Sancostein

Sancostein

erdosteine

Manufacturer:

Sanbe
Full Prescribing Info
Contents
Erdosteine.
Description
Each capsule contains: Erdosteine 300 mg.
Action
Pharmacology: Erdosteine pharmacologically acts as a bronchial mucus fluidifying agent. Erdosteine is classified under the mucolytic drugs. Erdosteine beside its property of fluidifying bronchial mucus thus facilitating expectorations, shows effects as antagonizing the formation "in loco" of free radicals and as contrasting the action of elastase enzyme. Pharmacological studies show that Erdosteine, as such, does not possess these properties but only after metabolization, transform into active metabolites which have the chemical -SH groups. These metabolites break the -SH groups and bringing about a reduction in the mucus elasticity and viscosity thus facilitating the expectoration.
The chemical -SH groups, distinctive of this activity, are chemically blocked and become free only after metabolization or in alkaline moiety. This property guarantees a good tolerability without bad tastes and without mercaptanic regurgitations and with good gastric tolerability.
Indications/Uses
SANCOSTEIN is indicated as mucolytic fluidifying agent in acute and chronic airways affections.
Dosage/Direction for Use
1 capsule, 2-3 times a day.
Overdosage
With dosage exceeding the suggested ones (900 mg/day): sweating, vertigo, and flushing have been observed.
Contraindications
In patient hypersensitive to Erdosteine and other compositions.
In patients suffering from hepatic cirrhosis and deficiency of the cystathionine-synthetase enzyme.
Phenylketonuria, due to the presence of aspartame, only for the granulate in suspension.
In patient with severe renal failure (creatinine clearance < 25 mL/min).
Special Precautions
The product in granulates (suspension) contains sucrose, keep this into consideration in case of diabetes or low-calorie diets.
Effect on ability to drive and use machines: No effects have been reported.
Use in Pregnancy & Lactation: safety of Erdosteine in pregnancy has not been established and therefore as with all new drugs, its use is not recommended, also during lactation its use is not recommended.
Use In Pregnancy & Lactation
Safety of Erdosteine in pregnancy has not been established and therefore as with all new drugs, its use is not recommended, also during lactation its use is not recommended.
Adverse Reactions
No gastrointestinal nor systemic side effects due to the drugs have been observed. If undesirable effect occurred, it should be informed to the physician.
Drug Interactions
No harmful interaction have been observed with other medicaments and the drug can be administered together with antibiotics, bronchodilators (theophylline, β2 - mimetics, cough sedatives, etc.).
Storage
Store below 30°C.
MIMS Class
Cough & Cold Preparations
ATC Classification
R05CB15 - erdosteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Presentation/Packing
Form
Sancostein cap 300 mg
Packing/Price
2 × 10's (Rp87,000/boks)
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