Fluimucil/Fluimucil A

Acetylcysteine.

Acetylcysteine is the N-acetyl derivative of the naturally occurring amino acid L-cysteine.
N-Acetylcysteine (NAC) is L-α-acetamido-β-mercaptopropionic acid. Empirical Formula: C₅H₉NO₃S. Molecular Weight: 163.2. Appearance: White or faintly ivory crystals or crystalline powder, with light sulfur odour and slightly saline taste.

Mucolytic.
Pharmacology: Fluimucil/A has an intense fluidifying action, through its free sulfhydryl group, on mucoid or mucopurulent secretions by clearing the disulfide bonds in glycoprotein aggregates. Fluimucil/A makes it easy to cough the viscous secretion up. In this way, the respiratory airways in acute and chronic bronchitis, as well as bronchial asthma, quickly become free, and the patient can breathe more easily.
Mucokinetic Actions: Mucolytic: Breaks disulfide bridges of mucoprotein.
Emetic-Expectorant: Stimulates gastropulmonary vagal reflex.
Bronchorrheic: Stimulates mucosal secretion.
Mucoregulator: Biochemical normalizing effect on secretory cells.
Chelation: Disrupts ionic binding of calcium in mucoprotein.
Antioxidant: Prevents airway damage by scavenging effect.
Non-Mucokinetic Actions: In addition, Fluimucil/A can promote one of the body's own detoxification mechanisms, the glutathione system, and thus protect the lung tissue against harmful inhaled substances.
Antidote Acetaminophen Poisoning: Poisoning can be followed by hepatic necrosis that results from excess acetaminophen being converted into alkylating compounds that depletes glutathione or damage hepatic cell membranes. NAC is thought to serve as a precursor for glutathione synthesis but it may also form complexes with the toxic, reactive metabolites of acetaminophen, which bind to proteins and enzymes thus causing hepatic cell necrosis.
NAC has been employed to prevent the hemorrhagic cystitis that result from the administration of alkylating agents eg, isophosphamide and cyclophosphamide; this depends on the ability of NAC to scavenge free radicals that are liberated by the chemotherapy drugs.
Pharmacokinetics: Acetylcysteine is stable in stimulated gastric and intestinal fluid. It is rapidly absorbed after oral administration and distributed to body tissue, the lung. It is subsequently excreted by the tracheobronchial mucosa and it then has a mucolytic effect on the respiratory secretions.

Adjuvant treatment in certain clinical conditions characterized by the presence of thick and viscous mucoid or mucopurulent secretions eg, chronic bronchopulmonary disease (chronic obstructive pulmonary disease emphysema with bronchitis, chronic asthmatic bronchitis, bronchiectasis); acute bronchopulmonary disease (asthma with bronchial mucous plugging, bronchitis, bronchopneumonia, bronchiolitis, pulmonary complications associated with surgery).
Internal Medicine and Lung Diseases: All forms of bronchitis, emphysema, bronchiectasis, as well as preparatory steps for bronchography, bronchoscopy and spirometry.
Ear-Nose-Throat Diseases: Inflammations associated with excessive mucus production in the ENT region, especially sinusitis, pharyngitis, otitis media and obstructive complications after tracheostomy.
Diseases of Childhood: All forms of bronchitis, as well as cystic fibrosis.
Surgery: Prophylaxis and therapy of bronchopulmonary complications with excessive mucus production and obstruction.
Ampoule: Diseases of the respiratory tract associated with excessive mucus production (eg, bronchitis, etc), as well as in cases of otitis and sinusitis.

Oral Use: Dissolve the granules in about ½ glass of water, avoiding the addition of drugs to the solution and taking it before or after meals.
Adults: Acute Treatment: 1 sachet of 200 mg or 2 sachets of 100 mg 3 times daily for 5-10 days.
Chronic Treatment: 1 sachet of 200 mg 2-3 times or 1 effervescent tablet daily for a period of 6 months to obtain the maximum benefit eg, in the prevention of chronic bronchitis excubation. But substantial symptomatic improvement is usually already noticeable in 1-2 months.
Children: Acute Treatment: Up to 2 years: ½ sachet of 200 mg or 1 sachet of 100 mg; from 2-6 years: 1 sachet of 200 mg or 2 sachets of 100 mg 2 times daily for 5-10 days.
Mucoviscidosis: Up to 2 years: 50 mg 3 times daily; from 2-6 years: 100 mg 3 times daily.
Local Therapy: Unless otherwise prescribed:
Aerosol Therapy: Adults: 1 amp/session 1-2 times a day. Children: ½ amp 1-2 times a day.
Endobronchial Instillations: Adults: ½-1 amp 1-2 times a day. Children: ¼-½ amp 1-2 times a day.
Intranasal Installation: Adults: 3-5 drops/instillation.
Intra-Auricular and Intranasal Instillation: Children: 2-3 drops/instillation.
Intrasinusal Instillation: Adults: ½-1 amp/instillation.
For aerosol therapy, the use of devices with glass or plastic parts is preferred. If devices with metal or rubber parts are used, these should be rinsed out with water immediately after use.
Parenteral Therapy:
IM Therapy: Adults: 1 amp injected 1-2 times a day (deep IM).
Children: Pre-school: Aerosol therapy should be given preference.
School Age: In general, inject ½ amp 1-2 times daily.
Since a slight, transient burning sensation can occur with superficial injection in persons with increased sensitivity, it is recommended that patients be given deep IM injection while lying in a relaxed position.
IV Therapy: As Mucolytic:
Normal Therapy: Adults: 1 amp 1-2 times a day, slowly IV.
Children: ½ amp 1-2 times a day slowly IV.
Intensive Therapy: Adults: 2-3 amps 2-3 times a day slowly IV.
Children: 1-1 ½ amp 2-3 times a day slow IV.
The 1st dose should be diluted with an equal volume of a 0.9% NaCl solution or a 5% glucose solution. The following doses should be used as infusions:
As antidote:
In the treatment of acetaminophen, acrylonitrile, methacrylonitrile and methyl bromide poisoning, Fluimucil/A antidote is available in vials containing 25 mL of 20% injection solution.
Suggested Dose for Antidote Therapy: Within the first 15 min, 150 mg/kg, without dilution, by slow direct IV injection. After 15 min and up to 4 hrs, as in infusion, 50 mg/kg, with 500 mL of 5% glucose solution.
The duration of treatment depends on the clinical picture. It generally lasts 1-2 weeks. Since Fluimucil/A causes no toxic side effects, the recommended dose can be exceeded if necessary.

Hypersensitivity to acetylcysteine.

Each Fluimucil sachet of 100 mg contains the equivalent of 4.3 g of sucrose and each Fluimucil sachet of 200 mg contains the equivalent of 2.7 g of sucrose; this should be taken into account, eg in diabetic patients. The sulfur odour on opening the sachet does not indicate deterioration of the product; but it is due to the active ingredient.
Fluimucil/A can be administered concurrently with such antibiotics as amoxycillin, doxycillin, erythromycin and thiamphenicol. When other oral antibiotics or drugs are required, they should be administered 1-2 hrs apart from Fluimucil/A in order to avoid possible interaction with the thiol group.
Use in pregnancy: Observations in humans have thus far shown no indication of harm to the fetus during pregnancy. Experimental studies have revealed no signs of harm to the offspring. Nevertheless, as a general precaution for both mother and child, the use of any drug during pregnancy, especially in the 1st trimester should be considered only when strictly indicated.
Use in children: In newborns, acetylcysteine should be administered only in life-threatening situations, at a dose of 10 mg/kg of body weight and under strictest medical monitoring.

Use in pregnancy: Observations in humans have thus far shown no indication of harm to the fetus during pregnancy. Experimental studies have revealed no signs of harm to the offspring. Nevertheless, as a general precaution for both mother and child, the use of any drug during pregnancy, especially in the 1st trimester should be considered only when strictly indicated.

Unusual type of toxicity has been reported from the prescription experience of oral Fluimucil/A; slight gastrointestinal disturbance (nausea, dyspepsia, pyrosis) have occurred occasionally.

It must be noted that bronchospasm can result in aerosol therapy with acetylcysteine in patients with a hypersensitive bronchial system (eg, asthmatics). Therefore, the simultaneous use of a bronchodilator is recommended for aerosol therapy.
Rarely, acetylcysteine can induce rhinitis and stomatitis. In very rare instances, allergic reactions (itching, urticaria and exanthema) have also been reported.

Possible interaction with thiol group.
Fluimucil/A can be administered simultaneously, in the same solution, with antibiotics eg, amoxicillin, doxycycline, erythromycin or thiamphenicol, as well as cefuroxime.
Until further studies are available on the compatibility of Fluimucil/A and antibiotics administered simultaneously in the same solution, all other antibiotics should be given via different routes of administration.
In cases of IV administration, because of its immediate distribution in the blood, Fluimucil/A can be given immediately before or after all antibiotics.

The ampoule containing Fluimucil/Fluimucil A should be used immediately after opening. Open ampoules must be kept in the refrigerator and used within 24 hrs.
The slight odor of hydrogen sulfide which occurs when the ampoule is broken disappears rapidly and does not represent a deterioration in quality.
Fluimucil/A may be administered with common bronchodilators, vasoconstrictors, etc. When local mucolytic and antibiotic treatment is required, it is advisable to administer the 2 drugs separately, or preferably use Fluimucil/A and thiamphenicol.
The aerosol apparatus used should be made of glass or plastic material. When the apparatus has parts of metal or rubber, these have to be washed with water after use.
Oral Use: Dissolve the granules in about ½ glass of water, avoiding the addition of drugs to the solution and take it before or after meals.

The storage of the sachets needs no special conditions.

Cough & Cold Preparations

R05CB01 - acetylcysteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.

Granules, tab: NP, Inj: P₁S₁S₃