naphazoline/pheniramine ophthalmic (OTC)

Frequency Not Defined

Stinging/tingling sensation upon instillation

Mydriasis

Ocular erythema

Contraindications

Hypersensitivity

Cautions

For external use only

Do not use if solution becomes cloudy

Ask healthcare professional if diagnosed with narrow-angle glaucoma, hypertension, heart disease, or benign prostatic hypertrophy

Treatment may cause pupils to become enlarged temporarily, causing light sensitivity

Overuse may cause more eye redness

Remove contact lenses before using; wait 15 minutes after dosing to apply them back on

Do not touch tip of container to any surface to avoid contamination

Replace cap after each use

Ask healthcare practitioner if feel eye pain, changes in vision occur, or redness or irritation of the eyes gets worse or lasts more than 72 hours

Keep out of reach of children; if swallowed, get medical help or contact a Poison Control Center right away; accidental swallowing by infants and children may lead to coma and marked reduction in body temperature

Pregnancy

There are no or limited amount of data from use of topical ophthalmic naphazoline or pheniramine in pregnant women; animal studies are insufficient with respect to reproductive toxicity

Lactation

Unknown whether topical naphazoline/metabolites are excreted in human milk; however, a risk to suckling child cannot be excluded

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.

Absorption: Negligible systemic absorption

Mechanism of Action

Naphazoline: alpha-adrenergic agonist (decongestant)

Pheniramine: H1 blocker (antihistamine)