Carbocisteine 2% syrup for children syrup

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

carbocisteine

Available from:

Arpimed LLC

ATC code:

R05CB03

INN (International Name):

carbocisteine

Dosage:

100mg/5ml

Pharmaceutical form:

syrup

Units in package:

glass bottle 120ml

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2019-08-15

Summary of Product characteristics

SUMMARY PRODUCT CHARACTERISTIC (SPC)
CARBOCISTEINE
2% SYRUP FOR CHILDREN
TRADE NAME – Carbocisteine 2 % syrup for children
INTERNATIONAL NON-PROPERTY NAME – Carbocisteine
COMPOSITION
Each 5 ml of Carbocisteine 2%
syrup for children
contains:
_ACTIVE INGREDIENT:_
carbocisteine-100 mg;
_INACTIVE INGREDIENTS:_ sodium saccharin, propylene glycol, _
_sucrose,
methylparaben,
aroma
caramel, sodium hydroxide, color yellow E 110,water deionized._ _
CHEMICAL NAME AND CAS NUMBER
(2R)-2-amino-3-[(carboxymethyl)sulphanyl]propanoic acid
,
2387-59-9.
PHARMACOLOGICAL GROUP AND ATC CODE
Mucolytic agent. ATC code
R05CB03.
PHARMACOLOGICAL ACTION
_Pharmacodynamic properties _
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 gastrointestinal tract,
peak plasma concentrations are
reached after about hour (рН 7-9). Bioavailability is low, less than
10%, probably, due to the
metabolism in the gastrointestinal tract and "first pass" through the
liver.
Carbocisteine is excreted primarily by the kidneys. The half-life is
about 2 hours.
USES
Violations of bronchial secretions (including acute bronchitis and
acute exacerbations of chronic
diseases of the bronchi and lungs).
DOSAGE AND