Vectrine

Vectrine

erdosteine

Manufacturer:

Dexa Medica
Full Prescribing Info
Contents
Erdosteine.
Action
Erdosteine is classified under the mucolytic drugs.
Pharmacology: Erdosteine pharmacologically acts as a bronchial mucus fluidifying agent.
Pharmacodynamics: Erdosteine, besides 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 metabolism, transform into active metabolites which have the chemical -SH groups. These metabolites break the -SH groups and brings 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 metabolism or in alkaline moiety. This property guarantees a good tolerability without bad tastes and without mercaptanic regurgitations and with good gastric tolerability.
Pharmacokinetics: Erdosteine is rapidly absorbed after oral administration; after a single oral dose, the Tmax is 1.2 hrs.
Erdosteine is rapidly metabolized into at least 3 active metabolites containing free thiol groups, which tentatively are N-thiodiglycolyl-homocysteine (metabolite I), N-acetyl-homocysteine (metabolite II) and homocysteine (metabolite III). The elimination half-life of erdosteine is 1.4 hrs on the average and that of the metabolite I and II of 1.2 and 2.7 hrs, respectively.
Multiple treatments do not modify the pharmacokinetics of erdosteine.
Age does not change the pharmacokinetics of erdosteine and of its metabolites.
In the elderly patients suffering from renal failure, whose creatinine clearance is comprised between 25 and 40 mL/min, the pharmacokinetic characteristics of erdosteine and its metabolites are not significantly different from those of the healthy elderly subjects.
Indications/Uses
Mucolytic, fluidifying agent in acute and chronic airways affections.
Dosage/Direction for Use
Capsule: 1 cap 2-3 times daily.
Dry Syrup: Adults and Children >30 kg: 10 mL 2 times daily. Children 20-30 kg: 5 mL 3 times daily, 15-19 kg: 5 mL 2 times daily.
Administration: Prepare suspension at the time of administration by adding 46 mL of water. Once reconstituted, the suspension must be used within 7 days.
Overdosage
With dosage exceeding 900 mg/day, sweating, vertigo and flushing have been observed.
Contraindications
Known individual hypersensitivity to Vectrine.
Patients suffering from hepatic cirrhosis and deficiency of the cystathionine-synthetase enzyme; phenylketonuria due to the presence of aspartame (only for the dry syrup); patients with severe renal failure (creatinine clearance <25 mL/min).
Special Precautions
Vectrine dry syrup contains sucrose. Take 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 during pregnancy and lactation is not recommended.
Side Effects
No gastrointestinal nor systemic side effects due to Vectrine has been observed. If undesirable effects occurred, inform the physician.
Drug Interactions
No harmful interaction have been observed with other drugs and Vectrine can be administered together with antibiotics, bronchodilators (eg, 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 20's. Dry syrup 175 mg/5 mL x 60 mL x 1's.
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