ACETILCISTEINAcapsules

ACETILCISTEINA<span>capsules

Trade name

Acetilcisteină

 

Drug description

Hard, gelatin #1 capsule with hemispherical heads and a smooth surface, having a white body with a light blue cap; a light blue body and cap or a blue body and a light blue cap.

Capsule contain a white to off-white powder.

 

Main Active Ingredient

Acetylcysteine

 

Pharmaceutical form:

Capsules

 

PHARMACOLOGICAL CLASSIFICATION:

A/10.2.2 Medicines acting on the respiratory system - other.

 

PHARMACOLOGICAL ACTION:

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.

 

INDICATIONS:

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.

 

CONTRA-INDICATIONS:

Hypersensitivity to N-acetylcysteine.

Safety in pregnancy has not been established.

 

WARNINGS:

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.

 

Shelf Life

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