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RESTASIS MULTIDOSE™
(cyclosporine ophthalmic emulsion) 0.05% For topical ophthalmic use
RESTASIS MULTIDOSE™ (cyclosporine ophthalmic emulsion) 0.05% contains a calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure:  Structural Formula
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Cyclosporine is a fine white powder. RESTASIS MULTIDOSE™ appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5-8.0. Each mL of RESTASIS MULTIDOSE™ ophthalmic emulsion contains: Active: cyclosporine 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer copolymer type A; purified water; and sodium hydroxide to adjust pH.
RESTASIS MULTIDOSE™ ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
Instill one drop of RESTASIS MULTIDOSE™ ophthalmic emulsion twice a day in each eye approximately 12 hours apart. RESTASIS MULTIDOSE™ can be used concomitantly with lubricant eye drops, allowing a 15-minute interval between products.
Step 1: Pull off the clear shipping cover by pulling straight up. Throw the shipping cover away. Do not use RESTASIS MULTIDOSE™ if shipping cover or pull tab are damaged or missing.
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Step 2: Remove the pull tab on the olive green colored protective cap by pulling the end of the pull tab away from the bottle then winding it counterclockwise. Throw away the pull tab.
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Step 3: Remove the olive green colored protective cap by pulling it straight up. Keep the colored protective cap.
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Step 4: Prime the bottle for first-time use by squeezing two drops onto a tissue. Do not let the bottle tip touch the tissue.
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Step 5: The bottle is now ready for use. After use, recap the bottle with the olive green colored protective cap by pushing it straight down onto the bottle.
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Step 6: Turn the bottle upside down a few times before giving your dose to make sure the medicine is mixed well.
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Step 7: Instill one drop in the affected eye. Replace the olive green colored protective cap.
Ophthalmic emulsion containing cyclosporine 0.5 mg/mL
RESTASIS MULTIDOSE™ ophthalmic emulsion is packaged in a sterile, multi-dose preservative-free bottle. Each bottle consists of a white opaque LDPE bottle, a white opaque polypropylene top with unidirectional valve and air filter, a protective olive green polypropylene cap, and a clear disposable shipping cover over the colored cap.
5.5 mL in 10-mL bottle - NDC 0023-5301-05
Store at 15-25 °C (59-77 °F).
Irvine, CA 92612, U.S.A. Revised: Oct 2016
The following serious adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, the most common adverse reaction following the use of cyclosporine ophthalmic emulsion, 0.05% was ocular burning (17%).
Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).
The following adverse reactions have been identified during post approval use of cyclosporine ophthalmic emulsion, 0.05%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Reported reactions have included: hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superficial injury of the eye (from the bottle tip touching the eye during administration).
No Information provided
No Information provided
RESTASIS MULTIDOSE™ is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation [see ADVERSE REACTIONS].
Cyclosporine is an immunosuppressive agent when administered systemically.
In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator. The exact mechanism of action is not known.
Blood cyclosporine A concentrations were measured using a specific high pressure liquid chromatography-mass spectrometry assay. Blood concentrations of cyclosporine, in all the samples collected, after topical administration of cyclosporine ophthalmic emulsion, 0.05%, twice daily, in humans for up to 12 months, were below the quantitation limit of 0.1 ng/mL. There was no detectable drug accumulation in blood during 12 months of treatment with cyclosporine ophthalmic emulsion, 0.05%.
Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1,200 patients with moderate to severe keratoconjunctivitis sicca. Cyclosporine ophthalmic emulsion, 0.05% demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle at six months in patients whose tear production was presumed to be suppressed due to ocular inflammation. This effect was seen in approximately 15% of cyclosporine ophthalmic emulsion, 0.05%-treated patients versus approximately 5% of vehicle-treated patients. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
No increase in bacterial or fungal ocular infections was reported following administration of cyclosporine ophthalmic emulsion, 0.05%.
INSTRUCTIONS FOR USE
RESTASIS MULTIDOSE™
(Re stay’ sis Mul tee dos)  (cyclosporine ophthalmic emulsion) 0.05%
Read this Instructions for Use before you start using RESTASIS MULTIDOSE™ and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
Important:
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PREPARING THE BOTTLE FOR FIRST-TIME USE:
Step 1: Pull off shipping cover by pulling straight up. Throw the shipping cover away. Do not use RESTASIS MULTIDOSE™ if shipping cover or pull tab are damaged or missing.
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Step 2: Remove the pull tab on the olive green colored protective cap by pulling the end of the pull tab away from the bottle then winding it counterclockwise. Throw away the pull tab.
 |
Step 3: Remove the olive green colored protective cap by pulling it straight up. Keep the colored protective cap.
 |
Step 4: Prime the bottle for first time use by squeezing 2 drops onto a tissue. Do not let the bottle tip touch the tissue.
 |
Step 5: The bottle is now ready for use. After use, recap the bottle with the olive green colored protective cap by pushing straight down onto the bottle.
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GIVING YOUR DOSE:
Step 6: Turn the bottle upside down a few times before giving your dose to make sure the medicine is mixed well.
Step 7: Instill one drop in the affected eye. Replace the olive green colored protective cap.
How do I store RESTASIS MULTIDOSE™?
Keep RESTASIS MULTIDOSE™ and all medicines out of the reach of children.
This Instructions for Use has been approved by the Food and Drug Administration.
