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, Alcon Tears, Artificial Tears, Bion Tears, Blink Tears, Clear eyes, Clear eyes Advance Dry and Itchy Relief, Clear eyes Outdoor Dry Eye Protection, Eye Lubricant, FreshKote, Gen Teal Moderate to Severe, GenTeal, GenTeal Moderate, GenTeal Tears Mild, GenTeal Tears Severe Dry Eye, Gonak, Goniosoft, Hypo Tears, Isopto Tears, LiquiTears, LubriFresh P.M., Moisture Eyes, Moisture Eyes Preservative Free, Murine, Natural Balance Tears, Nature's Tears, Opti-Free, Refresh, Refresh Celluvisc, Refresh Lacri-Lube, Refresh Liquigel, Systane, Systane Balance, Systane Complete, Systane Ultra, Teargen, Tears Naturale Free, Tears Naturale II, TheraTears, Visine Dry Eye Relief, Visine Pure Tears, Visine Tears

HOW SUPPLIED

Advanced Eye Relief/Akwa Tears/Artificial Tears/Clear eyes/Clear eyes Advance Dry and Itchy Relief/Dextran 70, Glycerin, Hypromellose/FreshKote/Glycerin, Hypromellose, Polyethylene Glycol 400/Gonak/Goniosoft/Hypromellose/LiquiTears/Moisture Eyes Preservative Free/Polyvinyl Alcohol/Propylene Glycol/Systane Balance/Systane Complete/Teargen/Visine Dry Eye Relief/Visine Maximum Redness Relief/Visine Pure Tears/Visine Tears Ophthalmic Sol: 0.25%, 0.6%, 0.95%, 1.4%, 2.5%, 0.1-0.2-0.3%, 0.2-0.2-1%, 0.3-1%, 2.7-2%
Akwa Tears/Artificial Tears/Eye Lubricant/Lanolin, Mineral Oil, White Petrolatum Base/LubriFresh P.M./Mineral Oil, White Petrolatum Base/Refresh Lacri-Lube Ophthalmic Ointment: 15-83%, 2-15-83%, 42.5-56.8%
Bion Tears/Blink Tears/Clear eyes/Dextran 70, Hypromellose 2910/GenTeal Moderate/Hypo Tears/Hypromellose/Murine/Refresh/Refresh Celluvisc/Refresh Liquigel/Systane/Systane Ultra/Tears Naturale Forte/TheraTears Ophthalmic Drops: 0.25%, 0.3%, 0.5%, 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%
Carboxymethylcellulose Sodium/Dextran, Hypromellose/Gen Teal Moderate to Severe/GenTeal Tears Severe Dry Eye/Moisture Eyes/Moisture Eyes Preservative Free/Systane/TheraTears Ophthalmic Gel: 0.3%, 1%, 0.1-0.8%, 0.25-0.3%

DOSAGE & INDICATIONS

MAXIMUM DOSAGE

No maximum dosage limit applies.

No maximum dosage limit applies.

No maximum dosage limit applies.

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

DOSING CONSIDERATIONS

No dosage adjustments are needed.

No dosage adjustments are needed.

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 opened bottle after 90 days
- 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)
Alcon Tears:
- Store at room temperature
Artificial Tears:
- Store between 15 to 30 degrees C (59 - 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:
- Discard product if it contains particulate matter, is cloudy, or discolored
- Store at room temperature (between 59 to 86 degrees F)
Clear eyes Advance Dry and Itchy Relief:
- Store at room temperature
Clear eyes Outdoor Dry Eye Protection:
- Discard product if it contains particulate matter, is cloudy, or discolored
- Store at room temperature (between 59 to 86 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 at room temperature
GenTeal Severe:
- Store between 59 to 77 degrees F
GenTeal Tears Mild:
- Discard product if it contains particulate matter, is cloudy, or discolored
- Store at room temperature (between 59 to 86 degrees F)
GenTeal Tears Severe Dry Eye:
- Store between 59 to 77 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:
- Discard product if it contains particulate matter, is cloudy, or discolored
- Store at room temperature
LiquiTears:
- Discard opened bottle after 90 days
- 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:
- Discard product if it contains particulate matter, is cloudy, or discolored
- Store at room temperature (between 59 to 86 degrees F)
Natural Balance Tears:
- Store between 59 to 77 degrees F
Nature's Tears:
- Store between 59 to 77 degrees F
Opti-Free:
- Store at room temperature
Puralube Tears:
- Store at room temperature (between 59 to 86 degrees F)
Refresh:
- Discard opened bottle after 30 days
- Discard product if it contains particulate matter, is cloudy, or discolored
- Store at room temperature (between 59 to 86 degrees F)
Refresh Celluvisc:
- Discard opened bottle after 30 days
- 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
Refresh Lacri-Lube:
- Avoid exposure to heat
- Protect from freezing
- Store at room temperature (between 59 to 86 degrees F)
Refresh Liquigel:
- Discard opened bottle after 30 days
- Discard product if it contains particulate matter, is cloudy, or discolored
- Store at room temperature (between 59 to 86 degrees F)
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
Systane Complete:
- Store at room temperature
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 opened bottle after 90 days
- 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:
- Discard product if it contains particulate matter, is cloudy, or discolored
- Store at room temperature (between 59 to 86 degrees F)
Tears Naturale II:
- Store between 59 to 77 degrees F
Tears Renewed :
- Store at controlled room temperature (between 68 and 77 degrees F)
TheraTears:
- Discard product if it contains particulate matter, is cloudy, or discolored
- Discard unused portion. Do not store for later use.
- See package insert for detailed storage information
Visine Dry Eye Relief:
- Store between 15 to 30 degrees C (59 - 86 degrees F)
Visine Maximum Redness Relief:
- Store between 59 to 77 degrees F
Visine Pure Tears:
- Store between 15 to 30 degrees C (59 - 86 degrees F)
Visine Tears:
- Store between 15 to 30 degrees C (59 - 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

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.

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.

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.

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.

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

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

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.