Bepotastine 1.5% Opth Drops 5ml
It is used to treat eye irritation due to allergies.
Drug Class
Ophthalmic antihistamine; Mast cell stabilizer
Pharmacologic Class
H1 receptor antagonist
Pregnancy Category
Category C
FDA Approved
Sep 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bepotastine ophthalmic drops are used to relieve itchy eyes caused by allergies. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction, and also helps stabilize cells that release histamine.
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. This medication is for use in the eyes only.
Administration Instructions
1. Wash your hands before and after using this medication.
2. Remove contact lenses before applying the medication. You can put them back in 10 minutes after use, unless your eyes are irritated or infected.
3. Avoid wearing contact lenses if your eyes are red.
4. To prevent contamination, do not touch the container tip to your eye, lid, or surrounding skin, as this can lead to bacterial infection and potentially cause severe eye problems or vision loss.
5. Tilt your head back and gently drop the medication into your eye.
6. After application, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes. This helps the medication stay in your eye.
Storage and Disposal
Store this medication at room temperature with the lid tightly closed. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it is 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. This medication is for use in the eyes only.
Administration Instructions
1. Wash your hands before and after using this medication.
2. Remove contact lenses before applying the medication. You can put them back in 10 minutes after use, unless your eyes are irritated or infected.
3. Avoid wearing contact lenses if your eyes are red.
4. To prevent contamination, do not touch the container tip to your eye, lid, or surrounding skin, as this can lead to bacterial infection and potentially cause severe eye problems or vision loss.
5. Tilt your head back and gently drop the medication into your eye.
6. After application, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes. This helps the medication stay in your eye.
Storage and Disposal
Store this medication at room temperature with the lid tightly closed. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it is 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
- Do not touch the dropper tip to any surface, including the eye, to avoid contamination.
- Remove contact lenses before instilling drops and wait at least 10 minutes before reinserting them.
- If using other eye drops, wait at least 5 minutes between applications.
- Store at room temperature, away from light and moisture.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in the affected eye(s) twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy not established in pediatric patients under 2 years of age)
Child:
One drop in the affected eye(s) twice daily (2 years of age and older)
Adolescent:
One drop in the affected eye(s) twice daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations due to minimal systemic absorption
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Bepotastine is a highly selective histamine H1-receptor antagonist. It also inhibits the release of histamine from mast cells and suppresses the migration of eosinophils into inflamed tissues, thereby inhibiting the early and late phases of allergic reactions.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (plasma concentrations generally below quantification limit of 0.3 ng/mL after ophthalmic administration)
Tmax:
Approximately 1-2 hours (if detectable systemically)
FoodEffect:
Not applicable for ophthalmic solution
Distribution:
Vd:
Not well characterized for ophthalmic use due to minimal systemic absorption
ProteinBinding:
Approximately 25% (systemic)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Approximately 2.5 hours (systemic, if detectable)
Clearance:
Not well characterized for ophthalmic use
ExcretionRoute:
Renal (primarily unchanged drug)
Unchanged:
High percentage (systemic, if detectable)
Pharmacodynamics
OnsetOfAction:
Within minutes (for ocular itching relief)
PeakEffect:
Within 15 minutes to 2 hours
DurationOfAction:
Up to 8 hours (twice daily dosing provides 24-hour coverage)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, including:
+ 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. 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 unusual symptoms that bother you or do not go away, contact your doctor for advice:
Eye irritation
Bad taste in your mouth
Headache
Nose and throat irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, including:
+ 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. 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 unusual symptoms that bother you or do not go away, contact your doctor for advice:
Eye irritation
Bad taste in your mouth
Headache
Nose and throat irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other 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:
- Increased eye pain
- Persistent or worsening eye irritation
- Changes in vision
- Signs of eye infection (e.g., discharge, swelling)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
Please describe the allergy and the symptoms you experienced.
This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about any health problems you have
You must verify that it is safe to take this medication with all your other medications and health conditions. Do not:
- Start taking a new medication
- Stop taking a medication
- Change the dose of any medication
without first consulting your doctor.
It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
Please describe the allergy and the symptoms you experienced.
This medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about any health problems you have
You must verify that it is safe to take this medication with all your other medications and health conditions. Do not:
- Start taking a new medication
- Stop taking a medication
- Change the dose 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.
Do not use this medication to treat irritation caused by contact lenses.
If swallowed, this medication can be harmful. If you or someone else accidentally ingests this drug, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
Do not use this medication to treat irritation caused by contact lenses.
If swallowed, this medication can be harmful. If you or someone else accidentally ingests this drug, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. If accidentally ingested, symptoms might include drowsiness, headache, or gastrointestinal upset, but severe toxicity is rare.
What to Do:
If accidental ingestion occurs, contact a poison control center or seek medical attention. For ocular overdose, flush eyes with water. Call 1-800-222-1222
Drug Interactions
Monitoring
Routine Monitoring
Ocular itching/redness
Frequency: Daily (patient self-assessment)
Target: Resolution or significant improvement of symptoms
Action Threshold: Persistent or worsening symptoms after several days of use; consult ophthalmologist
Symptom Monitoring
- Ocular itching
- Ocular redness
- Eye irritation
- Blurred vision
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential risk based on animal studies; human data lacking.
Second Trimester:
Potential risk based on animal studies; human data lacking.
Third Trimester:
Potential risk based on animal studies; human data lacking.
Lactation
It is not known whether bepotastine is excreted in human milk. Due to minimal systemic absorption, risk to a breastfed infant is considered low. Caution should be exercised when administered to a nursing woman.
Infant Risk:
Low
Pediatric Use
Safety and effectiveness have been established in pediatric patients 2 years of age and older. Not recommended for use in children younger than 2 years.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Dosage adjustment is generally not necessary.
Clinical Information
Clinical Pearls
- Bepotastine ophthalmic solution is effective for both seasonal and perennial allergic conjunctivitis.
- Patients should be advised on proper instillation technique to maximize efficacy and minimize contamination.
- Due to its dual mechanism (H1 antagonism and mast cell stabilization), it can provide rapid relief and sustained control of allergic symptoms.
- Minimal systemic absorption makes it a good option for patients concerned about systemic side effects from oral antihistamines.
Alternative Therapies
- Olopatadine ophthalmic solution (e.g., Pataday, Patanol)
- Azelastine ophthalmic solution (e.g., Optivar)
- Ketotifen ophthalmic solution (e.g., Zaditor, Alaway)
- Emedastine ophthalmic solution (e.g., Emadine)
- Cromolyn sodium ophthalmic solution
Cost & Coverage
Average Cost:
Varies, typically $50-$150 per 5mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.