sodium hyaluronate




The Glory Medicina
Full Prescribing Info
Purified sodium hyaluronate.
Each ml contains sodium hyaluronate 3 mg.
Purified sodium hyaluronate occurs as white powder, granules or fibrous masses. It is sparingly soluble in water, and practically insoluble in ethanol (99.5). It is hygroscopic.
Chemical name: [→3)-2-Acetamido-2-deoxy-β-D-glucopyranosyl-(1→4)-β-D-glucopyranosyluronic acid-(1→]n.
Molecular formula: (C14H20NNaO11)n.
Molecular weight: Average molecular weight: 500,000 - 1,200,000.
pH: 6.0 - 7.0.
Osmolar ratio: 0.9 - 1.1.
Excipients/Inactive Ingredients: ε-Aminocaproic acid, disodium edetate hydrate, propylene glycol, sodium chloride, sodium hydroxide, benzalkonium chloride and dilute hydrochloric acid.
Pharmacology: Pharmacodynamics: Mechanism of action: Sodium hyaluronate binds to fibronectin and accelerates the adhesion and extension of epithelial cells. Sodium hyaluronate also has an excellent water-holding property because each sodium hyaluronate molecule can retain many H2O molecules.
Acceleration of corneal wound healing (rabbits): Topical application of 0.1 - 0.5% sodium hyaluronate ophthalmic solutions accelerate the wound healing of corneal epithelium in rabbits.
Acceleration of corneal epithelial extension (rabbits): Sodium hyaluronate accelerates the extension of corneal epithelial cells in isolated strips of cultured rabbit cornea.
Water retentive property (in vitro): Weight loss of agar plugs due to water evaporation was prevented concentration-dependently by placing drops of 0.1 - 1.0% sodium hyaluronate solutions atop the plugs.
Clinical Studies: The effectiveness rates of this product in clinical studies including double blind study conducted on patients with keratoconjunctival epithelial disorder resulting from sicca syndrome (dry eye), Sjogren's syndrome, contact lens wearing, etc. are summarized as follows. (See Table 1.)

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Pharmacokinetics: Serum concentration: Serum concentrations of hyaluronic acid were determined before topical application as well as on treatment day 3, day 9 (the last day of dosing), and day 10 in 6 healthy adult male volunteers. To the unilateral eye of the subjects, 0.1% (day 1) and 0.5% (day 2-9) ophthalmic solutions of sodium hyaluronate were instilled at a dose of one drop 5 times daily (day 1-2) and one drop 13 times daily (day 3-9). All serum concentrations determined before, during, and after treatment were less than the limit of quantitation (10μg/ml).
Intraocular distribution (rabbits): Following a single topical application of 50 μl of 0.1% 14C-sodium hyaluronate ophthalmic solution in rabbits with a normal cornea, radioactivity was only detected in the outer ocular area. Especially, the radioactivity in the bulbar conjunctiva was high and it was detectable till at least 8 hours after application. In contrast, the radioactivity level in the cornea was low and it was only detectable for 30 minutes after application.
Following topical application of 50 μl of 0.1% 14C-sodium hyaluronate ophthalmic solution in rabbits with corneal epithelium wound, high radioactivity was detected in the cornea and aqueous humor even at 1 hour after application.
Keratoconjunctival epithelial disorder resulting from the following diseases: Intrinsic diseases such as Sjogren's syndrome, Stevens-Johnson syndrome and sicca syndrome (dry eye).
Extrinsic diseases caused by surgery, drugs, trauma, contact lens wearing, etc.
Dosage/Direction for Use
Usually, instill one drop a time to the eye 5-6 times daily. The dosage may be adjusted according to the patient's symptoms.
Adverse Reactions
Adverse reactions to this drug were reported in 74 of 4,208 patients evaluated before approval and during drug use investigation (1.76%). The major adverse reactions were itching sensation in 19 patients (0.45%), eye irritating sensation in 15 patients (0.36%), conjunctival hyperaemia in 10 patients (0.24%), blepharitis in 7 patients (0.17%), etc. [At the time of reexamination application in Japan].
If the following adverse reactions are observed, appropriate measures such as discontinuing administration should be taken. (See Table 2.)

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Caution For Usage
Precautions concerning Use: Route of administration: Ophthalmic use only.
At the time of administration: (1) Instruct the patient to be careful not to touch the tip of the bottle to the eye directly in order to avoid the contamination of the drug.
(2) Instruct the patient not to use this product while wearing soft contact lenses.
Store between 1-30°C.
ATC Classification
S01XA20 - artificial tears and other indifferent preparations ; Belongs to the class of other ophthalmologicals.
Eye drops (clear, colorless, viscous, sterile, aqueous ophthalmic solution) 0.1% x 5 mL. 0.3% x 5 mL.
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