DUODOPA Intestinal gel Ref.[116795] Active ingredients: Carbidopa Levodopa Levodopa and Carbidopa

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: AbbVie Limited, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Duodopa 20 mg/ml + 5 mg/ml intestinal gel.

Pharmaceutical Form

Intestinal gel.

Off white to slightly yellow gel.

Qualitative and quantitative composition

1 ml contains 20 mg levodopa and 5 mg carbidopa monohydrate.

100 ml contain 2000 mg levodopa and 500 mg carbidopa monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient

Carbidopa is a peripheral aromatic amino acid decarboxylase inhibitor. It prevents metabolism of levodopa to dopamine in the peripheral circulation, ensuring that a higher proportion of the dose reaches the brain, where dopamine exerts its therapeutic effects. A lower dose of levodopa can be used when it is coadministered with carbidopa, reducing the incidence and severity of peripheral side effects.

Levodopa is a precursor of dopamine, and is given as dopamine replacement therapy in Parkinson's disease.

List of Excipients

Carmellose sodium
Purified water

Pack sizes and marketing

Total amount of 100 ml in PVC bag inside a hard plastic cassette for protection, carton with 7 cassettes.

Marketing authorization holder

AbbVie Limited, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA1824/002/001

Date of first authorisation: 18 November 2005
Date of last renewal: 21 January 2009

Drugs

Drug Countries
DUODOPA Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, South Africa

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