Erdobat

Erdobat

erdosteine

Manufacturer:

Interbat
Full Prescribing Info
Contents
Erdosteine.
Description
Cap: Each capsule contains Erdosteine 300 mg.
Dry Syrup: After reconstitution with potable water, each measuring spoonful (5 ml) contains Erdosteine 175 mg.
Action
Pharmacotherapeutic group: Mucolytic drugs.
Pharmacology: Erdosteine pharmacologically acts as bronchial mucus fluidifying agent.
Pharmacodynamics: Erdosteine besides its property of fluidifying bronchial mucus thus facilitating expectorations, shows effects as antagonizing the formation of free radicals and as contrasting the action of elastase enzyme.
From pharmacological studies results that Erdosteine, as such, does not possess these properties but only after metabolization into active metabolites which have the chemical -SH groups. These metabolites break the -SH groups and bring 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 mercapturic regurgitations and with good gastric tolerability.
Pharmacokinetics: Erdosteine is rapidly absorbed after oral administration, after a single oral dose, the Tmax is 1.2 hours.
Erdosteine is rapidly metabolized into at least 3 active metabolites containing three thiol groups, which tentatively are: N-thioglycolyl-homocysteine (metabolite I), N-acetyl-homocysteine (metabolite II), and homocysteine (metabolite III). The elimination half-life of Erdosteine is 1.4 hours on the average, and that of the metabolite I and II at 1.2 and 2.7 hours, respectively.
Multiple treatments do not modify the pharmacokinetics of Erdosteine.
Age does not change the pharmacokinetics of Erdosteine and of its metabolism.
In the elderly patient suffering from renal failure, whose creatinine clearance is compressed between 25 and 40 mL/min, the pharmacokinetic characteristics of Erdosteine and its metabolites are not significantly different from those of the healthy elderly subject.
Indications/Uses
Mucolytic fluidifying agent in acute and chronic airways obstruction.
Dosage/Direction for Use
Capsule: 1 capsule, 2-3 times a day.
Dry Syrup: Adults and children with body weight >30 kg: 2 measuring spoonful (10 ml), 2 times a day.
Children with body weight 20-30 kg: 1 measuring spoonful (5 ml), 3 times a day.
Children with body weight 15-20 kg: 1 measuring spoonful (5 ml), 2 times a day.
Reconstitution: Add 48 ml of potable water, shake well to make 60 ml suspension. After reconstitution, the suspension is stable in a refrigerator (2-8°C) and should not be used more than 7 days.
Overdosage
With dosages exceeding the suggested ones (900 mg/day), sweating, vertigo and flushing have been observed.
Contraindications
Known individual hypersensitivity to the product.
Contraindicated in patients suffering from hepatic cirrhosis and deficiency of the cystathionine-synthase enzyme.
In patients with severe renal failure (creatinine clearance <25 mL/min).
Special Precautions
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.
Discontinue the administration and consult the physician when adverse reactions occur.
No effects have been reported on ability to drive and use machines.
The product contains sucrose (for suspension), keep this into consideration in case of diabetes or low-calorie diets.
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 this drug have been observed.
Drug Interactions
No interactions have been observed with other medicaments and this drug can be administered together with antibiotics, bronchodilators (Theophylline, β2-mimetics, cough sedatives, etc.).
Storage
Store below 30°C.
Protect from light.
ATC Classification
R05CB15 - erdosteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Presentation/Packing
Cap 300 mg x 2 x 10's. Dry syr 175 mg/5 mL x 60 mL x 1's.
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