Provisc

What is Provisc and how is it used?

Provisc is a prescription medicine used to treat the symptoms of Osteoarthritis of the Knee and Ophthalmic Viscoelastic Devices (OVDs). Provisc may be used alone or with other medications.

Provisc belongs to a class of drugs called Intra-Articular Agents; Ophthalmics, Other; Rheumatologics, Other.

It is not known if Provisc is safe and effective in children.

What are the possible side effects of Provisc?

Provisc may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• rash,
• itching,
• red, swollen, blistered, or peeling skin with or without fever,
• wheezing,
• tightness in the chest or throat,
• trouble swallowing,
• unusual hoarseness,
• vision changes,
• eye pain, and
• severe eye irritation

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Provisc include:

• temporary rise in intraocular (eye) pressure,
• post-operative inflammation, and
• eye swelling

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Provisc. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

PROVISC^® (sodium hyaluronate) Viscoelastic Preparation is a sterile, non-pyrogenic, high molecular weight, noninflammatory highly purified fraction of sodium hyaluronate, dissolved in physiological sodium chloride phosphate buffer. Each mL of PROVISC contains active 10.0mg sodium hyaluronate; 0.56mg dibasic sodium phosphate, anhydrous; 0.04mg monobasic sodium phosphate; 8.4mg sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust pH and water for injection.

INDICATIONS

PROVISC (sodium hyaluronate) Viscoelastic Preparation is indicated for use as an ophthalmic surgical aid in the anterior segment during cataract extraction and intraocular lens (IOL) implantation.

PROVISC (sodium hyaluronate) Viscoelastic Preparation serves to maintain a deep anterior chamber during anterior segment surgery allowing reduced trauma to the corneal endothelium and surrounding ocular tissues. The viscoelastic properties of PROVISC (sodium hyaluronate) Viscoelastic Preparation help to push back the vitreous face and prevent formation of a flat chamber postoperatively.

DOSAGE AND ADMINISTRATION

No information provided.

HOW SUPPLIED

PROVISC (sodium hyaluronate) is a sterile, non-pyrogenic, viscoelastic preparation(sodium hyaluronate, 10mg/mL, dissolved in physiological sodium chloride phosphate buffer) supplied in disposable glass syringes delivering 0.55mL or 0.85mL.

Each mL of PROVISC Viscoelastic Preparation contains 10mg sodium hyaluronate; 0.56mg dibasic sodium phosphate, anhydrous; 0.04mg monobasic sodium phosphate; 8.4mg sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust pH and QS water for injection. PROVISC (sodium hyaluronate) syringes are aseptically packaged in blister packs and terminally sterilized.

STORAGE RECOMMENDATIONS

Store in refrigerator (2° †? 8°C, 36° †? 46°F). Protect from freezing. Protect from light.

Refrigerated PROVISC (sodium hyaluronate) Viscoelastic Preparation should be allowed to attain room temperature prior to use (approximately 20 †? 40 minutes depending on quantity).

SIDE EFFECTS

PROVISC (sodium hyaluronate) Viscoelastic Preparation is extremely well-tolerated after injection into human eyes during ophthalmic surgical procedures. As with most viscoelastic ophthalmic preparations, a transient rise in intraocular pressure has been reported in some cases.

Postoperative inflammatory reactions such as hypopyon and iritis have been reported with the use of ophthalmic viscoelastic preparations, as well as incidents of corneal edema and corneal decompensation. Their relationship to the use of sodium hyaluronate (PROVISC (sodium hyaluronate) ) has not been established.

DRUG INTERACTIONS

No information provided.

WARNINGS

No information provided.

PRECAUTIONS

• Precautions normally associated with anterior segment surgical procedures should be observed.

• Postoperative increases in intraocular pressure have been reported with sodium hyaluronate products. The IOP should be carefully monitored and appropriate therapy instituted if significant increases occur.

• It is recommended that PROVISC (sodium hyaluronate) material be removed by irrigation and/or aspiration at the close of surgery. Do not overfill the anterior chamber.

• PROVISC (sodium hyaluronate) material is obtained from microbial fermentation by a purified proprietary process. Although precautions have been taken to make this device protein-free and it has been tested in animals for allergenic response, this device, used in susceptible persons, may produce allergenic responses.

• This product contains dry natural rubber (latex).

• In addition to the above, the following precautions should be observed:

  -Do not reuse cannulas.
  -Use only if material is clear.
  -Avoid trapping air bubble.

OVERDOSE

No information provided.

CONTRAINDICATIONS

At present there are no known contraindications to the use of PROVISC (sodium hyaluronate) Viscoelastic Preparation when used as recommended; care should be used in patients with hypersensitivity to any components in this material (see Precautions).

CLINICAL PHARMACOLOGY

CHARACTERISTICS

Sodium hyaluronate is a high molecular weight polysaccharide, composed of sodium, glucuronate and N-acetyl-glucosamine which forms a repeating disaccharide unit by linking alternately beta 1-3 and beta 1-4 glycosidic bonds. The 1% viscous and transparent material, PROVISC, is a specific fraction of sodium hyaluronate, developed as an aid in ophthalmic surgery. It acts as a space occupying fluid that is replaced by the body†?s natural fluids.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.