Drug Study: Fluimucil

Generic name: acetylcysteine

Brand name: Fluimucil granules and tablet
Category: Mucolytic

Characteristics:
N-acetyl-L-cysteine (NAC), active ingredient of Fluimucil, exerts an intensive mucolytic-fluidifying 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 of the secretions.
Furthermore, NAC exerts a direct antioxidant action having a free thiol (-SH) nucleophilic group which is able to interact directly with the electrophilic groups of the oxidant radicals. Of particular interest is the recent demonstration that NAC protects alpha 1-antitrypsin, enzyme inhibiting elastase, from the inactivation due to the action of hypochlorous acid (HOCI), a powerful oxidant agent produced by the myeloperoxidase enzyme of activated phagocytes. These features make Acetylcysteine (Fluimucil) particularly suitable for the treatment of acute and chronic affections of the respiratory system, characterized by thick, viscous, and mucopurulent secretions. In addition, due to its molecular structure, NAC can easily corss the cellular membranes. Inside the cell, NAC is deacetylized to L-cysteine, an amino acid-indispensable for the glutathione synthesis (GSH)
GSH is highly reactive tripeptide found ubiquitously in the various tissue of animals and is essential for the maintenance of functional capacity as well as cellular morphological integrity, as it represents for the most important protective endocellular mechanism against oxidant radical, either of external or internal nature, as well as toward numerous cytotoxic substances. NAC plays a role of primary importance in the maintenance of adequate GSH levels contributing to the cellular protection from harmful agents which, through progressive GSH depletion, would be able to express their cytotoxic action, as in case of acetaminophen poisoning. Due to this mechanism of action, NAC is also indicated as a specified antidote in acetaminophen poisoning, in the course of a cyclophosphamide treatment and hemorrhagic cystitis, (in the latter case, it provides SH-groups necessary to inactive acrolein, a toxic metabolite that affects the urinary mucosa, whilst not interfering with chemotherapy).

Indications:
Treatment of respiratory affections characterized by thick and viscous hypersecretions: acute bronchitis, chronic bronchitis and its exacerbations; pulmonary emphysema, mucoviscidosis and bronchieactasis.

Contraindications:
Known hypersensitivity to acetylcesteine. As Acetylcysteine (Fluimucil) granules and tablets contain aspartame, it is contraindicated in patients suffering from phenylketonuria.

Dosage and Administration:
Adults:
1 sachet of Acetylcysteine (Fluimucil) 200 mg or 2 sachets of Acetylcysteine (Fluimucil) 100 mg, 2-3 times a day.
1 Acetylcysteine (Fluimucil) 600 mg effervescent tablet daily (preferably in the evening)
For the prevention of exacerbation, the use of Fluimucil 200 mg sachets is recommended.

Children:
Aged up to 2 years:
1 sachet of 200 mg daily or 2 sachets of 100 mg daily.
3-7 years: 1 sachet of 200 mg two mg two times daily or 2 sachets of 100 mg two times daily.
The duration of treatment should be 5 to 10 days in acute phase, whereas it may be continued in the chronic state for several months, according to the advise of physician.

Modality of Use:
Dissolve the tablets or the contents of sachets in a glass containing a small quantity of water, mixing it, if necessary, with a spoon. A palatable solution is thus obtained, which can be drunk directly from a glass or in the case of infants, be given with a teaspoon or in a feeding bottle.

Warning and Precautions:
Patients suffering from bronchial asthma must be strictly monitored during the therapy. Should bronchospasm occur, the treatment must be suspended immediately. It should be used with caution in asthmatic patients and patients with a history of peptic ulceration.
The possible presence of a sulfur-like odor does not indicate an alteration of the product but is a characteristic of the active ingredient contained in the preparation. It is prefered not to mix other drugs with the Acetylcysteine (Fluimucil) solution.

Use During pregnancy and Lactation:
Animal studies indicated no evidence of teratogenic effect of NAC. However, as for the majority of pharmaceutical preparations, its administration during pregnancy and lactation should be performed only when strictly necessary and under direct physician’s control.

Drug interaction:
No cases of drug interactions are described in literature for NAC by oral use.

Adverse effects:
Hypersensitivity reactions have been reported in patients receiving acetylcysteine, including bronchospasm, angioedema, rashes and pruritus. Other adverse effects reported with acetylcysteine include nausea and vomiting, fever, syncope, sweating, arthralgia, blurred vision, disturbances of liver function.

Caution: foods, drugs, devices and cosmetics act prohibits dispensing without prescription.

Overdosage:
When orally administered, no particular signs and symptoms even in subjects treated with high dose of NAC have been observed. When necessary, proceed with postural drainage and bronchoaspiration.

Storage: Acetylcyseine (FLuimucil) 100 mg sachets, 200 mg sachets and 600 mg effervescent tablets: store at temperature not exceeding 25 degrees Celsius.

Formulation and availability:
Granulate
Acetylcysteine (Fluimucil) is supplied as granules, in two strengths, each containing 100 mg and 200 mg of acetylcysteine per sachet.
Acetylcysteine (Fluimucil) 100 mg and 200 mg are supplied in boxes of 30 sachets.

Tablets
Acetylcysteine (Fluimucil) effervescent tablets, each containing 600 mg of acetylcysteine are supplied in boxes of 10 blister-packed tablets.

Do not use after the Expiry date keep out of the reach of children.

Manufactured by: Zambon Switzerland Ltd., 6814 Cadempino, Switzerland.


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