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Artificial tears (Ophthalmic lubricants: solutions, gels, ointments): Pediatric drug information

Artificial tears (Ophthalmic lubricants: solutions, gels, ointments): Pediatric drug information
(For additional information see "Artificial tears (Ophthalmic lubricants: solutions, gels, ointments): Drug information" and see "Artificial tears (Ophthalmic lubricants: solutions, gels, ointments): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Special Alerts
Over-the-Counter Eye Drop Safety Alert October 2023

The FDA is alerting patients and health care providers that multiple OTC ophthalmic drop products should no longer be used or purchased after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. These findings show a potential risk of ophthalmic infections that could result in partial vision loss or blindness. Patients who have signs or symptoms of an ophthalmic infection after using these products should talk to their health care provider or seek medical care immediately. The affected products are marketed under various brand names (eg, CVS Health, Rugby, Velocity Health, etc.). The FDA has recommended that the manufacturer recall all lots of these products.

Further information, including the list of impacted products, may be found at https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye

Artificial Eye Ointment Safety Alert February 2023

Global Pharma Healthcare is initiating a recall of Delsam Pharma’s Artificial Eye Ointment due to possible contamination with Verona Integron–mediated Metallo-β-lactamase– and Guiana extended-spectrum β-lactamase–producing carbapenem-resistant Pseudomonas aeruginosa. Adverse events, including ophthalmic infections, permanent vision loss, and a death with a bloodstream infection, have been reported.

More information is available at https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-ezricare-artificial-tears-due-potential-contamination.

Brand Names: US
  • Advanced Eye Relief Dry Eye Environmental [OTC];
  • Advanced Eye Relief Dry Eye Rejuvenation [OTC];
  • Altalube [OTC];
  • Artificial Eye [OTC] [DSC];
  • Artificial Tears [OTC];
  • Bion Tears [OTC] [DSC];
  • FreshKote PF [OTC];
  • GenTeal Tears Mild [OTC];
  • GenTeal Tears Moderate [OTC];
  • GenTeal Tears Night-Time [OTC];
  • GenTeal Tears PF [OTC];
  • GenTeal Tears Severe Day/Night [OTC];
  • GoodSense Artificial Tears [OTC];
  • GoodSense Lubricant Eye Drops [OTC] [DSC];
  • HypoTears [OTC];
  • LubriFresh P.M. [OTC] [DSC];
  • Murine Tears [OTC];
  • Natural Balance Tears [OTC];
  • Natures Tears [OTC] [DSC];
  • Puralube [OTC];
  • Refresh Lacri-Lube [OTC];
  • Refresh P.M. [OTC];
  • Soothe Hydration [OTC];
  • Soothe [OTC];
  • Systane Balance [OTC];
  • Systane Complete [OTC];
  • Systane Hydration PF [OTC];
  • Systane Nighttime [OTC];
  • Systane Preservative Free [OTC];
  • Systane Ultra PF [OTC];
  • Systane Ultra [OTC];
  • Systane [OTC];
  • Tears Again [OTC] [DSC];
  • Tears Naturale II [OTC] [DSC];
  • Tears Naturale PM [OTC];
  • Vista Meibo Tears [OTC];
  • Vista Tears [OTC];
  • Viva-Drops [OTC]
Therapeutic Category
  • Ophthalmic Agent, Miscellaneous
Dosing: Neonatal

Note: Numerous products available, containing variable ingredients; ensure products containing propylene glycol or benzoate derivatives are NOT used in neonatal population; consult product specific labeling.

Ocular dryness/irritation or dry eye associated with ocular inflammation

Ocular dryness/irritation or dry eye associated with ocular inflammation: Limited data available (Ref): Ophthalmic: Preservative-free dosage form:

Gel, Solution: 1 drop into eye(s) as needed to relieve symptoms

Ointment: Apply small amount to inside of the eyelid(s) one or more times daily

Dosing: Pediatric
Ocular dryness/irritation

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

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 (Ref)

Dosing: Adult

(For additional information see "Artificial tears (Ophthalmic lubricants: solutions, gels, ointments): Drug information")

Ocular dryness/irritation

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

Adverse Reactions

There are no adverse reactions listed in the manufacturer's labeling.

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.

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).

Dosage Forms: US

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

Gel, ophthalmic:

GenTeal Tears Severe Day/Night: Polyethylene glycol 400 0.4% and propylene glycol 0.3% (8 mL)

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)

Artificial Eye: Petrolatum 83% and mineral oil 15% (3.5 g [DSC])

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 [DSC])

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]

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])

Vista Tears: Polyethylene glycol 0.4% and propylene glycol 0.3% (10 mL)

Vista Meibo Tears: Propylene glycol 0.6% (10 mL)

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 [DSC])

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

Systane Hydration PF: Polyethylene glycol 400 0.4% and propylene glycol 0.3% (30s)

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)

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

Generic Equivalent Available: US

Yes

Pricing: US

Gel (GenTeal Tears Severe Day/Night Ophthalmic)

0.4-0.3% (per mL): $1.25

Gel (Systane Ophthalmic)

0.4-0.3% (per mL): $1.24

Ointment (Altalube Ophthalmic)

85-15% (per gram): $0.82

Solution (Bion Tears PF Ophthalmic)

0.1-0.3% (per each): $0.53

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): $0.33

Solution (GenTeal Tears Ophthalmic)

0.1-0.2-0.3% (per mL): $0.47

Solution (GenTeal Tears PF Ophthalmic)

0.1-0.3% (per each): $0.30

Solution (Polyvinyl Alcohol Ophthalmic)

1.4% (per mL): $0.49 - $0.66

Solution (Refresh Ophthalmic)

1.4-0.6% (per each): $0.37

Solution (Systane Complete Ophthalmic)

0.6% (per mL): $1.07

Solution (Systane Hydration PF Ophthalmic)

0.4-0.3% (per mL): $1.17

Solution (Systane Ophthalmic)

0.4-0.3% (per mL): $0.77

Solution (Systane Preservative Free Ophthalmic)

0.4-0.3% (per each): $0.42

Solution (Systane Ultra Ophthalmic)

0.4-0.3% (per mL): $0.92

Solution (Systane Ultra PF Ophthalmic)

0.4-0.3% (per mL): $1.07

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.

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.

Use

Ophthalmic lubricant; for temporary relief of burning and eye irritation due to dry eyes; protectant against further irritation (OTC: FDA approved in adults; refer to product-specific information regarding FDA approval in pediatric patients); has also been used for symptomatic treatment of dry eye associated with conjunctivitis, blepharitis, and keratitis

Medication Safety Issues
Sound-alike/look-alike issues:

Isopto® Tears may be confused with Isoptin®

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (QA) Qatar: Duratears | Hypotears Plus | Isotears | Optifresh (Jamjoom) | Systane | Tears Naturale
  1. Alade SL, Brown RE, Paquet A. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  2. American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  3. Artificial Tears [prescribing information]. Lake Forest, IL: Akorn, Inc; January 2014.
  4. 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]
  5. 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]
  6. Craiglow BG. Ichthyosis in the newborn. Semin Perinatol. 2013;37(1):26-31. [PubMed 23419760]
  7. Freshkote (polyvinyl alcohol and povidone) [prescribing information]. Fort Worth, TX: Eyevance Pharmaceuticals, LLC; received May 2019.
  8. 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]
  9. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
  10. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  11. "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]
  12. Puralube (artificial tears) [prescribing information]. Minneapolis, MN: Perrigo; August 2014.
  13. Sethuraman U, Kamat D. The red eye: evaluation and management. Clin Pediatr (Phila). 2009 Jul;48(6):588-600. doi:10.1177/0009922809333094 [PubMed 19357422]
  14. 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]
  15. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
  16. Systane (artificial tears) [prescribing information]. Ft. Worth, TX: Alcon Laboratories, Inc; June 2016.
  17. Systane Ultra (polyethylene glycol and propylene glycol) [prescribing information]. Ft. Worth, TX: Alcon Laboratories, Inc; received April 2020.
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