MEDORPHAN Oral solution Ref.[27869] Active ingredients: Demorphan

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Medorphan 7.5mg/5ml oral solution.

Pharmaceutical Form

Oral solution.

The solution is a slightly yellowish, transparent, clear, flavoured liquid.

Qualitative and quantitative composition

Medorphan contains 7.5 mg dextromethorphan hydrobromide Ph Eur in each 5 ml of oral solution.

Excipients with known effect: sucrose, sorbitol, liquid glucose and ethanol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Demorphan

Dextromethorphan is a non-opioid antitussive drug. The major metabolite of dextromethorphan, dextrorphan, binds with high affinity to σ-receptors to produce its antitussive activity without exhibiting the classic opiate effects that occur from binding into μ- and δ-receptors. In larger than therapeutic doses, dextrorphan is also an antagonist of N-methyl-D-aspartate (NMDA) receptors.

List of Excipients

Saccharin Sodium, Sodium Benzoate, Sugar (Sucrose), Liquid Glucose, Sorbitol solution 70%, Glycerol, Absolute Ethanol, Levomenthol, Citric acid anhydrous, Caramel flavour (liquid), Peach flavour (liquid), Purified Water.

Pack sizes and marketing

150 ml and 200 ml Type III (Ph.Eur) brown glass bottles closed with caps (aluminium sheet; liner – EPE sealing disk: hot-foamed polyethylene).

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

21899

Date of first authorisation: 14/10/2013
Date of latest renewal: 26/09/2019

Drugs

Drug Countries
MEDORPHAN Cyprus

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