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  • 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-A

    HOW SUPPLIED

    Naphcon-A Ophthalmic Drops: 0.025-0.3%
    Opcon-A/Visine-A Ophthalmic Sol: 0.025-0.3%, 0.027-0.3%

    DOSAGE & 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.

    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.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustments are needed.

    Renal Impairment

    No dosage adjustments are needed.

    STORAGE

    Generic:
    - Protect from light
    - Store between 68 to 77 degrees F
    AK-Con-A:
    - Store between 68 to 77 degrees F
    Naphcon-A:
    - Store between 68 to 77 degrees F
    Opcon-A:
    - Protect from light
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Visine-A:
    - Store between 68 to 77 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Closed-angle glaucoma

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

    Cardiac disease, hypertension

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

    Prostatic hypertrophy

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

    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.

    Breast-feeding

    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.

    Children, infants

    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.

    Contact lenses

    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

    Moderate

    conjunctival hyperemia / Early / Incidence not known

    Mild

    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

    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.

    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.