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CycloSPORINE (Ophthalmic)

Pronunciation

Pronunciation

(SYE kloe spor een)

Index Terms

  • Ciclosporin
  • CsA
  • CyA
  • Cyclosporin A

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Emulsion, Ophthalmic [preservative free]:

Restasis: 0.05% (1 ea) [contains polysorbate 80]

Brand Names: U.S.

  • Restasis

Pharmacologic Category

  • Calcineurin Inhibitor
  • Immunosuppressant Agent

Absorption

Serum concentrations were below the quantitation limit of 0.1 ng/mL

Use: Labeled Indications

Increase tear production when suppressed tear production is presumed to be due to keratoconjunctivitis sicca-associated ocular inflammation (in patients not already using topical anti-inflammatory drugs or punctal plugs)

Contraindications

Hypersensitivity to cyclosporine or any component of the formulation.

Dosing: Adult

Keratoconjunctivitis sicca: Ophthalmic: Instill 1 drop in each eye every 12 hours

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Keratoconjunctivitis sicca: Ophthalmic: Adolescents ≥16 years: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Administration

Prior to use, invert vial several times to obtain a uniform emulsion. Remove contact lenses prior to instillation of drops; may be reinserted 15 minutes after administration. May be used with artificial tears; allow 15 minute interval between products. To avoid contamination, do not touch vial tip to eyelids or other surfaces.

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Storage

Store at 15°C to 25°C (59°F to 77°F). Vials are single-use; discard immediately following administration.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not always defined.

>10%: Ophthalmic: Burning sensation of eyes (17%)

1% to 5%: Ophthalmic: Blurred vision, conjunctival hyperemia, epiphora, eye discharge, eye pain, eye pruritus, foreign body sensation of eye, stinging of eyes, visual disturbance

<1% (Limited to important or life-threatening): Eye injury, hypersensitivity reaction (including angioedema [severe; rare], dyspnea, facial swelling, pharyngeal edema, swelling of eye, swollen tongue, urticaria)

Warnings/Precautions

Special populations:

• Contact lens wearers: Remove contact lens prior to administration and wait 15 minutes before reinserting.

Special handling:

• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Appropriate use: To avoid contamination, do not touch vial tip to eyelids or other surfaces.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were not observed following the use of oral cyclosporine in animal reproduction studies when using doses that were approximately 300,000 times greater than a human ophthalmic dose (assuming complete absorption).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience burning. Have patient report immediately to prescriber vision changes, eye pain, or severe eye irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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