NOPHLEGM Acetylcysteine 600mg Powder for Oral Solution 1's
RXDRUG-DRP-5362-21-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Used for its mucolytic activity in respiratory disorders associated with productive cough in the management of Paracetamol overdose.
Dosage/Direction for Use
200 mg: Acetylcysteine is used for its mucolytic activity in respiratory disorders associated with acute cough. It can be given by nebulisation of 3 to 5 mL of 20% solution or 6 to 10 mL of a 10% solution through a face mask or mouthpiece 3 or 4 times daily. Acetylcysteine has been given by mouth in doses of 200 mg two or three times daily as granules or effervescent dissolved in 30 mL of water. Children aged 1 month to 2 years may be given 100 mg twice daily, and those aged 2 to 7 years 200 mg twice daily.
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.
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
An acute overdose of Acetylcysteine can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea.
Treatment: Treatment of overdose is to be symptomatic and supportive treatment as indicated by the patient's clinical condition.
Treatment: Treatment of overdose is to be symptomatic and supportive treatment as indicated by the patient's clinical condition.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to Acetylcysteine or any component of the formulation.
Warnings
Generalized urticaria has been observed in patients receiving Acetylcysteine for acetaminophen overdose. If this occurs or other allergic symptoms appear, treatment with Acetylcysteine should be discontinued unless it is deemed essential and the allergic symptoms can be otherwise controlled.
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.
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
Discontinue if generalized urticaria or allergic symptoms, encephalopathy due to hepatic failure occurs.
Adverse Reactions
Hypersensitivity reactions have been reported in patients receiving Acetylcysteine, including bronchospasm, angioedema, rashes and pruritus; hypotension or occasionally hypertension may occur.
Storage
200 mg: Store at temperatures not exceeding 25°C.
600 mg: Store at temperatures not exceeding 30°C.
600 mg: Store at temperatures not exceeding 30°C.
Action
Pharmacotherapeutic Group: Mucolytics.
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.
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
Cough & Cold Preparations
Features
Brand
Nophlegm
Full Details
Dosage Strength
600 mg
Drug Ingredients
- Acetylcysteine
Drug Packaging
Powder for Oral Solution 1's
Generic Name
Acetylcysteine
Dosage Form
Powder for Oral Solution
Registration Number
DRP-5362-21
Drug Classification
Prescription Drug (RX)
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