Hydroxypropyl Methylcellulose (Ophthalmic)



INN:

Hypromellose {10}

VA CLASSIFICATION
Primary: OP500

Commonly used brand name(s): Artificial Tears; Bion Tears; Eyelube; Gonak; Goniosoft; Goniosol; Isopto Alkaline; Isopto Plain; Isopto Tears; Just Tears; Lacril; Methocel; Moisture Drops; Nature's Tears; Ocucoat; Ocucoat PF; Ocutears; Tearisol; Tears Naturale; Tears Naturale Free; Tears Naturale II; Tears Renewed; Ultra Tears.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Protectant (ophthalmic)—

tears (artificial)—

lubricant (ophthalmic)—

diagnostic aid (contact lens procedures; gonioscopy)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Keratitis, exposure (treatment)
Keratitis, neuroparalytic (treatment) or
Keratoconjunctivitis sicca (treatment)—Hydroxypropyl methylcellulose is indicated for the relief of dry eyes and eye irritation associated with deficient tear production in order to prevent corneal damage. {02} {03} {04} {05} {06} {08} {09} {14} {16} {21} {23} {24}

[Corneal erosions, recurrent (treatment)]1or{21}
[Corneal sensitivity, decreased (treatment)]1{21}—Hydroxypropyl methylcellulose is used in the treatment of recurrent corneal erosions and decreased corneal sensitivity. {01} {21}

Ocular lubrication1{21}—Hydroxypropyl methylcellulose is indicated as an ocular lubricant for hard contact lenses {02} {03} {08} and artificial eyes and to protect the cornea during gonioscopy {07} {17} {33} {34} {36} {37} and procedures involving use of a diagnostic contact lens, such as laser photocoagulation of the retina, laser gonioplasty, and laser iridectomy.

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Promotes corneal wetting by stabilizing and thickening the precorneal tear film and prolonging the tear film breakup time, which is usually shortened in dry eye conditions. Also acts to lubricate and protect the eye.


Precautions to Consider

Pregnancy/Reproduction

Problems in humans have not been documented.

Breast-feeding

Problems in humans have not been documented.

Pediatrics

Appropriate studies on the relationship of age to the effects of hydroxypropyl methylcellulose have not been performed in the pediatric population. However, pediatrics-specific problems that would limit the usefulness of this medication in children are not expected.


Geriatrics


Appropriate studies on the relationship of age to the effects of hydroxypropyl methylcellulose have not been performed in the geriatric population. However, geriatrics-specific problems that would limit the usefulness of this medication in the elderly are not expected.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
Sensitivity to hydroxypropyl methylcellulose


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
    
Eye irritation not present before therapy


Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
—more frequent with 1% solution    
Blurred vision
    
matting or stickiness of eyelashes





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Hydroxypropyl Methylcellulose (Ophthalmic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to hydroxypropyl methylcellulose

Proper use of this medication
Proper administration technique

Preventing contamination: Not touching applicator tip to any surface; keeping container tightly closed

» Proper dosing

» Proper storage

For patients wearing hard contact lenses
Taking care not to float lens from eye when applying medication

Precautions while using this medication
» Checking with physician if eye pain, changes in vision, or continued redness or irritation of the eye occurs, or if present symptoms continue for more than 3 days or become worse {19}


Side/adverse effects
Signs of potential side effects, especially eye irritation not present before use of medication


General Dosing Information
Although some manufacturers recommend that patients not wear soft contact lenses during treatment with ophthalmic hydroxypropyl methylcellulose, USP medical experts do not believe this precaution is necessary unless the patient has corneal epithelial problems and the medication is to be used more often than once every 1 to 2 hours. No significant problems have been documented with the use of ophthalmic solutions containing 0.03% or less of benzalkonium chloride as a preservative {25} in patients with no significant corneal surface problems. {25}


Ophthalmic Dosage Forms

HYDROXYPROPYL METHYLCELLULOSE OPHTHALMIC SOLUTION USP

Usual adult and adolescent dose
Keratitis, exposure (treatment)
Keratitis, neuroparalytic (treatment) or
Keratoconjunctivitis sicca (treatment)
Topical, to the conjunctiva, 1 drop of a 0.3 to 1% solution three or four times a day or as needed. {02} {03} {04} {05} {08} {09} {14} {16} {23} {24}


Note: The 2 and 2.5% solutions of hydroxypropyl methylcellulose are used in gonioscopic examinations, the gonioscopic prism being filled with solution as needed. {07} {17} {33} {34} {36} {37}


Usual pediatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


0.3% (OTC) [Bion Tears{35}] [Tears Naturale{32}] [Tears Naturale II{39}] [Tears Naturale Free{20}{38}]


0.4% (OTC) [Artificial Tears{11}] [Nature's Tears{12}]


0.5% (OTC) [Isopto Plain{26}{45}] [Isopto Tears{26}{45}] [Just Tears{26}{45}] [Lacril{08}{44}] [Moisture Drops{15}{23}] [Tearisol{26}{45}] [Tears Renewed{42}]


0.8% (OTC) [Ocucoat{18}] [Ocucoat PF{43}]


1% (OTC) [Isopto Alkaline{26}{45}] [Ultra Tears{26}{45}]


2.5% [Gonak{07}{36} (OTC)] [Goniosoft{34} (Rx)] [Goniosol{37} (OTC)]

Canada—


0.3% (OTC) [Tears Naturale{29}] [Tears Naturale II{41}] [Tears Naturale Free{40}]


0.5% (OTC) [Eyelube{31}] [Isopto Tears{30}] [Moisture Drops{24}{28}] [Ocutears{27}]


1% (OTC) [Eyelube{31}] [Isopto Tears{30}]


2% (OTC) [Methocel{33}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • For the eye.
   • Keep container tightly closed.



Revised: 08/14/1995



References
  1. Ophthalmic ballot of 9/86.
  1. Isopto Tears package insert (Alcon—US), Rev 8/87, Rec 4/88.
  1. Isopto Plain package insert (Alcon—US), Rev 10/83, Rec 4/87.
  1. Isopto Alkaline package insert (Alcon—US), Rev 4/83, Rec 4/87.
  1. Ultra Tears package insert (Alcon—US), Rev 9/87, Rec 4/88.
  1. Tears Naturale II package insert (Alcon—US), Rev 4/87, Rec 4/88.
  1. Gonak package insert (Akorn—US), Rec 4/88.
  1. Lacril package insert (Allergan—US), Rec 5/87.
  1. Moisture Drops package insert (Bausch & Lomb—US), Rec 4/88.
  1. Fleeger CA, editor. USAN 1993. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc. 1992.
  1. Artificial Tears package insert (Bausch & Lomb—US), Rec 4/95.
  1. Nature's Tears package insert (Rugby—US), Rec 3/95.
  1. Open.
  1. Isopto Tears package insert (Alcon—Canada), Rev 8/87, Rec 4/88.
  1. Moisture Drops (Bausch & Lomb, Personal Products Division). In: PDR Physicians' desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 266.
  1. Tearisol package insert (Iolab—US), Rec 5/88.
  1. Goniosol package insert (Iolab—US), Rec 5/88.
  1. Ocucoat package insert (Storz—US), Rev 8/93, Rec 4/95.
  1. FDA. Ophthalmic drug products for over-the-counter human use; final monograph. Fed Regist, 1988 Mar 4 Fri; 53(43): 7076-93.
  1. Tears Naturale Free, Tears Naturale II (Alcon). In: PDR Physicians' desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 233.
  1. Tears Naturale (Alcon). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 23rd ed. Ottawa: Canadian Pharmaceutical Association, 1988: 902.
  1. Open.
  1. Moisture Drops (Bausch & Lomb, Personal Products Division). In: PDR Physicians' desk reference for ophthalmology. 21st ed. 1993. Montvale, NJ: Medical Economics Data Production Company, 1993: 263.
  1. Moisture Drops (Bausch & Lomb). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 27th ed. Ottawa: Canadian Pharmaceutical Association, 1992: 700.
  1. Reviewers' consensus on the use of benzalkonium chloride-containing ophthalmic solutions and soft contact lenses in the Lodoxamide ophthalmic monograph revision of 12/93.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1993 Oct: 504a, 504b.
  1. Ocutears (Charton). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 30th ed. Ottawa: Canadian Pharmaceutical Association, 1995: 955.
  1. Moisture Drops package insert (Bausch & Lomb—Canada), Rec 4/95.
  1. Tears Naturale package insert (Alcon—Canada), Rec 4/95.
  1. Isopto Tears (Alcon). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 30th ed. Ottawa: Canadian Pharmaceutical Association, 1995: 645.
  1. Eyelube package insert (Sabex—Canada), Rec 3/95.
  1. Tears Naturale package insert (Alcon—US), Rec 3/95.
  1. Methocel package insert (CIBA Vision—Canada), Rec 4/95.
  1. Goniosoft package insert (Ocusoft—US), Rec 4/95.
  1. Bion Tears (Alcon—US), Rec 5/95.
  1. Gonak (Akorn). In: PDR Physicians' desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 202.
  1. Goniosol (Iolab). In: PDR Physicians' desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 279.
  1. Tears Naturale Free package insert (Alcon—US), Rec 3/95.
  1. Tears Naturale II package insert (Alcon—US), Rec 3/95.
  1. Tears Naturale Free (Alcon—Canada), Rec 4/95.
  1. Tears Naturale II (Alcon—Canada), Rec 4/95.
  1. Tears Renewed (Akorn). In: PDR Physicians' desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 202.
  1. Ocucoat PF package insert (Storz—US), Rev 8/93, Rec 4/95.
  1. Lacril package insert (Allergan—US), Rec 5/93.
  1. Red book 1994. Montvale, NJ: Medical Economics Data, 1994: 551, 553, 669, 682.
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