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ACETYLCYSTEINE is a brand name for Acetylcysteine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Acetylcysteine 600 mg tablet is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.
Verbatim from this product's MHRA label. Tap a section to expand.
In general the usual recommended dosage is:
Adults including elderly and adolescents 14 years and older: 600 mg (1 tablet) once daily.
Duration of therapy:
The duration of therapy is dependent on the nature and severity of the illness, and should be decided by the doctor.
Hepatic and Renal Impairment:
In patients with impaired kidney or liver impairment there is insufficient data on whether dosage adjustments are required. Hepatic and renal impairment can reduce clearance which may result in an increase in adverse drug reactions due to drug accumulation.
For oral use. Swallow the tablet with a drink of water. The tablet should be taken after food.
8. There are no studies on the efficacy and safety of once daily acetylcysteine 600 mg effervescent tablet in the adolescent population. However, mild, moderate or severe adverse reactions have been reported with the use of IV acetylcysteine in the adolescent population.
Patients with bronchial asthma should be closely monitored during treatment. If a bronchospasm occurs, acetylcysteine administration must be immediately stopped and appropriate treatment started. Caution is advised in patients with peptic ulcer disease or history thereof, at risk of gastrointestinal bleeding (history of peptic ulcer, esophageal varices), particularly with the simultaneous administration of other drugs with a known irritating effect on the gastric mucosa.
Drug monitoring, animal testing, and extensive experience with acetylcysteine, however, do not indicate an increased risk of irritation of the gastric mucosa by acetylcysteine at a dosage up to 600 mg/day. Acetylcysteine can increase the intensity of vomiting.
This product should be used with caution by patients with histamine intolerance. g. headaches, rhinitis, itching). Acetylcysteine can, especially at the start of treatment, cause thinning and increased volume of bronchial secretions. If the patient is not able to expectorate this adequately, appropriate supportive measures should be implemented (such as postural drainage and suction removal).
No specific studies have been performed in patients with renal or hepatic impairment. Hepatic and renal impairment can reduce clearance and increase acetylcysteine plasma levels which may result in an increase in adverse drug reactions due to drug accumulation.
This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’. 5 Interaction with other medicinal products and other forms of interaction Analysis of interactions with other medicines has been performed only in adults.
Allergic symptoms, including generalized urticaria, have been reported; discontinue administration if symptoms cannot be medically controlled. Serious skin reactions such as Stevens-Johnson syndrome and Lyell’s syndrome have been reported whilst taking acetylcysteine, but these occur rarely.
For this reason, medical advice should be sought immediately and the patient should stop taking acetylcysteine in the event of new-onset changes to the skin and mucous membranes. 8. There are no studies on the efficacy and safety of once daily acetylcysteine 600 mg effervescent tablet in the adolescent population.
However, mild, moderate or severe adverse reactions have been reported with the use of IV acetylcysteine in the adolescent population. Patients with bronchial asthma should be closely monitored during treatment. If a bronchospasm occurs, acetylcysteine administration must be immediately stopped and appropriate treatment started.
Caution is advised in patients with peptic ulcer disease or history thereof, at risk of gastrointestinal bleeding (history of peptic ulcer, esophageal varices), particularly with the simultaneous administration of other drugs with a known irritating effect on the gastric mucosa.
Drug monitoring, animal testing, and extensive experience with acetylcysteine, however, do not indicate an increased risk of irritation of the gastric mucosa by acetylcysteine at a dosage up to 600 mg/day. Acetylcysteine can increase the intensity of vomiting.
This product should be used with caution by patients with histamine intolerance. g. headaches, rhinitis, itching). Acetylcysteine can, especially at the start of treatment, cause thinning and increased volume of bronchial secretions. If the patient is not able to expectorate this adequately, appropriate supportive measures should be implemented (such as postural drainage and suction removal).
1. These tablets should not be used in children under 14 years of age.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Antitussives If this product is used in combination with cough-relieving medicines (antitussives) the suppressed cough reflex may cause a dangerous build-up of secretions, which means that the indication for this combination treatment should be established particularly carful.
Carbamazepine Simultaneous use of acetylcysteine and carbamazepine could lead to subtherapeutic carbamazepine blood levels. Activated charcoal Co-administration with activated charcoal can reduce the effectiveness of acetylcysteine.
Antibiotics Reports of inactivation of antibiotics by acetylcysteine indicate that this inactivation occurs only when these substances are mixed directly together in vitro. These antibiotics include tobramycin, netilmicin, piperacillin, sodium-ampicillin, erythromycin lactobionate, cefsulodin, ceftazidime, imipenem.
Orally administered acetylcysteine does not interfere, regarding bioavailability, with amoxicillin, erythromycin, doxycycline, bacampicillin, thiamphenicol, and amoxicillin in combination with clavulanic acid. Nevertheless, administration of oral doses of antibiotics and acetylcysteine effervescent tablets should be separated by minimum period of two hours.
This does not apply to the antibiotics cefixime or loracarbef. Acetylcysteine and glyceryl trinitrate (nitroglycerin) Simultaneous administration of these drugs may increase the vasodilatory and platelet aggregation-inhibiting effect of glyceryl trinitrate and increase dilation of the temporal artery.
If such combined treatment is considered necessary, the patient should be monitored for possible hypotension, which can be serious and may be indicated by headaches. Interface with the measurement of laboratory parameters Acetylcysteine can influence the colourmetric assay of salicyclates.
Acetylcysteine can influence results when measuring ketones in urine. Due to its chelating properties, acetylcysteine can reduce the bioavailability of salts of heavy metals such as gold and iron salts and of calcium salts. In the absence of exact data in this regard, it is advisable to separate the intake of acetylcysteine and these salts or to choose a different route of administration.
6 Fertility, pregnancy and lactation Pregnancy There are limited data on the use of acetylcysteine in pregnant women. 3). As a precautionary measure, it is preferable to avoid the use of Acetylcysteine during pregnancy. Before use during pregnancy, the possible risks should be weighed against the possible benefits.
Breast-feeding There is insufficient information on the excretion of acetylcysteine or its metabolites in human milk. Risk for infants cannot be excluded. Use during pregnancy and while breast-feeding should be subject to careful consideration of the risk/benefit balance.
Fertility No human data on the effect of acetylcysteine are available. 3). 7 Effects on ability to drive and use machines Acetylcysteine has no influence on the ability to drive and use machines. 8 Undesirable effects Summary of the safety profile The most common adverse reactions associated with oral administration of acetylcysteine are gastrointestinal in nature.
Hypersensitivity reactions, including anaphylactic shock, anaphylactic/anaphylactoid reactions, bronchospasm, angioedema, rash, and pruritus, have been reported less frequently. 000 to <1/ 100) Rare (> 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Unknown (frequency cannot be estimated from the available data) Adverse ReactionsSystem/organ […]
No specific studies have been performed in patients with renal or hepatic impairment. Hepatic and renal impairment can reduce clearance and increase acetylcysteine plasma levels which may result in an increase in adverse drug reactions due to drug accumulation.
This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.