lodoxamide ophthalmic (Rx)

>10%

Transient local burning, stinging, discomfort (15%)

1-10%

Headache (1.5%)

Foreign body sensation (1-5%)

Ocular itching/pruritus (1-5%)

Blurred vision (1-5%)

Dry eye (1-5%)

Tearing/discharge (1-5%)

Hyperemia (1-5%)

Crystalline deposits (1-5%)

<1%

Heat sensation

Dizziness

Somnolence

Sneezing

Dry nose

Nausea

Stomach discomfort

Rash

Corneal erosion/ulcer

Scales on lid/lash

Eye pain

Ocular edema/swelling

Ocular warming sensation

Ocular fatigue

Chemosis

Corneal abrasion

Keratopathy/keratitis

Blepharitis

Allergy

Sticky sensation

Epitheliopathy

Contraindications

Hypersensitivity to drug or any component

Cautions

For topical ophthalmic use only; not for injection

Nor for injection

May cause transient burning or stinging

Remove contact lenses prior to administration and wait 15 min before reinserting them; contains benzlkonium chloride

Pregnancy Category: B

Lactation: unknown whether distributed in breast milk, caution advised

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Lodoxamide tromethamine is a mast cell stabilizer that inhibits the in vivo Type I immediate hypersensitivity reaction; inhibits the increases in cutaneous vascular permeability associated with IgE and antigen-mediated reactions

Half-Life

8.5 hrs

Absorption

Systemic absorption minimal

Excretion

Primarily in urine