HYLOSOFT MAX | Sodium Hyaluronate Eye Drops
Composition:
Sodium Hyaluronate BP………………………………………………………………..0.3% w/v
Stabilized Oxychloro Complex (As Preservative)..………………………….0.01% w/v
Sterile Aqueous Vehicles……………………………………………………………….q.s.
Other Ingredients:
Trehalose USPNF, Taurine USP, Levocarnitine IP, Glycerin IP.
PHARMACEUTICAL FORM
Sodium Hyaluronate Eye Drops
THERAPEUTIC INDICATION
For temporary relief from burning, irritation and discomfort in the eye and relief from discomfort due to environmental elements such as wind, smoke, sun, dry air, air conditioning & prolonged use of computers.
APPLICATION AND ADMINISTRATION
Instill one drop a time to eye 5-6 times daily. The dosage may be adjusted according to the patient’s symptoms. As directed by the Eye Surgeon/Physician.
CONTRAINDICATIONS
Known hypersensitivity to active component.
SPECIAL WARNINGS AND PRECAUTIONS
Do not allow the tip to make contact with the eyes. Do not use while wearing soft contact lenses.
DRUG INTERACTIONS
There are no known drug interactions. In cases of co-administration with other eye medication, should always be applied last, after an interval of at least 5 minutes.
PREGNANCY AND LACTATION
Reproductive studies have not demonstrated any risk, but no controlled studies in pregnant women are available. Sodium Hyaluronate has a purely physical effect on the eyes without being absorbed and hence can be used during pregnancy and lactation.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Patients who experience blurred vision after application of the eye drops should not drive or use machinery until their vision has cleared.
UNDESIRABLE EFFECTS
Hylosoft Max Eye Drops rarely cause serious side effect or an allergic reaction. For a few moments, vision may temporarily get blurred after instillation of the eye drops. Minor irritation, burning may occur temporarily.
OVERDOSE
There are no known reports of overdosing.
PHARMACODYNAMIC
Sodium Hyaluronic acid contains a highly purified specific fraction of sodium salt of hyaluronic acid produced by bacterial fermentation and is therefore free from animal proteins. Hyaluronic acid is a natural polymer, which is present throughout the human body and also in the structure of human eyes. Its main physical characteristic is viscoelasticity. This means that sodium hyaluronic acid has a high viscosity between blinks and a low viscosity during blinking, ensuring efficient coating of the surface of the eye. Hyaluronic acid also possesses mucoadhesive properties and the ability to entrap water, thus resembling tear mucus glycoprotein. This, together with the coating properties of hyaluronic acid results in an increased pre-corneal residence time and tear film break-up time and therefore a longer lubrication of the corneal surface. The protective coating of the eye surface offered by sodium hyaluronic acid helps prevent dryness or irritation.
The core mechanisms of dry eye are driven by tear hyperosmolarity and tear film instability. The hypotonic solution counteracts the hyperosmolarity of altered tear fluid thus limiting corneal damage.
PHARMACOKINETIC
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 half-life (t1/2) for elimination from the aqueous humour was around 10.5 hrs after administration.
STORAGE
Store below 25°C. Protect from light & moisture. Do not freeze.
Store medicine out of reach of children.
Use the solution within one month after opening the container.
NOT FOR INJECTION
FOR TOPICAL OPHTHALMIC USE ONLY
PRESENTATION
Hylosoft Max Eye Drops is available in 10ml pack.