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Ocucoat

Last reviewed on RxList: 12/8/2004
Drug Description

DESCRIPTION

OCUCOAT (hydroxypropylmethylcellulose) is a sterile, isotonic, nonpyrogenic viscoelastic solution of highly purified, noninflammatory, 2% hydroxypropylmethylcellulose with a high molecular weight greater than 80,000 daltons. OCUCOAT (hydroxypropylmethylcellulose) is supplied in 1 mL syringes. Each mL provides 20 mg/mL of hydroxypropylmethylcellulose dissolved in a physiological balanced salt solution containing 0.49% sodium chloride, 0.075% potassium chloride, 0.048% calcium chloride, 0.03% magnesium chloride, 0.39% sodium acetate, 0.17% sodium citrate and water for injection. The osmolarity of OCUCOAT (hydroxypropylmethylcellulose) is 285 ± 32 mOsM, the viscosity is 4000 ± 1500 cst, and the pH is 7.2±0.4.

Characteristics: (hydroxypropylmethylcellulose)   OCUCOAT (hydroxypropylmethylcellulose) is an ophthalmic surgical aid for use in anterior segment surgery.

OCUCOAT (hydroxypropylmethylcellulose) :

  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)

For Consumers

What are the precautions when taking hydroxypropylmethylcellulose (Ocucoat)?

Before using this product, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any health problems, consult your doctor or pharmacist before using this product.

This product (especially ointments) may temporarily cause blurred vision right after being placed in the eye(s). Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities...

Indications & Dosage

INDICATIONS

OCUCOAT (hydroxypropylmethylcellulose) is indicated for use as an ophthalmic surgical aid in anterior segment surgical procedures, including cataract extraction and intraocular lens implantation. OCUCOAT (hydroxypropylmethylcellulose) 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 OCUCOAT (hydroxypropylmethylcellulose) helps the vitreous face to be pushed back, thus preventing formation of a postoperative flat chamber.

DOSAGE AND ADMINISTRATION

Clinical Applications:   In anterior segment surgery, OCUCOAT (hydroxypropylmethylcellulose) should be carefully introduced into the anterior chamber using a 20 gauge or smaller cannula. OCUCOAT (hydroxypropylmethylcellulose) may be injected into the chamber prior to or following delivery of the crystalline lens. Injection of OCUCOAT (hydroxypropylmethylcellulose) 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 OCUCOAT (hydroxypropylmethylcellulose) may protect the corneal endothelium from possible damage arising from surgical instrumentation during the cataract extraction surgery.

OCUCOAT (hydroxypropylmethylcellulose) may also be used to coat an intraocular lens as well as tips of surgical instruments prior to implantation surgery. Additional OCUCOAT (hydroxypropylmethylcellulose) may be injected during anterior segment surgery to fully maintain the chamber or to replace fluid lost during the surgical procedure. OCUCOAT (hydroxypropylmethylcellulose) should be removed from the anterior chamber at the end of surgery. Rather than aspirate OCUCOAT (hydroxypropylmethylcellulose) from the eye with the OCUCOAT (hydroxypropylmethylcellulose) syringe, it is recommended that OCUCOAT (hydroxypropylmethylcellulose) be aspirated using an automated I/A device, or irrigated using an irrigation syringe or a BSS squeeze bottle.

HOW SUPPLIED

OCUCOAT (hydroxypropylmethylcellulose) is a sterile, nonpyrogenic, viscoelastic preparation supplied in a 1 mL single use glass syringe with a Luer tip and a Luer lock cannula. OCUCOAT (hydroxypropylmethylcellulose) syringes are aseptically packaged and terminally sterilized. The sterility expiration date is on the outer package.

Store at room temperature; avoid excessive heat (60° C). Protect from light. For intraocular use.

Warning: Manufactured with CFC-12, a substance which harms public health and environment by destroying ozone in the upper atmosphere.

Caution:  Federal (USA) law restricts this device to sale by or on the order of a physician. For intraocular use only. Discard unused contents of OCUCOAT (hydroxypropylmethylcellulose) syringe after each use. Do not resterilize.

Contact your local representative or Bausch & Lomb Surgical directly at 1 (800) 338-2020 or (909) 624-2020.

Side Effects & Drug Interactions

SIDE EFFECTS

Clinical testing of OCUCOAT (hydroxypropylmethylcellulose) 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 OCUCOAT (hydroxypropylmethylcellulose) has not been established.

DRUG INTERACTIONS

No Information Provided.

Warnings & Precautions

WARNINGS

Manufactured with CFC-12, a substance which harms public health and environment by destroying ozone in the upper atmosphere.

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:

Overdosage & Contraindications

OVERDOSE

No Information Provided.

CONTRAINDICATIONS

At present, there are no known contraindications to the use of OCUCOAT (hydroxypropylmethylcellulose) when used as recommended.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

No Information Provided.

Medication Guide

PATIENT INFORMATION

No Information Provided.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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