Clinical Information
Gen. Code and Des.
39105 loteprednol etabonate OPHTHALMIC DROPS SUSP 0.2 %
GCN and Des.
95465 loteprednol etabonate OPHTHALMIC DROPS SUSP 0.2 %
Strength
0.2%
Dose Form
SUSPENSION, DROPS(FINAL DOSAGE FORM)(ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
52080800 CORTICOSTEROIDS (EENT)
Active Ingredients
7443 loteprednol etabonate 82034466
Inactive Ingredients
2537 povidone 9003398
3141 benzalkonium chloride 8001545
3785 edetic acid 60004
ALREX- loteprednol etabonate suspension/ drops
Bausch Lomb Incorporated
STERILE OPHTHALMIC SUSPENSION
Rx only
DESCRIPTION
ALREX? (loteprednol etabonate ophthalmic suspension) contains sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is white to off-white powder.
Chemical Name:
chloromethyl 17?-[(ethoxycarbonyl)oxy]-11?-hydroxy-3-oxoandrosta-1,4-diene-17?-carboxylate
Each mL contains:
ACTIVE: Loteprednol Etabonate mg (0.2%);
INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH. The suspension is essentially isotonic with tonicity of 250 to 310 mOsmol/kg.
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
CLINICAL PHARMACOLOGY
Corticosteroids inhibit the inflammatory response to 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
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.
INDICATIONS AND USAGE
ALREX Ophthalmic Suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
info. for Patients
This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. If redness or itching becomes aggravated, the patient should be advised to consult physician.
Patients should be advised not to wear contact lens if their eye is red. ALREX should not be used to treat contact lens related irritation.The preservative in ALREX, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least ten minutes after instilling ALREX before they insert their contact lenses.
DOSAGE AND ADMINISTRATION
SHAKE VIGOROUSLY BEFORE USING.
One drop instilled into the affected eye(s) four times daily.
HOW SUPPLIED
ALREX? (loteprednol etabonate ophthalmic suspension, 0.2%) is supplied in plastic bottle with controlled drop tip in the following sizes:
5 mL (NDC 24208-353-05)
10 mL (NDC 24208-353-10)
DO NOT USE IF NECKBAND IMPRINTED WITH ?Protective Seal? AND YELLOW IS NOT INTACT.
Storage
Store upright between 15??25?C (59??77?F). DO NOT FREEZE.
KEEP OUT OF REACH OF CHILDREN.
