bepreve
Bepreve (Bepotastine Besilate) is a histamine-1 receptor antagonist used to treat Allergic Conjunctivitis.
Bepotastine Besilate · by Bausch and Lomb
Key facts
- Active ingredient
- Bepotastine Besilate
- Drug class
- Histamine-1 Receptor Antagonist
- Form
- Drops
- Strength
- Bepotastine Besilate 1.5%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- allergic conjunctivitis
- Manufacturer
- Bausch and Lomb
- FDA application
- NDA022288
What is Bepreve?
From the FDA label:BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of BEPREVE contains 15 mg bepotastine besilate. Bepotastine besilate is designated chemically as (+) -4-[[(S)-p-chloro-alpha -2-pyridylbenzyl]oxy]-1-piperidine butyric acid monobenzenesulfonate. The chemical structure for bepotastine besilate is: Bepotastine besilate is a white to pale yellowish-white crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. BEPREVE ophthalmic solution is supplied as a sterile, aqueous 1.5% solution, with an approximate pH of 6.8. The osmolality of BEPREVE (bepotastine besilate ophthalmic solution) 1.5% is approximately 295 mOsm/kg. Each mL of BEPREVE (bepotastine besilate ophthalmic solution) 1.5% contains: • Active: bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine) • Inactives: monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP • Preservative: benzalkonium chloride 0.005% Chemical Structure
How to use
Instill one drop of BEPREVE into the affected eye(s) twice a day. Remove contact lenses prior to instillation of BEPREVE. • Instill one drop into the affected eye(s) twice a day. ( 2 ) • Remove contact lenses prior to instillation of BEPREVE. ( 2 )
Side effects
The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions which occurred in 2-5% of subjects were eye irritation, headache, and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis. 6.2 Post-Marketing Experience Hypersensitivity reactions have been reported rarely during the post-marketing use of BEPREVE. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The hypersensitivity reactions may include itching, body rash, and swelling of lips, tongue and/or throat. 6.1 Clinical Trials Experience Because clinical…
Warnings
Important safety information
Contamination of Solution: Do not touch the dropper tip to any surface. Keep bottle tightly closed when not in use. ( 5.1 ) • Contact Lens Wear: BEPREVE should not be used to treat contact lens-related irritation. ( 5.2 ) 5.1 Contamination of Tip and Solution To minimize contaminating the dropper tip and solution, advise the patient not to touch the eyelids or surrounding areas with the dropper tip of the bottle and to keep the bottle tightly closed when not in use. 5.2 Contact Lens Wear BEPREVE should not be used to treat contact lens-related irritation. BEPREVE should not be instilled while wearing contact lenses. Patient should remove contact lenses prior to instillation of BEPREVE, because benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of BEPREVE. 5.1 Contamination of Tip and Solution To minimize contaminating the dropper tip and solution, advise the patient not to touch the eyelids or surrounding areas with the dropper tip of the bottle and to keep the bottle tightly closed when not in use. 5.2 Contact Lens Wear BEPREVE should not be used to treat contact lens-related irritation. BEPREVE should not be instilled while wearing contact lenses. Patient should remove contact lenses prior to instillation of BEPREVE, because benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of BEPREVE.
Who should not take Bepreve
BEPREVE is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients [see Adverse Reactions ( 6.2 )] . Hypersensitivity to any component of this product. ( 4 )
Drug class
How this class works, per Antihistamines - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Bepreve ranks — best-rated histamine-1 receptor antagonist for:
Dosage forms
Drops
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Bepreve treat?
- Bepreve (Bepotastine Besilate) may be used to treat allergic conjunctivitis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Bepreve work?
- Bepreve is a histamine-1 receptor antagonist. H1 antihistamines work by blocking histamine, the chemical released during an allergic reaction, from attaching to H1 receptors. This prevents the sneezing, itching, runny nose, watery eyes, and hives that histamine would otherwise trigger.
- Is there a coupon or discount for Bepreve?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Bepreve. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Bepreve?
- Bepreve is marketed by Bausch and Lomb. You can see Bausch and Lomb's full profile, rating, and other products on pharmaranks.
- Is Bepreve a brand-name or generic drug?
- Bepreve is a brand-name product with the active ingredient Bepotastine Besilate.
- Is Bepreve available over the counter?
- No. Bepreve is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Bepreve come in?
- Bepreve is currently marketed as drops, per the FDA's National Drug Code Directory.
- What class of drug is Bepreve?
- Bepreve is classified as histamine-1 receptor antagonist, per the FDA's Established Pharmacologic Class.
- Is Bepreve FDA-registered?
- Bepreve is on record with the U.S. FDA under application number NDA022288. You can verify this on its official FDA label.
- Is Bepreve safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Bepreve. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Bepreve?
- Bepreve's side effects are taken directly from its FDA label. From the label: The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions which occurred in 2-5% of subjects were eye irritation, headache, and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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