Zerviate 0.24% Ophth Drops
It is used to ease allergy signs in the eye.
Drug Class
Ophthalmic Antihistamine
Pharmacologic Class
H1 Receptor Antagonist
Pregnancy Category
Not available
FDA Approved
May 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Zerviate is an eye drop used to relieve itchy eyes caused by allergies. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction.
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 use in the eyes only.
Before and after use, wash your hands thoroughly.
Remove contact lenses before applying the medication. You can put them back in 10 minutes after use, unless your eyes are irritated or infected. If your eyes are red, do not wear contact lenses.
Avoid touching the container tip to your eye, eyelid, or surrounding skin, as this can contaminate the medication and lead to severe eye problems or vision loss.
Tilt your head back and gently drop the medication into your eye.
After application, keep your eyes closed and apply pressure to the inner corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Container Handling
If you have a multi-dose container, replace the cap after each use.
If you have a single-dose container, use it immediately after opening and discard any remaining medication. Each single-dose container is for one use only.
If needed, you can use one container for both eyes.
Storage and Disposal
Store this medication at room temperature.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, use it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular 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 use in the eyes only.
Before and after use, wash your hands thoroughly.
Remove contact lenses before applying the medication. You can put them back in 10 minutes after use, unless your eyes are irritated or infected. If your eyes are red, do not wear contact lenses.
Avoid touching the container tip to your eye, eyelid, or surrounding skin, as this can contaminate the medication and lead to severe eye problems or vision loss.
Tilt your head back and gently drop the medication into your eye.
After application, keep your eyes closed and apply pressure to the inner corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Container Handling
If you have a multi-dose container, replace the cap after each use.
If you have a single-dose container, use it immediately after opening and discard any remaining medication. Each single-dose container is for one use only.
If needed, you can use one container for both eyes.
Storage and Disposal
Store this medication at room temperature.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, use it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Wash hands thoroughly before administering eye drops.
- Do not touch the dropper tip to your eye or any other surface to avoid contamination.
- Remove contact lenses before using Zerviate and wait at least 10 minutes before reinserting them.
- If using other eye drops, wait at least 5 minutes between applications.
- Store the bottle upright at room temperature.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in the affected eye(s) twice daily (approximately 8 hours apart)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
One drop in the affected eye(s) twice daily (approximately 8 hours apart) for ages 2 years and older
Adolescent:
One drop in the affected eye(s) twice daily (approximately 8 hours apart)
Dose Adjustments
Renal Impairment:
Mild:
No specific recommendations due to minimal systemic absorption
Moderate:
No specific recommendations due to minimal systemic absorption
Severe:
No specific recommendations due to minimal systemic absorption
Dialysis:
No specific recommendations due to minimal systemic absorption
Hepatic Impairment:
Mild:
No specific recommendations due to minimal systemic absorption
Moderate:
No specific recommendations due to minimal systemic absorption
Severe:
No specific recommendations due to minimal systemic absorption
Pharmacology
Mechanism of Action
Cetirizine is a selective H1-receptor antagonist. It inhibits the release of histamine from mast cells and reduces the chemotaxis and activation of eosinophils, neutrophils, and basophils, thereby reducing the inflammatory response associated with allergic conjunctivitis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption after ocular administration. Plasma concentrations are generally below the limit of quantification (0.3 ng/mL).
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (ophthalmic administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
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:
Within minutes
PeakEffect:
Not precisely quantified for ophthalmic, but rapid symptom relief
DurationOfAction:
Up to 12 hours (supports twice daily dosing)
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 unusual symptoms that bother you or do not go away, contact your doctor for advice:
* Eye redness
Not a Complete List of Side Effects
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 unusual symptoms that bother you or do not go away, contact your doctor for advice:
* Eye redness
Not a Complete List of Side Effects
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor.
Reporting Side Effects
You can 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:
- Worsening eye irritation or pain
- Changes in vision
- New eye symptoms
- Signs of an allergic reaction (e.g., rash, severe itching, swelling of face/tongue/throat, severe dizziness, trouble breathing) - seek immediate medical attention
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 affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, 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
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. 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 affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, 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
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. 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. If accidentally ingested, symptoms might include drowsiness, dizziness, or headache (similar to oral cetirizine).
What to Do:
If accidental ingestion occurs, contact a poison control center (1-800-222-1222) or seek medical attention. For ocular overdose, flush eyes with water.
Drug Interactions
Monitoring
Symptom Monitoring
- Reduction in ocular itching
- Reduction in ocular redness
- Absence of adverse ocular effects (e.g., irritation, blurred vision)
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, suggesting low risk.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Caution should be exercised when Zerviate is administered to a nursing woman. While oral cetirizine is excreted in human milk, systemic absorption from ophthalmic use is minimal, suggesting low infant exposure.
Infant Risk:
Low risk
Pediatric Use
Approved for use in pediatric patients 2 years of age and older. Safety and effectiveness in pediatric patients younger than 2 years of age have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No dosage adjustment is necessary.
Clinical Information
Clinical Pearls
- Zerviate is the first and only ophthalmic formulation of cetirizine, a well-known oral antihistamine.
- Patients should be instructed on proper eye drop administration technique to maximize efficacy and minimize contamination.
- Due to its minimal systemic absorption, Zerviate is unlikely to cause systemic side effects like drowsiness commonly associated with oral antihistamines.
- Advise patients to remove contact lenses before instillation and wait 10 minutes before reinserting.
Alternative Therapies
- Olopatadine ophthalmic (e.g., Patanol, Pataday)
- Azelastine ophthalmic (e.g., Optivar)
- Ketotifen ophthalmic (e.g., Zaditor, Alaway)
- Bepotastine ophthalmic (e.g., Bepreve)
- Epinastine ophthalmic (e.g., Elestat)
Cost & Coverage
Average Cost:
Varies widely, typically high for brand-name ophthalmic drops per 5 mL bottle
Insurance Coverage:
Tier 2 or 3 (Brand)
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 your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.