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.

Relate drugs

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 Ophthalmic

1 drop of a 0.05% emulsion into each eye twice daily, approximately 12 hours apart.

Warnings

Contraindications

  • Known hypersensitivity to cyclosporine or any ingredient in the formulation.
  • Active ocular infections.

    • Warnings/Precautions

    Warnings

    Safety and efficacy not established in patients with history of herpes keratitis.

    Specific Populations

    Pregnancy

    Category C.

    Lactation

    Distributed 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 Use

    Safety and efficacy not established in children <16 years of age.

    Geriatric Use

    No 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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