Dosing and uses of Cyclosporine ophthalmic emulsion, Restasis (cyclosporine ophthalmic)
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
Pediatric dosage forms and strengths
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
Cyclosporine ophthalmic emulsion, Restasis (cyclosporine ophthalmic) adverse (side) 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)
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
Pregnancy and 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.
Pharmacology of Cyclosporine ophthalmic emulsion, Restasis (cyclosporine ophthalmic)
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
