Mucolus

Each sachet of granules contains: Acetylcysteine, USP 600 mg (Apple, Orange, Lemon Flavor).
A homogeneous white granular powder with odor and taste of apple, orange or lemon.
Acetylcysteine is a precursor for the synthesis of glutathione. Its presence in the body promotes the synthesis of such important antioxidant in the liver. For this reason, acetylcysteine is regarded as a hepatoprotectant. Most of the beneficial effects of orally-administered acetylcysteine are said to be a result of its ability to either reduce extracellular cystine to cysteine or being a source of sulfhydryl (-SH) group metabolites.
As a source of SH groups, acetylcysteine can stimulate the synthesis of glutathione, enhance glutathione-S-transferase activity, promote detoxification and act directly on reactive oxygen species. It has also shown beneficial effects to individuals with conditions related to lowering of glutathione levels, including HIV infection, cancer, heart disease and cigarette smoking.

Pharmacology: Pharmacodynamics: The effect of this activity is a reduction in the viscosity of mucous secretions. Another possible effect is detoxification of free radicals by interaction with the active sulfhydryl group of acetylcysteine.
In addition acetylcysteine increases synthesis of glutathione. Due to this mechanism of action, acetylcysteine is also indicated as a specific antidote in paracetamol poisoning.
There are no studies on the efficacy and safety of once daily acetylcysteine 600 mg capsules in the adolescent population. However mild, moderate or severe adverse reactions have been reported with the use of IV acetylcysteine including the adolescent population.
Pharmacokinetics: Acetylcysteine is rapidly absorbed from the gastrointestinal tract and 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 peak concentration and bioavailability increasing with increasing doses.
Acetylcysteine may be present in plasma as the parent compound or as various oxidized 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.
In a study about 50% acetylcysteine was in a covalently protein-bound form 4 hours after a 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 first-pass metabolism in the liver. Renal clearance may account for about 30% of total body clearance. On intravenous dosage mean terminal half-lives have been calculated to be 1.95 and 5.58 hours for reduced and total acetylcysteine, respectively; the terminal half-life of total acetylcysteine was 6.25 hours after oral doses.
In other studies, it was observed that only three percent of radioactively-labeled acetylcysteine was excreted in the feces following oral administration which indicates almost complete absorption of acetylcysteine and its metabolites in the body.

For the treatment of respiratory tract disorders associated with excessive viscous mucous.
Acetylcysteine is a mucolytic that reduces the viscosity of secretions probably by the splitting of disulfide bonds in mucoproteins.
Acetylcysteine is also able to promote the detoxification of an intermediate paracetamol metabolite, and has a key role in the management of paracetamol overdosage.

Fill a cup with warm water. Pour the contents of one sachet into the cup. Stir until dissolved. Drink immediately for best results.
Drink one sachet once a day, preferably in the evening.
As a mucolytic, Acetylcysteine may be given by mouth as a single dosage of 600 mg a day for adults and children 8 years and above.
For acute paracetamol poisoning and other treatments, use as prescribed by the physician.

Symptoms after overdosage with acetylcysteine have been more severe. Hypotension appears to be especially prominent, additional symptoms have included respiratory depression, haemolysis, disseminated intravascular coagulation, and renal failure, but some of these may have been due to paracetamol poisoning.
It has been suggested that generalized reactions to acetylcysteine can be treated with intravenous injection of antihistamine infusion or acetylcysteine should be temporarily stopped but can usually be restarted at a slower rate without further reaction.

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 function, acidosis, convulsions, and cardiac or respiratory arrest. Haemoptysis, rhinorrhoea, and stomatitis have been associated with inhalation of acetylcysteine.

Acetylcysteine should be used with caution in asthmatic patients and those with a 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 a theoretical risk that mucolytics may disrupt the gastric mucosal barrier.
The total clearance of acetylcysteine in patients with cirrhosis was found to be markedly impaired, and the elimination half-life almost twice that of healthy controls, hence, an increased vigilance for untoward anaphylactoid reactions and other adverse effects for these patients.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.

Use in Pregnant Women: There are no data on the use of acetylcysteine in pregnant women. Animal studies do not indicate direct or indirect adverse effects on pregnancy, embryonic/fetal development, birth or postnatal development.
Use in Lactating Mothers: There is insufficient information on the excretion of acetylcysteine or its metabolites in human milk. Use during pregnancy and while breast-feeding should be subject to careful consideration of the risk/benefit balance.

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

Acetylcysteine is incompatible with some metals, including iron and copper, with rubber, and with oxygen and oxidizing substances. Some antimicrobials including amphotericin B, ampicillin sodium, erythromycin lactobionate, and some tetracyclines are either physically incompatible with, or may be inactivated on mixture with acetylcysteine.

Store at temperatures not exceeding 30°C.

Cough & Cold Preparations / Antidotes & Detoxifying Agents

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

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