Active Ingredients
Each mL contains 30mg of diquafosol sodium.
Therapeutic Indications
Dry eye
<Precautions related to Indications>
This product should be used in patients diagnosed with dry eye, associated with keratoconjunctival epithelium disorders that accompany lacrimal fluid abnormality.
Contraindications
Patients with a history of hypersensitivity to any of the ingredients of this product.
Pharmacodynamics
1.Mechanism of Action
Diquafosol sodium stimulated water and mucin secretion by acting on P2Y2 receptors on the conjunctival epithelial and goblet cell membrane and elevating intracellular calcium ion concentrations.
2.Stimulatory action on secretion of tear fluid including mucin
- A single dose administration of diquafosol sodium into the eyes of normal animals (rabbits and rats) promoted tear fluid secretion and mucin secretion from the conjunctival cells.
- A single dose administration of diquafosol sodium into the eyes of dry eye model rats promoted tear fluid secretion. Repeated dose administration increased mucin contents in the conjunctival tissues.
3.Improvement of corneal epithelial damage
Repeated dose administration of diquafosol sodium 6 times daily for 4 weeks improved corneal epithelial damage in rat dry eye model in a dose-dependent manner, and exhibited the maximal effect at the concentration of 1% or higher. Repeated dose of 1% diquafosol sodium for 2 weeks exhibited the maximal improvement effect when daily administration exceeded 6 times.
Precautions
1.Adverse Reactions
If adverse reactions are observed, appropriate measures such as discontinuing administration should be taken.
| Incidence Type | Incidence unknown | ≧5% | 0.1 – < 5% |
| Hypersensitivity | – | – | Blepharitis |
| Ophthalmic | Corneal epithelium disorder (filamentary keratitis, keratitis superficial, corneal erosion, etc.) , conjunctivitis | Eye irritation | Eye discharge, conjunctival hyperaemia, eye pain, eye itching, foreign body sensation in eyes, visual discomfort, hyposphagma, abnormal sensation in eye (eyes dry feeling of, eye strange sensation of, sticky eye sensation), vision blurred, photophobia, lacrimation |
| Others | – | – | Headache, increased eosinophils, elevated ALT(GPT) |
2.Precautions concerning Use
- Route of administration: Ophthalmic use only.
- At the time of administration:
- 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.
- Instruct the patient, if any other ophthalmic drug is used, to wait at least five minutes between applying this product and any other ophthalmic drug.
- Instruct the patient not to use this product while wearing hydrogel soft contact lenses. (Benzalkonium chloride contained in this product may be adsorbed to soft contact lenses.)
Dosage and administration
Usually, instill 1 drop a time 6 times daily
Pharmaceutical Form
Clear, colorless, sterile aqueous ophthalmic solution.
Storage
Keep below 30℃
How Supplied
Plastic bottle of 5 mL.
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