Registered Kenya · PPB

BETOACT

BEPOTASTINE BESILATE

H2022/CTD10078/22030 BEPOTASTINE BESILATE 1.5% W/V GENERIC/BIOSIMILARS INN generic

What it does

Bepotastine is an antihistamine used to relieve allergy symptoms.

Commonly used for: allergic rhinitis (hay fever), itchy skin conditions (urticaria)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2022/CTD10078/22030
Registration date
-
Expiry date
2028 February 17
Status
Registered
Active ingredient
BEPOTASTINE BESILATE
Strength
-
Pack size
5 ML SOLUTION FILLED IN A LDPE VIAL, A CARTON CONTAINING ONE SUCH VIAL ALONG WITH THE PACK INSERT.
Therapeutic class
GENERIC/BIOSIMILARS
RxNorm RxCUI
863035
Manufacturer / MAH
Harleys
Applicant / LTR
AJANTA PHARMA LIMITED
Country of origin
FOREIGN
Manufacturer location
63 Westlands Rd, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 19:32:16 · updated 2026-09-15 02:24:41

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Bepotastine is an antihistamine used to relieve allergy symptoms.

What it treats

  • allergic rhinitis (hay fever)
  • itchy skin conditions (urticaria)

How it works

Bepotastine works by blocking the effects of histamine, a substance in the body that causes allergic symptoms.

Who it's for

Bepotastine is for adults and children who experience allergy symptoms.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: bepotastine

BNF-referenced

Bepotastine is an antihistamine used primarily for the relief of symptoms associated with allergic conjunctivitis. It is a second-generation antihistamine that selectively antagonizes the histamine H1 receptor, providing effective relief from itching and discomfort in the eyes due to allergic reactions. Bepotastine also stabilizes mast cells and suppresses eosinophil migration, contributing to its therapeutic effects in managing allergic inflammation.

Indications

  • Allergic conjunctivitis
  • Allergic rhinitis

Dosage

Children: For pediatric patients aged 2 years and older, the recommended dosage is one drop in the affected eye(s) twice daily.

Adults: The usual adult dosage for bepotastine is one drop in the affected eye(s) twice daily.

Mechanism of action

Bepotastine acts by three primary mechanisms: it selectively antagonizes the histamine H1 receptor, thereby blocking the effects of histamine released during allergic reactions. Additionally, it stabilizes mast cells to prevent further degranulation and the release of pro-inflammatory mediators. Lastly, it suppresses the migration of eosinophils into inflamed tissues, which helps to prevent tissue damage and worsening of allergic conjunctival inflammation.

Pharmacodynamics

As a non-sedating, selective antagonist of the H1 receptor, bepotastine provides effective symptom relief without the sedation commonly associated with first-generation antihistamines. It belongs to the piperidine chemical class and has a rapid onset of action (approximately 0.25 hours) with a duration of action lasting between 12 to 24 hours. It does not interact with serotonin, muscarinic, benzodiazepine, or beta-adrenergic receptors, minimizing the risk of adverse effects such as dry mouth or somnolence.

Pharmacokinetics

Bepotastine is well-absorbed and has a favorable pharmacokinetic profile that supports its effectiveness in treating allergic conjunctivitis. Specific details regarding its distribution, metabolism, and excretion are not provided, but the drug's rapid onset and prolonged action suggest adequate systemic absorption and a suitable half-life for daily dosing.

Adverse effects

  • Headache
  • Eye irritation
  • Dry eye
  • Dizziness

Precautions

  • Use with caution in patients with a history of hypersensitivity to bepotastine or any component of the formulation.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.

Breast-feeding

It is not known whether bepotastine is excreted in human milk. Caution is advised when administered to nursing women.

Storage

Store at room temperature, away from light and moisture. Do not freeze.

Formulations

  • Ophthalmic solution 1.5%

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: bepotastine

PubChem CID 164522

Molecular formula: C21H25ClN2O3

Mechanism of action

Because of a type 1 hypersensitivity reaction cascade that is triggered by antigen exposure, allergic conjunctivitis occurs. Allergen exposure is followed by conjunctival mast cell degranulation and histamine released as a result of the formation of complementary IgE cross-links on the conjunctiva. Due to the release of histamine, symptoms such as itching can be observed. Bepotastine works to relieve itchy eyes by three primary mechanisms of action. It is a non-sedating, selective antagonist of the histamine 1 (H1) receptor, a mast cell stabilizer, and it suppresses the migration of eosinophils into inflamed tissues to prevent tissue damage and worsening of allergic inflammation of the conjunctiva.

Pharmacodynamics

Bepotastine is a non-sedating, selective antagonist of the histamine 1 (H1) receptor. It belongs to the second-generation piperidine chemical class. It is a mast cell stabilizer and suppresses the migration of eosinophils into inflamed tissues. Furthermore, bepotastine does not interact with serotonin, muscarinic, benzodiazepine, and beta-adrenergic receptor that would otherwise result in adverse reactions such as dry mouth or sonmolence. Onset of action = 0.25 hours; Duration of action = 12-24 hours;

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.

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