METHOGEL

DESCRIPTION
Methogel is a sterile, isotonic, nonpyrogenic viscoelastic solution of highly purified, noninflammatory, 2% hydroxypropyl methylcellulose in a physiological balanced salt solution with a high molecular weight greater than 80,000 daltons. The osmolarity of Methogel is 285±32 mOsM, the viscosity is 4000±1500 cst, and the pH is 7.2±0.4.

ACTIONS/CLINICAL PHARMACOLOGY
Methogel is an ophthalmic surgical aid for use in anterior segment surgery.

It:

1. Is a space occupying, tissue protective substance
2. Exhibits excellent flow properties
3. Is completely transparent
4. Is nonantigenic
5. Is easily removed from the anterior chamber
6. Contains no proteins which may cause inflammation or foreign body reactions
7. Requires no refrigeration or restrictive storage conditions
8. Does not interfere with normal wound healing process
9. Clears the trabecular meshwork in 24 hours (98% clearance rate)

INDICATIONS AND USAGE
Methogel is indicated for use as an ophthalmic surgical aid in anterior segment surgical procedures, including cataract extraction and intraocular lens implantation. Methogel maintains a deep chamber during anterior segment surgery and thereby allows for more efficient manipulation with less trauma to the corneal endothelium and other ocular tissues. The viscoelasticity of Methogel helps the vitreous face to be pushed back, thus preventing formation of a postoperative flat chamber.

CONTRAINDICATIONS
At present, there are no known contraindications to the use of Methogelâ when used as recommended.

WARNINGS
For single use only

PRECAUTIONS
Precautions are limited to those normally associated with the ophthalmic surgical procedure being performed.
There may be transient increased intraocular pressure following surgery because of pre-existing glaucoma or due to the surgery itself. For these reasons, the following precautions should be considered:

* Methogel should be removed from the anterior chamber at the end of surgery.
* If the postoperative intraocular pressure increases above expected values, appropriate therapy should be administered.

ADVERSE REACTIONS
Clinical testing of Methogel showed it to be extremely well tolerated after injection into the human eye. A transient rise in intraocular pressure postoperatively has been reported in some cases. Rarely, postoperative inflammatory reactions (iritis, hypopyon), as well as incidents of corneal edema and corneal decompensation, have been reported with viscoelastic agents. Their relationship to Methogel has not been established.

DOSAGE AND ADMINISTRATION

Clinical Applications
In anterior segment surgery, Methogel should be carefully introduced into the anterior chamber. Methogel may be injected into the chamber prior to or following delivery of the crystalline lens. Injection of Methogel prior to lens delivery will provide additional protection to the corneal endothelium and other ocular tissues. Injection of the material at this point is significant in that a coating of Methogel may protect the corneal endothelium from possible damage arising from surgical instrumentation during the cataract extraction surgery.

Other Applications
Methogel Hydroxypropyl methylcellulose may also be used to coat an intraocular lens as well as tips of surgical instruments prior to implantation surgery. Additional Methogel may be injected during anterior segment surgery to fully maintain the chamber, or to replace fluid lost during the surgical procedure. Methogel should be removed from the anterior chamber at the end of surgery.

HOW SUPPLIED
Glass vial 3mL for single use only
Store at room temperature; avoid excessive heat (60°C). Protect from light. For intraocular use.