Hialid 0.1/Hialid 0.3/Hialid Mini 0.3

Hialid 0.1/Hialid 0.3/Hialid Mini 0.3

sodium hyaluronate

Manufacturer:

Santen

Distributor:

DKLL

Marketer:

Santen
Full Prescribing Info
Contents
Sodium hyaluronate.
Description
Hialid 0.1/Hialid 0.3/Hialid Mini 0.3 is an ophthalmic solution of purified sodium hyaluronate developed by Santen Pharmaceutical Co., Ltd. and intended for use in the treatment of keratoconjunctival epithelial disorder. Purified sodium hyaluronate is a biological substance that has been shown in preclinical studies to accelerate the wound healing of corneal epithelium and to have water-holding properties. Its clinical usefulness has been established for the treatment of keratoconjunctival epithelial disorder associated with dry eye syndrome or other disorders.
This product may also be used while wearing contact lenses (Hialid 0.3 and Hialid Mini 0.3 only).
Hialid 0.1:
Each mL contains 1 mg of purified sodium hyaluronate.
Hialid 0.3/Hialid Mini 0.3:
Each mL contains 3 mg of purified sodium hyaluronate.
Excipients/Inactive Ingredients: Hialid 0.1/Hialid 0.3: ε-aminocaproic acid, sodium chloride, propylene glycol, disodium edetate hydrate, chlorhexidine gluconate solution and pH adjuster as additives. Its pH is 6.0 - 7.0 and its osmotic pressure ratio is 0.9 - 1.1.
Hialid Mini 0.3: It also contains ε-aminocaproic acid and disodium edetate hydrate as additives. Its pH is 6.0 - 7.0 and its osmotic pressure ratio is 0.9 - 1.1.
Action
Pharmacotherapeutic group: Artificial tears and other indifferent formulations. ATC code: S01XA20.
Pharmacology: Pharmacodynamics: Mechanism of action: Sodium hyaluronate binds to fibronectin and accelerates the adhesion and migration of corneal epithelial cells. Sodium hyaluronate also has an excellent water-retentive property because each sodium hyaluronate molecule can retain many H2O molecules.
Acceleration of corneal wound healing: When 0.1% - 0.5% ophthalmic solutions of sodium hyaluronate were instilled in rabbit wound models with corneal epithelium and corneal epithelial basement membrane detached, the wounded area decreased significantly compared to vehicle ophthalmic solution from 24 hours post-detachment and onwards.
Acceleration of corneal epithelial migration: Sodium hyaluronate significantly accelerated the migration of corneal epithelial layer compared to the control group (culture medium only) in isolated strips of cultured rabbit cornea.
Water retentive property: When 0.1% - 1.0% sodium hyaluronate solutions were dropped onto agar plugs, weight loss of agar plugs due to water evaporation was prevented in a concentration-dependently manner.
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 (10 µg/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 in the cornea was low and it was only detectable for 0.5 hour after application.
Following topical application of 50 µL of 0.1% 14C-sodium hyaluronate ophthalmic solution in rabbits with corneal epithelium wound, approximately 407.5 ng eq. of HA/g of the concentration was quantitated in the cornea even at 1 hour after application, indicating better penetration of 14C-radioactivity into the wound cornea. Radioactivity was also detected in the aqueous humor.
Indications/Uses
Keratoconjunctival epithelial disorder resulting from the following diseases: Intrinsic diseases such as Sjögren'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 1 drop a time 5-6 times daily. The dosage may be adjusted according to the patient's symptoms.
Hialid Mini 0.3: Hialid Mini 0.3 is a preservative free sterile solution packaged in a single-dose container. For single use only, one container is sufficient to treat both eyes. Any unused solution should be discarded immediately after use.
Overdosage
Not particularly specified.
Contraindications
Not particularly specified, but as with any medicines, Hialid 0.1/Hialid 0.3/Hialid Mini 0.3 is contraindicated in patients with a history of hypersensitivity to any of the components of this medication.
Special Precautions
Route of administration: ophthalmic use only.
The tip of the eyedropper must not come into contact with the eyes at the time of application.
Use In Pregnancy & Lactation
Not particularly specified.
Adverse Reactions
If any adverse reactions are observed, appropriate measures such as discontinuing administration should be taken. (See table.)

Click on icon to see table/diagram/image
Drug Interactions
Not particularly specified.
Storage
Hialid 0.1/Hialid 0.3: Keep below 30°C. Discard contents one month after opening (Hialid 0.3).
Hialid Mini 0.3: Do not store above 30°C. Store in a tight container.
MIMS Class
Ophthalmic Lubricants
ATC Classification
S01XA20 - artificial tears and other indifferent preparations ; Belongs to the class of other ophthalmologicals.
Presentation/Packing
Form
Hialid 0.1 ophth soln 0.1 %
Packing/Price
5 mL x 1's
Form
Hialid 0.3 ophth soln 0.3%
Packing/Price
5 mL x 1's
Form
Hialid Mini 0.3 ophth soln 0.3%
Packing/Price
0.4 mL x 30 × 1's
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