P - Caution when used during pregnancy
L - Caution when used during lactation
Naphazoline (in the hydrochloride form) is the common name for 2-(1-naphthylmethyl)-2-imidazoline hydrochloride. It is a sympathomimetic agent with marked alpha adrenergic activity. It is a vasoconstrictor with a rapid action in reducing swelling when applied to mucous membrane. It acts on alpha-receptors in the arterioles of the conjunctiva to produce constriction, resulting in decreased congestion. It is an active ingredient in several over-the-counter formulations including Clear Eyes and Naphcon eye drops.
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Ocular: Mydriasis, increased redness, irritation, discomfort, blurring, punctate keratitis, lacrimation, increased intraocular pressure.
Systemic: Dizziness, headache, nausea, sweating, nervousness, drowsiness, weakness, hypertension, cardiac irregularities, and hyperglycemia.
General
Use with caution in the presence of hypertension, cardiovascular abnormalities, hyperglycemia (diabetes), hyperthyroidism, infection or injury.
Information for patients
Patients should be advised to discontinue the drug and consult a physician if relief is not obtained within 48 hours of therapy, if irritation, blurring or redness persists or increases, or if symptoms of systemic absorption occur, i.e., dizziness, headache, nausea, decrease in body temperature, or drowsiness.
To prevent contaminating the dropper tip and solution, do not touch the eyelids or the surrounding area with the dropper tip of the bottle. If solution changes color or becomes cloudy, do not use.
NOT FOR INJECTION INTO THE EYE - FOR TOPICAL USE ONLY.
Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. Use in pediatric patients, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature.
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Instill one or two drops into the conjunctival sac(s) every three to four hours as needed.
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Category C
Animal reproduction studies have not been conducted with Naphazoline. It is also not known whether Naphazoline can cause fetal harm when administered to a pregnant woman or can effect reproduction capacity. Naphazoline should be given to a pregnant woman only if clearly needed.
It is not known whether Naphazoline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naphazoline is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established. See "WARNINGS" and "CONTRAINDICATIONS".
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Contraindicated in the presence of an anatomically narrow angle or in narrow angle glaucoma or in persons who have shown hypersensitivity to any component of this preparation.
Store between 15°- 30°C (59°-86°F).
DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.
KEEP OUT OF REACH OF CHILDREN.
Store between 15°- 30°C (59°-86°F).
DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.
KEEP OUT OF REACH OF CHILDREN.
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