MUCODYNE Capsule, hard Ref.[2616] Active ingredients: Carbocisteine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Pharmacodynamic properties

ATC code: R05CB03

Carbocisteine (S-carboxymethyl L-cysteine) has been shown in normal and bronchitic animal models to affect the nature and amount of mucus glycoprotein which is secreted by the respiratory tract. An increase in the acid:neutral glycoprotein ratio of the mucus and a transformation of serous cells to mucus cells is known to be the initial response to irritation and will normally be followed by hypersecretion. The administration of Carbocisteine to animals exposed to irritants indicates that the glycoprotein that is secreted remains normal; administration after exposure indicates that return to the normal state is accelerated. Studies in humans have demonstrated that Carbocisteine reduces goblet cell hyperplasia. Carbocisteine can therefore be demonstrated to have a role in the management of disorders characterised by abnormal mucus.

Pharmacokinetic properties

Carbocisteine is rapidly absorbed from the GI tract. In an ‘in-house’ study, at steady state (7 days) Mucodyne capsules 375 mg given as 2 capsules t.d.s. to healthy volunteers gave the following pharmacokinetic parameters:

Plasma DeterminationsMeanRange
TMax (Hr) 2.01.0–3.0
T½ (Hr) 1.871.4–2.5
KEL (Hr-1) 0.3870.28–0.50
AUC0-7.5 (mcg.Hr.ml-1) 39.2626.0–62.4
Derived Pharmacokinetic ParametersMeanRange
*CLS (L.Hr-1) 20.2 -
CLS (ml.min-1) 331-
VD (L) 105.2-
VD (L.Kg-1) 1/75-

* Calculated from dose for day 7 of study

Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.