Soluflem

Soluflem

acetylcysteine

Manufacturer:

Unicure

Distributor:

Labmate Pharma
Full Prescribing Info
Contents
Acetylcysteine.
Description
Each sachet contains Acetylcysteine 600 mg.
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.
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.
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.
Adverse Reactions
Hypersensitivity reactions have been reported in patients receiving acetylcysteine, including broncho-spasm, angioedema, rashes and pruritus, hypotension, or occasionally hypertension, may occur.
Drug Interactions
There are no known significant interactions.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Cough & Cold Preparations / Antidotes & Detoxifying Agents
ATC Classification
R05CB01 - acetylcysteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Presentation/Packing
Form
Soluflem powd for oral soln 600 mg
Packing/Price
10 × 1's
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