CYPORIN

Cyclosporine 0.05%
Sterile Ophthalmic Emulsion

Description:

Cyporin Ophthalmic Emulsion contains, Cyclosporine 0.05%, a topical immunomodulator, with anti-inflammatory effects.

Composition:

Each ml of Cyporin Ophthalmic Emulsion contains Cyclosporine USP 0.5mg.

Pharmacology:

Cyclosporine is an immunosuppressive agent when administered systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, topical Cyclosporine is thought to act as a partial immunomodulator.

Pharmacokinetics:

Blood cyclosporine A concentrations were measured using a specific high pressure liquid chromatography-mass spectrometry assay. Blood concentrations of cyclosporine, in all the samples collected, after topical administration of cyclosporine, BID, in humans for up to 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 ophthalmic emulsion. Clinical study was conducted with different concentrations of cyclosporine like 0.05%, 0.1%, 0.2% & 0.4%. Study concluded that all concentrations were safe and well tolerated. Cyclosporine 0.05% & 0.1% were deemed the most appropriate formulations because no additional benefits were observed with the higher concentrations.  

Indications:

Cyporin Ophthalmic Emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with dry eye syndrome (keratoconjunctivitis sicca).

In addition to this, several clinical study has showed that cyclosporine is effective in the management of different eye diseases like vernal keratoconjunctivitis, posterior blepharitis, non-infectious uveitis, superior limbic keratoconjunctivitis, phlyctenular keratoconjunctivitis and meibomian gland diseases.

Dosage and Administration:

One drop of Cyclosporine eye drop should be instilled twice a day in each eye approximately 12 hours apart. Cyclosporine eye drop can be used concomitantly with artificial tears, allowing a 15-minute interval between products

Contraindications:

Cyclosporine is contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.

Side effects:

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

Precautions:

Cyclosporine eye drop 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. Lenses may be reinserted 15 minutes following administration of Cyclosporine eye drop.

Use in Pregnancy:

There are no adequate and well-controlled studies of Cyclosporine Ophthalmic Emulsion in pregnant women. It should be administered to pregnant women if clearly needed.

Use in Lactating women:

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 drop, caution should be exercised when Cyclosporine is administered to a nursing woman.

Pediatric Use:

The safety and efficacy of Cyclosporine Ophthalmic Emulsion have not been established in pediatric patients.  
Storage:

Store in a cool, dry and dark place. The solution should be used within one month after opening the container.

Keep out of the reach of children.

Packing: