 to 5 times the anti-
inflammatory potency of hydrocortisone. Glucocorticoids inhibit the
edema, fibrin deposition, capillary
dilation, and phagocytic migration of the acute inflammatory response,
as well as capillary proliferation,
deposition of collagen, and scar formation.
INDICATIONS AND USAGE
PRED MILD is indicated for the treatment of mild to moderate
noninfectious allergic and
inflammatory disorders of the lid, conjunctiva, cornea, and sclera
(including chemical and thermal
burns).
CONTRAINDICATIONS
PRED MILD suspension is contraindicated in acute untreated purulent
ocular infections, in most viral
diseases of the cornea and conjunctiva including epithelial herpes
simplex keratitis (dendritic keratitis),
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vaccinia, and varicella, and also in mycobacterial infection of the
eye and fungal diseases of ocular
structures. PRED MILD suspension is also contraindicated in
individuals with known or suspected
hypersensitivity to any of the ingredients of this preparation and to
other corticosteroids.
WARNINGS
Prolonged use of corticosteroids may result in posterior subcapsular
cataract formation and may
increase intraocular pressure in susceptible individuals,