Bepotastine 1.5% Opth Drops 10ml
It is used to treat eye irritation due to allergies.
Drug Class
Ophthalmic Antihistamine and Mast Cell Stabilizer
Pharmacologic Class
Histamine H1-receptor Antagonist; Mast Cell Stabilizer
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 causes allergic symptoms and by stabilizing cells that release these substances.
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 eye use only.
Preparation and Administration
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 retain the medication 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, who may be aware of 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 eye use only.
Preparation and Administration
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 retain the medication 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, who may be aware of 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 wear contact lenses if your eyes are red. If you wear soft contact lenses, remove them before applying the drops and wait at least 10 minutes before reinserting them.
- Avoid touching the dropper tip to any surface to prevent contamination.
- Wash hands thoroughly before and after using the eye drops.
- If using other eye drops, wait at least 5 minutes between applications.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in the affected eye(s) twice daily
Condition-Specific Dosing:
allergicConjunctivitis:
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:
For children 2 years of age and older: One drop in the affected eye(s) twice daily
Adolescent:
One drop in the affected eye(s) twice daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment necessary due to minimal systemic absorption
Moderate:
No adjustment necessary due to minimal systemic absorption
Severe:
No adjustment necessary due to minimal systemic absorption
Dialysis:
No specific recommendations due to minimal systemic absorption
Hepatic Impairment:
Mild:
No adjustment necessary due to minimal systemic absorption
Moderate:
No adjustment necessary due to minimal systemic absorption
Severe:
No adjustment necessary due to minimal systemic absorption
Pharmacology
Mechanism of Action
Bepotastine is a direct H1-receptor antagonist and an inhibitor of mast cell degranulation, thereby preventing the release of inflammatory mediators such as histamine, leukotrienes, and prostaglandins. It also inhibits eosinophil migration into inflamed tissues.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption following ocular administration. Plasma concentrations are generally below the limit of quantification (0.3 ng/mL).
Tmax:
Not reliably quantifiable due to minimal systemic absorption (typically <1 hour if detectable)
FoodEffect:
Not applicable for ophthalmic administration
Distribution:
Vd:
Not reliably quantifiable due to minimal systemic absorption
ProteinBinding:
Not reliably quantifiable due to minimal systemic absorption (in vitro: approximately 50% bound to human serum albumin)
CnssPenetration:
Limited/No (due to minimal systemic absorption)
Elimination:
HalfLife:
Not reliably quantifiable systemically (systemic half-life of oral bepotastine is approximately 2-3 hours)
Clearance:
Not reliably quantifiable systemically
ExcretionRoute:
Primarily renal excretion of unchanged drug for systemically absorbed portion
Unchanged:
Not reliably quantifiable systemically
Pharmacodynamics
OnsetOfAction:
Within minutes (typically 3 minutes for relief of ocular itching)
PeakEffect:
Not precisely defined for ocular itching, but rapid onset suggests peak effect shortly after onset.
DurationOfAction:
Up to 8 hours (supports twice-daily dosing)
Confidence:
High
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, these side effects can be life-threatening:
- 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Changes in vision, 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. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- Eye irritation
- Bad taste in your mouth
- Headache
- Nose and throat irritation
Reporting Side Effects
This list does not include 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. 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, these side effects can be life-threatening:
- 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Changes in vision, 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. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- Eye irritation
- Bad taste in your mouth
- Headache
- Nose and throat irritation
Reporting Side Effects
This list does not include 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. 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:
- Persistent or worsening eye irritation
- Eye pain
- Changes in vision
- Redness or swelling around the eyes
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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 assess 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 this medication can be taken safely with all your other 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 assess 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 this medication can be taken safely with all your other 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.
Do not use this medication to treat irritation or discomfort associated with contact lens use.
If this medication is accidentally ingested, it can be harmful. If you or someone else swallows this drug, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, consult your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication during this time to ensure the best possible outcome for both you and your baby.
Do not use this medication to treat irritation or discomfort associated with contact lens use.
If this medication is accidentally ingested, it can be harmful. If you or someone else swallows this drug, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, consult your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication during this time to ensure the best possible outcome for both 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.
What to Do:
If accidental ingestion occurs, contact a poison control center immediately. For ocular overdose, flush eyes with water. Call 1-800-222-1222
Drug Interactions
Monitoring
Symptom Monitoring
- Resolution of ocular itching
- Presence of eye irritation or discomfort
- Visual disturbances
- Signs of allergic reaction (e.g., rash, swelling)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high systemic doses, but human data are limited. Systemic exposure from ophthalmic use is minimal.
Trimester-Specific Risks:
First Trimester:
Limited data; minimal systemic exposure suggests low risk.
Second Trimester:
Limited data; minimal systemic exposure suggests low risk.
Third Trimester:
Limited data; minimal systemic exposure suggests low risk.
Lactation
It is not known whether bepotastine is excreted in human milk. Due to minimal systemic absorption, excretion into breast milk is expected to be low. Caution should be exercised when administered to a nursing mother.
Infant Risk:
Low risk expected due to minimal systemic absorption.
Pediatric Use
Safety and efficacy established in pediatric patients 2 years of age and older. Not recommended for children under 2 years of age.
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
- Bepotastine ophthalmic solution provides rapid relief of ocular itching, typically within minutes.
- It acts as both an antihistamine and a mast cell stabilizer, offering dual mechanisms of action for allergic conjunctivitis.
- Due to minimal systemic absorption, it has a favorable systemic side effect profile and low potential for drug interactions.
- Patients should be advised to remove contact lenses before administration and wait 10 minutes before reinserting them.
- Common side effects are generally mild and localized to the eye, such as irritation or taste disturbance (dysgeusia).
Alternative Therapies
- Olopatadine ophthalmic solution (e.g., Pataday, Patanol)
- Azelastine ophthalmic solution (e.g., Optivar)
- Ketotifen ophthalmic solution (e.g., Zaditor, Alaway)
- Epinastine ophthalmic solution (e.g., Elestat)
- Alcaftadine ophthalmic solution (e.g., Lastacaft)
- Cromolyn sodium ophthalmic solution (mast cell stabilizer)
Cost & Coverage
Average Cost:
Varies, typically $150-$250 per 10ml 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's a good idea 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.