emedastine (Discontinued)

>10%

Headache (11%)

Frequency Not Defined

Blurred vision

Corneal infiltrates

Corneal staining

Dry eye

Foreign body sensation

Keratitis

Ocular burning or stinging

Ocular discomfort

Ocular hyperemia

Ocular pruritus

Tearing

Abnormal dreams

Asthenia

Bad taste

Dermatitis

Rhinitis

Sinusitis

Contraindications

Hypersensitivity

Contact lens-related irritation

Cautions

Do not wear contact lenses if eyes are red; wait 15 min after emedastine to insert contacts

Keratitis may occur from multi-dose ophthalmic solutions due to inadvertent contamination

Pregnancy Category: B

Lactation: Not known if excreted in milk; use caution

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

Histamine H1 antagonist, inhibits vascular permeability and release of histamine and other mediators involved in allergic response

Pharmacokinetics

Absorption: Extremely low systemic exposure

Half-Life: 3-4 hr

Metabolism: Liver