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30 X 0.4 ml
Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of RESTASIS ophthalmic emulsion twice a day in each eye approximately 12 hours apart. RESTASIS can be used concomitantly with lubricant eye drops, allowing a 15-minute interval between products. Discard vial immediately after use.
RESTASIS ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
RESTASIS is contraindicated in patients with known or suspected hypersensitivity to the active substance or to any of the excipients.
Potential for Eye Injury and Contamination: Be careful not to touch the vial tip to your eye or other surfaces to avoid potential for eye injury and contamination.
Use with Contact Lenses: RESTASIS 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 emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS ophthalmic emulsion.
In clinical trials, the most common adverse reaction following the use of RESTASIS was ocular burning (17%). Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
See prescribing information for full details.
Pregnancy and Lactation
Pregnancy: Clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration, and maternal use is not expected to result in fetal exposure to the drug. Oral administration of cyclosporine to pregnant rats or rabbits did not produce
teratogenicity at clinically relevant doses.
Lactation: Cyclosporine is known to appear in human milk following systemic administration, but its presence in human milk following topical treatment has not been investigated. Although blood concentrations are undetectable following topical administration of RESTASIS™ ophthalmic emulsion, caution should be exercised when RESTASIS is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RESTASIS and any potential adverse effects on the breast-fed child from cyclosporine.