Cyclosporine 0.05% Op Single Use 60
It is used to help some patients make more tears and treat dry eyes.It may be used to treat a type of seasonal eye irritation called vernal keratoconjunctivitis (VKC).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Calcineurin inhibitor, Immunosuppressant (Ophthalmic)
Pharmacologic Class
Calcineurin inhibitor
Pregnancy Category
Category C
FDA Approved
Dec 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cyclosporine ophthalmic emulsion is an eye drop used to treat chronic dry eye disease. It works by reducing inflammation in your eyes, which helps your eyes produce more of their own natural tears. It's not an artificial tear, but rather a medication that helps your eyes function better over time.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided.
Administration Instructions
This medication is for eye use only. Remove your contact lenses before applying the medication and wait 15 minutes before putting them back in. However, if your eyes are irritated or infected, do not put your contact lenses back in.
To avoid contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
Wash your hands before and after using the medication.
Tilt your head back, drop the medication into your eye, and then keep your eyes closed.
Apply gentle pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Using Multiple Eye Products
If you are using other eye medications in the same eye, make sure you understand the correct order and timing for each product. If you are unsure, consult your pharmacist to avoid any potential interactions.
Single-Use Vial Instructions
Some single-use vials may require mixing by turning them upside down a few times or shaking before use. Others are ready to use. If you have questions, consult your pharmacist.
Each single-use vial is for one use only. Use the medication immediately after opening the vial and discard any remaining medication after use.
Multi-Dose Container (Restasis) Instructions
Before first use, prepare the bottle according to your doctor's instructions or the package insert.
Prime the bottle by squeezing 2 drops onto a tissue without touching the bottle tip to the tissue.
Mix the medication by turning the bottle upside down a few times before use.
Replace the cap after each use.
Storage and Disposal
Store all products at room temperature, avoiding freezing.
Missed Dose Instructions
If you miss a dose, skip it and continue with your regular dosing schedule.
Do not use two doses at the same time or take extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided.
Administration Instructions
This medication is for eye use only. Remove your contact lenses before applying the medication and wait 15 minutes before putting them back in. However, if your eyes are irritated or infected, do not put your contact lenses back in.
To avoid contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
Wash your hands before and after using the medication.
Tilt your head back, drop the medication into your eye, and then keep your eyes closed.
Apply gentle pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Using Multiple Eye Products
If you are using other eye medications in the same eye, make sure you understand the correct order and timing for each product. If you are unsure, consult your pharmacist to avoid any potential interactions.
Single-Use Vial Instructions
Some single-use vials may require mixing by turning them upside down a few times or shaking before use. Others are ready to use. If you have questions, consult your pharmacist.
Each single-use vial is for one use only. Use the medication immediately after opening the vial and discard any remaining medication after use.
Multi-Dose Container (Restasis) Instructions
Before first use, prepare the bottle according to your doctor's instructions or the package insert.
Prime the bottle by squeezing 2 drops onto a tissue without touching the bottle tip to the tissue.
Mix the medication by turning the bottle upside down a few times before use.
Replace the cap after each use.
Storage and Disposal
Store all products at room temperature, avoiding freezing.
Missed Dose Instructions
If you miss a dose, skip it and continue with your regular dosing schedule.
Do not use two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Administer drops exactly as prescribed by your doctor.
- Wash hands thoroughly before administering drops.
- Invert the single-use vial a few times to ensure uniform emulsion before use.
- Avoid touching the tip of the vial to your eye or any other surface to prevent contamination.
- Discard the single-use vial immediately after use, even if there is solution remaining.
- If using other eye drops, wait at least 15 minutes between applications.
- Remove contact lenses before applying drops and wait 15 minutes before reinserting them.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in each eye twice a day, approximately 12 hours apart
Condition-Specific Dosing:
chronic_dry_eye_disease:
One drop in each eye twice a day, approximately 12 hours apart
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for dry eye disease (safety and efficacy not demonstrated)
Adolescent:
Not established for dry eye disease (safety and efficacy not demonstrated)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No adjustment needed (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Cyclosporine is a calcineurin inhibitor. It is believed to act as a partial immunomodulator. In patients with chronic dry eye disease, cyclosporine ophthalmic emulsion is thought to increase natural tear production by inhibiting T-cell activation and reducing inflammation in the lacrimal glands and ocular surface.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (minimal systemic absorption)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Typically 3-6 weeks for initial improvement, full effect may take 3-6 months.
PeakEffect:
3-6 months
DurationOfAction:
Continues as long as treatment is maintained.
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious side effect:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Verkazia:
+ Eye irritation
+ Eye pain
+ Cough
All other products:
+ Burning
+ Eye pain, redness, or other irritation
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious side effect:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Verkazia:
+ Eye irritation
+ Eye pain
+ Cough
All other products:
+ Burning
+ Eye pain, redness, or other irritation
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- New or worsening eye pain
- Significant vision changes
- Signs of eye infection (e.g., pus, severe redness, swelling)
- Severe allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
It is crucial to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
It is crucial to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. When taking this drug, exercise caution when driving or performing tasks that require clear vision to ensure your safety. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor promptly. Your doctor will discuss the potential benefits and risks of this medication with you, considering both your health and the well-being of your baby, to help you make an informed decision.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If an overdose is suspected, contact a poison control center or emergency medical services. For local irritation, rinse eye with water. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Ocular examination (e.g., Schirmer's test, fluorescein staining)
Rationale: To assess baseline severity of dry eye disease and inflammation.
Timing: Prior to initiation of therapy
Patient symptoms (e.g., dryness, irritation, foreign body sensation)
Rationale: To establish baseline symptom burden.
Timing: Prior to initiation of therapy
Routine Monitoring
Ocular examination (e.g., Schirmer's test, fluorescein staining)
Frequency: Every 3-6 months or as clinically indicated
Target: Improvement in tear production and reduction in ocular surface damage
Action Threshold: Lack of improvement or worsening symptoms after 3-6 months may warrant re-evaluation of therapy.
Patient symptoms
Frequency: Regularly (e.g., monthly or at follow-up visits)
Target: Reduction in dryness, irritation, foreign body sensation
Action Threshold: Persistent or worsening symptoms despite consistent use.
Symptom Monitoring
- Ocular discomfort (burning, stinging, itching)
- Foreign body sensation
- Blurred vision
- Redness
- Photophobia
- Excessive tearing (reflex tearing due to irritation)
Special Patient Groups
Pregnancy
Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal with ophthalmic use.
Trimester-Specific Risks:
First Trimester:
Potential for risk based on animal data, but minimal systemic exposure from ophthalmic use limits concern.
Second Trimester:
Potential for risk based on animal data, but minimal systemic exposure from ophthalmic use limits concern.
Third Trimester:
Potential for risk based on animal data, but minimal systemic exposure from ophthalmic use limits concern.
Lactation
It is not known whether cyclosporine is excreted in human milk following ophthalmic administration. Systemic cyclosporine is excreted in human milk. However, due to minimal systemic absorption from ophthalmic use, excretion into breast milk is unlikely to be clinically significant. Use with caution.
Infant Risk:
Low risk due to minimal systemic absorption.
Pediatric Use
Safety and efficacy have not been established in pediatric patients for chronic dry eye disease. Higher concentrations (e.g., 0.1% cyclosporine ophthalmic emulsion) are approved for vernal keratoconjunctivitis in children 4 years of age and older.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustment is required.
Clinical Information
Clinical Pearls
- Cyclosporine ophthalmic emulsion is not an 'instant fix' for dry eye; it typically takes several weeks to months to see the full therapeutic effect.
- Consistent, twice-daily use is crucial for optimal results.
- Patients should be advised that a temporary burning or stinging sensation upon instillation is common.
- Single-use vials are designed for one-time use and should be discarded immediately after applying drops to both eyes, even if solution remains, to prevent contamination.
- If patients wear contact lenses, they should remove them prior to instilling drops and wait at least 15 minutes before reinserting them.
Alternative Therapies
- Lifitegrast ophthalmic solution (Xiidra)
- Artificial tears (over-the-counter lubricants)
- Punctal plugs
- Topical corticosteroids (short-term use for acute inflammation)
- Omega-3 fatty acid supplements
- Warm compresses and lid hygiene
Cost & Coverage
Average Cost:
$600 - $900 per 60 single-use vials (0.4 mL)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Specialty drug)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.