Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Acetylcysteine 200mg/ml Injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Acetylcysteine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Acetylcysteine Injection contains sodium This medicinal product contains 32.26mg of sodium per
What you need to know before you take it
ml of infusion (a total of 322.6mg of sodium in each 10ml Acetylcysteine Injection ampoule for infusion). This amount must be taken into 3. How you will be given Acetylcysteine Injection consideration by patients on a salt-restricted diet. 4. Possible side effects 5. How to store Acetylcysteine Injection
Possible side effects
For example for a child weighing 12 kg, the first infusion would be 38 ml infused at 38 ml/h over 1 hour, the second infusion would be 100 ml infused at 25 ml/h over 4 hours and the third infusion is 208 ml infused at 13 ml/h over 16 hours.
Paediatric Dosage Table Paediatric acetylcysteine prescription (each ampoule = 200mg/ml acetylcysteine) Regimen
First Infusion
Infusion
50mg/ml for 1 hour
Infusion rate
3ml/kg/h
Please circle appropriate weight and volume.
Second Infusion
Third Infusion
6.25mg/ml for 4 hours 6.25mg/ml for 16 hours 2ml/kg/h
1ml/kg/h
Total Total Total Patient Infusion Infusion Infusion Infusion Infusion Weight1 Rate Rate Volume Volume Volume
1
Infusion Rate
kg
ml
ml/h
ml
ml/h
ml
ml/h
1 2 3 4 5 6 7 8 9 10-14 15-19 20-24 25-29 30-34 35-39
3 6 9 12 15 18 21 24 27 38 53 68 83 98 113
3 6 9 12 15 18 21 24 27 38 53 68 83 98 113
8 16 24 32 40 48 56 64 72 100 140 180 220 260 300
2 4 6 8 10 12 14 16 18 25 35 45 55 65 75
16 32 48 64 80 96 112 128 144 208 288 368 448 528 608
1 2 3 4 5 6 7 8 9 13 18 23 28 33 38
Dose calculations are based on the weight in the middle of each band. If the patient weighs more than 40kg use the adult dosage table. Figures have been rounded up to the nearest whole number
The Summary of Product Characteristics should be referred to for full prescribing information. Marketing Authorisation Holder Aurum Pharmaceuticals Ltd., T/A Martindale Pharma, Bampton Rd, Harold Hill, Romford, Essex RM3 8UG, United Kingdom. Marketing Authorisation Number: PL 12064/0026 This leaflet was last revised in: December 2019
Bampton Rd, Harold Hill, Romford, Essex RM3 8UG, United Kingdom
D05160
Acetylcysteine 200mg/ml Injection Acetylcysteine
Children
Adult Dosage Table
D05160
How to store it
Acetylcysteine Injection
Like all medicines, this medicine can cause side effects, Keep this medicine out of the sight and reach of children. although not everybody gets them. Do not use Acetylcysteine Injection after the expiry date Tell your doctor or nurse immediately if you notice any which is stated on the label. The expiry date refers to the of the following: last day of that month. The doctor or nurse will check that the product has not passed this date.
- swelling of the face, lips or tongue
- wheezing, difficulty in breathing Once diluted according to directions, start using within 3
- feeling or being sick hours.
- irritation at the injection site Do not store above 25oC. Store ampoules in the original
- skin rash, itching container until use.
- flushing (red face or feeling hot) Do not throw away medicines via wastewater or
- low blood pressure resulting in dizziness household waste. Ask your pharmacist how to throw away
- rapid heart beat or increased blood pressure. medicines you no longer use. These measures will help These symptoms often happen 15 to 60 minutes after the protect the environment. start of the infusion, and may be relieved by stopping the infusion. You may need to be treated with antihistamines 6. Contents of the pack and other information or corticosteroids. Once the reaction is under control the What Acetylcysteine Injection contains infusion can be restarted. The active ingredient is Acetylcysteine 200 mg/1 ml. Other rare side effects: The other ingredients are disodium edetate, nitrogen
- coughing, noisy breathing gas, sodium hydroxide and water for injection.
- respiratory arrest (stop breathing) What Acetylcysteine Injection looks like and contents
- chest tightness or pain, of the pack:
- puffy eyes, blurred vision, pain in the face or eyes Acetylcysteine Injection is a clear colourless solution for
- sweating, feeling unwell infusion.
- raised temperature, hot, red face and skin
- liver problems The product is available in (Type I) clear glass ampoules in
- slow heart beat, cardiac arrest (heart stops beating) pack sizes of 10x 10ml, 10x 20ml or 5x 20ml ampoules.
- fainting, collapsing, fits Not all pack sizes may be marketed.
- reduction in blood platelets, which increases the risk of Marketing Authorisation bleeding or bruising Manufacturer:
- a condition called acidosis, which may cause weariness, Holder: Aurum Panpharma GmbH, vomiting, thirst or restlessness Pharmaceuticals Ltd., Bunsenstrasse 4,
- anxiety T/A Martindale Pharma, 22946 Trittau,
- joint pain or disease Bampton Road, Germany
- bluish skin from low oxygen levels in the blood Harold Hill, Reporting of side effects If you get any side effects, talk to your doctor, pharmacist Romford, or nurse. This includes any possible side effects not listed RM3 8UG, UK. in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: Product Licence Number: PL 12064/0026 www.mhra.gov.uk/yellowcard This leaflet was last revised in: December 2019 By reporting side effects you can help provide more information on the safety of this medicine.
5160-A
100mm Measurement Verification Bar
Bampton Rd, Harold Hill, Romford, Essex RM3 8UG, United Kingdom
D05160
PROFESSIONAL LEAFLET
Contents of the pack and other information
PACKAGE LEAFLET: INFORMATION FOR THE USER
D05160
Injection 1. What Acetylcysteine Injection is and what it Acetylcysteine Injection will be diluted in glucose or is used for sodium chloride solution and given as an intravenous
infusion (a drip into a vein) by a doctor or nurse. Adults: Acetylcysteine Injection is given in three stages. During each stage a different dose of Acetylcysteine will be given. You will be given a total dose of 300mg of Acetylcysteine per kg of your body weight, over a period of 21 hours. Some patients may require longer treatment with acetylcysteine. The doctor will calculate how much to give you in each stage. Children: Children should be given Acetylcysteine Injection in three stages, like adults. However, the amount of fluid used to 2. What you need to know before you are dilute Acetylcysteine Injection will be calculated to take given Acetylcysteine Injection into consideration the age and weight of the child, as too The level of paracetamol in your blood should be checked much fluid can be harmful. Blood tests may be carried out before, during and after treatment with this medicine. before treatment is started. If you receive more Acetylcysteine Injection than you Warnings and precautions should Talk to your doctor or nurse before using Acetylcysteine Acetylcysteine Injection will be given to you by a doctor Injection if: or nurse, therefore it is unlikely that you will be given
- you suffer from asthma or breathing difficulties too much or that you will miss a dose. However, if you
- you have had an adverse reaction to Acetylcysteine are concerned about your treatment, please talk to your before doctor.
- you are pregnant or breast-feeding Continued overleaf Acetylcysteine Injection is used for the treatment of paracetamol overdose (where you may have taken too much paracetamol). You will be given Acetylcysteine Injection if you have taken a potentially harmful amount of paracetamol. Acetylcysteine protects the liver from damage by the high levels of paracetamol. It is very effective when given during the first 8 hours following paracetamol overdose. The effectiveness is reduced as the time interval increases, but it can still help when given up to 24 hours after the overdose.
Children are treated with the same doses and regimen as adults. However, the quantity of intravenous fluid used has been modified to take into account age and weight, as fluid overload is a potential danger. Doses should be administered sequentially using an appropriate infusion pump. Preparation and administration of paediatric infusions
- Weigh the child to determine the correct weight band.
- Read off the table the total infusion volume required for each dose according to the weight of the child and make up the solutions according to the directions below. First infusion
- Prepare a 50 mg/ml solution by diluting each 10 ml ampoule of N-acetylcysteine (200 mg/ml) with 30 ml glucose 5% or sodium chloride 0.9% to give a total volume of 40 ml.
- Prepare the appropriate volume for the weight of the child.
- The dose is infused over 1 hour at the infusion rate stated in the table. Second Infusion
- Prepare a 6.25 mg/ml solution by diluting each 10 ml ampoule of N-acetylcysteine (200 mg/ml) with 310 ml glucose 5% or sodium chloride 0.9% to give a total volume of 320 ml.
- Prepare the appropriate volume for the weight of the child.
- The dose is infused over 4 hours at the infusion rate stated in the table. Third Infusion
- Prepare a 6.25 mg/ml solution by diluting each 10 ml ampoule of N-acetylcysteine (200 mg/ml) with 310 ml glucose 5% or sodium chloride 0.9% to give a total volume of 320 ml.
- Prepare the appropriate volume for the weight of the child.
- The dose is infused over 16 hours at the infusion rate stated in the table.
Frequently asked questions about Acetylcysteine 200mg/ml Injection
How do I take Acetylcysteine 200mg/ml Injection?
Acetylcysteine 200mg/ml Injection comes as injection containing 200mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Acetylcysteine 200mg/ml Injection?
The active substance in Acetylcysteine 200mg/ml Injection is acetylcysteine.
Are there equivalent medicines to Acetylcysteine 200mg/ml Injection?
Medicines with the same active substance, strength and form include: Acetylcysteine 200mg/ml Injection (DEMO). They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Acetylcysteine 200mg/ml Injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Acetylcysteine 200mg/ml Injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: acetylcysteine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
N-acetylcysteine is indicated for the treatment of paracetamol overdose in patients:
a) who have taken a staggered overdose irrespective of plasma paracetamol level. Staggered is defined as an overdose where the paracetamol was ingested over a period of 1 hour or more; or
b) where there is any doubt over the time of the overdose, irrespective of plasma paracetamol level; or
c) who present with a plasma paracetamol level on or above a line joining points of 100mg/L at 4h and 15mg/L at 15h (see below nomogram).
4.2. Posology and method of administration
The injection should be administered by intravenous infusion preferably using Glucose 5% as the infusion fluid. Sodium Chloride 0.9% solution may be used if Glucose 5% is not suitable.
Adults
The full course of treatment with acetylcysteine comprises 3 consecutive intravenous infusions:
First infusion
Initial loading dose of 150 mg/kg body weight infused in 200 mL over 1 hour.
Second infusion
50 mg/kg in 500 mL over the next 4 hours.
Third infusion
100 mg/kg in 1 litre over the next 16 hours.
The patient should therefore receive a total of 300 mg/kg over a 21 hour period.
Continued treatment with acetylcysteine (given at the dose and rate as used in the third infusion) may be necessary depending on the clinical evaluation of the individual patient.
A ceiling weight of 110 kg should be used when calculating the dosage for obese patients.
Dosage should be calculated using the patient's actual weight.
Adult N-acetylcysteine prescription
(each ampoule = 200mg/mL N-acetylcysteine)
Please circle appropriate weight, dose and volume.
Regimen
Dose 1
Dose 2
Dose 3
Fluid
200 mLs 5% glucose or sodium chloride 0.9%
500 mLs 5% glucose or sodium chloride 0.9%
1000 mLs 5% glucose or sodium chloride 0.9%
Duration of infusion
60 minutes
4 hours
16 hours
Drug dose
150 mg/kg
N-acetylcysteine
50 mg/kg
N-acetylcysteine
100 mg/kg
N-acetylcysteine
Patient Weight1
Dose
Ampoule volume2
Infusion Rate
Dose
Ampoule volume2
Infusion Rate
Dose
Ampoule volume2
Infusion Rate
kg
mg
mL
mL/h
mg
mL
mL/h
mg
mL
mL/h
40-49
6750
34
234
2250
12
128
4500
23
64
50-59
8250
42
242
2750
14
129
5500
28
64
60-69
9750
49
249
3250
17
129
6500
33
65
70-79
11250
57
257
3750
19
130
7500
38
65
80-89
12750
64
264
4250
22
131
8500
43
65
90-99
14250
72
272
4750
24
131
9500
48
66
100-109
15750
79
279
5250
27
132
10500
53
66
>110- Max dose
16500
83
283
5500
28
132
11000
55
66
1 Dose calculations are based on the weight in the middle of each band.
2 Ampoule volume has been rounded up to the nearest whole number.
Children
Children should be treated with the same doses and regimen as adults; however, the quantity of intravenous fluid used should be modified to take into account age and weight, as fluid overload is a potential danger.
N-acetylcysteine should be administered by intravenous infusion preferably using Glucose 5% as the infusion fluid. Sodium Chloride 0.9% solution may be used if Glucose 5% is not suitable.
Doses should be administered using an appropriate infusion pump.
The full course of treatment with N-acetylcysteine comprises 3 consecutive intravenous infusions:
First infusion
Initial loading dose of 150 mg/kg infused over 1 hour (150 mg/kg/h).
Given as a 50 mg/mL solution at a rate of 3 mL/kg/h.
Second Infusion
Dose: 50 mg/kg infused over 4 hours (12.5 mg/kg/h).
Given as a 6.25 mg/mL solution at a rate of 2 mL/kg/h.
Third Infusion
Dose: 100 mg/kg infused over 16 hours (6.25 mg/kg/h).
Given as a 6.25 mg/mL solution at a rate of 1 mL/kg/h.
Preparation of the solution
Dose 1
Prepare a 50 mg/mL solution. Dilute each 10mL ampoule of N-acetylcysteine (200 mg/mL) with 30 mL glucose 5% or sodium chloride 0.9% to give a total volume of 40 mL.
Dose 2
Prepare a 6.25 mg/mL solution. Dilute each 10 mL ampoule of N-acetylcysteine (200 mg/mL) with 310 mL glucose 5% or sodium chloride 0.9% to give a total volume of 320 mL.
Dose 3
Prepare a 6.25 mg/mL solution. Dilute each 10 mL ampoule of N-acetylcysteine (200 mg/mL) with 310 mL glucose 5% or sodium chloride 0.9% to give a total volume of 320 mL.
Any unused solution should be disposed of in accordance with local requirements.
Administration
Weigh the child.
Determine the total volume of solution to be infused (infusion fluid + N-acetylcysteine prepared as above) into the child from the table. A separate volume will be required for each of the three infusion periods.
For example for a child weighing 12 kg, 38mL of solution is required for Dose 1, 100mL for Dose 2 and 200mL for Dose 3.
Infuse intravenously according to the weight of the child (see table).
For example for a child weighing 12 kg, Dose 1 is infused at 38mL/h over 60 minutes, Dose 2 would be infused at 25mL/h and Dose 3 at 13mL/h.
Doses should be administered sequentially with no break between the doses.
Paediatric N-acetylcysteine prescription
(each ampoule = 200mg/mL N-acetylcysteine)
Please circle appropriate weight, dose and volume.
Regimen
Dose 1
Dose 2
Dose 3
N-acetylcysteine dose
150 mg/kg
50 mg/kg
100 mg/kg
Duration of infusion
1 hour
4 hours
16 hours
Infusion concentration
50mg/ml
6.25mg/ml
6.25mg/ml
Rate of infusion
3ml/kg/h
2ml/kg/h
1ml/kg/h
Patient Weight1
Dose
Rate of Infusion
Total Infusion Volume
Dose
Rate of Infusion
Total Infusion Volume
Dose
Rate of Infusion
Total Infusion Volume
Kg
mg
mL/h
mL
mg
mL/h
mL
mg
mL/h
mL
1
150
3
3
50
2
8
100
1
16
2
300
6
6
100
4
16
200
2
32
3
450
9
9
150
6
24
300
3
48
4
600
12
12
200
8
32
400
4
64
5
750
15
15
250
10
40
500
5
80
6
900
18
18
300
12
48
600
6
96
7
1050
21
21
350
14
56
700
7
112
8
1200
24
24
400
16
64
800
8
128
9
1350
27
27
450
18
72
900
9
144
10-14
1875
38
38
625
25
100
1250
13
208
15-19
2625
53
53
875
35
140
1750
18
288
20-24
3375
68
68
1125
45
180
2250
23
368
25-29
4125
83
83
1375
55
220
2750
28
448
30-34
4875
98
98
1625
65
260
3250
33
528
35-39
5625
113
113
1875
75
300
3750
38
608
1 Dose calculations are based on the weight in the middle of each band.
4.3. Contraindications
There are no contraindications to the treatment of paracetamol overdose with N-acetylcysteine.
4.4. Special warnings and precautions for use
Intravenous N-acetylcysteine, given within 24 hours of ingestion of a potentially hepatotoxic overdose of paracetamol, is indicated to prevent or reduce the severity of liver damage. It is most effective when administered within 8 to 10 hours of a paracetamol overdose. Although the efficacy of N-acetylcysteine diminishes between 10 and 24 hours post-overdose, it should be administered up to 24 hours as it can still be of benefit. It may still be administered after 24 hours in patients at risk of severe liver damage.
Anaphylactoid reactions
Anaphylactoid hypersensitivity reactions occur with N-acetylcysteine, particularly with the initial loading dose. The patient should be carefully observed during this period for signs of an anaphylactoid reaction. Nausea, vomiting, flushing, skin rash, pruritus and urticaria are the most common features, but more serious anaphylactoid reactions have been reported where the patient develops angioedema, bronchospasm, respiratory distress, tachycardia and hypotension. In very rare cases these reactions have been fatal. There is some evidence that patients with a history of atopy and asthma may be at increased risk of developing an anaphylactoid reaction.
Most anaphylactoid reactions can be managed by temporarily suspending the N-acetylcysteine infusion, administering appropriate supportive care and restarting at a lower infusion rate. Once an anaphylactoid reaction is under control, the infusion can normally be restarted at an infusion rate of 50 mg/kg over 4 hours, followed by the final 16 hour infusion (100 mg/kg over 16 hours).
Coagulation
Changes in haemostatic parameters have been observed in association with N-acetylcysteine treatment, some leading to decreased prothrombin time, but most leading to a small increase in prothrombin time. An isolated increase in prothombin time up to 1.3 at the end of a 21 hour course of N-acetylcysteine without an elevated transaminase activity do not require further monitoring or treatment with N-acetylcysteine.
Fluid and electrolytes
Use with caution in children, patients requiring fluid restriction or those who weigh less than <40 kg because of the risk of fluid overload which may result in hyponatraemia and seizures which may be life threatening.
Each 10ml of N-acetylcysteine for Infusion contains 322.6mg sodium. To be taken into consideration with patients on a controlled sodium diet.
4.5. Interaction with other medicinal products and other forms of interaction
There are no known interactions.
4.6. Fertility, pregnancy and lactation
The safety of N-acetylcysteine in pregnancy has not been investigated in formal prospective clinical trials. However, clinical experience indicates that use of N-acetylcysteine in pregnancy for the treatment of paracetamol overdose is effective. Prior to use in pregnancy, the potential risks should be balanced against the potential benefits.
No information is available on the excretion of the drug into breast milk. Breast-feeding is thus not advised during or immediately following the use of this drug.
4.7. Effects on ability to drive and use machines
There are no known effects on ability to drive and use machines.
4.8. Undesirable effects
The most common adverse reactions reported with N-acetylcysteine are nausea, vomiting, flushing and skin rash.
Less commonly, more serious anaphylactoid reactions have been reported that include angioedema, bronchospasm/respiratory distress, hypotension, tachycardia or hypertension.
Adverse reactions to N-acetylcysteine usually occur between 15 and 60 minutes after the start of infusion and, in many cases, symptoms are relieved by stopping the infusion. An antihistamine drug may be necessary, and occasionally corticosteroids may be required. Once an adverse reaction is under control, the infusion can normally be restarted at the lowest infusion rate (100mg/kg in 1 litre over 16 hours).
Other reported adverse reactions include: injection site reactions, pruritus, cough, chest tightness or pain, puffy eyes, sweating, malaise, raised temperature, vasodilation, blurred vision, bradycardia, facial or eye pain, syncope, acidosis, thrombocytopenia, respiratory or cardiac arrest, stridor, anxiety, extravasation, arthropathy, arthralgia, deterioration of liver function, generalised seizure, cyanosis, lowered blood urea.
Case reports of fatalities with N-acetylcysteine have been reported very rarely.
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.
If any adverse reactions to N-acetylcysteine develop, advice should be sought from the National Poisons Centre to ensure that the patient receives adequate treatment of the paracetamol overdose.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
There is a theoretical risk of hepatic encephalopathy. Overdosage of N-acetylcysteine has been reported to be associated with effects similar to the 'anaphylactoid' reactions noted in section 4.8 (Undesirable Effects), but they may be more severe. General supportive measures should be carried out. Such reactions are managed with antihistamines and steroids in the usual way. There is no specific antidote.
💬 Ask about this leaflet
Ask anything about Acetylcysteine 200mg/ml Injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.