NOPHLEGM Acetylcysteine 600mg Powder for Oral Solution 10's
Indications/Uses
Dosage/Direction for Use
Acetylcysteine is given by intravenous infusion or by mouth in the treatment of paracetamol poisoning. If given intravenously, 150 mg/kg of Acetylcysteine in 200 mL of glucose 5% is given initially over 15 minutes, followed by infusion of 50 mg/kg in 500 mL of glucose 5% over the next 4 hours and then 100 mg/kg in one liter of glucose 5% over the next 16 hours. Sodium chloride 0.9% maybe used where glucose 5% is unsuitable.
Burns, children with inhalation injury who were treated with aerosolised heparin 5000 units alternating with 3 mL of 20% Acetylcysteine solution, inhaled every 2 hours for the 1st 7 days after injury, appeared to have significantly reduced mortality and reintubation rates compared with historical control. Or as prescribed by the physician.
600 mg: Empty sachet in a glass of water, stir with spoon. If necessary and drink immediately.
Adult: 600 mg daily or 200 mg twice a day or three times a day.
Children: 100 mg twice a day or four times a day according to age or as prescribed by the physician.
Overdosage
Treatment: Treatment of overdose is to be symptomatic and supportive treatment as indicated by the patient's clinical condition.
Administration
Contraindications
Warnings
If encephalopathy due to hepatic failure becomes evident, Acetylcysteine treatment should be discontinued to avoid further administration of nitrogenous substances.
There are no data indicating that Acetylcysteine influences hepatic failure, but this remains a theoretical possibility.
Special Precautions
Adverse Reactions
Storage
600 mg: Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: N-acetyl-L-cysteine (NAC), the active ingredient in Acetylcysteine 200 mg and 600 mg powder for oral solution, exerts an intense mucolytic-fluidizing action on mucous and mucopurulent secretions by depolymerizing the mucoproteic complexes and the nucleic acids which confer viscosity to the vitreous and purulent component of the sputum and other secretions.
Furthermore, Acetylcysteine exerts a direct antioxidant action, having a free thiol (-SH) nucleophilic group that is able to interact directly with electrophilic groups of oxidant radicals. Of particular interest is the recent finding that Acetylcysteine protects α1-antitrypsin enzyme inhibiting elastase from inactivation by hypochlorous acid (HOCl), a powerful oxidant agent produced by the myeloperoxidase enzyme of activated phagocytes. Due to its molecular structure, Acetylcysteine can readily cross cell membranes. Inside the cell, NAC is deacetylated to L-cysteine, an amino acid essential for glutathione synthesis (GSH).
GSH is a highly reactive tripeptide found ubiquitously in the various tissues of animals and is essential for the maintenance of functional capacity as well as cellular morphological integrity. It is the most important protective intracellular mechanism against oxidant radicals, both exogenous and endogenous, as well as toward numerous cytotoxic substances. These features make Acetylcysteine 200 mg and 600mg Powder for Oral Solution particularly suitable for the treatment of acute and chronic infections of the respiratory system, characterized by thick, viscous mucous and mucopurulent secretions.
There is no evidence on the efficacy and safety of mucolytics including Acetylcysteine in acute bronchitis.
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. Acetylcysteine may be present in plasma as the parent compound or as various oxidised metabolites such as N-acetylcysteine, N,N-diacetylycysteine and cysteine either free or bound to plasma proteins by labile disulfide bonds or as fraction incorporated into protein peptide, peptide chains. In a study, about 50% was in a covalently protein-bound form 4 hours after oral dose. 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 the total body clearance.
MedsGo Class
Features
- Acetylcysteine