bepotastine (Rx)

Brand and Other Names:Bepreve
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic solution

  • 1.5% (10mL)

Allergic Conjunctivitis

Instill 1 gtt into affected eye(s) q12hr

Dosage Forms & Strengths

ophthalmic solution

  • 1.5% (10mL)

Allergic Conjunctivitis

<2 years: Safety & efficacy not established

>2 years: Administer as in adults; instill 1 gtt into affected eye(s) q12hr

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Adverse Effects

>10%

Mild taste disturbance (25%)

1-10%

Ocular irritation (2-5%)

Headache (2-5%)

Nasopharyngitis (2-5%)

Postmarketing Reports

Hypersensitivity reactions, including itching, body rash, and swelling lips, tongue and/or throat

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Warnings

Contraindications

Hypersensitivity

Cautions

Remove contact lenses prior to instillation; benzalkonium chloride may be absorbed by soft contact lenses

To minimize contaminating dropper tip and solution, advise the patient not to touch the eyelids

Store at room temp; protect from light & excessive heat

Keep bottle tightly closed when not in use

Do not wear contact lenses if eye is red

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Pregnancy & Lactation

Pregnancy

There are no available human data for use during pregnancy to inform any drug-associated risks; oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures; maternal toxicity was observed in rabbits at lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, RHOD, on a mg/m² basis)

Lactation

There are no data on human milk, effects on breastfed infant or milk production; developmental and health benefits of breastfeeding should be considered, along with mother’s clinical need for therapy, and any potential adverse effects on breastfed infant

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Topical H1 receptor antagonist; inhibits histamine release from mast cells

Pharmacokinetics

Cmax: 5.1-7.3 ng/mL

Absorption: Minimal systemic absorption

Protein bound: 55%

Peak serum time: 1-2 hr

Metabolism: Minimally metabolized by CYP450 isozymes

Excretion: Urine (75-90% excreted unchanged)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Bepreve ophthalmic (eye)
-
1.5 % drops
Bepreve ophthalmic (eye)
-
1.5 % drops

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
bepotastine besilate ophthalmic (eye)

BEPOTASTINE - OPHTHALMIC

(BEP-oh-TAS-teen)

COMMON BRAND NAME(S): Bepreve

USES: This medication is used to treat itching of the eyes due to allergies. Bepotastine is an antihistamine. It works by blocking a certain natural substance (histamine) that causes allergic symptoms.Do not use this medication to treat red or irritated eyes due to wearing contact lenses. Contact your doctor for further instructions if this occurs.

HOW TO USE: Apply this medication in the affected eye(s) usually twice a day or as directed by your doctor.Wash your hands before each use. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.The preservative in this product may be absorbed by contact lenses. If you wear contact lenses, remove them before using this medication and keep them out of your eyes for at least 10 minutes after each dose.Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed.Do not rinse the dropper. Replace the dropper cap after each use.If you are using another kind of eye medication (for example, other drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.Do not use this product if it becomes contaminated (for example, drops turn a dark color). Use of contaminated eye medication can cause infection, serious damage to the eye, and loss of vision. Contact your doctor or pharmacist for more information.Tell your doctor if your condition does not improve in a few days or if it worsens.

SIDE EFFECTS: A mild taste in the mouth, headache, eye irritation, or sore throat may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using bepotastine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current bottle of bepotastine eye drops or start a new bottle.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.Ask your doctor about additional ways to reduce your symptoms (such as minimizing your exposure to allergens, using cold compresses and lubricating eye drops).

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Keep the bottle tightly closed and store between 59-77 degrees F (15-25 degrees C) away from moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised February 2022. Copyright(c) 2022 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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Adding plans allows you to:

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.