Plemstop

Effervescent tablet - White to light yellow, round, flat-faced tablets, embossed with "SYN" on one side.
Each effervescent tablet contains: Acetylcysteine 600 mg.

Pharmacotherapeutic group: Mucolytics.
Pharmacology: Pharmacodynamics: Acetylcysteine exerts its mucolytic action through its free sulfhydryl group, which opens the disulfide bonds and lowers mucus viscosity. This action increases with increasing pH and is most significant at pH 7 to 9. The mucolytic action of acetylcysteine is not affected by the presence of DNA. N-acetylcysteine has been demonstrated to cause a decrease in sputum consistency, to facilitate easier expectoration, and to increase sputum volume. Bronchial mucus is composed of over 95% water; however, the physical characteristics of the mucus are due to glycoproteins. These glycoproteins bind to each other by way of disulfide bonds and give the mucus viscosity. N-acetylcysteine ruptures these disulfide bonds causing depolymerization and a rapid decrease in mucus viscosity. It also produces an irritative bronchorrheic effect on the mucosa, stimulating mucociliary clearance; this irritative effect may cause bronchospasm, thus acetylcysteine is not recommended in asthmatics.
Pharmacokinetics: Absorption: Absorption of acetylcysteine is rapid following oral administration, but the bioavailability is only 6-10% due to extensive first past metabolism. Oral bioavailability is similar for a single 600-mg dose and three 200-mg doses.
Peak plasma levels of acetylcysteine occur approximately one hour following oral administration.
Distribution: Acetylcysteine may be present in plasma as the parent compound or as various oxidised metabolites such as N-acetylcysteine, N,N-diacetylcysteine, and cysteine either free or bound to plasma proteins by labile disulfide bonds or as a fraction incorporated into protein peptide chains.
Following a 100-mg oral dose, 48% was present in lung tissue.
Metabolism: Acetylcysteine undergoes extensive metabolism in the liver and intestinal wall.
Acetylcysteine undergoes rapid deacetylation in vivo to yield cysteine or oxidation to yield diacetylcysteine. Following deacetylation in the liver, it enters the normal metabolic pathway of the amino acid cysteine. An appreciable elevation in total serum sulfhydryl concentration occurs.
Elimination: Renal Excretion: 22% to 30% Feces: 3% Total Body Clearance: 6.5 L/hr (healthy subjects). The mean terminal half-life is approximately 6 hours.

Reduce the viscosity of the secretion from respiratory tract.

Adults including elderly and adolescents 14 years: 600 mg (1 effervescent 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.
The effervescent tablets should be dissolved completely in a glass of water before use and taken after food.
Mode of Administration: Oral route.

No cases of overdosage with oral dosage forms of acetylcysteine are known to be observed to date.
Symptoms of overdose: Overdoses can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea.
Treatment: Symptomatic treatment if necessary.

It is contraindicated in patients with a history of hypersensitivity to acetylcysteine or any of the drug product's components. The effervescent tablet contains aspartame and is therefore contraindicated in patients with phenylketonuria.

Patients with asthma should be carefully monitored. Treatment with acetylcysteine should be stopped when bronchospasm occurred. The sulfur odor on opening the sachets does not indicate deterioration of the product, but is due to the active ingredient.
Other drugs should not be used with acetylcysteine solution.

Pregnancy: There is a limited amount of data from the use of acetylcysteine in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
Breastfeeding: No information is available on the excretion of the drug into breast milk.
The product can be used during pregnancy or breastfeeding only after careful evaluation of the risk/benefit.

Side effects reported after oral administration of N-acetylcysteine are shown in the following table. (See Table.)

Click on icon to see table/diagram/image

Incidents of severe skin reactions, such as Stevens Johnson syndrome and Lyell's syndrome, with the use of acetylcysteine are very rare. In most cases at least one other drug was administered concomitantly, so the described mucocutaneous effects could be exacerbated. Immediate medical advice should be sought in case of onset of skin or mucosal changes and the use of acetylcysteine should be discontinued.
Various studies confirmed a decrease in platelet aggregation during administration of acetylcysteine. The clinical significance of this is unclear.

Dissolving Acetylcysteine 600 mg effervescent tablet together with other medicinal products is not recommended.
The inactivation of antibiotics (tetracycline, aminoglycosides, penicillin) by acetylcysteine has been reported up to now only in in vitro tests whereby the relevant substances were mixed directly with each other. However, if oral antibiotics are required, it is advised that these should be administered separately and at an interval of at least 2 hours.
Acetylcysteine may potentiate the vasodilatory effect of nitroglycerine. If concomitant therapy is necessary, caution is required and the patient's blood pressure has to be monitored in terms of hypotension that can become serious.
Activated charcoal can decrease the effect of acetylcysteine due to reduced absorption.

Store at temperatures not exceeding 30°C.

Cough & Cold Preparations

R05CB01 - acetylcysteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.

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