BETADEXAMINE Liquid Ref.[51176] Active ingredients: Betamethasone Dexchlorpheniramine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2017  Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Product name and form

BETADEXAMINE (liquid).

Pharmaceutical Form

A bright, clear orange solution with a fruity peach odour.

Qualitative and quantitative composition

Each 5 ml of BETADEXAMINE liquid contains:

Betamethasone 0,25 mg

Dexchlorpheniramine maleate 2,00 mg

Excipients:

Colour sunset yellow (C.I. 15985), citric acid monohydrate, disodium edetate, flavor peach, glycerol, polysorbate 80, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sorbitol solution 70%.

Preservative:

Sodium benzoate 0,1% m/v.

Contains sugar: Sorbitol solution (70%) 2,00 g.

Contains sweetener: Saccharin sodium 3,50 mg.

Active Ingredient Description
Betamethasone

Betamethasone is a glucocorticoid which is about eight to ten times as active as prednisolone on a weight-for-weight basis. Betamethasone has anti-inflammatory, antipruritic, and vasoconstrictive properties.

Dexchlorpheniramine

Dexchlorpheniramine, the d-isomer of the racemic compound chlorpheniramine, is two times more active than chlorpheniramine. Dexchlorpheniramine does not prevent the release of histamine, but rather, competes with free histamine for binding at the H1-receptor sites, and competitively antagonizes the effects of histamine on H1-receptors in the GI tract, uterus, large blood vessels, and bronchial muscle. Blockade of H1-receptors also suppresses the formation of oedema, flare, and pruritus that result from histaminic activity. Since dexchlorpheniramine binds to central and peripheral H1-receptors, sedative effects are likely to occur. Dexchlorpheniramine has high antihistaminic activity, moderate anticholinergic effects and minimal sedative effects.

List of Excipients

Pack sizes and marketing

100 ml round, amber, glass bottle with white, tamper-evident, polypropylene screw cap. The bottle is placed in an outer cardboard carton together with a leaflet.

100 ml, high density polyethylene, brown bottle with a white, low density polyethylene, snap-cap closure. The bottle is placed in an outer cardboard carton together with a leaflet.

Not all packs are necessarily marketed.

Marketing authorization holder

PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191

Marketing authorization dates and numbers

A40/21.5.4/0623

Date of registration: 23 November 2017

Drugs

Drug Countries
BETADEXAMINE South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.