CLASSES

Ocular Decongestants, Sympathomimetics

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

COMMON BRAND NAMES

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

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%

DOSAGE & INDICATIONS

MAXIMUM DOSAGE

8 drops/day in each affected eye.

8 drops/day in each affected eye.

8 drops/day in each affected eye.

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

DOSING CONSIDERATIONS

No dosage adjustments are needed.

No dosage adjustments are needed.

STORAGE

AK-Con-A:
- Store between 68 to 77 degrees F
Naphcon-A:
- Discard product if it contains particulate matter, is cloudy, or discolored
- Protect from light
- Store between 68 to 77 degrees F
Opcon-A:
- Protect from light
- Store at controlled room temperature (between 68 and 77 degrees F)
Visine Multi-Action Eye Allergy Relief:
- Store between 59 to 77 degrees F
Visine-A:
- Store at room temperature (between 59 to 86 degrees F)

CONTRAINDICATIONS / PRECAUTIONS

Naphazoline; pheniramine should be used cautiously in patients with closed-angle glaucoma.

Naphazoline; pheniramine should be used cautiously in patients with cardiac disease or hypertension.

Naphazoline; pheniramine should be used cautiously in patients with prostatic hypertrophy.

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.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Accidental oral ingestion in infants and children may lead to coma and marked reduction in body temperature.

Instruct patients to removed contact lenses prior to ophthalmic administration of naphazoline; phenylephrine. The inactive preservative, benzalkonium chloride, may be absorbed to the surface of soft contact lenses.

ADVERSE REACTIONS

conjunctival hyperemia / Early / Incidence not known

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

DRUG INTERACTIONS

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

PREGNANCY AND LACTATION

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.

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.