Bepreve 1.5% Opth Drops 10ml
It is used to treat eye irritation due to allergies.
Drug Class
Ophthalmic Antihistamine; Ophthalmic Mast Cell Stabilizer
Pharmacologic Class
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 substances in your body that cause 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, but avoid doing so if your eyes are irritated or infected. Do not wear contact lenses if your eyes are red.
3. To avoid contamination, do not touch the container tip to your eye, lid, or other skin, as this can lead to bacterial infection and potentially severe eye problems or vision loss.
4. Tilt your head back and gently drop the medication into your eye.
5. 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 dosing schedule. Do not use two doses at once 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, but avoid doing so if your eyes are irritated or infected. Do not wear contact lenses if your eyes are red.
3. To avoid contamination, do not touch the container tip to your eye, lid, or other skin, as this can lead to bacterial infection and potentially severe eye problems or vision loss.
4. Tilt your head back and gently drop the medication into your eye.
5. 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 dosing schedule. Do not use two doses at once or take extra doses.
Lifestyle & Tips
- Do not touch the dropper tip to any surface to avoid contamination.
- Remove contact lenses before applying 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:
Generic Alternatives:
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:
One drop in the affected eye(s) twice daily (for patients 2 years of age and older)
Adolescent:
One drop in the affected eye(s) twice daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (due to minimal systemic absorption)
Moderate:
No adjustment needed (due to minimal systemic absorption)
Severe:
No adjustment needed (due to minimal systemic absorption)
Dialysis:
No specific considerations; minimal systemic absorption
Hepatic Impairment:
Mild:
No adjustment needed (due to minimal systemic absorption)
Moderate:
No adjustment needed (due to minimal systemic absorption)
Severe:
No adjustment needed (due to minimal systemic absorption)
Pharmacology
Mechanism of Action
Bepotastine is a direct H1-receptor antagonist and inhibits the release of histamine from mast cells. This dual mechanism of action contributes to its effectiveness in treating ocular itching associated with allergic conjunctivitis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption after ocular administration
Tmax:
Not precisely quantifiable for ophthalmic use due to minimal systemic absorption; if detectable, typically within 1-2 hours systemically.
FoodEffect:
Not applicable for ophthalmic administration
Distribution:
Vd:
Not precisely quantifiable for ophthalmic use due to minimal systemic absorption
ProteinBinding:
Not precisely quantifiable for ophthalmic use; systemically, approximately 25% bound to plasma proteins.
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Approximately 2.5 hours (systemic, but largely irrelevant for ophthalmic use due to minimal absorption)
Clearance:
Not precisely quantifiable for ophthalmic use
ExcretionRoute:
Primarily renal excretion of unchanged drug
Unchanged:
High percentage (systemically, but minimal overall systemic exposure)
Pharmacodynamics
OnsetOfAction:
Within minutes (for relief of ocular itching)
PeakEffect:
Within 15-30 minutes
DurationOfAction:
Up to 8 hours (allowing for twice-daily dosing)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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. 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 or seek medical help:
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, contact your doctor for medical advice. 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 or seek medical help right away:
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. 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 or seek medical help:
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, contact your doctor for medical advice. 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
- Vision changes
- 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 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) medications, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is vital 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) medications, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is vital 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.
Do not use this medication for treating irritation related to contact lens use.
If swallowed, this medication can be harmful. In the event of accidental ingestion, 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 for treating irritation related to contact lens use.
If swallowed, this medication can be harmful. In the event of accidental ingestion, 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, dizziness, or dry mouth, but severe effects are not expected.
What to Do:
If accidental ingestion occurs, drink fluids. For any concerning symptoms, contact a poison control center (Call 1-800-222-1222) or seek medical attention.
Drug Interactions
Monitoring
Symptom Monitoring
- Ocular itching
- Ocular redness
- Discomfort
- Vision changes (rare)
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. Caution should be exercised when bepotastine ophthalmic solution is administered to a nursing woman. Due to minimal systemic absorption, risk to infant is likely low.
Infant Risk:
Low (L3 - Moderately Safe)
Pediatric Use
Safety and efficacy have been 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. Dosage adjustment is generally not needed.
Clinical Information
Clinical Pearls
- Bepotastine offers a dual mechanism of action (H1-antagonist and mast cell stabilizer) for comprehensive allergic conjunctivitis relief.
- Patients should be instructed on proper instillation technique to maximize efficacy and minimize contamination.
- Advise patients that temporary blurred vision or stinging may occur immediately after instillation.
- This medication is for ocular use only and should not be injected or taken orally.
Alternative Therapies
- Olopatadine ophthalmic (e.g., Pataday, Patanol)
- Azelastine ophthalmic (e.g., Optivar)
- Ketotifen ophthalmic (e.g., Zaditor, Alaway)
- Epinastine ophthalmic (e.g., Elestat)
- Cromolyn sodium ophthalmic (e.g., Crolom)
Cost & Coverage
Average Cost:
Check current market price 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.