Bepotastine Besilate Ophthalmic Solution 1.5% 15 mg/mL Solution/ Drops
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Bepotastine ophthalmic is used to treat itching of the eyes caused by allergic conjunctivitis (a condition in which the eyes become itchy, swollen, red, and teary when they are exposed to certain substances in the air). Bepotastine is in a class of medications called antihistamines. It works by blocking the action and preventing the release of histamine, a substance in the body that causes allergic symptoms.
Read the full MedlinePlus article ↗- It's designed to stop the itching that comes with eye allergies — what doctors call allergic conjunctivitis. It works by blocking histamine, the chemical your immune system release...
- What exactly is this eye drop supposed to do?
- That mild taste after instillation is actually the most common side effect — about 1 in 4 people notice it. It happens because a tiny amount of the drop drains from the eye into th...
- Why do I taste something weird after I put in the drops?
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 5QWK665956
A salt derived from phosphoric acid and sodium, used primarily as a buffer to control the acidity or pH of a medication, helping keep it stable during storage and use.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $8.359 | $83.59 / 10 ml |
| Medicaid paysCMS SDUD · 12 mo | $11.34 | $113.43 / 10 ml |
| Medicare drug plans payPart D · Q2 2026 | $21.36 | $213.63 / 10 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bepotastine Besilate Ophthalmic Solution 1.5% 15 mg/mLthis 62332-0598-10 | Alembic | 1 bottle | $8.359 | AT | Availability likely | — |
| Bepotastine Besilate 15 mg/mL 70069-0712-01 | Somerset | 1 bottle | $8.359 | AT | Availability likely | — |
| Bepotastine Besilate 15 mg/mL 00378-7055-35 | Mylan | 1 bottle | $11.253 | AT | Availability likely | +35% |
| Bepotastine Besilate 15 mg/mL 24208-0630-05 | Bausch | 1 bottle | $11.253 | AT | Availability likely | +35% |
| Bepotastine Besilate 15 mg/mL 70069-0711-01 | Somerset | 1 bottle | $11.253 | AT | Availability likely | +35% |
| Bepotastine Besilate 15 mg/mL 82260-0630-05 | Bausch | 1 bottle | $11.253 | AT | Availability likely | +35% |
| Bepreve 15 mg/mL 24208-0629-01 | Bausch | 1 bottle | $53.811 | AT | FDA listed | +544% |
| Bepotastine Besilate Ophthalmic Solution 1.5% 15 mg/mL 46708-0598-05 | Alembic | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 62332-0598-05 | 1 BOTTLE in 1 CARTON (62332-598-05) / 5 mL in 1 BOTTLE | $11.25 / mL | $56.27 | 2023-07-18 | Active |
| 62332-0598-10 You're viewing this | 1 BOTTLE in 1 CARTON (62332-598-10) / 10 mL in 1 BOTTLE | $8.36 / mL | $83.59 | 2023-04-05 | Active |
This pack has the lowest per-mL cost of the 2 priced pack sizes ($8.36 NADAC).
This pack accounts for about 14% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 62332-0598-10?
What NDC number is used to bill for this package of Bepotastine Besilate Ophthalmic Solution 1.5% 15 mg/mL Solution/ Drops?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Bepotastine besilate ophthalmic solution 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. Bepotastine besilate ophthalmic solution is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION Instill one drop of bepotastine besilate ophthalmic solution into the affected eye(s) twice a day. Remove contact lenses prior to instillation of bepotastine besilate ophthalmic solution. Instill one drop into the affected eye(s) twice a day. (2) Remove contact lenses prior to instillation of Bepotastine besilate ophthalmic solution.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Ophthalmic solution containing bepotastine besilate 15 mg/mL (1.5%). Ophthalmic solution containing bepotastine besilate, 15 mg/mL (1.5%).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Bepotastine besilate ophthalmic solution 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.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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: Bepotastine besilate ophthalmic solution should not be used to treat contact lens-related irritation. ( 5.2 )
5.1Contamination 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.
5.2Contact Lens Wear Bepotastine besilate ophthalmic solution should not be used to treat contact lens-related irritation. Bepotastine besilate ophthalmic solution should not be instilled while wearing contact lenses. Patient should remove contact lenses prior to instillation of bepotastine besilate ophthalmic solution, because benzalkonium chloride may be absorbed by soft contact lenses.
Lenses may be reinserted after 10 minutes following administration of bepotastine besilate ophthalmic solution.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions which occurred in 2 to 5% of subjects were eye irritation, headache, and nasopharyngitis. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trial 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 to 5% of subjects were eye irritation, headache, and nasopharyngitis.
6.2Post-Marketing Experience Hypersensitivity reactions have been reported rarely during the post-marketing use of bepotastine besilate ophthalmic solution. 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available human data for the use of bepotastine besilate ophthalmic solution during pregnancy to inform any drug-associated risks. Oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. Maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, RHOD, on a mg/m 2 basis) [ see Data ].
The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data In embryofetal development studies, oral administration of bepotastine besilate to pregnant rabbits throughout organogenesis did not produce teratogenic effects at maternal doses up to 500 mg/kg/day (approximately 5400 times the maximum RHOD, on a mg/m 2 basis).
A maternal no observed adverse effect level (NOAEL) was not identified in this study due to spontaneous abortion observed at the lowest dose tested, 20 mg/kg/day (approximately 215 times higher than the maximum RHOD, on a mg/m 2 basis). Oral administration of bepotastine besilate to pregnant rats throughout organogenesis produced skeletal anomalies at 1000 mg/kg/day (5400 times higher than the maximum RHOD, on a mg/m2 basis), a dose that also produced maternal toxicity and lethality. No teratogenic effects were observed in rats at maternal doses up to 200 mg/kg/day (corresponding to an estimated blood plasma concentration 3300 times higher than that anticipated in humans at the maximum RHOD).
A maternal NOAEL was observed at 10 mg/kg/day (54 times higher than the maximum RHOD, on a mg/m 2 basis). Following a single 3 mg/kg oral dose in rats (16 times higher than the maximum RHOD, on a mg/m 2 basis), the concentration of radio-labeled bepotastine besilate was similar in fetal liver and maternal blood plasma. The concentration in other fetal tissues was one-third to one-tenth the concentration in maternal blood plasma.
In a pre/postnatal development study, oral administration of bepotastine besilate to rats during the perinatal and lactation periods produced an increase in stillbirths and decreased growth and development in offspring at a maternal dose of 1000 mg/kg/day (5400 times higher than the maximum RHOD, on a mg/m 2 basis). There were no observed adverse effects on offspring of rats treated with 100 mg/kg/day (540 times higher than the maximum RHOD, on a mg/m 2 basis). Effects on parturition and maternal lethality were observed at 100 mg/kg/day and 1000 mg/kg/day, respectively.
A maternal NOAEL was observed at 10 mg/kg/day (54 times higher than the maximum RHOD, on a mg/m 2 basis).
8.2Lactation Risk Summary There are no data on the presence of bepotastine besilate ophthalmic solution in human milk, the effects on the breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for bepotastine besilate ophthalmic solution, and any potential adverse effects on the breastfed infant from bepotastine besilate ophthalmic solution. Animal Data Following a single 3 mg/kg oral dose (16 times the maximum RHOD, on a mg/m2 basis) of radiolabeled bepotastine besilate to nursing rats 11 days after delivery, the maximum concentration of radioactivity in milk was 0.40 mcg-eq/mL 1 hour after administration; at 48 hours after administration, the radioactivity concentration was below detection limits.
The milk radioactivity concentration was higher than the maternal blood plasma radioactivity concentration at each time of measurement. It is not known whether bepotastine besilate would be presen…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available human data for the use of bepotastine besilate ophthalmic solution during pregnancy to inform any drug-associated risks. Oral administration of bepotastine besilate to pregnant rats or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant systemic exposures. Maternal toxicity was observed in the rabbits at the lowest dose administered, 20 mg/kg/day (215 times the maximum recommended human ophthalmic dose, RHOD, on a mg/m 2 basis) [ see Data ].
The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies. Data Animal Data In embryofetal development studies, oral administration of bepotastine besilate to pregnant rabbits throughout organogenesis did not produce teratogenic effects at maternal doses up to 500 mg/kg/day (approximately 5400 times the maximum RHOD, on a mg/m 2 basis).
A maternal no observed adverse effect level (NOAEL) was not identified in this study due to spontaneous abortion observed at the lowest dose tested, 20 mg/kg/day (approximately 215 times higher than the maximum RHOD, on a mg/m 2 basis). Oral administration of bepotastine besilate to pregnant rats throughout organogenesis produced skeletal anomalies at 1000 mg/kg/day (5400 times higher than the maximum RHOD, on a mg/m2 basis), a dose that also produced maternal toxicity and lethality. No teratogenic effects were observed in rats at maternal doses up to 200 mg/kg/day (corresponding to an estimated blood plasma concentration 3300 times higher than that anticipated in humans at the maximum RHOD).
A maternal NOAEL was observed at 10 mg/kg/day (54 times higher than the maximum RHOD, on a mg/m 2 basis). Following a single 3 mg/kg oral dose in rats (16 times higher than the maximum RHOD, on a mg/m 2 basis), the concentration of radio-labeled bepotastine besilate was similar in fetal liver and maternal blood plasma. The concentration in other fetal tissues was one-third to one-tenth the concentration in maternal blood plasma.
In a pre/postnatal development study, oral administration of bepotastine besilate to rats during the perinatal and lactation periods produced an increase in stillbirths and decreased growth and development in offspring at a maternal dose of 1000 mg/kg/day (5400 times higher than the maximum RHOD, on a mg/m 2 basis). There were no observed adverse effects on offspring of rats treated with 100 mg/kg/day (540 times higher than the maximum RHOD, on a mg/m 2 basis). Effects on parturition and maternal lethality were observed at 100 mg/kg/day and 1000 mg/kg/day, respectively.
A maternal NOAEL was observed at 10 mg/kg/day (54 times higher than the maximum RHOD, on a mg/m 2 basis).
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy of bepotastine besilate ophthalmic solution 1.5% have not been established in pediatric patients under 2 years of age. Efficacy in pediatric patients under 10 years of age was extrapolated from clinical trials conducted in pediatric patients greater than 10 years of age and from adults.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Bepotastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells.
12.3Pharmacokinetics Absorption: The extent of systemic exposure to bepotastine following topical ophthalmic administration of bepotastine besilate 1% and 1.5% ophthalmic solutions was evaluated in 12 healthy adults. Following one drop of 1% or 1.5% bepotastine besilate ophthalmic solution to both eyes four times daily (QID) for 7 days, bepotastine plasma concentrations peaked at approximately 1 to 2 hours post-instillation. Maximum plasma concentrations for the 1% and 1.5% strengths were 5.1 ± 2.5 ng/mL and 7.3 ± 1.9 ng/mL, respectively.
Plasma concentrations at 24 hours post-instillation were below the quantifiable limit (2 ng/mL) in 11/12 subjects in the two dose groups. Distribution : The extent of protein binding of bepotastine is approximately 55% and independent of bepotastine concentration. Metabolism: In vitro metabolism studies with human liver microsomes demonstrated that bepotastine is minimally metabolized by CYP450 isozymes.
In vitro studies demonstrated that bepotastine besilate does not inhibit the metabolism of various cytochrome P450 substrates via inhibition of CYP3A4, CYP2C9, and CYP2C19. The effect of bepotastine besilate on the metabolism of substrates of CYP1A2, CYP2C8 and CYP2D6 was not studied. Bepotastine besilate has a low potential for drug interaction via inhibition of CYP3A4, CYP2C9, and CYP2C19.
Excretion: The main route of elimination of bepotastine besilate is urinary excretion (with approximately 75 to 90% excreted unchanged in urine).
🧬 Mechanism of Action ▾
12.1Mechanism of Action Bepotastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Bepotastine besilate ophthalmic solution 1.5% is supplied in a white low density polyethylene (LDPE) bottle with a white LDPE nozzle and a white high density polyethylene (HDPE) cap in the following size: 5 mL (NDC 62332-598-05) 10 mL (NDC 62332-598-10) STORAGE Store at 15°C to 25°C (59°F to 77°F).
📋 Description ▾
11 DESCRIPTION Bepotastine besilate ophthalmic solution 1.5% is a sterile, topically administered drug for ophthalmic use. Each mL of bepotastine besilate ophthalmic solution 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 white or pale yellowish crystalline powder. The molecular weight of bepotastine besilate is 547.06 daltons. Bepotastine besilate ophthalmic solution is supplied as a sterile, aqueous 1.5% solution, with a pH of 6.8.
The osmolality of bepotastine besilate ophthalmic solution 1.5% is approximately 290 mOsm/kg. Each mL Bepotastine besilate ophthalmic solution 1.5% contains: Active: bepotastine besilate 15 mg (equivalent to 10.7 mg bepotastine) Preservative: benzalkonium chloride 0.005% Inactives: monobasic sodium phosphate dihydrate, sodium chloride, sodium hydroxide to adjust pH, and water for injection, USP. bepotastine-structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Sterility of Dropper Tip Advise patients not to touch the dropper tip to any surface, as this may contaminate the solution and to keep the bottle tightly closed when not in use. Concomitant Use of Contact Lenses Advise patients not to wear a contact lens if their eye is red and that bepotastine besilate ophthalmic solution should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of bepotastine besilate ophthalmic solution, which may be reinserted after 10 minutes following administration.
Rx Only Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Made in India. Manufactured by: Alembic Pharmaceuticals Limited Karkhadi – 391 450 Gujarat, India Issued: 04/2023