SOLUFLEM Acetylcysteine 600mg Powder for Oral Solution 10's
RXDRUG-DRP-5362-05
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.
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.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to acetylcysteine or any component of the formulation.
Warnings
Generalized urticaria has been observed rarely in patients receiving oral 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
Generalized urticaria (rare). Discontinue if allergic symptoms appear. Possibility of hepatic failure.
Adverse Reactions
Hypersensitivity reactions have been reported in patients receiving acetylcysteine, including broncho-spasm, angioedema, rashes and pruritus, hypotension, or occasionally hypertension, may occur.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: 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.
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
Soluflem
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-5362-05
Drug Classification
Prescription Drug (RX)
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