Registered Rwanda · Rwanda FDA

EROSTIN-20

Ebastine

Rwanda FDA-HMP-MA-1581 Tablets 20 mg respiratory system INN generic

What it does

Ebastine is an antihistamine used to relieve allergy symptoms.

Commonly used for: allergic rhinitis (hay fever), urticaria (hives)

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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.
Rwanda FDA-HMP-MA-1581
Registration date
17/08/2024
Expiry date
16/08/2029
Status
Registered
Active ingredient
Ebastine
Dosage form
Tablets
Strength
20 mg
Pack size
1x10 Tablets
Therapeutic class
-
ATC class (WHO)
R06AX - Other antihistamines for systemic use
Drug group
RESPIRATORY SYSTEM
RxNorm RxCUI
23796
Manufacturer / MAH
Micro Labs
Applicant / LTR
MICRO LABS LIMITED
Country of origin
INDIA
Manufacturer location
31, Race Course Rd, Madhava Nagar, Gandhi Nagar, Bengaluru, Karnataka 560001, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:05 · updated 2026-09-21 02:30:19

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Ebastine is an antihistamine used to relieve allergy symptoms.

What it treats

  • allergic rhinitis (hay fever)
  • urticaria (hives)

How it works

Ebastine blocks the action of histamine, a substance in the body that causes allergy symptoms.

Who it's for

Ebastine is for adults and children over a certain age who suffer from allergies.

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

Clinical monograph: ebastine

BNF-referenced

Ebastine is a second-generation antihistamine primarily used to manage allergic conditions by blocking histamine H1 receptors. It is effective in alleviating symptoms associated with allergic rhinitis and chronic urticaria (hives). As a non-sedating antihistamine, it does not typically cause drowsiness, making it suitable for use during the day.

Indications

  • Allergic rhinitis
  • Chronic urticaria
  • Seasonal allergies

Dosage

Children: For children aged 6 to 12 years, the recommended dose is 5 mg once daily. For children over 12 years, the adult dose may be used.

Adults: The typical adult dose is 10 mg once daily.

Mechanism of action

Ebastine acts as a selective antagonist of the histamine H1 receptor. By binding to these receptors, it prevents the action of histamine, a substance in the body that is responsible for allergy symptoms such as itching, sneezing, and runny nose. This selective action contributes to its efficacy in treating allergic reactions while minimizing sedation.

Pharmacodynamics

Ebastine shows a rapid onset of action, typically within 1 to 3 hours of administration, and its effects can last for up to 24 hours. This allows for once-daily dosing in most cases. The drug is primarily effective in reducing symptoms such as nasal congestion, sneezing, and itching associated with allergic reactions.

Pharmacokinetics

Ebastine is well absorbed after oral administration, with peak plasma concentrations occurring approximately 1 to 2 hours post-dose. It undergoes extensive hepatic metabolism, primarily via cytochrome P450 enzymes, resulting in the formation of an active metabolite, carebastine. The elimination half-life of ebastine is approximately 15 hours, allowing for prolonged therapeutic effects. It is excreted mainly in the urine, with a small percentage eliminated in the feces.

Pregnancy

The safety of ebastine during pregnancy has not been established. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Ebastine is excreted in breast milk. Caution should be exercised when administering to breastfeeding mothers.

Storage

Store at room temperature, away from moisture and heat.

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: ebastine

PubChem CID 3191

Molecular formula: C32H39NO2

Mechanism of action

Ebastine is a second-generation antihistamine that acts as a selective histamine H1-receptor antagonist to relieve allergic symptoms.

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.