PHARMACEUTICAL FORM: Ophthalmic solution.

CLINICAL PARTICULARS

Therapeutic Indications:

0.1% sodium hyaluronate, ophthalmic solution are used for treatment of dry eyes and burning sensations due to environmental conditions.

Dosage and Method of Administration:

Posology

Normally one drop of HYLOSOFT is applied three times a day into each eye. If necessary it can also be used more frequently and as often as required. However a more frequent application (i.e. more than 10 times per day) of HYLOSOFT should be done under an ophthalmologists’ control.

HYLOSOFT can be used while wearing contact lenses. Wearing soft or hard contact lenses can be more comfortable by using HYLOSOFT as it does not form crusts or residues.

HYLOSOFT is suitable for long-term treatment.

Method of administration

For ocular use

Use in Elderly: Dosage recommendations and indications for use in elderly have not been established.

Use in Patients with Renal Impairment: Not applicable

Use in Patients with Hepatic Impairment: Not applicable

Use in Children: Dosage recommendations and indications for use in children have not been established.

Contraindications:

Hypersensitivity to any of the ingredients. In the event of persisting eye irritation discontinue use and consult your doctor.

Special Warnings and Special Precautions for Use:

Do not touch the nozzle and do not allow the nozzle tip to touch the eye during use.

HYLOSOFT should not be used at the same time as other ophthalmic drugs. If any other eye drops have to be used there should be an adequate gap before applying HYLOSOFT. Eye ointments should, however always be administered after the application of HYLOSOFT.

Interaction with Other Medicinal Products and Other Forms of Interaction :

As HYLOSOFT reaches its target directly by topical application and has primarily a physical effect (wetting of the surface) and no systemic effect, no drug interactions other than the physical interaction of topically applied eye drops are known.

Pregnancy and Lactation:

HYLOSOFT can be applied during pregnancy and lactation as there is no pharmacological effect.

Effects on Ability to Drive and Use Machines:

HYLOSOFT ophthalmic solution may cause blurred vision for a short time after application even at normal dosages and with proper use.

This can subsequently impair reaction time while driving or operating machinery.

Undesirable Effects:

Because it is preservative-free, HYLOSOFT is well tolerated even when used over a long period of time. Safety data does not provide any evidence that would represent an unacceptable hazard to its use in humans. In rare cases hypersensitive reactions like burning, itching, tearing has been reported which recedes immediately on discontinuation of HYLOSOFT.

Overdose:

Overdosage is unlikely to occur with this topical preparation.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamic Properties

Dry eye patients present with instability of the precorneal fear film which breaks up much earlier than normal. The instability of the precorneal tear film leads to dry eye symptoms such as the sensation of sand in the eye, recurrent blurred vision, itching and the sensation of dryness.

The main objective of dry eye treatment is to increase the precorneal tear film stability Hyaluronic Acid (HA) as a tear substitute behaves like a pseudoplastic fluid. This means that at very low shear the solution has a very high viscosity and relatively low elasticity, and at higher shear the solution is extremely elastic. These Viscoelastic properties are important to lubricate. In addition, the water binding capacity of HA keeps the eye’s surface wet. HA solution forms a lubricating moisture film on the surface of the eye that is not easily rinsed off. The macromolecule sodium hyaluronate has bioadhesive and mucomimelic properties when applied to the eye because of interactions with the precorneal mucin layer. By this, the solution spreads out very well and forms a regular, stable and long-lasting tear film. It however does not cause blurred vision and it protects the eyes from dryness and irritation for a long time.

In HYLOSOFT, Sodium Hyaluronate acts in a physico-chemical manner without pharmacological action by lubricating the ocular surface HA binds to many extracellular matrix molecules, specifically to cell bodies through cell surface receptors like CD44.

Expression of CD44 is increased in patients with moderate dry eye and superficial keratitis. HA might have a direct role in control of ocular surface inflammation in dry eye patients because it is associated with a decreased expression of CD44 in patients with moderate eye and superficial keratitis

The duration of contact with the ocular surface (the so-called residence time) is important for the efficacy of artificial tears. Wearing soft or hard contact lenses can be more comfortable by using HYLOSOFT as it does not form crust or residue.

It is a phosphate-free, citrate buffered formulation. This can improve the safety as the formulation of insoluble calcium phosphate deposits in the cornea is not formed after instillation of these eye drops.

Pharmacokinetic Properties:

0.1% sodium hyaluronate, ophthalmic solution reach their target directly by topical application and have primarily a physical effect (wetting of the surface). The substance does not become systemically available and are not metabolised in the human body. It is washed out of the eye after a while.

Preclinical Safety Data:

There is no data known about any toxic effect of sodium hyaluronate.

Because sodium hyaluronate is a naturally physiologic substance occurring in the eye but also in other parts of the body, the substance is very well tolerated in general.

Incompatibilities: None Known

PRESENTATION: 10 ml available in 10ml Vial.

STORAGE INSTRUCTIONS: Store in a cool & dry place. Protect from light.

For external use only.

KEEP OUT OF REACH OF CHILDREN.