Pharmacokinetics

Blood cyclosporine concentrations were measured using a specific high pressure liquid chromatography mass spectrometry assay. Blood concentrations of cyclosporine in all samples collected, after topical administration of cyclosporine 0.01%, BID, in humans for upto 12 months, were below the quantitation limit of 0.1 ng/ml. There was no detectable drug accumulation in blood during 12 months of treatment with cyclosporine 0.01%.

Indications:

Cyclosporine is indicated for treatment of moderate to severe dry eye syndrome (keratoconjunctivitis Sicca).

Contraindications:

Known or suspected hypersensitivity to any of the ingredients of the formulation. Patients with active ocular infections.

Warnings and Precautions:

FOR EXTERNAL USE ONLY. NOT FOR INJECTION

Cyclosporine eye drops has not been studied in patients with a history of herpes keratitis. Cyclosporine eye drops should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of this formulation and may by reinserted 15 minutes following administration of the eye drops.

Pregnancy & Lactation

There are no adequate and well controlled studies of cyclosporine eye drops in pregnant women. It should be administered to pregnant women only if clearly needed.

Cyclosporine is known to be excreted in human milk following systemic administration but excretion in human milk after topical treatment has not been investigated. Although blood concentrations are undetectable after topical administration of cyclosporine eye drops. caution should be exercised when cyclosporine eye drops are administered to nursing women.

Side Effects:

The most common adverse effect reported was ocular burning. Other events reported include conjunctival hyperemia, discharge, epihora, eye pain, foreign body sensation, pruritus, stinging and visual disturbance (most often blurring).

Dosage and Administration:

one drops of cyclosporine eye drops should be instilled twice a day in each eye approximately 12 hours apart. It can be used concomitantly with artificial tears, allowing a 15 minutes interval between products.

This tip of the dropper should not be allowed to touch the eye or any surface, as this may contaminate the formulation.

Elderly: No overall difference in safety or effectiveness has been observed between elderly and younger subjects.

Pediatric use: Safety and effectiveness has not been established in pediatric patients below the age of 16.

Storage: Store at a temperature not exceeding 30°C. Protect from light & moisture. Do not freeze.

Use the solution within one month after opening the container.

Keep out of reach of children.

Presentation:

CYNQ Eye Drops is available in 5 ml pack.