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Ectrin

Ectrin

erdosteine

Manufacturer:

OEP Phils

Distributor:

Zuellig
Full Prescribing Info
Contents
Erdosteine.
Action
Pharmacokinetics: Peak plasma levels are reached after 30-60 min. Ectrin has subsequent complete metabolism in similar metabolites.
Indications/Uses
Treatment of acute bronchitis, chronic bronchitis and its exacerbations. Respiratory disorders characterized by abnormal bronchial secretions and impaired mucus transport.
Dosage/Direction for Use
Capsule: 1 cap 2-3 times daily.
Suspension: Adults and Children >30 kg: 10 mL (2 tsp) twice daily.
Children 20-30 kg: 5 mL (1 tsp) 3 times a day; 15-19 kg: 5 mL (1 tsp) twice daily.
Direction for Reconstitution: To make 60 mL suspension: Add 42 mL of water and shake well until all the powder are evenly suspended.
To make 100 mL suspension: Add 70 mL of water and shake well until all the powder are evenly suspended.
Overdosage
With dosages exceeding the recommended dose (1200 mg/day), sweating, vertigo and flushing have been observed.
Contraindications
Known hypersensitivity to erdosteine. Because of a possible interference of erdosteine metabolites with the methionine metabolism, erdosteine is contraindicated in patients suffering from hepatic cirrhosis and deficiency of the cystathionine-synthetase enzyme.
Suspension: Phenylketonuria, due to the presence of aspartame.
Special Precautions
Effects on the Ability to Drive or Operate Machinery: No effects have been reported.
Use in pregnancy & lactation: The safety of erdosteine during human pregnancy has not been established and therefore, as with all other new drugs, its use is not recommended. Ectrin is also not recommended during lactation.
Use In Pregnancy & Lactation
The safety of erdosteine during human pregnancy has not been established and therefore, as with all other new drugs, its use is not recommended. Ectrin is also not recommended during lactation.
Side Effects
No gastrointestinal nor systemic side effects due to Ectrin have been observed.
Drug Interactions
No harmful interactions have been observed with other medicaments and Ectrin can therefore be administered together with antibiotics and bronchodilators (theophylline or β2-mimetics and cough sedatives).
Storage
Store at a temperature not exceeding 30°C. Protect from light.
The reconstituted suspension is stable for 1 week (7 days) at temperatures not exceeding 30°C (room temperature) and 2 weeks (14 days) at 2-8°C temperature (refrigerated).
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
Ectrin cap 300 mg
Packing/Price
100's;20's
Form
Ectrin powd for oral susp 175 mg/5 mL
Packing/Price
60 mL x 1's
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