LOTEPREDNOL ETABONATE suspension/ drops

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

LOTEPREDNOL ETABONATE (UNII: YEH1EZ96K6) (LOTEPREDNOL - UNII:Z8CBU6KR16)

זמין מ:

ARMAS PHARMACEUTICALS INC.

מסלול נתינה (של תרופות):

OPHTHALMIC

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Loteprednol etabonate is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with loteprednol etabonate and 6% with prednisolone acetate 1%. Loteprednol etabonate should not be used in patients who require a more potent corticosteroid for this indi

leaflet_short:

Loteprednol Etabonate Ophthalmic Suspension, 0.5% is supplied in a plastic bottle with a controlled drop tip and a pink cap in the following sizes: 5 mL - NDC 72485-665-05 10 mL - NDC 72485-665-10 15 mL - NDC 72485-665-15 DO NOT USE IF NECKBAND IMPRINTED WITH "SEALED FOR YOUR PROTECTION' IS NOT INTACT. Storage: Store upright between 15°–25°C (59°–77°F). DO NOT FREEZE. KEEP OUT OF REACH OF CHILDREN. Rx Only Distributed by: Armas Pharmaceuticals, inc. Freehold, NJ 07728 USA Manufactured by: Ophtapharm AG Rithofstrasse 1, Hettlingen, 8442, Switzerland (CHE) for Sentiss Made in Switzerland Rev. 08/23

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

LOTEPREDNOL ETABONATE- LOTEPREDNOL ETABONATE SUSPENSION/ DROPS
ARMAS PHARMACEUTICALS INC.
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LOTEPREDNOL ETABONATE OPHTHALMIC SUSPENSION, 0.5%
Sterile Ophthalmic Suspension
DESCRIPTION
Loteprednol Etabonate Ophthalmic Suspension contains a sterile,
topical anti-
inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate
is a white to off-
white powder.
Loteprednol etabonate is represented by the following structural
formula:
Chemical Name:
chloromethyl
17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-
carboxylate
EACH ML CONTAINS:
ACTIVE: Loteprednol Etabonate 5 mg (0.5%);
INACTIVES: Edetate disodium, glycerin, povidone K-30, purified water
sodium hydroxide
and tyloxapol. Hydrochloric acid may be added to adjust the pH to 5.0
- 6.0. The
suspension is essentially isotonic with a tonicity of 250 to 310
mOsmol/kg.
PRESERVATIVE ADDED: Benzalkonium chloride 0.01%.
CLINICAL PHARMACOLOGY
Corticosteroids inhibit the inflammatory response to a variety of
inciting agents and
probably delay or slow healing. They inhibit the edema, fibrin
deposition, capillary dilation,
leukocyte migration, capillary proliferation, fibroblast
proliferation, deposition of collagen,
and scar formation associated with inflammation. There is no generally
accepted
explanation for the mechanism of action of ocular corticosteroids.
However,
corticosteroids are thought to act by the induction of phospholipase A
inhibitory
proteins, collectively called lipocortins. It is postulated that these
proteins control the
biosynthesis of potent mediators of inflammation such as
prostaglandins and
leukotrienes by inhibiting the release of their common precursor
arachidonic acid.
Arachidonic acid is released from membrane phospholipids by
phospholipase A
.
Corticosteroids are capable of producing a rise in intraocular
pressure.
Loteprednol etabonate is structurally similar to other
corticosteroids. However, the
number 20 position ketone group is absent. It is highly lipid soluble
which enhances its
penetration into cells.