Alomide

Ocular Anti-Allergics, Mast Cell Stabilizers

Lodoxamide is for ophthalmic use only.
Instruct patient on proper instillation of the eye solution.
Wash hands before and after use.
Care should be taken to avoid contamination. Do not touch the tip of the dropper to the eye, fingertips, or other surface.
To avoid contamination or the spread of infection, do not use dropper for more than one person.

keratitis / Delayed / 0-1.0
corneal erosion / Delayed / 0-1.0

blurred vision / Early / 1.0-5.0
hyperemia / Delayed / 1.0-5.0
keratopathy / Delayed / 0-1.0
blepharitis / Early / 0-1.0

ocular irritation / Rapid / 15.0-15.0
xerosis / Delayed / 1.0-5.0
ocular pruritus / Rapid / 1.0-5.0
lacrimation / Early / 1.0-5.0
foreign body sensation / Rapid / 1.0-5.0
headache / Early / 1.5-1.5
ocular pain / Early / 0-1.0
dizziness / Early / 0-1.0
nausea / Early / 0-1.0
abdominal pain / Early / 0-1.0
sneezing / Early / 0-1.0
rash / Early / 0-1.0
drowsiness / Early / 0-1.0

Alomide

Rx

Mast cell stabilizer for ophthalmic administration
Used for ocular inflammatory states such as vernal conjunctivitis, vernal keratitis, or vernal keratoconjunctivitis
Patients should not wear soft contact lenses during treatment with lodoxamide

1 to 2 drops in affected eye(s) 4 times per day; not to be used for longer than 3 months.

Safety and efficacy have not been established.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

There are no drug interactions associated with Lodoxamide products.

Alomide/Lodoxamide Tromethamine Ophthalmic Sol: 0.1%

8 drops/day per affected eye.

8 drops/day per affected eye.

8 drops/day per affected eye.

>= 2 years: 8 drops/day per affected eye.
< 2 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Lodoxamide is an ophthalmic mast cell stabilizer that inhibits type I immediate hypersensitivity reactions; it inhibits the increases in cutaneous vascular permeability 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 (e.g., SRS-A, slow-reacting substances of anaphylaxis, also known as the peptidoleukotrienes) 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.

Lodoxamide is administered via ophthalmic administration.

The disposition of 14C-lodoxamide was studied in six healthy adult volunteers receiving a 3 mg (50 mCi) oral dose of lodoxamide. Urinary excretion was the major route of elimination. The elimination half-life of 14C-lodoxamide was 8.5 hours in urine.

Ophthalmic
In twelve healthy adult volunteers, ophthalmic administration of lodoxamide tromethamine 0.1% solution at a dose of one drop in each eye four times per day for ten days did not result in any measurable plasma concentrations (detection limit = 2.5 ng/mL).

There are no adequate and well-controlled studies of lodoxamide use in pregnant women. However, ophthalmic administration of the drug does not result in detectable levels in the plasma and therefore use of the drug during pregnancy would not be expected to cause significant exposure to the fetus. Orally administered lodoxamide at doses of 100 mg/kg/day (1,000 times the proposed human clinical dose) was not associated with any developmental toxicity in rats and rabbits. According to the manufacturer, lodoxamide should be used during pregnancy only if clearly needed.

It is unknown whether lodoxamide is excreted in human milk. However, ophthalmic administration does not result in detectable levels in the plasma and therefore use of the drug during breast-feeding would not be expected to cause significant exposure to the nursing infant. To minimize the amount of drug that reaches systemic circulation, apply pressure over the tear duct in the corner of the eye for 1 to 2 minutes after ophthalmic administration. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.