ITRACONAZOLE Oral solution Ref.[6946] Active ingredients: Itraconazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: UK: Beacon Pharmaceuticals Limited, DCC Vital, Westminster Industrial Estate, Repton Road, Measham, DE12 7DT, England IE: Athlone Laboratories Limited, Ballymurray, Co Roscommon, Ireland

Product name and form

Itraconazole 10 mg/ml Oral Solution.

Pharmaceutical Form

Oral solution.

Itraconazole oral solution is a clear, yellow solution.

Qualitative and quantitative composition

1 ml Itraconazole oral solution contains 10mg itraconazole.

Excipients with known effect: Each ml of Itraconazole oral solution contains 283.1mg of sorbitol E420, 103.6mg of propylene glycol (E1520), less than 100mg of Ethanol and less than 23mg of sodium.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Itraconazole

Itraconazole is a triazole derivative that inhibits fungal 14α-demethylase, resulting in a depletion of ergosterol and disruption of membrane synthesis by fungi.

List of Excipients

Hydroxypropyl-β-cyclodextrin
Sorbitol 70% (E420)
Propylene glycol
Cherry flavour
Caramel (contains ethanol and propylene glycol)
Sodium saccharin dihydrate
Hydrochloric acid and sodium hydroxide (for pH adjustment)
Purified water

Pack sizes and marketing

Type III 150 ml amber glass bottle, with child resistant polyethylene screw cap and LDPE internal coating, in a cardboard carton.

A graduated measuring cup is provided. Graduation is from 2.5-30ml, initially in 2.5ml and then 5ml intervals.

Marketing authorization holder

UK: Beacon Pharmaceuticals Limited, DCC Vital, Westminster Industrial Estate, Repton Road, Measham, DE12 7DT, England

IE: Athlone Laboratories Limited, Ballymurray, Co Roscommon, Ireland

Marketing authorization dates and numbers

PL 18157/0258
PA 0298/023/001

27/03/2013

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