Artificial Tears

Pharmacologic Category

Ophthalmic Agent, Miscellaneous

Dosing: Adult

Ocular dryness/irritation: Ophthalmic: 1-2 drops into eye(s) as needed to relieve symptoms

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Ocular dryness/irritation: Infants, Children, and Adolescents: Ophthalmic:

Gel; Solution: 1 to 2 drops into eye(s) as needed to relieve symptoms

Ointment: Apply small amount (~1/4 inch) to inside of the eyelid(s) one or more times daily

Dry eye associated with ocular inflammation (eg, blepharitis, conjunctivitis, keratitis): Limited data available: Infants, Children, and Adolescents: Ophthalmic 1 to 2 drops into eye(s) at least twice daily or as needed to relieve symptoms (Sethuraman 2009)

Use: Labeled Indications

Ophthalmic lubricant; for temporary relief of burning and eye irritation due to dry eyes

Administration: Pediatric

Ophthalmic: Wash hands thoroughly before administration; do not touch tip of container to the eye or any surface; replace cap after use. Some products should not be used with contact lenses; consult specific product information.

Storage/Stability

Store at room temperature.

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat dry eyes.

• It is used to treat eye irritation.

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Vision changes

• Eye pain

• Severe eye irritation

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

Warnings/Precautions

Special populations:

• Contact lens wearers: Ophthalmic solutions may contain benzalkonium chloride which may be absorbed by contact lenses. Remove contact lenses before using.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer’s labeling.

• Preservative free formulations: Preservative free formulations are preferred in patients with severe dry eye or patients on multiple eye drops for chronic disease. Once opened, single use containers should be discarded; do not reuse.

Other warnings/precautions:

• Self-medication (OTC use): When used for self-medication (OTC), stop use and contact healthcare provider if changes in vision, eye pain, continued redness or irritation occur, or if the condition worsens or persists for more than 72 hours. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. Do not use if solution is cloudy or changes color.

Geriatric Considerations

Evaluate the patient's or caregiver's ability to safely administer the correct dose of ophthalmic medication.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Adverse Reactions

Frequency not defined.

Ophthalmic: Blurred vision, crusting of eyelid, stinging of eyes (mild)

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

There are no known significant interactions.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Gel, ophthalmic:

Systane: Polyethylene glycol 400 0.4% and propylene glycol 0.3% (10 mL, 15 mL)

Ointment, ophthalmic:

Altalube: Petrolatum 83% and mineral oil 15% (3.5 g)

GenTeal Tears Night-Time: Petrolatum 94% and mineral oil 3% (3.5 g)

Puralube: Petrolatum 85% and mineral oil 15% (3.5 g)

Refresh Lacri-Lube: Petrolatum 83% and mineral oil 15% (3.5 g, 7 g)

Tears Naturale PM: Petrolatum 94% and mineral oil 3% (3.5 g) [contains lanolin]

Ointment, ophthalmic [preservative free]:

HypoTears: Petrolatum 83% and mineral oil 15% (3.5 g)

LubriFresh P.M.: Petrolatum 83% and mineral oil 15% (3.5 g)

Puralube: Petrolatum 85% and mineral oil 15% (1 g)

Refresh P.M.: Petrolatum 83% and mineral oil 15% (3.5 g)

Systane Nighttime: Petrolatum 94% and mineral oil 3% (3.5 g)

Tears Again: Petrolatum 83% and mineral oil 15% (3.5 g)

Solution, ophthalmic:

Advanced Eye Relief Dry Eye Environmental: Glycerin 1% (15 mL) [contains benzalkonium chloride]

Advanced Eye Relief Dry Eye Rejuvenation: Glycerin 0.3% and propylene glycol 1% (30 mL) [contains benzalkonium chloride]

Artificial Tears: Glycerin 0.2%, hydroxypropyl methylcellulose 0.2%, and polyethylene glycol 400 1% (15 mL) [contains benzalkonium chloride, edetate disodium]

GenTeal Tears Mild: Dextran 70 0.1%, and hydroxypropyl methylcellulose 2910 0.3% (15 mL)

GenTeal Tears Moderate: Dextran 70 0.1%, glycerin 0.2%, and hydroxypropyl methylcellulose 2910 0.3% (15 mL)

GoodSense Artificial Tears: Polyvinyl alcohol 0.5% and povidone 0.6% (15 mL) [contains benzalkonium chloride, edetate disodium]

HypoTears: Polyvinyl alcohol 1% and polyethylene glycol 400 1% (30 mL) [contains benzalkonium chloride]

LiquiTears: Polyvinyl alcohol 1.4% (15 mL [DSC]) [contains benzalkonium chloride, edetate disodium]

Murine Tears: Polyvinyl alcohol 0.5% and povidone 0.6% (15 mL) [contains benzalkonium chloride]

Natural Balance Tears: Dextran 70 0.1% and hydroxypropyl methylcellulose 2910 0.3% (15 mL) [contains benzalkonium chloride, edetate disodium]

Natures Tears: Dextran 70 0.1% and hydroxypropyl methylcellulose 2910 0.3 % (15 mL [DSC]) [contains benzalkonium chloride, edetate disodium]

Soothe Hydration: Povidone 1.25% (15 mL)

Systane Balance: Propylene glycol 0.6% (10 mL)

Systane Complete: Propylene glycol 0.6% (10 mL) [contains edetate disodium]

Systane Ultra: Polyethylene glycol 400 0.4% and propylene glycol 0.3% (4 mL, 10 mL)

Systane: Polyethylene glycol 400 0.4% and propylene glycol 0.3% (5 mL, 15 mL, 30 mL)

Tears Again: Polyvinyl alcohol 1.4% (15 mL [DSC], 30 mL [DSC]) [contains benzalkonium chloride]

Tears Naturale II: Dextran 70 0.1% and hydroxypropyl methylcellulose 2910 0.3% (15 mL [DSC])

Solution, ophthalmic [preservative free]:

Bion Tears: Dextran 70 0.1% and hydroxypropyl methylcellulose 2910 0.3% per 0.4 mL (28s [DSC])

FreshKote PF: Polyvinyl alcohol 2.7% and povidone 2% (10 mL) [contains edetate disodium]

GenTeal Tears Mild: Dextran 70 0.1%, and hydroxypropyl methylcellulose 2910 0.3% (36s)

GenTeal Tears PF: Dextran 70 0.1% and Hydroxypropyl methylcellulose 2910 0.3% (36s)

GoodSense Lubricant Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3% (30s)

Soothe: Glycerin 0.6% and propylene glycol 0.6% per 0.6 mL (28s)

Systane Preservative Free: Polyethylene glycol 400 0.4% and propylene glycol 0.3% per 0.4 mL (28s, 30s)

Systane Ultra PF: Polyethylene glycol 400 0.4% and propylene glycol 0.3% per 0.4 mL (24s [DSC], 25s, 60s)

Tears Naturale Free: Dextran 70 0.1% and hydroxypropyl methylcellulose 2910 0.3% per 0.5 mL (36s [DSC], 60s [DSC])

Viva-Drops: Polysorbate 80 1% (0.5 mL, 10 mL)

Anatomic Therapeutic Chemical (ATC) Classification

• S01XA20

Generic Available (US)

Yes

Pricing: US

Gel (Systane Ophthalmic)

0.4-0.3% (per mL): $1.15

Ointment (Altalube Ophthalmic)

85-15% (per gram): $0.82

Ointment (Puralube Ophthalmic)

85-15% (per gram): $3.58

Solution (Bion Tears PF Ophthalmic)

0.1-0.3% (per each): $0.50

Solution (Dakrina Ophthalmic)

2.7-2% (per mL): $0.46

Solution (Dwelle Ophthalmic)

2.7-2% (per mL): $0.46

Solution (FreshKote Ophthalmic)

2.7-2% (per mL): $2.22

Solution (FreshKote PF Ophthalmic)

2.7-2% (per mL): $3.36

Solution (GenTeal Tears Moderate PF Ophthalmic)

0.1-0.3% (per each): $0.30

Solution (GenTeal Tears Ophthalmic)

0.1-0.2-0.3% (per mL): $0.44

0.1-0.3% (per mL): $0.44

Solution (GenTeal Tears PF Ophthalmic)

0.1-0.3% (per each): $0.30

Solution (NutraTear Ophthalmic)

0.6% (per mL): $0.40

Solution (Polyvinyl Alcohol Ophthalmic)

1.4% (per mL): $0.66

Solution (Refresh Ophthalmic)

1.4-0.6% (per each): $0.34

Solution (Systane Complete Ophthalmic)

0.6% (per mL): $1.00

Solution (Systane Hydration PF Ophthalmic)

0.4-0.3% (per each): $0.57

Solution (Systane Ophthalmic)

0.4-0.3% (per mL): $0.72

Solution (Systane Preservative Free Ophthalmic)

0.4-0.3% (per each): $0.39

Solution (Systane Ultra Ophthalmic)

0.4-0.3% (per mL): $0.86

Solution (Systane Ultra PF Ophthalmic)

0.4-0.3% (per each): $0.47

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Products contain demulcents (ie, cellulose derivatives, dextran 70, gelatin, polyols, polyvinal alcohol, or povidone); usually a water-soluble polymer, applied topically to the eye to protect and lubricate mucous membrane surfaces and relieve dryness and irritation

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Hydroxyethylcellulose; Polyvinyl Alcohol

References

Alade SL, Brown RE, Paquet A. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597.[PubMed 3960626]

American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Artificial Tears [prescribing information]. Lake Forest, IL: Akorn, Inc; January 2014.

Calonge M, "The Treatment of Dry Eye," Surv Ophthalmol, 2001, 45(Suppl 2):227-39.[PubMed 11587147]

Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm[PubMed 6423951]

Cogen MS, Parker JS, Sleep TE, Elsas FJ, Metz TH Jr, McGwin G Jr. Masked trial of topical anesthesia for retinopathy of prematurity eye examinations. J AAPOS. 2011;15(1):45-48.[PubMed 21397805]

Craiglow BG. Ichthyosis in the newborn. Semin Perinatol. 2013;37(1):26-31.[PubMed 23419760]

Freshkote (polyvinyl alcohol and povidone) [prescribing information]. Fort Worth, TX: Eyevance Pharmaceuticals, LLC; received May 2019.

Harvey HB, Shaw MG, Morrell DS. Perinatal management of harlequin ichthyosis: a case report and literature review. J Perinatol. 2010;30(1):66-72.[PubMed 20038941]

Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313.[PubMed 12534540]

Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172.[PubMed 10985636]

"Management and Therapy of Dry Eye Disease: Report of the Management and Therapy Subcommittee of the International Dry Eye WorkShop (2007)," Ocul Surf, 2007, 5(2):163-78.[PubMed 17508120]

Puralube (artificial tears) [prescribing information]. Minneapolis, MN: Perrigo; August 2014.

Refresh Optive (artificial tears) [prescribing information]. Irvine, CA: Allergan, Inc; 2016.

Sethuraman U and Kamat D, "The Red Eye: Evaluation and Management," Clin Pediatr (Phila), 2009, 48(6):588-600.[PubMed 19357422]

Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259.[PubMed 19188870]

Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313.[PubMed 7746084]

Systane (artificial tears) [prescribing information]. Ft. Worth, TX: Alcon Laboratories, Inc; June 2016.

Brand Names: International

Acuolens (ES); Aquatears (IN); Artelac (AR, AT, BE, BG, BR, DE, DK, EE, EG, FI, FR, GB, IL, KR, LT, MX, NL, NO, PH, PL, PT, SE, SG, UA, UY); Artelac Advanced (AE); Artific (ES); Artificial Tears (RU); Atear (VN); Atier (BD); Bio Tears (AR); Bion Tears (AU, CN, HK, MY, SE, SG); Blink (GB); Blink-N-Clean (AU); Celoftal (DE); Coatel (PY); Dacriosol (DK, IT); Dacrolux (ES, HU, MY, TR); Davilose (PT); Eye Glo Moist (PH); Eye Mo Moist (MY, SG); Eysol (IN); Gen Teal (KR); Genteal (AE, AR, AU, BR, CO, DE, HK, ID, IL, IN, IT, MX, MY, NZ, PE, PH, SG, TH, VE, VN); Hydromoor (GB); Hypotears (IT, MY, PH, SG); Hypotears E (IL); Hypotears Plus (AR, BR, IN, MX, VE); Hypromax (PH); Hyprosan (DK, FI, NO, SE); Insto Moist (ID); Isopto Plain (FI, GB, SE); Isopto Tears (BE, CH, HK, HR); Kliner (CL); Lac-Oph (HK); Lacribell (BR); Lacrigel (IN); Lacrigestina (AR); Lacril (BR, DK); Lacrilux (IT); Lacrimal (PL); Lacrimal OK (DE); Lacrisan (IN); Lacrisifi (RU); Lacrisol (IT); Lacrisyn (RU); Lagrifilm Plus (MX); Lagrifresh (CO); Liquifilm (AU, BE, DE, FI, HK, MY, NZ, PT); Liquifilm Lagrimas (ES); Liquifilm Tears (GB, IL, IN, SG, TH); Liquifresh (ES); Liquitears (CH); Lubric (BD); Lubrilac (GR); Luvis (CL); Luvistar (MX); Minims Artificial Tears (GB); Murine (AU); Murine Bright & Moist Eyes (GB); Murine Hayfever (GB); Murine Plus (SG); Murine Revital Eyes (AU); Murine Sore Eyes (AU); Murine Tears (AU); Natear (TH); Novo Tears (UY); Novo-Tears (CL, PY); Novotears (EC, PE); Ocutear (BD); Ocutears (AR); Onufrid (GR); Optal-Tears (TH); Optear (IN); Opti-Tears (BR, VN); OptiFresh (VE); Plenox (AR); Poly-Tears (AU, NZ, VN); Protear Plus (BD); Red Off Aqua (CL); Refresh (AU, BR, CR, DO, FR, GB, GR, GT, HK, HN, IL, KR, MX, NI, NZ, PA, SG, SV, TH, TR, ZA); Refresh Celluvisc (CN); Refresh Liquigel (AE, AR, AU, CL, CR, DO, GT, HN, KR, MX, NI, PA, SG, SV, TR, VE, ZA); Refresh Plus (AE, CN, GR, KR, MY, SG); Refresh Tears (AE, CL, CR, DO, GT, HN, IL, MX, MY, NI, PA, SG, SV, VE, ZA); Refresh Tears Plus (AU, NZ); RefreshTears (AR); Sanvisc (IN); Siccaprotect (CH, CZ, DE, TR); Sincon (SE); Softdrops (GB); Spersatear (ZA); Systane (AE, AR, AU, BR, CL, CN, CR, DE, DO, FR, GB, GT, HK, HN, ID, IL, IT, KR, MX, MY, NI, PA, PH, SG, SV, TH, TR, VE); Systane Balance (CR, DO, GT, HN, KR, MY, NI, PA, PH, PL, SG, SV); Systane Gel (PL); Systane Ultra (AE, CR, DO, GT, HN, KR, NI, PA, PL, SV); Tears (ID); Tears Natural (IL); Tears Naturale (AU, BE, CH, CL, CO, CZ, EE, EG, GR, HK, HR, HU, LT, MX, MY, NL, NO, NZ, PL, RU, SG, TH, TR, UA, ZA); Tears Naturale Forte (AR, CN, HK); Tears Naturale Free (CO); Tears Naturale II (BG, CN, ID, PE, VN); Unitears (PE); Vidilac (GR); Viscosan (AT)

Last Updated 4/29/20