Source: Health Products Regulatory Authority (ZA) Revision Year: 2017 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
BETADEXAMINE (liquid).
Pharmaceutical Form |
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A bright, clear orange solution with a fruity peach odour. |
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 | |
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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. |
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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 |
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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.
PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
A40/21.5.4/0623
Date of registration: 23 November 2017
Drug | Countries | |
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BETADEXAMINE | South Africa |
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