Rx Item-Alomide 0.1% Drops 10ml By Alcon Labs

Clinical Information
Gen. Code and Des.
44695 lodoxamide tromethamine OPHTHALMIC DROPS 0.1 %
GCN and Des.
69079 lodoxamide tromethamine OPHTHALMIC DROPS 0.1 %
Strength
0.1%
Dose Form
DROPS
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
52020000 ANTIALLERGIC AGENTS
Active Ingredients
3992 lodoxamide tromethamine 63610093
Inactive Ingredients
2272 mannitol 69658
2332 sodium citrate 68042
3141 benzalkonium chloride 8001545
3785 edetic acid 60004

ALOMIDE- lodoxamide tromethamine solution/ drops
Alcon Laboratories, Inc.
DESCRIPTION
ALOMIDE? (lodoxamide tromethamine ophthalmic solution) 0.1% is sterile ophthalmic solution containing the mast cell stabilizer lodoxamide tromethamine for topical administration to the eyes. Lodoxamide tromethamine is white, crystalline, water-soluble powder with molecular weight of 553.91
Chemical Name:
N,N?-(2-chloro-5-cyano-m-phenylene)dioxamic acid tromethamine salt
Molecular Formula: C19 H28 O12 N5 Cl
Each mL of ALOMIDE? (lodoxamide tromethamine ophthalmic solution) 0.1% contains: Active: 1.78 mg lodoxamide tromethamine equivalent to mg lodoxamide. Preservative: benzalkonium chloride 0.007%. Inactive: mannitol, hypromellose 2910, sodium citrate, citric acid, edetate disodium, tyloxapol, hydrochloric acid and/or sodium hydroxide (adjust pH), and purified water.
CLINICAL PHARMACOLOGY
Lodoxamide tromethamine is mast cell stabilizer that inhibits the in vivo Type immediate hypersensitivity reaction. Lodoxamide therapy inhibits the increases in cutaneous vascular permeability that are associated with reagin or IgE and antigen-mediated reactions
INDICATIONS AND USAGE
ALOMIDE? (lodoxamide tromethamine ophthalmic solution) 0.1% is indicated in the treatment of the ocular disorders referred to by the terms vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
WARNINGS
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. As with all ophthalmic preparations containing benzalkonium chloride, patients should be instructed not to wear soft contact lenses during treatment with ALOMIDE? Ophthalmic Solution. Do not touch the dropper tip to any surface, as this may contaminate the solution.
PRECAUTIONS
General
Patients may experience transient burning or stinging upon instillation of ALOMIDE? Ophthalmic Solution. Should these symptoms persist, the patient should be advised to contact the prescribing physician.
DOSAGE AND ADMINISTRATION
The dose for adults and children greater than two years of age is one to two drops in each affected eye four times daily for up to months.

Rx Item-Alomide 0.1% Drops 10ml By Alcon
RX738445 738445 NDC No.NEW 00078-0736-10 00078-736-10 00078-0736-10 00078-0736-10 OLD 00065-0345-10 UPC/GTIN No.NEW 3-00780-73610-7 300780736107 300780-736107 OLD 3-00650-34510-1 MPN No. NEW 073610 OL

Rx Item-Alomide 0.1% Drops 10m
RX738445 738445 NDC No.NEW 00078-0736-10 00078-736-10 00078-0736-10 00078-0736-10 OLD 00065-0345-10 UPC/GTIN No.NEW 3-00780-73610-7 300780736107 300780-736107 OLD 3-00650-34510-1 MPN No. NEW 073610 OL

LODOXAMIDE TROMETHAMINE O
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