Hydroxypropyl Methylcellulose (Parenteral-Local )


VA CLASSIFICATION
Primary: OP900


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

Commonly used brand name(s): Ocucoat.

Another commonly used name is
hypromellose .
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Surgical aid (ophthalmic){01}

Indications

Accepted

Anterior segment, surgical procedures of—Hydroxypropyl methylcellulose is indicated for use as an ophthalmic surgical aid in anterior segment surgical procedures, including cataract extraction and intraocular lens implantation. {01}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    > 80,000 {01}


pH
    7.2 ± 0.4 {01}.

Mechanism of action/Effect:

Hydroxypropyl methylcellulose is a nonpyrogenic viscoelastic solution that occupies space and protects tissue. {01} When used in anterior segment surgeries, it allows for more efficient manipulation with less trauma to the ocular tissues, such as the corneal endothelium, by maintaining a deep chamber. {01} The viscoelastic properties of hydroxypropyl methylcellulose facilitates pushing back the vitreous face, which prevents the formation of a postoperative flat chamber. {01}

Elimination:
    Hydroxypropyl methylcellulose clears the trabecular meshwork in 24 hours with a clearance rate of 98%. {01}


Precautions to Consider

Carcinogenicity/Tumorigenicity/Mutagenicity

Studies have not been done to evaluate the carcinogenic and mutagenic potential of hydroxypropyl methylcellulose.

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented.

Breast-feeding

Problems in humans have not been documented.

Pediatrics

Safety and efficacy have not been established.


Geriatrics


No information is available on the relationship of age to the effects of hydroxypropyl methycellulose in geriatric patients.

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 problems exist
» Glaucoma    (may increase the likelihood of an increase in intraocular pressure following the surgical procedure {01})


Sensitivity to hydroxypropyl methylcellulose


Side/Adverse Effects

Note: A transient increase in intraocular pressure following surgery has been reported. This effect may be due to pre-existing glaucoma or to the surgery itself. {01}

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
Incidence more frequent
    
Increase in intraocular pressure{01} (asymptomatic)

Incidence rare
    
Corneal edema or decompensation{01} (blurred vision or other change in vision)
    
hypopyon{01} (pooling of whitish fluid visible on the colored part of the eye)
    
iritis{01} (sensitivity to light; tearing; throbbing pain in eye)





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Hydroxypropyl Methylcellulose (Parenteral-Local) .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to hydroxypropyl methylcellulose
Other medical problems, especially glaucoma

Proper use of this medication

» Proper dosing


Side/adverse effects
Signs of potential side effects, especially a transient increase in intraocular pressure (asymptomatic), corneal edema or decompensation, hypopyon, or iritis


General Dosing Information
For anterior segment surgery, 2% hydroxypropyl methylcellulose should be injected carefully into the anterior chamber by using a 20 gauge or smaller cannula. {01} Additional hydroxypropyl methylcellulose may be injected during anterior segment surgery to maintain fully the chamber and to replace any fluid lost during the surgical procedure. {01} For intraocular lens implantation, the injection of hydroxypropyl methylcellulose may be performed either prior to or following the delivery of the crystalline lens {01}. If hydroxypropyl methylcellulose is injected prior to the lens delivery, the viscoelastic agent will provide additional protection to the corneal endothelium and other ocular tissues. {01} Hydroxypropyl methylcellulose also may be used to coat the intraocular lens and the surgical instruments prior to implantation surgery. {01} In cataract extraction surgery, it provides a coating that serves to protect the corneal endothelium from possible trauma from surgical instrumentation. {01}

Removal of hydroxypropyl methylcellulose is required at the end of the surgery. This is to reduce the likelihood of a transient increase in intraocular pressure following the surgery. To remove the hydroxypropyl methylcellulose, the manufacturer recommends aspiration of the solution using an automated I/A device or irrigation using an irrigation syringe or a balanced salt solution (BSS) squeeze bottle. {01}

Any unused contents of hydroxypropyl methylcellulose should be discarded. Do not resterilize. {01}

For treatment of adverse effects
Recommended treatment consists of the following:    • If intraocular pressure rises above the expected values following the surgical procedure, appropriate therapy should be administered. {01}



Parenteral Dosage Forms

HYDROXYPROPYL METHYLCELLULOSE INJECTION

Usual adult dose
Surgery, anterior segment
Intraocular injection, a quantity of solution is injected carefully into the anterior chamber as required to maintain fully the anterior chamber and replace fluid lost during the procedure. {01}


Usual pediatric dose
Surgery, anterior segment
Safety and efficacy have not been established.


Usual geriatric dose
Surgery, anterior segment
See Usual adult dose .


Strength(s) usually available
U.S.—


2% (Rx) [Ocucoat{01} (sodium chloride 0.49%) (potassium chloride 0.075%) (calcium chloride 0.048%) (magnesium chloride 0.03%) (sodium acetate 0.39%) (sodium citrate 0.17%)]

Note: This product is supplied as a 1 mL single-use glass syringe with a Luer tip and a Luer lock cannula that have been aseptically packaged and terminally sterilized. {01}


Packaging and storage:
Store below 40 ºC (104 ºF), preferably between 15 and 30 ºC (59 and 86 ºF), unless otherwise specified by manufacturer. Protect from light. {01}

Preparation of dosage form:
Directions for syringe assembly {01}:


The pouch should be opened using sterile opening technique and the contents dropped onto a sterile field. {01}


The glass cartridge should be inserted into the plastic holder and pushed until the spike penetrates the rubber tip. {01}


The plunger rod is then screwed clockwise into the rubber stopper. The Luer lock cannula is connected to the syringe tip and twisted firmly into place, then checked for proper function. {01}


Any air bubbles should be allowed to rise to the surface and the plunger rod pushed slightly to release the bubbles from the syringe tip and the cannula. {01}


The manufacturer also recommends that the cannula hub be partially or totally filled with balanced salt solution (BSS) before attaching it to the syringe. This further reduces the introduction of air bubbles into the anterior chamber. {01}

Auxiliary labeling:
   • For intraocular use only.



Revised: 10/28/1998



References
  1. Ocucoat package insert (Storz—US), Rev 5/97, Rec 9/98.
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