A A A

Tearkool (Sterile Ophthalmic Solution / Gel)

COMPOSITION

Tearkool Eye drops:

Each ml contains:

Hydroxypropyl Methylcellulose U.S.P. (Hypromellose)…………………………3mg

Preservative: Sodium perborate (a unique disappearing preservative).

Excipients: Sodium chloride , boric acid, potassium chloride, diethylenetriamine pentamethylene phosphonic acid & purified water. May contain hydrochloric acid and / or sodium hydroxide to adjust pH.

Tearkool Eye Gel:

Each gram contains:

Hydroxypropyl Methylcellulose U.S.P. (Hypromellose)…………………………3mg

Carbomer 980.…………………………………………………………………………………….2.2mg

Preservative: Sodium perborate (a unique disappearing preservative).

Excipients: Sorbitol, diethylenetriamine pentamethylene phosphonic acid, sodium hydroxide & purified water.

CLINICAL PHARMACOLOGY

Pharmacodynamics:

Eye drops:

Tearkool Eye Drops are suitable for use with all types of contact lenses to increase comfort of the lens during wear or to aid in the insertion of the contact lens. The product has a buffered pH close to that of tears and contains a unique disappearing preservative, sodium perborate. Sodium perborate degrades in water to yield trace amounts of hydrogen peroxide (50-500 ppm), providing an antimicrobial action. Instilled in the eye, hydrogen peroxide is rapidly degraded by catalases to yield water and oxygen. The antimicrobial buffer system results in a solution which is free of the usual preservatives which may cause hypersensitivity or allergic reactions and yet prevents the opened bottle from becoming contaminated.

Eye Gel:

Tearkool Gel is a long acting eye gel for lubricating the surface of the eye for all patients with ocular discomfort. The slight hypotonicity of the gel is rapidly “neutralised” by the slightly hypertonic tear fluid caused by dry eyes. Tearkool Gel contains the same unique preservative system as Tearkool Eye Drops.

 

Pharmacokinetics:

No studies were performed.

 

INDICATIONS

Eye Drops:

For the temporary relief of discomfort due to minor irritations of the eye from exposure to wind, sun or other irritation. For use as a protectant  against further irritation or to relive dryness of the eye.

Eye Gel:

Tearkool Gel soothes the sensation of dryness induced for example, by contact lenses, smoke, wind, extended computer screen use or other irritations by wetting and lubricating the surface of the eye.

 

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients.

 

 

PRECAUTIONS:

If eye pain, changes in vision, continued redness or irritation of the eye are noticed, Tearkool must be discontinued and a doctor should be consulted.

If Tearkool Gel changes colour or becomes cloudy, the product should not be used.

Eye drops/gels are not for injection. They should never be injected subconjunctivally, nor should they be directly introduced into the anterior chamber of the eye.

Tearkool Gel is not intended to be used during surgery.

 

Use in Pregnancy and Lactation:

There is no experience regarding the safety of Tearkool in human pregnancy or lactation.

 

Interactions with Other Drugs:

Eye Drops:

The compatibility of Tearkool Eye Drops has been demonstrated with lotrafilcon, tefilcon and vifilcon soft contact lenses. Optical, physical and surface properties were unchanged after soaking in Tearkool for up to 7 days.

Eye Gel:

Tearkool Gel can be used in combination with contact lenses. No compatibility study with lens material is available, however the results obtained with Tearkool Eye Drops can also be applied for Tearkool Gel.

 

Effects on ability to drive and use machines:

Any patient who experiences blurred vision should not drive or operate machines.

 

ADVERSE REACTIONS: Eye Drops and Eye Gel

Tearkool is very well tolerated by users. However, some cases of burning, stinging, allergic reactions or red eyes after instillation have been reported. Transient blurring of vision after administration has also been reported.

 

DOSAGE AND ADMINISTRATION:

Eye Drops: Adults

  • Instil 1 or 2 drops into the affected eye(s) and blink several times.
  • Apply a few drops to each lens before insertion.
  • Or use as directed by the Ophthalmologist.

Eye Gel:

Adults: Instil 1 or 2 drops in the conjunctival sac of the affected eye(s), as needed. The frequency of administration depends on the severity of the condition. On average, one drop is administered 1-3 times daily. If needed,Tearkool Gel may be administered more frequently, or as directed by the ophthalmologist. The tube must be held vertically above the eye.

Elderly: There is no indication that dosage needs to be modified for the elderly.

Paediatric use: Studies in the paediatric population have not been performed.

Patients must be instructed to avoid allowing the tip of the dispensing container to contact the eyes, surrounding structures or anything else as this may contaminate the solution/gel.

If more than one medication needs to be instilled in the eye, an interval of at least 5 minutes between application of the different products must be allowed. Tearkool should be applied last.

 

OVERDOSAGE:

No case of overdose has been reported. As Tearkool contains no pharmacologically active ingredients, no adverse effects are likely to occur in case of overdose.

 

HOW SUPPLIED:

Tearkool Eye Drops are available as a sterile ophthalmic solution 10ml in pilfer proof plastic dropper bottles (Gamma Irradiated).

Tearkool Eye Gel is available as an ophthalmic gel 10gm in plastic tube.  

 

STORAGE: Protect from sunlight & heat. Keep away from children’s reach. Do not freeze.

Eye Drops: Store below 25°C.

Eye Gel: Store between 8°C to 25°

After opening the bottle / tube, use within 4 weeks.