Naphcon-A

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Naphcon-A

Classes

Ocular Decongestants, Sympathomimetics

Adverse Reactions
Moderate

conjunctival hyperemia / Early / Incidence not known

Mild

ocular pain / Early / Incidence not known
ocular irritation / Rapid / Incidence not known

Common Brand Names

AK-Con-A, Naphcon-A, Opcon-A, Visine Multi-Action Eye Allergy Relief, Visine-A

Dea Class

OTC

Description

Combination of an ocular antihistamine and decongestant
Used for the temporary relief of redness and itching of the eye due to pollen, ragweed, grass, animal hair and dander
Use should be discontinued if symptoms worsen or persist for more than 72 hours

Dosage And Indications
For the temporary relief of ocular pruritus and conjunctival hyperemia caused by pollen, ragweed, grass, and animal hair and dander. Ophthalmic dosage Adults, Adolescents, and Children >= 6 years

Instill 1—2 drops into the affected eye(s) up to 4 times daily.

Dosing Considerations
Hepatic Impairment

No dosage adjustments are needed.

Renal Impairment

No dosage adjustments are needed.

Drug Interactions

There are no drug interactions associated with Naphazoline; Pheniramine products.

How Supplied

Naphazoline Hydrochloride, Pheniramine/Naphazoline Hydrochloride, Pheniramine Maleate/Opcon-A/Visine Multi-Action Eye Allergy Relief Ophthalmic Sol: 0.025-0.3%, 0.0268-0.315%

Maximum Dosage
Adults

8 drops/day in each affected eye.

Geriatric

8 drops/day in each affected eye.

Adolescents

8 drops/day in each affected eye.

Children

>= 6 years: 8 drops/day in each affected eye.
< 6 years: Safety and efficacy have not been established.

Mechanism Of Action

Naphazoline: Naphazoline stimulates alpha-adrenergic receptors in the arterioles of the conjunctiva. Ophthalmic administration causes vasoconstriction of conjunctival blood vessels thereby decreasing conjunctival congestion.
Pheniramine: Pheniramine is an H1-receptor antagonist.

Pharmacokinetics

Naphazoline; pheniramine is administered ophthalmically.

Pregnancy And Lactation
Pregnancy

Naphazoline; pheniramine is in FDA pregnancy category C. Limited human data suggest a possible relationship between oral administration of pheniramine in the first trimester and respiratory malformations and eye/ear defects. However, when used anytime during pregnancy, no association to congential abnormalities was found. Additionally, it is not known if naphazoline can cause fetal harm when administered to a pregnant woman. Limited data have not demonstrated a clinically significant effect on the fetus during first trimester exposure of naphazoline; however, other sympathomimetic drugs have been associated with minor malformations, inguinal hernia, and clubfoot. According to the manufacturer, naphazoline should be given to a pregnant woman only if clearly needed.

According to the manufacturer, it is not known whether naphazoline is excreted in human milk. Because the systemic concentrations of naphazoline would be expected to be low following ocular administration, it is likely that the risk of exposure of the drug to a nursing infant would be minimal. No data are available regarding the use of pheniramine during breast-feeding. 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 ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.