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.

{ "type": "p", "children": [], "text": "\nRESTASIS 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." }

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.

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 two 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 it straight down onto the bottle.

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.

Ophthalmic emulsion containing cyclosporine 0.5 mg/mL

{ "type": "p", "children": [], "text": "Ophthalmic emulsion containing cyclosporine 0.5 mg/mL" }

RESTASIS MULTIDOSE is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation [see Adverse Reactions (6.2)].

{ "type": "p", "children": [], "text": "\nRESTASIS MULTIDOSE is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation [see Adverse Reactions (6.2)]." }

Be careful not to touch the bottle tip to your eye or other surfaces to avoid potential for eye injury and contamination.

RESTASIS MULTIDOSE should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS MULTIDOSE ophthalmic emulsion.

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). 

Risk Summary Clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [see Clinical Pharmacology (12.3)], and maternal use is not expected to result in fetal exposure to the drug. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see Data].

Data Animal Data At maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (USP) was teratogenic as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. These doses (normalized to body surface area) are 5,000 and 32,000 times greater, respectively, than the daily recommended human dose of one drop (approximately 28 mcL) of cyclosporine ophthalmic emulsion 0.05% twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryofetal toxicity was observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively. These doses in rats and rabbits are approximately 3,000 and 10,000 times greater, respectively, than the daily recommended human dose.

An oral dose of 45 mg/kg/day cyclosporine administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. This dose is 7,000 times greater than the daily recommended human dose. No adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (2,000 times greater than the daily recommended human dose).

Risk Summary Cyclosporine is known to appear in human milk following systemic administration, but its presence in human milk following topical treatment has not been investigated. Although blood concentrations are undetectable following topical administration of cyclosporine ophthalmic emulsion 0.05% [see Clinical Pharmacology (12.3)], caution should be exercised when RESTASIS MULTIDOSE is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RESTASIS MULTIDOSE and any potential adverse effects on the breast-fed child from cyclosporine.

Safety and efficacy have not been established in pediatric patients below the age of 16.

No overall difference in safety or effectiveness has been observed between elderly and younger patients.

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:

{ "type": "p", "children": [], "text": "\nRESTASIS 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

{ "type": "p", "children": [], "text": "Structural Formula" }

Formula: C62H111N11O12 Mol. Wt.: 1202.6

{ "type": "p", "children": [], "text": "Formula: C62H111N11O12 Mol. Wt.: 1202.6" }

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.

{ "type": "p", "children": [], "text": "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." }

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%.

Carcinogenesis Systemic carcinogenicity studies were conducted in male and female mice and rats. In the 78-week oral (diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value.

In the 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas significantly exceeded the control rate in the low dose level. The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related. The low doses in mice and rats are approximately 80 times greater (normalized to body surface area) than the daily recommended human dose of one drop (approximately 28 mcL) of cyclosporine ophthalmic emulsion, 0.05% twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed.

Mutagenesis Cyclosporine has not been found to be mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA-repair test in sperm from treated mice. A study analyzing sister chromatid exchange (SCE) induction by cyclosporine using human lymphocytes in vitro gave indication of a positive effect (i.e., induction of SCE).

Impairment of Fertility No impairment in fertility was demonstrated in studies in male and female rats receiving oral doses of cyclosporine up to 15 mg/kg/day (approximately 2,000 times the human daily dose of 0.001 mg/kg/day normalized to body surface area) for 9 weeks (male) and 2 weeks (female) prior to mating.

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.

{ "type": "p", "children": [], "text": "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%.

{ "type": "p", "children": [], "text": "No increase in bacterial or fungal ocular infections was reported following administration of cyclosporine ophthalmic emulsion, 0.05%." }

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.

{ "type": "p", "children": [], "text": "\nRESTASIS 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

{ "type": "p", "children": [], "text": "5.5 mL in 10-mL bottle - NDC 0023-5301-05" }

Storage:  Store at 15-25 °C (59-77 °F).

{ "type": "p", "children": [], "text": "\nStorage:  Store at 15-25 °C (59-77 °F)." }

Handling the Container

{ "type": "p", "children": [], "text": "\nHandling the Container\n" }

Advise patients to not allow the tip of the bottle to touch the eye or any surface, as this may contaminate the emulsion. Advise patients to not touch the bottle tip to their eye to avoid the potential for injury to the eye [see Warnings and Precautions (5.1)].

{ "type": "p", "children": [], "text": "Advise patients to not allow the tip of the bottle to touch the eye or any surface, as this may contaminate the emulsion. Advise patients to not touch the bottle tip to their eye to avoid the potential for injury to the eye [see Warnings and Precautions (5.1)]." }

Use with Contact Lenses

{ "type": "p", "children": [], "text": "\nUse with Contact Lenses\n" }

RESTASIS MULTIDOSE should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. Advise patients that if contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS MULTIDOSE ophthalmic emulsion [see Warnings and Precautions (5.2)].

{ "type": "p", "children": [], "text": "\nRESTASIS MULTIDOSE should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. Advise patients that if contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS MULTIDOSE ophthalmic emulsion [see Warnings and Precautions (5.2)]." }

Administration

{ "type": "p", "children": [], "text": "\nAdministration\n" }

Advise patients to read the “Instructions for Use” for detailed first-time use instructions.

{ "type": "p", "children": [], "text": "Advise patients to read the “Instructions for Use” for detailed first-time use instructions." }

Distributed by:AbbVie Inc. North Chicago, IL 60064

{ "type": "p", "children": [], "text": "Distributed by:AbbVie Inc. North Chicago, IL 60064" }

© 2024 AbbVie. All rights reserved. RESTASIS MULTIDOSE and its design are trademarks of Allergan, Inc., an AbbVie company.

{ "type": "p", "children": [], "text": "© 2024 AbbVie. All rights reserved.\nRESTASIS MULTIDOSE and its design are trademarks of Allergan, Inc., an AbbVie company." }

v1.0USPI5301

{ "type": "p", "children": [], "text": "v1.0USPI5301" }

INSTRUCTIONS FOR USE RESTASIS MULTIDOSE® (Re stay’ sis Mul tee dōs) (cyclosporine ophthalmic emulsion) 0.05%

{ "type": "p", "children": [], "text": "\nINSTRUCTIONS FOR USE\n\nRESTASIS MULTIDOSE® (Re stay’ sis Mul tee dōs)\n\n(cyclosporine ophthalmic emulsion) 0.05%\n" }

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.

{ "type": "p", "children": [], "text": "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:

{ "type": "p", "children": [], "text": "\nImportant:\n" }

{ "type": "ul", "children": [ "\nRESTASIS MULTIDOSE is for use in the eye\n", "Wash your hands before using RESTASIS MULTIDOSE.\n", "Do not let the bottle tip touch the eye or any other surfaces to avoid contamination or injury to your eye.\n", "Use 1 drop of RESTASIS MULTIDOSE in each eye, 2 times each day, about 12 hours apart. \n", "If you wear contact lenses, remove them before using RESTASIS MULTIDOSE. Wait for at least 15 minutes before placing them back in your eyes.\n", "\nRESTASIS MULTIDOSE can be used with lubricant eye drops, but you should wait at least 15 minutes between using each product." ], "text": "" }

PREPARING THE BOTTLE FOR FIRST-TIME USE:      

{ "type": "p", "children": [], "text": "\nPREPARING THE BOTTLE FOR FIRST-TIME USE:\n\t\t     \n\t" }

<div class="scrollingtable"><table> <col width="444"/> <col width="194"/> <tbody class="Headless"> <tr class="First"> <td><span class="Bold">Step 1:</span> Pull off shipping cover by pulling straight up. Throw the shipping cover away. <span class="Bold">Do not</span> use <span class="Bold">RESTASIS MULTIDOSE</span> if shipping cover or pull tab are damaged or missing.<br/> </td><td><img alt="Step 1: Pull off shipping cover by pulling straight up. Throw the shipping cover away. Do not use RESTASIS MULTIDOSETM if shipping cover or pull tab are damaged or missing." src="/dailymed/image.cfm?name=restasis-multidose-0b.jpg&amp;setid=7224d810-bb96-4682-a942-3355e6e8061a"/></td> </tr> <tr> <td><span class="Bold">Step 2:</span> 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.<br/> </td><td><img alt="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." src="/dailymed/image.cfm?name=restasis-multidose-0c.jpg&amp;setid=7224d810-bb96-4682-a942-3355e6e8061a"/></td> </tr> <tr> <td><span class="Bold">Step 3:</span>   Remove the olive green colored protective cap by pulling it straight up. Keep the colored protective cap.<br/> </td><td><img alt="Step 3: Remove the olive green colored protective cap by pulling it straight up. Keep the colored protective cap." src="/dailymed/image.cfm?name=restasis-multidose-0d.jpg&amp;setid=7224d810-bb96-4682-a942-3355e6e8061a"/></td> </tr> <tr> <td><span class="Bold">Step 4:</span>   Prime the bottle for first time use by squeezing 2 drops onto a tissue. Do not let the bottle tip touch the tissue.<br/> </td><td><img alt="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." src="/dailymed/image.cfm?name=restasis-multidose-0e.jpg&amp;setid=7224d810-bb96-4682-a942-3355e6e8061a"/></td> </tr> <tr class="Last"> <td><span class="Bold">Step 5:</span>   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.<br/> </td><td><img alt="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." src="/dailymed/image.cfm?name=restasis-multidose-0f.jpg&amp;setid=7224d810-bb96-4682-a942-3355e6e8061a"/></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table>\n<col width=\"444\"/>\n<col width=\"194\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td><span class=\"Bold\">Step 1:</span> Pull off shipping cover by pulling straight up. Throw the shipping cover away. <span class=\"Bold\">Do not</span> use <span class=\"Bold\">RESTASIS MULTIDOSE</span> if shipping cover or pull tab are damaged or missing.<br/>\n</td><td><img alt=\"Step 1: Pull off shipping cover by pulling straight up. Throw the shipping cover away. Do not use RESTASIS MULTIDOSETM if shipping cover or pull tab are damaged or missing.\" src=\"/dailymed/image.cfm?name=restasis-multidose-0b.jpg&amp;setid=7224d810-bb96-4682-a942-3355e6e8061a\"/></td>\n</tr>\n<tr>\n<td><span class=\"Bold\">Step 2:</span> 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.<br/>\n</td><td><img alt=\"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.\" src=\"/dailymed/image.cfm?name=restasis-multidose-0c.jpg&amp;setid=7224d810-bb96-4682-a942-3355e6e8061a\"/></td>\n</tr>\n<tr>\n<td><span class=\"Bold\">Step 3:</span>   Remove the olive green colored protective cap by pulling it straight up. Keep the colored protective cap.<br/>\n</td><td><img alt=\"Step 3: Remove the olive green colored protective cap by pulling it straight up. Keep the colored protective cap.\" src=\"/dailymed/image.cfm?name=restasis-multidose-0d.jpg&amp;setid=7224d810-bb96-4682-a942-3355e6e8061a\"/></td>\n</tr>\n<tr>\n<td><span class=\"Bold\">Step 4:</span>   Prime the bottle for first time use by squeezing 2 drops onto a tissue. Do not let the bottle tip touch the tissue.<br/>\n</td><td><img alt=\"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.\" src=\"/dailymed/image.cfm?name=restasis-multidose-0e.jpg&amp;setid=7224d810-bb96-4682-a942-3355e6e8061a\"/></td>\n</tr>\n<tr class=\"Last\">\n<td><span class=\"Bold\">Step 5:</span>   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.<br/>\n</td><td><img alt=\"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.\" src=\"/dailymed/image.cfm?name=restasis-multidose-0f.jpg&amp;setid=7224d810-bb96-4682-a942-3355e6e8061a\"/></td>\n</tr>\n</tbody>\n</table></div>" }

GIVING YOUR DOSE: 

{ "type": "p", "children": [], "text": "\nGIVING YOUR DOSE: " }

<div class="scrollingtable"><table> <col width="444"/> <col width="194"/> <tbody class="Headless"> <tr class="First"> <td><span class="Bold">Step 6:</span> Turn the bottle upside down a few times before giving your dose to make sure the medicine is mixed well. </td><td><img alt="Step 6: Turn the bottle upside down a few times before giving your dose to make sure the medicine is mixed well. " src="/dailymed/image.cfm?name=restasis-multidose-10.jpg&amp;setid=7224d810-bb96-4682-a942-3355e6e8061a"/></td> </tr> <tr class="Last"> <td><span class="Bold">Step 7: </span>Instill one drop in the affected eye. Replace the olive green colored protective cap.<span class="Bold"> </span> <br/> </td><td></td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table>\n<col width=\"444\"/>\n<col width=\"194\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td><span class=\"Bold\">Step 6:</span> Turn the bottle upside down a few times before giving your dose to make sure the medicine is mixed well. </td><td><img alt=\"Step 6: Turn the bottle upside down a few times before giving your dose to make sure the medicine is mixed well. \" src=\"/dailymed/image.cfm?name=restasis-multidose-10.jpg&amp;setid=7224d810-bb96-4682-a942-3355e6e8061a\"/></td>\n</tr>\n<tr class=\"Last\">\n<td><span class=\"Bold\">Step 7: </span>Instill one drop in the affected eye. Replace the olive green colored protective cap.<span class=\"Bold\"> </span>\n<br/>\n</td><td></td>\n</tr>\n</tbody>\n</table></div>" }

How do I store RESTASIS MULTIDOSE?

{ "type": "p", "children": [], "text": "\nHow do I store RESTASIS MULTIDOSE?\n" }

{ "type": "ul", "children": [ "Store RESTASIS MULTIDOSE between 15-25 °C (59-77 °F)." ], "text": "" }

Keep RESTASIS MULTIDOSE and all medicines out of the reach of children.

{ "type": "p", "children": [], "text": "\nKeep RESTASIS MULTIDOSE and all medicines out of the reach of children.\n" }

This Instructions for Use has been approved by the Food and Drug Administration. 

{ "type": "p", "children": [], "text": "This Instructions for Use has been approved by the Food and Drug Administration. " }

Distributed by:AbbVie Inc. North Chicago, IL 60064

{ "type": "p", "children": [], "text": "Distributed by:AbbVie Inc. North Chicago, IL 60064" }

© 2024 AbbVie. All rights reserved.RESTASIS MULTIDOSE and its design are trademarks of Allergan, Inc., an AbbVie company.      

{ "type": "p", "children": [], "text": "© 2024 AbbVie. All rights reserved.RESTASIS MULTIDOSE and its design are trademarks of Allergan, Inc., an AbbVie company.      " }

Approved: 9/2024v1.0IFU5301

{ "type": "p", "children": [], "text": "Approved: 9/2024v1.0IFU5301" }

PRINCIPAL DISPLAY PANEL – Restasis Multidose Carton Label

{ "type": "p", "children": [], "text": "\nPRINCIPAL DISPLAY PANEL – Restasis Multidose Carton Label\n" }

NDC 0023-5301-05 abbvie Restasis MultiDose™ (Cyclosporine Ophthalmic Emulsion) 0.05% For Topical Application In the Eye PRIOR TO FIRST USE, PLEASE READ BOTTLE PREPARATION INSTRUCTIONS Sterile, 5.5 mL Preservative-Free Rx Only

{ "type": "p", "children": [], "text": "NDC 0023-5301-05\nabbvie\n\nRestasis\nMultiDose™\n\n(Cyclosporine Ophthalmic Emulsion) 0.05%\n\nFor Topical Application \n\nIn the Eye\n\nPRIOR TO FIRST USE, PLEASE READ \n\nBOTTLE PREPARATION INSTRUCTIONS\nSterile, 5.5 mL\nPreservative-Free Rx Only\n" }

CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). (1)

{ "type": "p", "children": [], "text": "CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). (1)" }

Instill one drop of CEQUA twice daily (approximately 12 hours apart) into each eye. CEQUA can be used concomitantly with artificial tears, allowing a 15 minute interval between products. Discard the vial immediately after using in both eyes. (2)

{ "type": "p", "children": [], "text": "Instill one drop of CEQUA twice daily (approximately 12 hours apart) into each eye. CEQUA can be used concomitantly with artificial tears, allowing a 15 minute interval between products. Discard the vial immediately after using in both eyes. (2)" }

Ophthalmic solution containing cyclosporine 0.9 mg/mL (3)

{ "type": "p", "children": [], "text": "Ophthalmic solution containing cyclosporine 0.9 mg/mL (3)" }

None. (4)

{ "type": "p", "children": [], "text": "None. (4)" }

To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.

CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution.

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, 769 subjects received at least 1 dose of cyclosporine ophthalmic solution. The majority of the treated subjects were female (83%). The most common adverse reactions reported in greater than 5% of subjects were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of the patients were blepharitis, eye irritation, headache, and urinary tract infection.

Risk Summary

There are no adequate and well-controlled studies of CEQUA administration in pregnant women to inform a drug-associated risk. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see Data].

Data

Animal Data

Oral administration of cyclosporine oral solution (USP) to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. These doses (normalized to body weight) were approximately 3200 and 21000 times higher than the maximum recommended human ophthalmic dose (MRHOD) of 1.5 mcg/kg/day, respectively. No adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively (approximately 1800 and 6400 times higher than the MRHOD, respectively).

An oral dose of 45 mg/kg/day cyclosporine (approximately 4800 times higher than MRHOD) administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. No adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (approximately 1600 times greater than the MRHOD).

Risk Summary

Cyclosporine blood concentrations are low following topical ocular administration of CEQUA [see Clinical Pharmacology (12.3)]. There is no information regarding the presence of cyclosporine in human milk following topical administration or on the effects of CEQUA on the breastfed infants and milk production. Administration of oral cyclosporine to rats during lactation did not produce adverse effects in offspring at clinically relevant doses [see Pregnancy (8.1)]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CEQUA and any potential adverse effects on the breast-fed child from cyclosporine.

The safety and efficacy of CEQUA ophthalmic solution have not been established in pediatric patients below the age of 18.

No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.

CEQUA (cyclosporine ophthalmic solution) 0.09% contains a topical calcineurin inhibitor immunosuppressant. 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:

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Structural Formula

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Formula: C62H111N11O12 Mol. Wt.: 1202.6

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Cyclosporine is a white powder that is insoluble in water. CEQUA is supplied as a sterile, clear, colorless ophthalmic solution for topical ophthalmic use. It has an osmolality of 160 to 190 mOsmol/kg and a pH of 6.5-7.2. Each mL of CEQUA contains:

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Cyclosporine is a calcineurin inhibitor immunosuppressant agent when administered systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, topical administration of cyclosporine is thought to act as a partial immunomodulator. The exact mechanism of action is not known.

Blood concentrations of cyclosporine after twice daily topical ocular administration of CEQUA into each eye of healthy subjects for up to 7 days, and once on Day 8, were either not detectable or were marginally above the lower limit of assay quantitation of 0.100 ng/mL (range 0.101 to 0.195 ng/mL) for up to 2 hours after a single dose, and up to 4 hours after multiple doses.

Carcinogenesis

Systemic carcinogenicity studies were carried out in male and female mice and rats. In the 78-week oral (diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value.

In the 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas significantly exceeded the control rate in the low dose level. The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related. The low doses in mice and rats are approximately 55 times higher than the maximum recommended human ophthalmic dose (1.5 mcg/kg/day), normalized to body surface area.

Mutagenesis

In genetic toxicity tests, cyclosporine has not been found to be mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA-repair test in sperm from treated mice. Cyclosporine was positive in an in vitro sister chromatid exchange (SCE) assay using human lymphocytes.

Impairment of Fertility

Oral administration of cyclosporine to rats for 12 weeks (male) and 2 weeks (female) prior to mating produced no adverse effects on fertility at doses up to 15 mg/kg/day (1620 times higher than the maximum recommended human ophthalmic dose).

Two multicenter, randomized, adequate and well-controlled clinical studies treated 1,048 patients with keratoconjunctivitis sicca (NCT # 02254265 and NCT # 02688556). In both studies, compared to vehicle at Day 84, there was a statistically significant (p<0.01) higher percentage of eyes with increases of ≥ 10 mm from baseline in Schirmer wetting. This effect was seen in approximately 17% of CEQUA-treated patients versus approximately 9% of vehicle-treated patients.

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<div class="scrollingtable"><table width="100%"> <col align="left" valign="middle" width="20%"/> <col align="left" valign="middle" width="20%"/> <col align="left" valign="middle" width="20%"/> <col align="left" valign="middle" width="20%"/> <col align="left" valign="middle" width="20%"/> <thead> <tr class="First Last"> <td align="center" colspan="5"> <p class="First"> <span class="Bold">Tear Production</span> </p> </td> </tr> </thead> <tbody> <tr class="First"> <td align="left" class="Lrule Rrule"> <p class="First"> </p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold">OTX-101-2014-001</span> </p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2"> <p class="First"> <span class="Bold">OTX-101-2016-001</span> </p> </td> </tr> <tr> <td align="left" class="Lrule Rrule"></td><td align="center" class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">CEQUA</span> </p> <p> <span class="Bold">N=152</span> </p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Vehicle</span> </p> <p> <span class="Bold">N=152</span> </p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">CEQUA</span> </p> <p> <span class="Bold">N=371</span> </p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Vehicle</span> </p> <p> <span class="Bold">N=373</span> </p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> <p class="First">≥ 10-mm increase in tear production</p> <p>(% of eyes) at Day 84 </p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">16.8%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">8.6%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">16.6%</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">9.2%</p> </td> </tr> <tr> <td align="left" class="Botrule Lrule Rrule"> <p class="First">Difference (95% CI)</p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2"> <p class="First">8.2% (1.9%, 14.6%)</p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2"> <p class="First">7.3% (3.3%, 11.3%)</p> </td> </tr> <tr class="Last"> <td align="left" class="Botrule Lrule Rrule"> <p class="First">p-value versus vehicle </p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2"> <p class="First">&lt;0.01</p> </td><td align="center" class="Botrule Lrule Rrule" colspan="2"> <p class="First">&lt;0.01</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<col align=\"left\" valign=\"middle\" width=\"20%\"/>\n<thead>\n<tr class=\"First Last\">\n<td align=\"center\" colspan=\"5\">\n<p class=\"First\">\n<span class=\"Bold\">Tear Production</span>\n</p>\n</td>\n</tr>\n</thead>\n<tbody>\n<tr class=\"First\">\n<td align=\"left\" class=\"Lrule Rrule\">\n<p class=\"First\"> </p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">OTX-101-2014-001</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">\n<span class=\"Bold\">OTX-101-2016-001</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Lrule Rrule\"></td><td align=\"center\" class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">CEQUA</span>\n</p>\n<p>\n<span class=\"Bold\">N=152</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">Vehicle</span>\n</p>\n<p>\n<span class=\"Bold\">N=152</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">CEQUA</span>\n</p>\n<p>\n<span class=\"Bold\">N=371</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">Vehicle</span>\n</p>\n<p>\n<span class=\"Bold\">N=373</span>\n</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">\n<p class=\"First\">≥ 10-mm increase in tear production</p>\n<p>(% of eyes) at Day 84 </p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">\n<p class=\"First\">16.8%</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">\n<p class=\"First\">8.6%</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">\n<p class=\"First\">16.6%</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">\n<p class=\"First\">9.2%</p>\n</td>\n</tr>\n<tr>\n<td align=\"left\" class=\"Botrule Lrule Rrule\">\n<p class=\"First\">Difference (95% CI)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">8.2% (1.9%, 14.6%)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">7.3% (3.3%, 11.3%)</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td align=\"left\" class=\"Botrule Lrule Rrule\">\n<p class=\"First\">p-value versus vehicle </p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">&lt;0.01</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" colspan=\"2\">\n<p class=\"First\">&lt;0.01</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

CEQUA ophthalmic solution is packaged in sterile, preservative-free, single-use vials. Each vial

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contains 0.25 mL fill in a 0.9 mL LDPE vial; 10 vials (2 cards of 5 vials) are packaged in a

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polyfoil aluminum pouch; 6 pouches are packaged in a box. The entire contents of each box of

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60 vials must be dispensed intact.

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60 Single-Use Vials 0.25 mL each - NDC 47335-506-96

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Storage: Store at 20°C to 25°C (68°F to 77°F). Store single-use vials in the original foil pouch.

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Handling the Vial

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Advise patients to not allow the tip of the vial to touch the eye or any surface, as this may

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contaminate the solution. Advise patients also not to touch the vial tip to their eye to avoid the

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potential for injury to the eye [see Warnings and Precautions (5.1)].

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Use with Contact Lenses

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CEQUA should not be administered while wearing contact lenses. Patients with decreased tear

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production typically should not wear contact lenses. Advise patients that if contact lenses are

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worn, they should be removed prior to the administration of the solution. Lenses may be

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reinserted 15 minutes following administration of CEQUA ophthalmic solution [see Warnings

{ "type": "p", "children": [], "text": "reinserted 15 minutes following administration of CEQUA ophthalmic solution [see Warnings\n" }

and Precautions (5.2)].

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Administration

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Advise patients that the solution from one individual single-use vial is to be used immediately

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after opening for administration to one or both eyes, and the remaining contents should be

{ "type": "p", "children": [], "text": "after opening for administration to one or both eyes, and the remaining contents should be" }

discarded immediately after administration.

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Rx Only

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Manufactured for: Sun Pharmaceutical Industries Limited

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By: Laboratoire Unither

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1 rue de l’Arquerie

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50200 Coutances

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France

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Cyclosporine (active ingred.) Product of Czech Republic.

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Product of France

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Distributed by:

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Sun Pharmaceutical Industries, Inc.

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Cranbury, NJ 08512

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Copyright 2022, Sun Pharmaceutical Industries Limited

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All rights reserved

{ "type": "p", "children": [], "text": "All rights reserved" }

07/2022

{ "type": "p", "children": [], "text": "07/2022" }

uspi-CEQUA-sol-00004

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PRINCIPAL DISPLAY PANEL

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NDC 47355-506-96

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For topical use in the eye sterile, Preservative-Free

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Cequa® (cyclosporine ophthalmic solution) 0.09%

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60 SINGLE-USE VIALS

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6 pouches x 10 single-use vials (0.25 mL each)

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Rx only

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Keep out of reach of children. Not child resistant.

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SUN PHARMA

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PRINCIPAL DISPLAY PANEL

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NDC 47355-507-97

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For topical use in the eye sterile, Preservative-Free

{ "type": "p", "children": [], "text": "\nFor topical use in the eye\n\nsterile, Preservative-Free\n" }

Cequa® (cyclosporine ophthalmic solution) 0.09%

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10 SINGLE-USE SAMPLE VIALS

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1 pouches x 10 single-use vials (0.25 mL each)

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Rx only

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Keep out of reach of children. Not child resistant.

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SUN PHARMA

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