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  • CLASSES

    Artificial Tears and Ocular Lubricants
    High Dextrans
    Ocular Decongestants, Sympathomimetics

    DEA CLASS

    OTC, Rx

    DESCRIPTION

    Lubricant ophthalmic solutions or ointments for the temporary relief of xerophthalmia (dry eyes) or minor ocular irritations. Artificial tears products are of varying formulations; some products are preservative-free.

    COMMON BRAND NAMES

    Advanced Eye Relief, Akwa Tears, Artificial Tears, Bion Tears, Blink Tears, Clear eyes, Clear eyes Outdoor Dry Eye Protection, Eye Lubricant, FreshKote, Gen Teal Moderate to Severe, GenTeal, GenTeal Mild, GenTeal Moderate, GenTeal Severe, GenTeal Tears Mild, Gonak, Goniosoft, Hypo Tears, Lacrilube SOP, LiquiTears, LubriFresh P.M., Moisture Eyes, Moisture Eyes Preservative Free, Murine, Natural Balance Tears, Nature's Tears, Refresh, Refresh Celluvisc, Systane, Systane Balance, Systane Complete, Systane Ultra, Teargen, Tears Naturale Free, Tears Naturale II, TheraTears, Visine Dry Eye Relief, Visine Maximum Redness Relief, Visine Pure Tears, Visine Tears, Visine Tired Eye Relief

    HOW SUPPLIED

    Advanced Eye Relief/Akwa Tears/Artificial Tears/FreshKote/GenTeal Mild/Glycerin, Hypromellose, Polyethylene Glycol 400/Gonak/Goniosoft/Hypromellose/LiquiTears/Moisture Eyes Preservative Free/Polyvinyl Alcohol/Propylene Glycol/Systane Balance/Teargen/Visine Dry Eye Relief/Visine Maximum Redness Relief/Visine Pure Tears/Visine Tears/Visine Tired Eye Relief Ophthalmic Sol: 0.2%, 0.6%, 0.95%, 1.4%, 2.5%, 0.2-0.2-1%, 0.2-0.36-1%, 0.3-1%, 2.7-2%
    Akwa Tears/Lacrilube SOP/Lanolin, Mineral Oil, White Petrolatum Base/Mineral Oil, White Petrolatum Base Ophthalmic Ointment: 15-83%, 2-15-83%, 42.5-56.8%
    Bion Tears/Blink Tears/Clear eyes/Dextran, Hypromellose/GenTeal Moderate/GenTeal Tears Mild/Hypo Tears/Murine/Natural Balance Tears/Nature's Tears/Refresh/Refresh Celluvisc/Systane/Systane Ultra/Tears Naturale Forte/Tears Naturale II/TheraTears Ophthalmic Drops: 0.25%, 0.3%, 1%, 0.1-0.2-0.3%, 0.1-0.3%, 0.4-0.3%, 0.5-0.6%, 1-0.2-0.3%, 1-1%, 1.4-0.6%
    Dextran, Hypromellose/Gen Teal Moderate to Severe/GenTeal Severe/Moisture Eyes/Moisture Eyes Preservative Free/Systane/TheraTears Ophthalmic Gel: 0.3%, 1%, 0.1-0.8%, 0.25-0.3%

    DOSAGE & INDICATIONS

    For the temporary relief of xerophthalmia and minor ocular irritation.
    Ophthalmic dosage (eye solution and eye gel)
    Adults, Adolescents, and Children 6 years of age and older

    Instill 1 to 2 drops into the affected eye(s) 2 to 4 times per day as needed, adjusting frequency of application as needed. If necessary, may instill every hour (such as for ventilated critical care patients who are receiving neuromuscular blockers). Discontinue use of a particular non-prescription (OTC) product if ocular pain, ocular pruritus, or other ocular irritation symptoms occur or worsen, or if the condition has not improved within 72 hours of use of the product; the patient should consult a health care professional for ophthalmic evaluation.

    Children less than 6 years of age and Infants

    Instill 1 to 2 drops into the affected eye(s) 1 or more times per day as needed to relieve symptoms. Discontinue use of the specific product if ocular pain, ocular pruritus, or other ocular irritation symptoms occur or worsen, or if the condition has not improved within 72 hours of use of the product. A health care professional should evaluate young children prior to use of non-prescription (OTC) ophthalmic products.

    Ophthalmic dosage (eye ointment)
    Adults, Adolescents, and Children 6 years of age and older

    Apply a small amount of ointment, roughly 6 mm or one-fourth (1/4) inch, to the inside of the lower eyelid. Apply 1 to 4 times per day as needed, adjusting frequency of application as needed. It is common to apply the ointment just once daily at bedtime. If necessary, the ointment may be applied every few hours (such as for ventilated critical care patients who are receiving neuromuscular blockers). Discontinue non-prescription (OTC) use of the specific product if ocular pain, ocular pruritus, or other ocular irritation symptoms occur or worsen, or if the condition has not improved within 72 hours of use of the product; the patient should consult a health care professional for ophthalmic evaluation.

    Children less than 6 years of age and Infants

    Apply a small amount of ointment, roughly 6 mm or one-fourth (1/4) inch, to the inside of the lower eyelid. Apply 1 or more times per day as needed, adjusting frequency of application as needed. Discontinue use of the specific product if ocular pain, ocular pruritus, or other ocular irritation symptoms occur or worsen, or if the condition has not improved within 72 hours of use of the product. A health care professional should evaluate young children prior to use of non-prescription (OTC) ophthalmic products.

    MAXIMUM DOSAGE

    Adults

    No maximum dosage limit applies.

    Elderly

    No maximum dosage limit applies.

    Adolescents

    No maximum dosage limit applies.

    Children

    >= 6 years: No maximum dosage limit applies.
    < 6 years: No maximum dosage limit applies; consult health care professional before use.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustments are needed.

    Renal Impairment

    No dosage adjustments are needed.

    ADMINISTRATION

    Ophthalmic Administration

    For topical ophthalmic application only. Do not ingest internally.
    Wash hands well before use.
    Remove contact lenses prior to use unless the product specifies that contact lenses may be worn in application (e.g., Clear Eyes CLR).
     
    Artificial Tears ophthalmic solutions:
    If the patient has other eye drops of any type prescribed along with artificial tears, separate the application of the different eye drops by roughly 5 minutes. This ensures that the eye drops do not interfere with each other. If the patient is administered both eye drops and an eye ointment, use the eye drops 10 minutes before the eye ointment so that the eye ointment does not interfere with the action of the drops.
    Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch and close eyes for 1—2 minutes.
    Have the patient close the eye(s) gently for a few moments to allow contact.
    Care should be taken to avoid contamination. Do not touch the tip of the dropper to the eye, fingertips, or other surface. Replace cap when not in use.
    Use only one open bottle per patient to avoid contamination.
    If the solution changes color or becomes cloudy, discontinue use and obtain a new bottle.
     
    Artificial Tears ophthalmic ointments:
    If the patient is administered both eye drops and an eye ointment, use the eye drops 10 minutes before the eye ointment so that the eye ointment does not interfere with the action of the drops.
    Gently pull down the lower lid of the affected eye(s) and apply a small amount of ointment (roughly one-fourth (1/4) of an inch) to the inside of the eyelid.
    Have the patient close the eye(s) gently for a few moments to allow contact.
    Wipe away any excessive residue with a clean tissue.
    Care should be taken to avoid contamination. Do not touch the tip of the tube to the eye, fingertips, or other surface. Replace cap when not in use.
    Use only one open tube per patient to avoid contamination.

    STORAGE

    Generic:
    - Store at room temperature (between 59 to 86 degrees F)
    Advanced Eye Relief:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store between 59 to 77 degrees F
    Akwa Tears:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store at room temperature (between 59 to 86 degrees F)
    Akwa Tears Renewed:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Artificial Tears:
    - Avoid exposure to heat
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Bion Tears:
    - Store at room temperature (between 59 to 86 degrees F)
    Blink Tears:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    Clear eyes:
    - Store between 59 to 77 degrees F
    Clear eyes Outdoor Dry Eye Protection:
    - Store between 59 to 77 degrees F
    Eye Lubricant :
    - Avoid exposure to heat
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    FreshKote:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Store between 68 to 77 degrees F
    Gen Teal Moderate to Severe:
    - Store between 59 to 77 degrees F
    GenTeal :
    - Store at room temperature (between 59 to 86 degrees F)
    GenTeal Mild:
    - Store at room temperature (between 59 to 86 degrees F)
    GenTeal Moderate:
    - Store between 59 to 77 degrees F
    GenTeal Severe:
    - Store between 59 to 77 degrees F
    GenTeal Tears Mild:
    - Store at room temperature (between 59 to 86 degrees F)
    Gonak:
    - Store at room temperature (between 59 to 86 degrees F)
    Goniosoft:
    - Store at room temperature (between 59 to 86 degrees F)
    Hypo Tears :
    - Store at room temperature (between 59 to 86 degrees F)
    Isopto Tears:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Lacrilube SOP:
    - Avoid exposure to heat
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    LiquiTears:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store at room temperature (between 59 to 86 degrees F)
    LubriFresh P.M.:
    - Avoid exposure to heat
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Moisture Eyes:
    - Store between 59 to 77 degrees F
    Moisture Eyes Preservative Free:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Murine:
    - Store at room temperature (between 59 to 86 degrees F)
    Natural Balance Tears:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Nature's Tears:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Opti-Free:
    - Store at room temperature (between 59 to 86 degrees F)
    Puralube Tears:
    - Store at room temperature (between 59 to 86 degrees F)
    Refresh:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store at room temperature (between 59 to 86 degrees F)
    Refresh Celluvisc:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store at room temperature (between 59 to 86 degrees F)
    Refresh Endura:
    - Avoid exposure to heat
    - Protect from freezing
    Systane:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store at room temperature (between 59 to 86 degrees F)
    Systane Balance:
    - Store at room temperature (between 59 to 86 degrees F)
    Systane Complete:
    - Store at room temperature (between 59 to 86 degrees F)
    Systane Ultra:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store at room temperature (between 59 to 86 degrees F)
    Teargen:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store at room temperature (between 59 to 86 degrees F)
    Tears Naturale Forte:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Tears Naturale Free:
    - Store at room temperature (between 59 to 86 degrees F)
    Tears Naturale II:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Tears Renewed :
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Visine Dry Eye Relief:
    - Store at room temperature (between 59 to 86 degrees F)
    Visine Maximum Redness Relief:
    - Store between 59 to 77 degrees F
    Visine Pure Tears:
    - Store at room temperature (between 59 to 86 degrees F)
    Visine Tears:
    - Store at room temperature (between 59 to 86 degrees F)
    Visine Tired Eye Relief:
    - Store between 59 to 77 degrees F
    Viva:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Contact lenses

    Some artificial tears solutions are formulated with preservatives (e.g., benzalkonium chloride) that may be absorbed by soft contact lenses. It is recommended that contact lenses be removed prior to the administration of artificial tears products unless the product specifies that contact lenses may be worn in application (e.g., Clear Eyes CLR). Patients with contact lenses who present with eye irritation should be evaluated by a practitioner prior to self-treating the condition with artificial tears.

    Corneal abrasion, ocular infection, ocular trauma, visual disturbance

    Consult a health care professional for patient evaluation prior to use of artificial tears if corneal abrasion, ocular infection, foreign body trapping or ocular trauma is suspected. If visual disturbance is present, the patient requires evaluation by a practitioner to determine appropriate treatment.

    Pregnancy

    Artificial tears products have not been assigned a specific FDA pregnancy risk category rating. These ophthalmic products are not expected to pose significant problems during pregnancy due to lack of systemic absorption of the active vehicles. As with any drug in pregnancy, use should be determined by medical necessity and only under the direction of a health care provider. Select preservative-free products when possible, and limit use to the lowest dosage and shortest duration feasible to treat the condition.

    Children, infants, neonates

    If non-prescription artificial tears products are to be used in neonates, infants or children < 6 years, a health care professional should be consulted for evaluation prior to use.

    Breast-feeding

    Artificial tears ophthalmic products are not expected to pose significant problems during breast-feeding due to lack of systemic absorption of the active vehicles. As with any drug in breast-feeding, use should be determined by medical necessity and only under the direction of a health care provider. Select preservative-free products when possible, and limit use to the lowest dosage and shortest duration feasible to treat the condition. To minimize the amount of drug that reaches systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after each application.

    ADVERSE REACTIONS

    Moderate

    blurred vision / Early / Incidence not known
    contact dermatitis / Delayed / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Artificial Tears products.

    PREGNANCY AND LACTATION

    Pregnancy

    Artificial tears products have not been assigned a specific FDA pregnancy risk category rating. These ophthalmic products are not expected to pose significant problems during pregnancy due to lack of systemic absorption of the active vehicles. As with any drug in pregnancy, use should be determined by medical necessity and only under the direction of a health care provider. Select preservative-free products when possible, and limit use to the lowest dosage and shortest duration feasible to treat the condition.

    Artificial tears ophthalmic products are not expected to pose significant problems during breast-feeding due to lack of systemic absorption of the active vehicles. As with any drug in breast-feeding, use should be determined by medical necessity and only under the direction of a health care provider. Select preservative-free products when possible, and limit use to the lowest dosage and shortest duration feasible to treat the condition. To minimize the amount of drug that reaches systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after each application.

    MECHANISM OF ACTION

    The surface active properties of the vehicles found in artificial tears solutions act to stabilize the tear film and increase tear viscosity to prevent tear evaporation and retard tear drainage. Agents like povidone additionally mimic the action of mucin, the inner tear film layer that promotes wetting and adhesion of tears to the ocular surface. The vehicles found in bland lubricant artificial tear ointments also enhance the tear film and additionally have a prolonged duration of action in the eye versus artificial tear solutions.

    PHARMACOKINETICS

    Artificial tears solutions and ointments are applied topically to the eye.

    Other Route(s)

    Ophthalmic Route
    Ointments are not systemically absorbed and contain no medicated ingredients. No pharmacokinetic data are available for ophthalmic solutions; it is expected that the formulas act locally and are not systemically absorbed.