Aceten is indicated as an adjuvant treatment in certain
clinical condition characterized by the presence of thick and viscous mucoid or
mucopurulent secretions such as: Chronic bronchopulmonary diseases (chronic
obstructive pulmonary disease, emphysema with bronchitis, chronic asthmatic
bronchitis, bronchiectasis); Acute bronchopulmonary diseases (asthma with
bronchial mucus plugging, bronchitis, bronchopneumonia, tracheobronchitis,
bronchiolitis, pulmonary complications of cystic fibrosis, pulmonary complications
associated with surgery).
Acetylcysteine is a mucolytic agent that reduces the
viscosity of secretions probably by the splitting of disulphide bonds in
mucoproteins. Moreover it gives antisecretory effect. These results in clearing
of respiratory ducts and facilitate breathing. Acetylcysteine also has
anti-oxidant properties by reacting with free radicals and also by serving as a
precursor to glutathione, which is an important intra and extra-cellular
antioxidant. By providing anti-oxidant action, it neutralizes exogenous and
endogenous oxidants, which in fact act as pathogens in respiratory
inflammations.
Dosage & Administration
Effervescent tablet or Dispersible tablet: Adults and children
above 6 years: One effervescent tablet of Acetylcysteine 600 mg a day
(preferably in the evening). The duration of treatment should be 5 to 10 days
in the acute treatment, whereas it may be continued in the chronic states for
several months, according to the advice of the physician. Dissolve the tablets
in a glass containing a small quantity of water, mixing it, if necessary, with
a spoon. A palatable solution is thus obtained, which can be drunk directly
from the glass.
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Effervescent Granules:
Adults and children above 6 years: 1 sachet Acetylcysteine
200 mg or 2 sachets Acetylcysteine 100 mg, 2-3 times a day.
Children (2-6 years of age): 1 sachet Acetylcysteine 100 mg
from 2 to 4 times a day, according to the age.
The duration of treatment should be 5 to 10 days in the
acute treatment, whereas it may be continued in the chronic states for several
months, according to the advice of the physician.
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Dissolve the contents of the sachets in a glass containing a
small quantity of water; mixing it, if necessary, with a spoon. A palatable
solution is thus obtained, which can be drunk directly from the glass.
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Nebuliser Solution: The 20% solution may be diluted to a
lesser concentration with either Sodium Chloride for injection, Sodium Chloride
for inhalation, sterile water for injection, or sterile water for inhalation.
Adult: 5-10 ml of 10% or 20% solution by Nebuliser every 6-8
hr PRN.
Children: 1-11 months: 1-2 ml of 20% or 2-4 ml of 10%
solution by Nebuliser every 6-8 hr PRN.
12 months-11 years: 3-5 ml of 20% or 6-10 ml of 10% solution
by Nebuliser every 6-8 hr PRN.
Below 12 years: 5-10 ml of 10/20% solution by Nebuliser
every 6-8 hr PRN.
** Diagnostic Bronchograms: 1-2 ml of 20% or 2-4 ml of 10%
solution 2-3 times by Nebulisation or by instillation intratracheally prior to
procedure.
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** Nebulisation tent or croupette: This form of
administration requires very large volumes of the solution, occasionally as
much as 300 ml during a single treatment period. If a tent or croupette must be
used, the recommended dose is the volume of acetylcysteine (using 20%) that
will maintain a very heavy mist in the tent or croupette for the desired
period. Administration for intermittent or continuous prolonged periods,
including overnight, may be desirable.
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** Direct Instillation: When used by direct instillation,
1-2 ml of a 20% solution may be given as often as every hour. When used for the
routine nursing care of patients with tracheostomy, 1-2 ml of a 20% solution
may be given every 1-4 hours by instillation into the tracheostomy.
The thiol group of Aceten can reduce the efficacy of certain
antibiotics such as ampicillin, tetracycline, macrolides, cephalosporins,
aminoglycosides and amphotericin. Concomitant use of Aceten and amoxicillin
will increase the level of the antibiotic in tissues. It is, therefore,
advisable to use the two medicines 2 hours apart from each other. Aceten can
increase the inhibitory effect of thrombocyte aggregation and vasodialation by
nitroglycerine.
Contraindications
Known hypersensitivity to Acetylcysteine. Acetylcysteine
contains aspartame, thus it is contraindicated in patients suffering from
phenylketonuria.
Side Effects
Like all medicines, Aceten can cause side effects, although
not everybody gets them. In very rare cases, severe immune reactions may occur
such as anaphylactic shock and severe skin reaction. In rare cases the oral
administration can be followed by shortness of breath, upset stomach and bronchospasm.
The most frequent side effects are headache, increased heart rate, stomatitis,
pruritus, urticaria, nausea, vomiting, abdominal pain, fever, decrease in the
blood pressure, diarrhoea and noises in the ears.
Pregnancy & Lactation
In case of pregnancy & lactation the medicine should be
taken consulting physician or pharmacist.
Precautions & Warnings
Patients suffering from bronchial asthma must be strictly
controlled during the therapy; should bronchospasm occur, the treatment must
immediately be suspended. Caution should be taken in patients suffering from or
with a history of peptic ulcer. As Viscotin contains sodium (156.9mg per dose)
this has to be taken into consideration by patients on a controlled sodium
diet. The possible presence of a sulphureous odor does not indicate an
alteration of the product but is a characteristic of the active ingredient
contained in Aceten. It is preferable not to mix other drugs with the Viscotin
solution.
Overdose Effects
Overdose of Aceten may cause nausea, vomiting or diarrhoea.