A/10.2.2 Medicines acting on the respiratory system - other.
N-acetylcysteine is a mucolytic agent that reduces the viscosity of secretions probably by the splitting of disulphide bonds in mucoproteins.
It limits hepatic toxicity in paracetamol overdosage by replenishing hepatic stores of glutathion.
N-acetylcysteine is used as a mucolytic, of non-infective secretions in cystic fibrosis and in respiratory conditions.
N-acetylcysteine is an effective antidote in paracetamol overdosage.
Hypersensitivity to N-acetylcysteine.
Safety in pregnancy has not been established.
N-acetylcysteine should be used with caution in asthmatic patients and since mucolytics may disrupt the gastric mucosal barrier, it should be used with caution in patients with a history of peptic ulceration.
DOSAGE AND DIRECTIONS FOR USE:
As a mucolytic:
Children: Under 2 years –200 mg once daily.
2 - 6 years –200 mg twice daily.
Adults: 200 mg three times daily.
In paracetamol overdose:
Initially 140 mg/kg, followed by 70 mg/kg every 4 hours for an additional 17 doses. As an antidote, N-acetylcysteine is reported to be very effective when administered within 8 hours of paracetamol overdose, with the protective effect diminishing after this time. Initiation of treatment after a lapse of 15 hours has previously thought to be ineffective, but recent studies suggest that beneficial results may still be obtained.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Adverse effects include bronchospasm, nausea, vomiting, stomatitis, rhinorrhoea, headache, tinnitus, urticaria, chills and fever. Anaphylaxis has less frequently been reported.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects. Treatment would be symptomatic and supportive.
3 years. Do not use after the expiry date.
Special Precautions For Storage
Store in the original package, in a dry, dark place, away from the reach of the children, at a temperature not exceeding 25°C.
Nature And Contents Of Package
Capsules 200 mg. 10 capsules in each blister. 1, 2 or 3 blisters in every package.
Name and address of the manufacturer
SC “Balkan Pharmaceuticals” SRL
4 Gradescu str.
Chisinau,Republic of Moldova