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  • CLASSES

    Ocular Decongestants, Sympathomimetics

    DEA CLASS

    Rx, OTC

    DESCRIPTION

    Ophthalmic vasoconstrictor used for redness and lubrication

    COMMON BRAND NAMES

    AK-Con, Albalon, All Clear, All Clear AR, Napha Forte, Naphcon Forte, Ocu-Zoline

    HOW SUPPLIED

    AK-Con/Albalon/Napha Forte/Naphazoline Hydrochloride/Naphcon Forte/Ocu-Zoline Ophthalmic Sol: 0.1%

    DOSAGE & INDICATIONS

    For use as a topical ocular vasoconstrictor in the treatment of conjunctival hyperemia.
    Ophthalmic dosage
    Adults

    Instill 1—2 drops in the conjunctival sac(s) every 3—4 hours as needed.

    MAXIMUM DOSAGE

    Adults

    16 drops/day in each eye

    Geriatric

    16 drops/day in each eye

    Adolescents

    Safety and efficacy not established.

    Children

    Safety and efficacy not established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustments are needed.

    Renal Impairment

    No dosage adjustments are needed.

    STORAGE

    AK-Con:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Albalon:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    All Clear:
    - Store at room temperature (between 59 to 86 degrees F)
    All Clear AR:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store between 59 to 77 degrees F
    Napha Forte:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Naphcon:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store at room temperature (between 59 to 86 degrees F)
    Naphcon Forte:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Ocu-Zoline :
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Closed-angle glaucoma

    Naphazoline causes vasoconstriction of conjunctival blood vessels, which may exacerbate the effects of glaucoma; thus, use of the prescription strength ophthalmic solution (i.e., naphazoline 0.1%) is contraindicated in patients with closed-angle glaucoma. Some over-the-counter ophthalmic solutions also contain naphazoline; however, they are formulated with a lower drug concentration (i.e., naphazoline 0.03% or less). Glaucoma patients should use these OTC products only after receiving approval from their prescriber.

    MAOI therapy

    Naphazoline should be used cautiously in patients receiving MAOI therapy as the combination of an MAOI and a sympathomimetic drug may result in hypertensive crisis.

    Children, infants, neonates

     The safety and efficacy of naphazoline ophthalmic solution have not been established in neonates, infants, children, and adolescents. Use in pediatric patients, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature.

    Contact lenses

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

    Cardiac disease, hypertension

    Naphazoline should be used with caution in patients with hypertension or cardiac disease as systemic absorption of the drug may result in increased blood pressure and cardiac irregularities.

    Hyperthyroidism

    Naphazoline should be used with caution in thyroid disease patients with hyperthyroidism, because they can be more sensitive to catecholamines.

    Diabetes mellitus

    Naphazoline should be used with caution in patients with diabetes mellitus as systemic absorption of the drug may result in hyperglycemia.

    Ocular infection, ocular trauma

    Use naphazoline ophthalmic solution with caution in the presence of ocular infection or ocular trauma.

    Pregnancy

    Naphazoline is classified as FDA pregnancy category C. It is not known if the drug 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. 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.

    ADVERSE REACTIONS

    Severe

    keratitis / Delayed / Incidence not known
    ocular hypertension / Delayed / Incidence not known
    coma / Early / Incidence not known
    bradycardia / Rapid / Incidence not known

    Moderate

    hypertension / Early / Incidence not known
    blurred vision / Early / Incidence not known
    hyperglycemia / Delayed / Incidence not known
    respiratory depression / Rapid / Incidence not known
    hypotension / Rapid / Incidence not known
    sinus tachycardia / Rapid / Incidence not known

    Mild

    mydriasis / Early / Incidence not known
    lacrimation / Early / Incidence not known
    ocular irritation / Rapid / Incidence not known
    hyperhidrosis / Delayed / Incidence not known
    drowsiness / Early / Incidence not known
    weakness / Early / Incidence not known
    headache / Early / Incidence not known
    dizziness / Early / Incidence not known
    nausea / Early / Incidence not known
    lethargy / Early / Incidence not known
    vomiting / Early / Incidence not known
    hypothermia / Delayed / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Naphazoline products.

    PREGNANCY AND LACTATION

    Pregnancy

    Naphazoline is classified as FDA pregnancy category C. It is not known if the drug 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. 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 stimulates alpha-adrenergic receptors in the arterioles of the conjunctiva. Ophthalmic administration causes vasoconstriction of conjunctival blood vessels thereby decreasing conjunctival congestion. When applied topically to mucous membranes, the drug causes vasoconstriction that shrinks the mucus membranes, promotes drainage, and improves ventilation.

    PHARMACOKINETICS

    Naphazoline is administered ophthalmically.

    Other Route(s)

    Ophthalmic Route
    After ophthalmic administration of naphazoline, local vasoconstriction usually occurs within 10 minutes and may persist for 2—6 hours.