Sporium Max Sterile (Cyclosporine 0.09%)

Therapeutic Group: Ophthalmic- Immunosuppressant

Presentation

Sporium Max Sterile Ophthalmic Solution: Each ml contains Cyclosporine USP 0.9 mg.

Description

SporiumMax Sterile Ophthalmic Solution is a preparation of Cyclosporine 0.09% which acts as immunomodulator in patients whose tear production is suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.

Indications

This drug is indicated to increase tear production in patients whose tear production is suppressed due to ocular inflammation associated with dry eye syndrome (keratoconjunctivitis sicca).

Dosage & Administration

Instill one drop of this drug twice a day in each eye approximately 12 hours apart. It can be used concomitantly with artificial tears, allowing a 15 minute interval between products.

Side Effects

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

Precautions

This drug 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 the Solution. Lenses may be reinserted 15 minutes following administration of this medication.

This drug may cause blurred vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Use in Pregnancy & Lactation

Pregnancy category C. There are no adequate and well-controlled studies of Cyclosporine ophthalmic Solution in pregnant women. It should be administered to pregnant women 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 ophthalmic Solution, caution should be exercised when it is administered to a nursing woman.

Pediatric Use
The safety and efficacy of cyclosporine ophthalmic Solution has not been established in pediatric patients below the age of 18.

Storage

Do not store above 30 0C. Keep away from light and out of the reach of children. Do not use more than 4 weeks after opening.

Commercial Pack

Sporium Max Sterile Ophthalmic Solution: Each plastic dropper bottle contains 5 ml of sterile ophthalmic Solution.