Bepreve 1.5% Opth Drops 5ml
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
C
FDA Approved
Sep 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bepreve is an eye drop used to relieve itchy eyes caused by allergies. It works by blocking a natural substance called histamine that your body makes during an allergic reaction, and also by stabilizing 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 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 administration, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes to help 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, 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 administration, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes to help 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, 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 wear contact lenses if your eyes are red. Bepreve should not be used to treat contact lens-related irritation.
- Remove contact lenses prior to instillation of Bepreve and wait at least 10 minutes after instillation before reinserting contact lenses.
- Avoid touching the dropper tip to any surface to prevent contamination.
- If using other ophthalmic medications, wait at least 5 minutes between applications.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in the affected eye(s) twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
One drop in the affected eye(s) twice daily for children 2 years of age and older
Adolescent:
One drop in the affected eye(s) twice daily
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 adjustment needed (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
Bepotastine is a direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells. This dual mechanism of action contributes to its effectiveness in treating allergic conjunctivitis symptoms.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption after ophthalmic administration. Plasma concentrations are generally below the limit of quantification (0.3 ng/mL).
Tmax:
Not precisely quantifiable due to minimal systemic absorption; typically within 1-2 hours if detectable.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not available (minimal systemic absorption)
ProteinBinding:
Not available (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Approximately 2.5-3.7 hours (systemic data, not clinically relevant for ophthalmic use)
Clearance:
Not available (minimal systemic absorption)
ExcretionRoute:
Primarily renal excretion of unchanged drug (systemic data)
Unchanged:
High percentage (systemic data)
Pharmacodynamics
OnsetOfAction:
Within minutes (typically 3 minutes for symptom relief)
PeakEffect:
Within 15-30 minutes
DurationOfAction:
Up to 8 hours (allowing twice-daily dosing)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
While 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 attention 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, or 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 or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- Eye irritation
- Bad taste in your mouth
- Headache
- Nose and throat irritation
Important Note
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.
While 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 attention 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, or 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 or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- Eye irritation
- Bad taste in your mouth
- Headache
- Nose and throat irritation
Important Note
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
- Signs of 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) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Be sure to discuss all relevant information with both your doctor and pharmacist to ensure safe and effective treatment.
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 is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Be sure to discuss all relevant information with both your doctor and pharmacist to ensure safe and effective treatment.
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 may cause harm. In the event of ingestion, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breast-feeding, notify 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 may cause harm. In the event of ingestion, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breast-feeding, notify 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, but severe effects are not expected.
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
Symptom Monitoring
- Ocular itching
- Ocular redness
- Ocular irritation
- Blurred vision (transient)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies showed adverse effects at high systemic doses, but systemic exposure from ophthalmic use is minimal.
Trimester-Specific Risks:
First Trimester:
Risk cannot be ruled out. Minimal systemic exposure expected.
Second Trimester:
Risk cannot be ruled out. Minimal systemic exposure expected.
Third Trimester:
Risk cannot be ruled out. Minimal systemic exposure expected.
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. Use with caution.
Infant Risk:
Low risk (L3 - Moderately safe)
Pediatric Use
Safety and effectiveness established in pediatric patients 2 years of age and older. Not established for children younger than 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
- Bepreve is a dual-acting agent, providing both antihistamine and mast cell stabilizing effects, which can offer rapid relief and sustained control of allergic conjunctivitis symptoms.
- Patients should be instructed on proper instillation technique to minimize contamination and maximize efficacy.
- While generally well-tolerated, transient eye irritation or blurred vision immediately after instillation can occur.
Alternative Therapies
- Olopatadine (e.g., Pataday, Patanol)
- Azelastine (e.g., Optivar)
- Ketotifen (e.g., Zaditor, Alaway)
- Epinastine (e.g., Elestat)
- Alcaftadine (e.g., Lastacaft)
- Cromolyn sodium (e.g., Crolom)
- Nedocromil sodium (e.g., Alocril)
Cost & Coverage
Average Cost:
$200 - $300 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'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 this 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 medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.