Each 1 ml of solution contains sodium hyaluronate 1.8 mg, sodium chloride 2.8 mg, potassium chloride 1.0 mg, disodium-hydrogen phosphate 3.2 mg, sodium citrate 0.3 mg, magnesium chloride 0.09 mg, calcium chloride 0.09 mg and purified water to 1 mL.
This formulation is hypotonic (140-160 mOsm/l) and free of preservative.
The average molecular weight of hyaluronic acid used is about 1,200,000 Daltons (range 800,000-1,600,000 Daltons).
Pharmacology: Pharmacodynamics: VISLUBE multi contains sodium hyaluronate, a natural polymer, which is also present in the structures of the human eye. The particular physical characteristics of sodium hyaluronate confer to VISLUBE multi its viscoelastic, mucomimetic and water retaining properties. In clinical studies, VISLUBE multi was shown to stabilize the tear film and increase the tear film break-up time (tear film BUT). This resulted in a reduction in the subjective ocular symptoms of burning, photophobia, pain and foreign body sensations and objective signs including tear film BUT, tear volume and staining with Rose Bengal and fluorescein together with an improvement in patient comfort and well being. The hypotonic formulation of VISLUBE multi also enhanced the treatment effect of VISLUBE multi in dry eye patients by compensation the hypertonicity of tears in dry eye patients. Tear hyperosmolarity, a core mechanism of dry eye disease, stimulates inflammatory cascade and cells apoptosis leading to ocular surface damage. Thus hypotonic eye drops would be a reasonable alternative for dry eye treatment. The evidences from many studies exhibited the treatment with hypotonic eye drops (150 mOsm/l) providing better results in improving signs and symptoms of dry eye disease than isotonic eye drops (300 mOsm/l).
VISLUBE multi also showed a marked reduction in the expression of the CD44 protective marker, the hyaluronic acid receptor which is over-expressed in inflammatory diseases, and increased the expression of protective markers such as mucus and goblet cells, CD63 and UIC2. It also reduced the expression of other inflammatory markers such as human leucocyte antigen-DR (HLA-DR) and cluster differentiation CD40 and caused a decrease in the expression apoptosis markers such as Fas and Apo 2.7. Sodium hyaluronate can also reduce toxic effect from Benzalkonium Chloride (BAK) on the ocular surface by neutralizing the cationic charge of BAK, entrapping BAK molecule into its sponge-like structure, and forming a cytoprotective coat on cell membrane. Moreover, sodium hyaluronate can stimulate corneal epithelial cells migration and proliferation leading to rapid corneal wound healing. The results from many studies showed the ability of sodium hyaluronate to increase healing rate, reduce wound area and improve ocular surface damage. Thus, this would explain the protective, anti-inflammatory, reducing BAK toxic, and wound healing effects of VISLUBE multi.
Pharmacokinetics: Due to its high molecular weight, sodium hyaluronate is not expected to pass through the conjunctiva and the corneal epithelium.
Following intraocular administration of sodium hyaluronate, the t½ for elimination of the product from the aqueous humour was around 10.5h and no product was detected 24h after administration.
After parenteral administration of sodium hyaluronate, this molecule is efficiently metabolized in the liver (t½=2.5 to 5.5 min).
Treatment of dry eye and ocular surface damage due to some conditions and/or diseases for example, post operative eye surgeries; eg. Cataract surgery, LASIK, prolonged use of preservative-containing eye drops such as antiglaucoma drugs. In addition, it can be used for the treatment of superficial keratitis, Sjögren syndrome or primary dry eye syndrome (Keratoconjunctivitis sicca). Temporary relief of dryness, burning and ocular fatigue induced, for example, by dust smoke, dry heat, air conditioning, extended computer screen use or contact lens wear.
Instructions for proper use: Tear off the tamper-evident seal before the first administration. Remove the protective cap. Tilt the head backwards and position the tip of the container above the eye to be treated. Move the lower eyelid down with the forefinger of one hand. Press the container and one drop of VISLUBE multi will easily flow out. If not otherwise recommended, place one or two drops of VISLUBE multi into the conjunctival sac of the eye as often as needed. After blinking, the solution will disperse and form a transparent and long lasting coating on the surface of the eye. VISLUBE multi may also be used while wearing contact lenses (rigid or soft).
1. Remove the tamper-evident seal.
2. Remove the protective cap.
3. Instill one or two drops onto the eye.
4. Put the protective cap back on after administration.
Given the nature of the product and the route of administration, no problems of overdosage are expected as the excess fluid will flow from the eye. A toxicology study following topical ocular administration of VISLUBE multi, conducted in the rabbit, showed that overdosing with VISLUBE multi did not result in any clinical or histological adverse events.
Individual hypersensitivity to any constituent of the product.
Do not touch the tip of the opened container and do not touch the surface of the eye with the tip of opened container. Put the protective cap back after using VISLUBE multi. Do not use VISLUBE multi if the container is damaged. VISLUBE multi can be used up to three months after first use. Any solution not used within 3 months after opening must be discarded. Otherwise the sterility is no longer guaranteed and this may be associated with a risk of infection. If discomfort persists while using VISLUBE multi or reappears after discontinuation of treatment, consult a physician. Patients who experience blurred vision after application of the eye drops should not drive or use machinery until their vision has cleared.
Pregnancy and lactation: There is no experience regarding the safety of VISLUBE multi in human pregnancy or lactation. Administration during pregnancy or lactation is therefore depending on physician judgment.
No undesirable effects are expected if used as recommended.
Do not use VISLUBE multi at the same time as any other drug or product applied to the eye since it may modify their effects. If more than one type of eye drops are applied to the eye, administer them at least five minutes apart. Avoid using VISLUBE multi with quaternary ammonium compound.
S01KA01 - hyaluronic acid ; Belongs to the class of viscoelastic substances used as ophthalmologic surgical aids.
Vislube Multi eye drops 0.18%
10 mL x 1's
Sign Out
Continue with Google
Sign Up With Email
Already a member?
Sign In
