DEXSOL Oral solution Ref.[2733] Active ingredients: Dexamethasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Rosemont Pharmaceuticals Ltd., Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

Product name and form

Dexsol 2mg/5ml Oral Solution.

Pharmaceutical Form

Oral Solution.

A colourless to faint yellow solution with odour of mint.

Qualitative and quantitative composition

Dexamethasone 2mg/5ml (as dexamethasone sodium phosphate).

Excipients:

Propylene glycol (E1520) – 450.6mg/5ml
Liquid maltitol (E965) - 1375mg/5ml
Sorbitol, liquid (non-crystallising) (E420) - 700mg/5ml
Benzoic acid (E210) - 5mg/5ml

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dexamethasone

Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity. It has an approximately 7 times greater anti-inflammatory potency than prednisolone, another commonly prescribed corticosteroid. At high doses it reduces the immune response.

List of Excipients

Benzoic acid (E420)
Propylene glycol (E1520)
Citric acid monohydrate
Liquid maltitol (E965)
Garden mint flavour (containing isopropanol and propylene glycol (E1520))
Liquid sorbitol (non-crystallising) (E420)
Sodium citrate
Purified water

Pack sizes and marketing

Bottles: 75ml and 150ml in Amber (Type III) glass.

Closures: HDPE, EPE wadded, tamper evident, child resistant closure.

Marketing authorization holder

Rosemont Pharmaceuticals Ltd., Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

Marketing authorization dates and numbers

PL 00427/0137

8th March 2005

Drugs

Drug Countries
DEXSOL Ireland, United Kingdom

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