• UNIT
    Box
  • Formula

    Acetylcysteine ....................................................... 100 mg
    Excipients q.s....................................................... 1 sachet

  • Dosage forms

    Powder.

  • Packing specification

    Box of 24 sachets x 1.5 g.

  • Driving and operating machinery

    No special cautions.

  • CAREFUL

    Patients with bronchial asthma should be closely monitored during therapy; if bronchospasm occurs in patients with known hypertension, salbutamol or ipratropium inhaler should be given and treatment with acetylcysteine should be discontinued immediately.
    Administration of acetylcysteine may liquefy bronchial secretions. At the same time, tracheal suction should be used.

  • PREGNANT AND LACTATING WOMEN

    Pregnancy: There are no controlled data on safety in pregnancy. Acetylcysteine is only taken if the potential benefits to the mother outweigh the risks to the fetus.
    Lactation: There is no information on the excretion of acetylcysteine into human milk; however, acetylcysteine should be used with caution in nursing women.

  • DRUG INTERACTIONS

    Concomitant administration of antitussive drugs and/or agents for drying mucous secretion and acetylcysteine is unreasonable.

  • UNWANTED EFFECTS

    Commonly: nausea, vomiting.
    Uncommonly: drowsiness, headache, tinnitus, stomatitis, severe rhinorrhea, skin rash, urticaria.
    Rarely: bronchospasm associated with systemic anaphylactic reaction, fever, tremble.
    Inform your physician about any adverse effects occur during the treatment.

  • OVERDOSE AND TREATMENT

    Symptoms following overdosage with acetylcysteine have been similar to those of anaphylactoid reactions, but they may be more severe. Hypotension appears to be especially prominent. Other symptoms including respiratory insufficiency, hemolysis, disseminated intravascular coagulation, renal impairment have been reported. Fatality occurred in patients following overdosage with acetylcysteine while treating paracetamol poisoning. Treatment of overdosage depends on each symptom.

  • STORAGE CONDITIONS

    Store in a dry place, not exceeding 30oC, protect from light.

  • Materiality

    Mitux E containing the active ingredient Acetylcysteine is a mucolytic agent which impacts on gel phase of viscous mucus by splitting of disulfur bonds in glycoproteins. The drug is used in the reduction of viscosity of pulmonary sputum to facilitate expectoration. After oral administration, acetylcysteine is rapidly absorbed from the gastrointestinal tract and achieves peak plasma concentrations within 0.5 - 1 hour. Due to the particular affinity to pulmonary tissues and bronchial secretions, acetylcysteine concentrations are effectively achieved after 3 hours of taking the drug.

  • Expiry
    36 months from the manufacturing date.
  • Indication

    Used as a mucolytic drug in the treatment of respiratory pathologies associated with viscous sputum e.g., bronchitis, tracheobronchitis, acute and chronic bronchopneumonia, rhinitis, laryngitis, sinusitis, secretory otitis media.

  • Contraindicated

    Hypersensitivity to acetylcysteine. Children aged less than 2 years.
    A history of asthma (the risk of bronchospasm reaction to all acetylcysteine-containing drugs)

  • DOSAGE AND HOW TO USE

    Children aged from 2 - 6 years: 2 sachets twice daily.
    Or as directed by the physician.
    Read the directions carefully before use.
    Consult the physician for more information.