CycloSPORINE (EENT)
Brand names: Restasis
Drug class:
Antineoplastic Agents , Antineoplastic Agents
Usage of CycloSPORINE (EENT)
Keratoconjunctivitis Sicca
Used to increase tear production in adults whose tear production presumably is suppressed secondary to ocular inflammation related to keratoconjunctivitis sicca.
Increased tear production not observed in patients already receiving topical anti-inflammatory agents or using punctal plugs.
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How to use CycloSPORINE (EENT)
Administration
For ophthalmic use only. Not for injection. Not for subconjunctival injection or introduction directly into the anterior chamber of the eye.
Ophthalmic Administration
Apply topically to the eye as an ophthalmic emulsion.
Avoid contamination of emulsion container.
Invert unit-dose vial a few times before use to obtain a uniform, opaque, white emulsion.
Preservative-free emulsion is for single use only in one or both eyes; discard any unused portion immediately after administration.
Remove contact lenses prior to administration; may reinsert lenses 15 minutes after dose.
When used concomitantly with artificial tears, administer ophthalmic preparations at least 15 minutes apart.
Dosage
Adults
Keratoconjunctivitis Sicca Ophthalmic1 drop of a 0.05% emulsion into each eye twice daily, approximately 12 hours apart.
Warnings
Contraindications
Warnings/Precautions
Warnings
Safety and efficacy not established in patients with history of herpes keratitis.
Specific Populations
PregnancyCategory C.
LactationDistributed into milk after systemic administration; it is not known whether distributed into milk after topical application to the eye. Caution advised if used in nursing women.
Pediatric UseSafety and efficacy not established in children <16 years of age.
Geriatric UseNo substantial differences in safety and efficacy relative to younger adults.
Common Adverse Effects
Ocular burning, conjunctival hyperemia, discharge, epiphora, ocular pain, foreign body sensation, pruritus, stinging, visual disturbance (e.g., blurring).
What other drugs will affect CycloSPORINE (EENT)
No formal drug interaction studies to date.
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