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Antitussives

Acetylcystein STADA® 200 mg

 

Pack size:

Box of 10 blisters x 10 capsules.

 

Composition:

Each capsule contains acetylcystein 200 mg.

 

Shelf - life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place, protect from light. Do not store above 30oC.

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Administered orally as: 

  • A mucolytic agent in the adjunctive treatment of patients with inspissated mucous secretions in such conditions as acute and chronic bronchopulmonary disorders. 
    Use as granules dissolved in water. 
    ​Adults: 200 mg (1 capsule) three times daily.
    Children aged 2 to 6 years old (*): 200 mg (1 capsule) twice daily.
    (*) Hard gelatin capsule is not a suitable dosage form for children under 3 years old, the other suitable dosage forms are recommended.
  • An antidote for the treatment of paracetamol overdosage.
    An initial dose of 140 mg/kg as a 5% solution followed by 70 mg/kg every 4 hours for additional 17 doses. 
    Acetylcysteine is reported to be very effective when administered within 8 hours of paracetamol overdosage, with the protective effect diminishing after this time. Initiation of treatment with acetylcysteine later than 15 hours had been considered to be ineffective but recent work suggests that beneficial results may still be obtained.


Or as prescribed by physicians.

 

  • Known hypersensitivity to acetylcysteine or to any ingredient of the drug.
  • Patients with asthma or a history of bronchospasm.
  • Children under 2 years old.

     

Hypersensitivity:

  • Bronchospasm, angioedema, rashes and pruritus; hypotension, or occasionally hypertension may occur.

Other adverse effects:

  • Flushing, nausea and vomiting, fever, syncope, sweating, arthralgia, blurred vision, disturbances of liver function, acidosis, convulsions, and cardiac or respiratory arrest.


 

  • Since oral administration of acetylcysteine may result in vomiting or aggravate vomiting associated with paracetamol overdosage, patients at risk of gastric hemorrhage should be evaluated with regard to the relative risks of upper gastrointestinal hemorrhage and paracetamol-induced hepatotoxicity and treatment with acetylcysteine given accordingly.
  • Asthmatic patients receiving acetylcysteine should be observed closely during such therapy; if bronchospasm occurs, a bronchodilator should be given by nebulization. If bronchospasm progresses, acetylcysteine should be discontinued immediately.
  • An increased volume of liquefied bronchial secretions may develop after administration of acetylcysteine. If cough is inadequate to maintain an open airway during acetylcysteine therapy, mechanical suction or endotracheal aspiration should be instituted.
  • Hepatic impairment: The total clearance of acetylcysteine in patients with cirrhosis was found to be markedly impaired, and the elimination half-life almost twice that of healthy controls.
  • Pregnancy: Use of acetylcysteine to treat paracetamol overdose in pregnant women is safe, effective and able to prevent hepatotoxicity in the fetus as well as in the mother.
  • Lactation: The drug is safe to be used in nursing women.
  • There are no known effects on ability to drive and use machines.
     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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