cyclosporine ophthalmic (Rx)Brand and Other Names:Restasis

 
 
 

Dosing & Uses

AdultPediatric

Dosing Forms & Strength

ophthalmic emulsion

  • 0.05%

Keratoconjuntivitis Sicca

1 gtt twice daily approximately 12 hours apart in each eye

May be used with artificial tears; allow 15-minute interval between products

Orphan Indications

Cornal Melting

  • For use in corneal melting syndromes of known or presumed immunologic etiopathogenesis, including Mooren's ulcer
  • Orphan indication sponsor: Allergan, Inc; 2525 Dupont Drive, P.O. Box 19534; Irvine, CA 92623-9534

Prevention of Graft Rejection

  • Treatment of patients at high risk of graft rejection following penetrating keratoplasty
  • Orphan indication sponsor: Allergan, Inc; 2525 Dupont Drive, P.O. Box 19534; Irvine, CA 92623-9534

Keratoconjunctivitis

  • Treatment of vernal keratoconjunctivitis
  • Treatment of herpes simplex virus stromal keratitis
  • Orphan indication sponsor: NOVAGALI Pharma SA; Batiment Genavenir IV F-91058-Evry cedex; France

Keratoconjunctivitis Sicca

  • Treatment of severe keratoconjunctivitis sicca associated with Sjogren's syndrome
  • Orphan indication sponsor: University Of Georgia; College Of Veterinary Medicine, Department of Small Animal Medicine; Athens, GA 30602

Corneal Graft Rejection

  • Prevention of corneal graft rejection
  • Orphan indication sponsor: NOVAGALI Pharma SA; Batiment Genavenir IV F-91058-Evry cedex; France

Dosing Forms & Strength

ophthalmic emulsion

  • 0.05%

Keratoconjuntivitis Sicca

<16 years

  • Safety and efficacy not established

≥16 years

  • 1 gtt twice daily approximately 12 hours apart in each eye
  • May be used with artificial tears; allow 15-minute interval between products
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Adverse Effects

>10%

Ocular burning (17%)

Frequency Not Defined

Conjunctival hyperemia

Discharge

Epiphora

Eye pain

Foreign body sensation

Pruritus

Postmarketing Reports

Hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema and dyspnea)

Superficial injury of the eye (from the vial tip touching the eye during administration)

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Warnings

Contraindications

Hypersensitivity to ingredients

Cautions

Has not been studied in patients with history of herpes keratitis

Remove contact lenses prior to administration

Do not touch eyelids with vial tip to avoid contamination

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Excretion in milk unknown; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Unknown; immunosuppressive when administered systemically; may act as immunomodulator to suppress tear production in keratoconjunctivitis sicca

Pharmacokinetics

No detectable drug accumulation in blood during 12 months treatment with ophthalmic emulsion

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Images

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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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