Registered Tanzania · TMDA

EROSTIN-10

Ebastine 10 mg,Magnesium Stearate mg,Pregelatinised Starch mg

TAN 06,191 R06A MIC Tablets 10 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)

Read more in plain English ↓

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

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Registration & product details

Registration no.
TAN 06,191 R06A MIC
Registration date
2026-03-21
Expiry date
2031-03-19
Status
Registered/Compliant
Active ingredient
Ebastine 10 mg,Magnesium Stearate mg,Pregelatinised Starch mg
Dosage form
Tablets
Strength
10
Pack size
-
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: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:44:58 · updated 2026-11-02 03:00:48

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About ebastine

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.

About pregelatinised

Pregelatinised is a modified form of starch used as a thickening agent and stabilizer in various products.

What it treats

  • thickening agent in food
  • stabilizer in pharmaceutical products

How it works

Pregelatinised starch helps improve the texture and consistency of products by absorbing water and forming a gel-like substance.

Who it's for

Suitable for people needing thickening agents in food or pharmaceuticals, including those with swallowing difficulties.

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

About starch

Starch is a carbohydrate that serves as a source of energy and is often used in various food products.

What it treats

  • energy source
  • dietary supplement

How it works

Starch is broken down by the body into glucose, which provides energy for daily activities.

Who it's for

Starch can be used by anyone needing extra energy in their diet, particularly those with increased energy needs.

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.

Clinical monograph: pregelatinised

Pregelatinised starch is a modified starch used as an excipient in pharmaceutical formulations. It is created by pre-gelatinizing starch granules through a process of heating and moisture, making it soluble in cold water. This property allows it to be used as a binder, disintegrant, and thickening agent in tablet and capsule formulations. It enhances the bioavailability of active pharmaceutical ingredients by improving their solubility.

Indications

  • Used as a binder in tablet formulations
  • Serves as a disintegrant to improve drug release
  • Acts as a thickening agent in liquid formulations
  • Enhances bioavailability of poorly soluble drugs

Dosage

Children: Dosage is dependent on the specific formulation and intended use. Refer to formulation guidelines for appropriate concentrations.

Adults: Dosage is dependent on the specific formulation and intended use. Refer to formulation guidelines for appropriate concentrations.

Mechanism of action

Pregelatinised starch acts primarily as a thickening agent and binder in pharmaceutical formulations. When mixed with water, it swells and forms a gel-like consistency, which helps in the uniform distribution of active ingredients and enhances their release and absorption in the gastrointestinal tract. Its ability to gel enables better disintegration of tablets upon administration, facilitating the dissolution of the drug.

Pharmacodynamics

The pharmacodynamics of pregelatinised starch is closely related to its physical properties as a polymer. Upon contact with water, it hydrates and expands, creating a viscous solution that can improve the release profile of drugs. This can lead to enhanced dissolution rates of poorly soluble compounds, improving their bioavailability. Additionally, it can impact the stability and shelf-life of formulations by providing a protective matrix for active ingredients.

Pharmacokinetics

Pregelatinised starch is not absorbed systemically as it primarily acts as an excipient. It undergoes gastrointestinal transit without significant degradation. Its function is to facilitate the release and absorption of the active pharmaceutical ingredients in the formulation rather than exhibiting pharmacokinetic properties of its own.

Pregnancy

Pregelatinised starch is generally considered safe for use during pregnancy, but it is recommended to consult a healthcare provider before use.

Breast-feeding

Pregelatinised starch is considered safe during breastfeeding, but it is advisable to seek medical advice.

Storage

Store in a cool, dry place, away from direct sunlight and moisture.

Formulations

  • Powder
  • Capsules
  • Tablets

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

Clinical monograph: starch

Starch is a polysaccharide carbohydrate consisting of a large number of glucose units joined by glycosidic bonds. It is a major energy source in the human diet and is found in numerous food sources such as grains, legumes, and tubers. In a clinical setting, starch can also be used as an excipient in various pharmaceuticals and is sometimes utilized in enteral nutrition formulations.

Indications

  • Nutritional supplementation
  • Energy source in enteral nutrition
  • Excipient in pharmaceutical formulations

Dosage

Children: Refer to specific guidelines or product inserts for dosing information, as it can vary based on the context of use.

Adults: Refer to specific guidelines or product inserts for dosing information, as it can vary based on the context of use.

Mechanism of action

Starch is broken down into glucose units by enzymes such as amylase during digestion. The glucose is then absorbed in the intestines and utilized for energy production in the body's cells. This pathway involves hydrolysis of the glycosidic bonds, converting starch into simpler sugars.

Pharmacodynamics

Starch primarily serves as an energy source. Its digestion and absorption lead to an increase in blood glucose levels, which provides energy for metabolic processes. In this context, it plays a crucial role in maintaining energy homeostasis in the body.

Pharmacokinetics

Starch is not absorbed in its polymeric form; it must first be enzymatically hydrolyzed into simpler sugars such as maltose and glucose. The digestion and absorption of starch occur predominantly in the small intestine, with glucose being readily absorbed into the bloodstream. The rate of absorption can vary depending on the type of starch and its physical form.

Adverse effects

  • Allergic reactions
  • Gastrointestinal discomfort
  • Diarrhea
  • Constipation

Precautions

  • Use with caution in individuals with known allergies to starch or starch derivatives
  • Monitor for gastrointestinal symptoms in patients with a history of digestive disorders

Pregnancy

Starch is generally considered safe for use during pregnancy. However, it should be consumed in moderation as part of a balanced diet.

Breast-feeding

Starch is deemed safe for nursing mothers when used in moderation as part of a balanced diet.

Storage

Store in a cool, dry place away from moisture and direct sunlight.

Formulations

  • Powder
  • Granules
  • Tablets
  • Suspensions

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.