OPTIMOIST Gel | Hydroxypropyl Methylcellulose (Hypromellose) Ophthalmic Gel

Composition:

Hydroxypropyl Methylcellulose IP    0.3 % w/w

Sterile Aqueous Buffered Vehicle     q.s.

Sodium Perborate BP     0.028 % w/w

Excipients:

Carbomer (Carbopol 980), Sorbitol, Sodium Hydroxide

Dosage Forms:

Sterile Lubricant Eye Gel

Indications:

Optimoist Gel is indicated to substitute tear fluid for the alleviation of dry eye condition, as well as for the management of an unstable tear film.

Dosage and Administration:

FOR EXTERNAL USE ONLY. NOT FOR INJECTION.

Adults and elderly: Wash your hands. Place one drop in each eye (avoid touching eye with container tip) and blink several times.

Optimoist Gel may be used by contact lens wearers (Soft or hard), but lenses are recommended to be removed prior to instillation.

Pediatric use: studies in children have not been performed

Contraindications:

In patients having known hypersensitivity to any of the ingredients of this formulation.

Warnings and Precautions:

Do not use if tube is damaged, broken or open. If you experience persistent discomfort or irritations, stop using the product and consult your eye care professional. Optimoist Gel should not be used during surgery.

Consult your eye care professional before changing medication and before using any eye medication with contact lenses. Never touch the dropper of the tube to any surface including the eye, since this may contaminate the gel.

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

Drug Interaction:

No drug interaction studies have been performed.

Side Effects:

Hydroxypropyl Methylcellulose gel is very well tolerated by users but there have been some reports of burning and stinging, allergic reactions and red eyes after instillation. If you notice any of these, discontinue and consult your eye care professional.

Overdosage:

No case of overdosage has been reported.

Clinical Pharmacology:

Optimoist Gel is a long acting eye gel to wet and lubricate the surface of the eye for all patients with ocular discomfort caused by dry eye conditions. This product contains a unique disappearing preservative, which is sodium perborate.

Sodium perborate degrades with water, one of the ingredients of Optimoist Gel formulation, to yield trace amount of hydrogen peroxide, which provides antimicrobial action. The unique antimicrobial buffer system prevents the opened tube form becoming contaminated while avoiding preservative related hypersensitivity reactions. Once instilled in the eye, hydrogen peroxide is rapidly degraded by enzymes present in ocular tissues to yield water and oxygen.

Pharmacokinetics:

No pharmacokinetic studies have been performed.

Incompatibilities:

None reported.

Storage and Handling:

Use within one month after opening the tube. Replace the cap immediately after use.

Store below 30°C.

Presentation:

Long nozzle 10 gm tube packed in a carton along with pack insert.

Keep out of reach of children.

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