ALOMIDE- lodoxamide tromethamine solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LODOXAMIDE TROMETHAMINE (UNII: 50LV9A548L) (LODOXAMIDE - UNII:SPU695OD73)

Available from:

Novartis Pharmaceuticals Corporation

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Hypersensitivity to any component of this product.

Product summary:

ALOMIDE® (lodoxamide tromethamine ophthalmic solution) 0.1% is supplied in a plastic ophthalmic dispenser as follows: 10 mL NDC 0078-0736-10 Storage: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 © Novartis Revised: January 2021 T2021-01

Authorization status:

New Drug Application

Summary of Product characteristics

ALOMIDE- LODOXAMIDE TROMETHAMINE SOLUTION/ DROPS
NOVARTIS PHARMACEUTICALS CORPORATION
----------
ALOMIDE
(LODOXAMIDE TROMETHAMINE OPHTHALMIC SOLUTION) 0.1%
DESCRIPTION:
ALOMIDE (lodoxamide tromethamine ophthalmic solution) 0.1% is a
sterile ophthalmic
solution containing the mast cell stabilizer lodoxamide tromethamine
for topical
administration to the eyes. Lodoxamide tromethamine is a white,
crystalline, water-
soluble powder with a molecular weight of 553.91 g/mol. The chemical
structure is
presented below:
STRUCTURAL FORMULA:
CHEMICAL NAME:
N,N'-(2-chloro-5-cyano-m-phenylene) dioxamic acid tromethamine salt
Molecular Formula: C
H
O
N Cl
EACH ML OF ALOMIDE (LODOXAMIDE TROMETHAMINE OPHTHALMIC SOLUTION) 0.1%
CONTAINS: ACTIVE: 1.78 mg lodoxamide tromethamine equivalent to 1 mg
lodoxamide.
PRESERVATIVE: benzalkonium chloride 0.007%. INACTIVES: citric acid,
edetate disodium,
hydrochloric acid and/or sodium hydroxide (adjust pH), hypromellose
2910, mannitol,
purified water, sodium citrate, and tyloxapol.
CLINICAL PHARMACOLOGY:
Lodoxamide tromethamine is a mast cell stabilizer that inhibits the
_in vivo_ Type I
immediate hypersensitivity reaction. Lodoxamide therapy inhibits the
increases in
®
®
19
28
12
5
®
cutaneous vascular permeability that are associated with reagin or IgE
and antigen-
mediated reactions.
_In vitro_ studies have demonstrated the ability of lodoxamide to
stabilize rodent mast
cells and prevent antigen-stimulated release of histamine. In
addition, lodoxamide
prevents the release of other mast cell inflammatory mediators (i.e.,
SRS-A, slow-
reacting substances of anaphylaxis, also known as the
peptido-leukotrienes) and inhibits
eosinophil chemotaxis. Although lodoxamide's precise mechanism of
action is unknown,
the drug has been reported to prevent calcium influx into mast cells
upon antigen
stimulation.
Lodoxamide has no intrinsic vasoconstrictor, antihistaminic,
cyclooxygenase inhibition,
or other anti-inflammatory activity.
The disposition of
C-lodoxamide was studied in six healthy adult volu