Each effervescent tablet contains the following inactive ingredients: Anhydrous citric acid, sodium hydrogen carbonate, aspartame, lemon flavor and purified water.
Pharmacology: Pharmacodynamics: The viscosity of pulmonary mucus secretions depends on the concentration of mucoprotein in the secretory fluid, the presence of disulfide bonds between the macromolecules and, to a lesser extent deoxyribonucleic acid (DNA). The mucolytic action of acetylcysteine is related to the sulfhydryl group in the molecule, which acts directly to split disulfide linkages between mucoprotein molecular complexes, resulting in depolymerization and a decrease in mucus viscosity. Its action is unaffected by the presence of DNA. The mucolytic activity of acetylcysteine increases with increasing pH. Significant mucolysis occurs between pH 7 and 9.
Acetylcysteine also reduces the extent of liver injury following acetaminophen overdosage. It is thought that acetylcysteine protects the liver by maintaining or restoring glutathione levels, or by acting as an alternate substrate for conjugation with and thus, detoxification of the reactive metabolite of acetaminophen.
Pharmacokinetics: Acetylcysteine is rapidly absorbed from the gastrointestinal tract and peak plasma concentrations (Cmax) occur about 0.5-1 hr after oral dosed of 200-600 mg. About 50% was in a covalently protein-bound from 4 hrs after a dose. Volume of distribution is 0.33-0.47 L/kg. The terminal half-life (t½) of reduced acetylcysteine is 6.25 hrs. Approximately 70% of total body clearance is nonrenal.
Mucolytic agent in the adjuvant treatment of patients with abnormal, viscid or inspissated mucous secretion in such conditions as acute and chronic bronchopulmonary disorders (eg, pneumonia, bronchitis, emphysema, tracheobronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis, primary amyloidosis of the lung). Antidote for acetaminophen overdosage.
Mucolytic Effects: Adults and Children >12 Years: Dissolve 1 tab in a ½ glass of water and drink after dinner daily.
Acetaminophen Overdosage: Initial Dose: 140 mg/kg and followed by oral maintenance dose of 70 mg/kg every 4 hrs for 17 doses.
The treatment of acetylcysteine toxicity is usually aimed at reversing anaphylactoid symptoms or controlling nausea and vomiting. The use of epinephrine, antihistamines and steroids may be beneficial.
Hypersensitivity or intolerance to acetylcysteine or to any of the excipients of Muclear.
Muclear should be used with caution in patients with phenylketonuria (a hereditary metabolic disease) because Muclear contains aspartame as a source of phenylalanine; asthmatic patients; history of peptic ulcer, both because drug-induced nausea and vomiting may increase the risk of gastrointestinal haemorrhage in patients predisposed to the condition and because of a theoretical risk that mucolytics may disrupt the gastric mucosal barrier.
Use in pregnancy & lactation: Muclear should not be used during pregnancy and lactation without medical advice.
Muclear should not be used during pregnancy and lactation without medical advice.
May occur stomatitis, nausea, vomiting, fever, rhinorrhea, drowsiness, clamminess, chest tightness, bronchoconstriction. Hypersensitivity reactions have been reported in patients receiving acetylcysteine, including bronchospasm, angioedema, rashes and pruritus, hypotension or occasionally hypertension may occur.
For use as an antidote for acetaminophen overdosage, may result in nausea, vomiting and other gastrointestinal symptoms. Rash (with or without mild fever), pruritus, angioedema, bronchospasm, tachycardia, hypotension and hypertension have occurred.
Adsorbed by activated charcoal, clinical significance is minimal though, once a pure acetaminophen ingestion requiring N-acetylcysteine is established, further charcoal dosing is unnecessary once the appropriate initial charcoal dose is achieved (5-10 g: g acetaminophen).
Store below 25°C in a dry place, away from direct sunlight.
Shelf-Life: 3 years.
R05CB01 - acetylcysteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Effervescent tab 600 mg (lemon flavor) x 10's.
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