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Provisc (Sodium Hyaluronate): Side Effects, Uses, Dosage, Interactions, Warnings

Provisc

Medical Reviewer: John P. Cunha, DO, FACOEP Last updated on RxList: 8/1/2022

Drug Summary

What Is Provisc?

Provisc (1% sodium hyaluronate) is an ophthalmic surgical aid used in the anterior segment during cataract extraction and intraocular lens (IOL) implantation. The brand name Provisc is discontinued, but generic versions may be available.

What Are Side Effects of Provisc?

Common side effects of Provisc include:

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

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.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Provisc

Dosing of Provisc is determined by a physician.

What Drugs, Substances, or Supplements Interact with Provisc?

Provisc may interact with other drugs. Tell your doctor all medications and supplements you use.

Provisc During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant before receiving Provisc. Consult your doctor before breastfeeding.

Additional Information

Our Provisc (1% sodium hyaluronate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Description for Provisc

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.

Uses for Provisc

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 for Provisc

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 for Provisc

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 for Provisc

No information provided.

Warnings for Provisc

No information provided.

Precautions for Provisc

  • 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 Information for Provisc

No information provided.

Contraindications for Provisc

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 for Provisc

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 for Provisc

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

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