Cyclosporine 0.05% Op Single Use 30
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
Immunomodulator, Ophthalmic
Pharmacologic Class
Calcineurin Inhibitor
Pregnancy Category
Category C
FDA Approved
Dec 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cyclosporine ophthalmic solution is an eye drop used to treat chronic dry eye disease. It works by reducing inflammation in your eyes, which can help your eyes produce more of their own natural tears. It's not an artificial tear, and it takes time to work, often several months, so it's important to use it regularly as prescribed.
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.
Avoid touching the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss.
Wash your hands before and after using the medication.
Tilt your head back and gently drop the medication into your eye.
After application, keep your eyes closed and apply gentle pressure to the inner corner of your eye for 1 to 2 minutes. This helps the medication stay in your eye.
Using Multiple Eye Products
If you are using other eye products in the same eye, make sure you understand the correct order and timing of application, as well as the interval between each product. If you are unsure, consult your pharmacist.
Single-Use Vial Instructions
Some single-use vials may require shaking or turning upside down to mix the medication before use. Others may be ready to use. If you have questions, consult your pharmacist.
Each single-use container is for one use only. Use the medication immediately after opening, and discard any remaining medication after application.
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. Avoid touching the bottle tip to the tissue.
Shake the bottle a few times to mix the medication before use.
Replace the cap after each use.
Storage and Disposal
Store all products at room temperature, away from freezing temperatures.
Missed Dose
If you miss a dose, skip it and resume your regular dosing schedule.
Do not use two doses at the same time or take extra doses.
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.
Avoid touching the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss.
Wash your hands before and after using the medication.
Tilt your head back and gently drop the medication into your eye.
After application, keep your eyes closed and apply gentle pressure to the inner corner of your eye for 1 to 2 minutes. This helps the medication stay in your eye.
Using Multiple Eye Products
If you are using other eye products in the same eye, make sure you understand the correct order and timing of application, as well as the interval between each product. If you are unsure, consult your pharmacist.
Single-Use Vial Instructions
Some single-use vials may require shaking or turning upside down to mix the medication before use. Others may be ready to use. If you have questions, consult your pharmacist.
Each single-use container is for one use only. Use the medication immediately after opening, and discard any remaining medication after application.
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. Avoid touching the bottle tip to the tissue.
Shake the bottle a few times to mix the medication before use.
Replace the cap after each use.
Storage and Disposal
Store all products at room temperature, away from freezing temperatures.
Missed Dose
If you miss a dose, skip it and resume your regular dosing schedule.
Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Do not touch the tip of the single-use vial to your eye or any other surface to avoid contamination.
- Invert the single-use vial a few times to ensure a uniform, white, opaque emulsion before use.
- Discard the single-use vial immediately after use, even if there is solution remaining.
- If you use other eye drops, wait at least 15 minutes between applying cyclosporine and other eye medications.
- Remove contact lenses before applying the drops and wait at least 15 minutes before reinserting them.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in each eye twice daily, approximately 12 hours apart.
Dose Range:
0.05 - 0.05 mg
Condition-Specific Dosing:
chronicdryeye:
One drop in each eye twice daily, approximately 12 hours apart.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients under 16 years of age).
Adolescent:
Not established (Safety and efficacy not established in pediatric patients under 16 years of age).
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 specific considerations for ophthalmic use due to 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. In patients with chronic dry eye disease, it is believed to act as a partial immunomodulator. It is thought to inhibit T-lymphocyte activation by blocking the production of pro-inflammatory cytokines such as interleukin-2 (IL-2). This reduces inflammation on the ocular surface, which is associated with chronic dry eye disease, thereby leading to increased natural tear production.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (plasma concentrations generally below quantifiable limit of 0.1 ng/mL).
Tmax:
Not applicable for systemic levels due to minimal absorption.
FoodEffect:
Not applicable for ophthalmic formulation.
Distribution:
Vd:
Not applicable for systemic levels due to minimal absorption.
ProteinBinding:
Not applicable for systemic levels due to minimal absorption.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable for systemic levels due to minimal absorption.
Clearance:
Not applicable for systemic levels due to minimal absorption.
ExcretionRoute:
Not applicable for systemic levels due to minimal absorption. Systemically, primarily biliary/fecal.
Unchanged:
Not applicable for systemic levels due to minimal absorption.
Pharmacodynamics
OnsetOfAction:
Improvement in tear production may take 3 to 6 months of continuous use.
PeakEffect:
Typically observed after 3-6 months of continuous use.
DurationOfAction:
Effects persist as long as treatment is continued; chronic therapy is often required.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, some individuals may be at risk of life-threatening reactions when taking this medication. Be aware of the following signs and symptoms that may indicate a serious side effect:
- Allergic reaction symptoms, such as rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, chest or throat tightness, breathing difficulties, swallowing or talking problems, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Changes in vision
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they persist, consult your doctor:
- Verkazia: eye irritation, eye pain, cough
- All other products: burning sensation, eye pain, redness, or other irritation
Important Note
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, discuss them with your doctor. For medical advice on side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, some individuals may be at risk of life-threatening reactions when taking this medication. Be aware of the following signs and symptoms that may indicate a serious side effect:
- Allergic reaction symptoms, such as rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, chest or throat tightness, breathing difficulties, swallowing or talking problems, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Changes in vision
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they persist, consult your doctor:
- Verkazia: eye irritation, eye pain, cough
- All other products: burning sensation, eye pain, redness, or other irritation
Important Note
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, discuss them with your doctor. For medical advice on side effects, contact 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:
- Severe eye pain or discomfort that worsens
- Signs of eye infection (e.g., pus, severe redness, swelling)
- Significant decrease in vision
- Allergic reaction symptoms (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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 breast-feeding, notify your doctor promptly. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Due to minimal systemic absorption, an ophthalmic overdose is unlikely to cause systemic toxicity. Local irritation may occur.
What to Do:
If an overdose is suspected, flush the eye with water. For systemic concerns, contact a poison control center (1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Ocular surface examination
Rationale: To assess baseline severity of dry eye disease and rule out other causes.
Timing: Prior to initiation of therapy.
Schirmer's test (with or without anesthesia)
Rationale: To objectively measure baseline tear production.
Timing: Prior to initiation of therapy.
Routine Monitoring
Patient symptoms (e.g., dryness, irritation, foreign body sensation)
Frequency: Regularly (e.g., at follow-up visits every 3-6 months).
Target: Improvement or resolution of symptoms.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.
Ocular surface examination (e.g., corneal and conjunctival staining)
Frequency: Regularly (e.g., at follow-up visits every 3-6 months).
Target: Reduction in staining scores.
Action Threshold: Persistent or worsening staining.
Schirmer's test
Frequency: Periodically (e.g., every 6-12 months or as clinically indicated).
Target: Increase in tear production.
Action Threshold: No improvement in tear production after 6 months of consistent use.
Ocular adverse reactions (e.g., burning, stinging, redness, blurred vision)
Frequency: At each follow-up visit and as reported by patient.
Target: Absence or mild, tolerable symptoms.
Action Threshold: Severe or persistent adverse reactions may require discontinuation.
Symptom Monitoring
- Ocular burning or stinging
- Ocular redness
- Blurred vision
- Eye irritation
- Discharge
- Watery eyes
- Pain in eyes
- Foreign body sensation
- Itching
- Photophobia
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. While systemic exposure from ophthalmic administration is negligible, animal studies with systemic cyclosporine have shown adverse effects.
Trimester-Specific Risks:
First Trimester:
Minimal systemic exposure, unlikely to pose significant risk.
Second Trimester:
Minimal systemic exposure, unlikely to pose significant risk.
Third Trimester:
Minimal systemic exposure, unlikely to pose significant risk.
Lactation
Caution should be exercised when cyclosporine ophthalmic emulsion is administered to a nursing woman. However, due to minimal systemic absorption, it is unlikely to be present in breast milk in clinically significant amounts.
Infant Risk:
Low risk to breastfed infant due to minimal maternal systemic absorption.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 16 years of age.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dosage adjustment is required.
Clinical Information
Clinical Pearls
- Cyclosporine ophthalmic is a long-term treatment for chronic dry eye; it is not for acute relief.
- Patients should be advised that it may take 3 to 6 months of consistent use to see significant improvement in tear production.
- Burning or stinging upon instillation is a common side effect, especially at the beginning of treatment.
- Ensure proper administration technique, including inverting the vial and waiting 15 minutes before other eye drops or reinserting contact lenses.
- This medication works by addressing the underlying inflammation of dry eye, rather than just providing temporary lubrication.
Alternative Therapies
- Artificial tears (over-the-counter lubricants)
- Lifitegrast ophthalmic solution (Xiidra)
- Topical corticosteroids (short-term use for acute inflammation)
- Punctal plugs
- Oral omega-3 fatty acids
- Tear stimulators (e.g., diquafosol, rebamipide - not available in all regions)
- Thermal pulsation (e.g., LipiFlow) for meibomian gland dysfunction
- Intense Pulsed Light (IPL) therapy
Cost & Coverage
Average Cost:
Varies widely, typically high per 30 single-use vials (0.05%)
Generic Available:
Yes
Insurance Coverage:
Often Tier 3 or higher, may require prior authorization or step therapy.
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.