Ophthalmic corticosteroid potency

Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS : General ).

NDC 61314-637-10

Prednisolone Acetate Ophthalmic Suspension USP 1%

Rx only

STERILE
10 mL

SANDOZ

FOR TOPICAL OPHTHALMIC USE ONLY.

INGREDIENTS: Each mL contains:
Active: prednisolone acetate %.
Preservative: benzalkonium chloride %.
Vehicle: hypromellose.
Inactives: dibasic sodium phosphate, polysorbate 80, edetate disodium, glycerin, citric acid and/or sodium hydroxide (to adjust pH), purified water.

USUAL DOSAGE: Two drops topically in the eye(s) four times daily.

WARNING: Do not touch dropper tip to any surface, as this may contaminate the suspension.

Read enclosed insert.

SHAKE WELL BEFORE USING.

STORAGE: STORE UPRIGHT at 8° - 24°C (46° - 75° F).

Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Sandoz Inc.
Princeton, NJ 08540
Printed in USA

H13438-0214

LOT/EXP.:

Patients who had undergone a PKP and had been using corticosteroid-based eye drops continuously for more than 6 months, with no history of concomitant steroid (oral, inhaled, or cutaneous) use, were included within the study. A low-dose short Synacthen (LDSST) test was performed in each patient followed later by a short Synacthen test (SST). The mean SST and LDSST after 30 min were calculated along with their corresponding 95% confidence intervals (CIs). Correlation between both baseline SST and baseline LDSST with duration of treatment was determined using Spearman's correlation.

Uveitis : Controlled clinical studies of patients with uveitis demonstrated that LOTEMAX (loteprednol etabonate ophthalmic suspension) was less effective than prednisolone acetate 1%. Overall, 72% of patients treated with LOTEMAX (loteprednol etabonate ophthalmic suspension) experienced resolution of anterior chamber cell by day 28, compared to 87% of patients treated with 1% prednisolone acetate. The incidence of patients with clinically significant increases in IOP ( ≥ 10 mmHg) was 1% with LOTEMAX (loteprednol etabonate ophthalmic suspension) and 6% with prednisolone acetate 1%.

As a glucocorticoid , the lipophilic structure of prednisolone allows for easy passage through the cell membrane where it then binds to its respective glucocorticoid receptor (GCR) located in the cytoplasm. Upon binding, formation of the GC/GCR complex causes dissociation of chaperone proteins from the glucocorticoid receptor enabling the GC/GCR complex to translocate inside the nucleus. This process occurs within 20 minutes of binding. Once inside the nucleus, the homodimer GC/GCR complex binds to specific DNA binding-sites known as glucocorticoid response elements (GREs) resulting in gene expression or inhibition. Complex binding to positive GREs leads to synthesis of anti-inflammatory proteins while binding to negative GREs block the transcription of inflammatory genes. [28]

Ophthalmic corticosteroid potency

ophthalmic corticosteroid potency

Uveitis : Controlled clinical studies of patients with uveitis demonstrated that LOTEMAX (loteprednol etabonate ophthalmic suspension) was less effective than prednisolone acetate 1%. Overall, 72% of patients treated with LOTEMAX (loteprednol etabonate ophthalmic suspension) experienced resolution of anterior chamber cell by day 28, compared to 87% of patients treated with 1% prednisolone acetate. The incidence of patients with clinically significant increases in IOP ( ≥ 10 mmHg) was 1% with LOTEMAX (loteprednol etabonate ophthalmic suspension) and 6% with prednisolone acetate 1%.

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