FLEMISTEN Acetylcysteine 600mg Powder for Oral Solution 10's
RXDRUG-DRP-5362-24
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Used for its mucolytic activity in respiratory disorders associated with productive cough and in the management of Paracetamol overdosage.
Dosage/Direction for Use
Empty the 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.
The solution should be freshly prepared and utilized within 1 hour.
Should be administered orally.
Mix with water or beverage.
Do not mix in very cold or hot liquid.
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.
The solution should be freshly prepared and utilized within 1 hour.
Should be administered orally.
Mix with water or beverage.
Do not mix in very cold or hot liquid.
Overdosage
An acute overdose of Acetylcysteine can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea.
Treatment of Overdose: Treatment of overdose is to be symptomatic and supportive treatment as indicated by the patient's clinical condition.
Treatment of Overdose: 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 rarely 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 other allergic symptoms appear; encephalopathy due to hepatic failure becomes evident. Pregnancy & lactation.
Use In Pregnancy & Lactation
Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Acetylcysteine 600 mg Powder for Oral Solution during pregnancy.
Breastfeeding: There is insufficient information on the excretion of Acetylcysteine in human milk. A risk to the newborns/infants cannot be excluded.
Breastfeeding: There is insufficient information on the excretion of Acetylcysteine in human milk. A risk to the newborns/infants cannot be excluded.
Adverse Reactions
Hypersensitivity reactions have been reported in patients receiving Acetylcysteine including bronchospasm, angioedema, rashes and pruritus; hypotension or occasionally hypertension, may occur.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacotherapeutic group: Mucolytics.
Pharmacology: Pharmacodynamics: N-acetyl-L-cysteine (NAC), the active ingredient in Acetylcysteine 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 600 mg 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-diacetylcysteine, 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. 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.
Pharmacology: Pharmacodynamics: N-acetyl-L-cysteine (NAC), the active ingredient in Acetylcysteine 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 600 mg 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-diacetylcysteine, 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. 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.
MedsGo Class
Cough & Cold Preparations / Antidotes & Detoxifying Agents
Features
Brand
FLEMISTEN
Full Details
Dosage Strength
600 mg
Drug Ingredients
- Acetylcysteine
Drug Packaging
Powder for Oral Solution 10's
Generic Name
Acetylcysteine
Dosage Form
Powder for Oral Solution
Registration Number
DRP-5362-24
Drug Classification
Prescription Drug (RX)
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