Mucucil

100 mg: Acetylcysteine 100 mg Granules for Solution is an Orange-White granules, orange solution upon reconstitution with orange flavor.
Each sachet contains: Acetylcysteine 100 mg.
200 mg: Acetylcysteine 200 mg Granules for Solution is an Orange-White granules, orange solution upon reconstitution with orange flavor.
Each sachet contains: Acetylcysteine 200 mg.
600 mg: Acetylcysteine 600 mg Granules for Solution is an Orange-White granules, orange solution upon reconstitution with orange flavor.
Each sachet contains: Acetylcysteine 600 mg.

Mucolytic.
Pharmacology: Pharmacodynamics/Pharmacokinetics: Acetylcysteine is rapidly absorbed from the gastrointestinal tract peak plasma concentrations occur about 0.5 to 1 hour after oral doses of 200 to 600 mg. Some studies indicate dose-dependent pharmacokinetics with peak concentrations, the time taken to reach the peak concentrations, and bioavailability increasing with increasing doses. Acetylcysteine may be present in plasma as the parent compound or as various oxidised metabolites such as N-acetylcysteine, N,N-diacetylcystine, and cysteine either free or bound plasma to proteins by labile disulfide bonds or as a fraction incorporated into protein peptide chains. In a study about 50% was in a covalently protein bound from 4 hours after oral dose. Oral bioavailability is low and mean values have ranged from 4 to 10% depending on whether total Acetylcysteine or just the reduced forms are measured. It has been suggested that Acetylcysteine's low oral bioavailability may be due to metabolism in the gut wall and the first-pass metabolism in the liver.

Treatment of respiratory affections characterized by thick viscous hypersecretions due to acute bronchitis and its exacerbation, pulmonary emphysema, mucoviscidosis and bronchiectasis.

The duration of treatment should be 5 to 10 days in acute phase. It may be continued in chronic state for several months according to the advice of the physician. Acetylcysteine is contraindicated in children below 2 years of age.
100 mg: Adults: 2 Mucucil 100 mg sachets, 2 to 3 times a day.
Children: 1 Mucucil 100 mg sachet, 2 to 4 times a day according to age.
Or as prescribed by the physician.
200 mg: Adults: 1 Mucucil 200 mg sachet daily or 2 sachets of Mucucil 100 mg, 2-3 times a day. For prevention of exacerbation, the use of Mucucil 200 mg sachet is recommended.
600 mg: Adults: 1 Mucucil 600 mg sachet daily (preferably in the evening). Or as prescribed by the physician.

For oral pharmaceutical forms of Acetylcysteine, no case of overdose has been reported to date. Health volunteers received 11.6 g of Acetylcysteine daily for three months without any serious undesirable effects. Oral doses up to 500 mg of Acetylcysteine kg/body weight were tolerated without any symptoms of poisoning.
Symptoms: Overdose may lead to gastrointestinal symptoms such as nausea, vomiting and diarrhea.
Treatment: There is no specific antidote for Acetylcysteine and treatment is symptomatic.

Acetylcysteine should be used with caution in asthmatic patients. It should also be used with caution in patients with history of peptic ulcer disease, both because drug-induced nausea and vomiting may increase the risk of gastrointestinal haemorrhage in patients predisposed to the condition, and because of the theoretical risk that mucolytics may disrupt the gastric mucosal barrier.

Pregnancy: There is limited clinical data relating to woman exposed to Acetylcysteine during pregnancy. Animal studies do not suggest any direct or indirect harmful effects on the pregnancy, embryo/fetal development, birth or post natal development. As a precautionary measure, it is preferable to avoid use of Acetylcysteine during pregnancy. Prior to use in pregnancy, the potential risks should be weighed against the potential benefits.
Lactation: There is no available information on the excretion in breast milk. A risk to the child cannot be excluded. The product should only be used during pregnancy and lactation after the benefits/risks have been weighed up carefully. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Acetylcysteine therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.

Hypersensitivity reactions have been reported in patients receiving acetylcysteine, including bronchospasm, angioedema, rashes and pruritus; hypotension, or occasionally hypertension may occur.
Other adverse effects reported with acetylcysteine include flushing, nausea and vomiting, fever, syncope, sweating, arthralgia, blurred vision, disturbances of liver functions, acidosis, convulsion, and cardiac or respiratory arrest.

Drug interaction studies have been performed in adults only.
Antitussive drugs and mucolytic agents like Acetylcysteine should not be concurrently administered because the reduction in cough reflex could lead to the accumulation of bronchial secretions.
Concurrent administration of Nitroglycerin and Acetylcysteine has been shown to cause significant hypotension and enhance temporal artery dilation. If concurrent nitroglycerin and acetylcysteine therapy is necessary, patients should not be monitored for hypotension, which can be severe and warned of the possibility headaches.

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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