Each ml contains: Acetylcysteine USP 200 mg, Water for Injections BP q.s.
Acetylcysteine is the N-acetyl derivative of cysteine used primarily as a mucolytic agent and as intravenous (I .V.) medication in the management of acetaminophen overdose.
Pharmacology: Pharmacodynamics: Mechanism of Action: Acetylcysteine has been shown to reduce the extent of liver injury following acetaminophen overdose. It is most effective when given early, with benefit seen principally in patients treated within 8-10 hours of the overdose. Acetylcysteine likely protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite.
This medication is used as an antidote for acetaminophen overdose to prevent life-threatening liver damage.
Patients ≥40 kg: Loading Dose: 150 mg/kg in 200 ml of diluent administered over 60 min.
Dose 2: 50 mg/kg in 500 ml of diluent administered over 4 hr.
Dose 3: 100 mg/kg in 1000 ml of diluent dextrose administered over 16 hr.
Patients > 20- < 40 kg: Loading Dose: 150 mg/kg in 100 ml of diluent administered over 60 min.
Dose 2: 50 mg/kg in 250 ml of diluent administered over 4 hr.
Dose 3: 100 mg/kg in 500 ml of diluent administered over 16 hr.
Patients ≤ 20 kg: Loading Dose: 150 mg/kg in 3 ml/kg of body weight of diluent administered over 60 min.
Dose 2: 50 mg/kg in 7 ml/ kg of body weight of diluent administered over 4 hr.
Dose 3: 100 mg/kg in 14 ml/ kg of body weight of diluent administered over 16 hr.
Symptoms: Symptoms following overdosage with acetylcysteine have been similar to those of anaphylactoid reactions noted under "Adverse Reactions", but they may be more severe. Hypotension appears to be especially prominent. There is also a theoretical risk of hepatic encephalopathy.
Treatment: It has been suggested that generalised reactions to acetylcysteine can be treated with intravenous injection of an antihistamine, and infusion of acetylcysteine should be temporarily stopped but can be restarted at a slower rate without further reaction.
Acetylcysteine is contraindicated in patients with hypersensitivity or previous anaphylactic reaction to acetylcysteine or any component of the preparation.
Monitor, acute flushing and erythema of the skin may occur; usually associated with the loading dose; often resolves spontaneously despite continued infusion.
Monitor for serious anaphylactoid reactions; infusion may be interrupted until treatment of anaphylactoid symptoms has been initiated.
Should be used with caution in patients with asthma, or where there is a history of bronchospasm.
Total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction.
Intravenous administration of acetylcysteine, especially in the large doses may result in nausea, vomiting and other gastrointestinal symptoms. Hypersensitivity reactions have been reported following intravenous administration of acetylcysteine. Bronchospasm may occur in conjunction with a generalised anaphylactoid reaction. The symptoms of the anaphylactic-like reaction to acetylcysteine include airway obstruction (bronchospasm), angioedema, dyspnoea, hypotension, shock, tachycardia, urticaria, and injection site reaction (including rash). These reactions occur most commonly either during, or at the end of the period of the loading dose infusion, and may in fact be dose related. Since these anaphylactic-like reactions usually occur following the loading dose, careful monitoring is recommended.
Store below 30°C. Protect from light.
V03AB23 - acetylcysteine ; Belongs to the class of antidotes. Used to neutralize paracetamol overdose.
Inj 200 mg/mL (amp) x 2 mL x 2's.
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