PARVOLEX® Injection
SCHEDULING STATUS :
S2
PROPRIETARY NAME
(and dosage form):
PARVOLEX® Injection
COMPOSITION :
Each mL contains N-acetylcysteine 200mg i.e. each 10mL ampoule contains 2g N-acetylcysteine.
PHARMACOLOGICAL CLASSIFICATION:
Category A 34 other.
PHARMACOLOGICAL ACTION:
In paracetamol poisoning, N-acetylcysteine protects the liver, possibly by restoring depleted hepatic-reduced glutathione or by acting as an alternative substrate for the toxic paracetamol metabolite.
INDICATIONS:
Paracetamol overdosage.
CONTRA-INDICATIONS:
Hypersensitivity to any ingredient in the preparation.
PARVOLEX is ineffective 15hours after paracetamol overdosage and its use after this time may be associated with harmful effects.
DOSAGE AND DIRECTIONS FOR USE:
Adults:
Initial dose: 150mg/kg body mass of N-acetylcysteine infused in 200mL of 5% dextrose intravenously over 15minutes, followed by continuous infusion: 50mg/kg body mass in 500mL of 5% dextrose over next 4hours, followed by 100mg/kg body mass in 1litre of 5% dextrose over 16hours.
PARVOLEX INTRAVENOUS INFUSION DOSAGE GUIDE
PATIENTS
BODY
MASS |
INITIAL |
SECOND |
THIRD |
TOTAL
PARVOLEX |
|
(kg) |
150mg/kg in
200mL of 5%
dextrose over
15 mins |
50mg/kg in
500mL of 5%
dextrose over
4 hours |
100mg/kg in
1 litre of 5%
dextrose over
16 hours |
(mL) |
|
|
PARVOLEX (mL) |
PARVOLEX (mL) |
PARVOLEX (mL) |
|
|
50 |
37,5 |
12,5 |
25 |
75 |
|
60 |
45,0 |
15,0 |
30 |
90 |
|
70 |
52,5 |
17,5 |
35 |
105 |
|
80 |
60,0 |
20,0 |
40 |
120 |
|
90 |
67,5 |
22,5 |
45 |
135 |
|
x |
0,75x |
0,25x |
0,5x |
1,5x |
If the patient’s body mass is x kg then the infusion volumes of PARVOLEX in mL will be:
|
Initial infusion |
0,75x |
PARVOLEX contains 200mg |
|
Second infusion |
0,25x |
N-acetylcysteine in each mL |
|
Third infusion |
0,5x |
i.e. each 10mL ampoule |
|
Total |
1,5x |
contains 2g N-acetylcysteine |
Children:
The quantity of intravenous fluid used in children should be modified to take into account age and mass.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Administer with caution in asthma or a history of asthma.
Rash, bronchospasm and anaphylactoid reactions have been reported. These have occurred between 15minutes and 1hour after the start of the infusion.
Hypokalaemia and ECG changes have been noted in patients with paracetamol poisoning irrespective of the treatment given. Monitoring of plasma potassium concentration is therefore recommended.
N-acetylcysteine is not compatible with rubber and metals, particularly iron, copper and nickel. Silicone rubber and plastic are satisfactory for use with PARVOLEX. The safety of PARVOLEX in pregnancy has not been established.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT :
There is a theoretical risk of hepatic encephalopathy. There is no specific treatment and general supportive measures should be carried out.
IDENTIFICATION:
Clear, colourless solution.
PRESENTATION:
Cartons of 10 x 10mL ampoules.
STORAGE INSTRUCTIONS:
Store below 25° C.
Keep out of reach of children.
REGISTRATION NUMBER:
NX/34/156
NAME AND BUSINESS ADDRESS OF APPLICANT:
GlaxoSmithKline South Africa (Pty) Limited
57 Sloane Street
Bryanston
2012
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19 July 1984
P3758/0603
New addition to this site:April 2005
Source: Hospital Pharmacy |
