HYCLO Cyclosporine 0.05%/0.1%

Composition   

Each ml contains:        

Cyclosporine IP  0.1% |  Cyclosporine IP           0.05%

Benzalkonium Chloride Solution IP       0.004% w/v     

(as preservative)

Aqueous buffered vehicle         q.s

Dosage Form

Ophthalmic Solution (Eye Drops)

Category

Anti-inflammatory agent, Immunosuppressant

Description

Cyclosporine belongs to a class of medications called Immunomodulator. Cyclosporine is shown to increase tear production in patients with inflammation induced Dry eye.

Indication and Usage

Hyclo 0.1% and 0.05% eye drops are indicated for treatment of moderate to severe dry eye conditions.

Dosage and Administration

One drop should be instilled twice a day in each eye or as directed by the physician.

Contraindications

Patients who are hypersensitive to Cyclosporine or to any ingredient in the formulation.

Warnings and Precautions

Cyclosporine eye drops should not be administered while wearing contact lens. If irritation of the eye is reported or if the condition worsen or persists, use of drug should be discontinued.

Pregnancy and Lactation :

There are no adequate and well controlled studies of the formulation in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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

Storage

Keep in a cool, dark and dry place.

Presentation

Hyclo 0.05% is with Cyclosporine 0.05% is available as 5ml content in 5ml bottle.

Hyclo 0.1% is with Cyclosporine 0.1% is available as 5ml content in 5ml bottle.