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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]

Restasis Multidose: 0.05% (5.5 mL) [contains polysorbate 80]

Brand Names: U.S.

  • Restasis
  • Restasis Multidose

Pharmacologic Category

  • Calcineurin Inhibitor
  • Immunosuppressant Agent

Absorption

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

Use: Labeled Indications

Keratoconjunctivitis sicca: 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 twice daily (approximately 12 hours apart).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the 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. Prime multidose bottle for first-time use by squeezing 2 drops onto a tissue (do not let bottle tip touch tissue). 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).

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. Serum concentrations are below the limit of detection (<0.1 ng/mL) following ophthalmic use; fetal exposure following ophthalmic administration is not expected.

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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