One drop in each eye BID, approximately 12 hours apart
Corneal staining improves by week 2, while symptom scores keep improving out to 1 year.
Contraindications
None.
Available Forms
0.1% (1 mg/mL) water-free, preservative-free solution, 2 mL in a 5 mL multiple-dose bottle, drop volume about 0.01 mL delivering 0.01 mg cyclosporine
Mechanism of Action
Calcineurin inhibitor, described by the label only as a relatively selective immunomodulatory drug, with no ocular mechanism given beyond that. The vehicle is water-free and preservative-free, perfluorobutylpentane with anhydrous ethanol, and blood concentrations stay below the 0.1 ng/mL limit of quantification on BID dosing.
Warnings & Precautions
Bottle tip contamination: Contact between the bottle tip and the eye or any other surface risks eye injury and contamination.
Contact lens wear: Not to be administered during lens wear; remove lenses before instillation and reinsert them 15 minutes afterward.
Common Side Effects
Ocular: Instillation site reactions 8%, temporary decreases in visual acuity 3%.
Pregnancy & Lactation
Pregnancy: No adequate and well-controlled studies in pregnant women. Oral cyclosporine was not teratogenic in rats or rabbits at clinically relevant doses; teratogenicity appeared only at maternally toxic oral doses roughly 7,250 (rat) and 48,000 (rabbit) times the maximum recommended human ophthalmic dose of 0.67 mcg/kg/day, and ocular dosing runs about 4,700 times below oral doses with undetectable blood concentrations.
Lactation: Cyclosporine is excreted in human milk after systemic administration; excretion after topical ocular treatment has not been investigated, so caution applies in a nursing woman.
Pediatric Use
Safety and effectiveness below age 18 not established.