Fluimucil

N-acetylcysteine.

Granules: 600 mg: Each sachet contains Acetylcysteine 600 mg.

Pharmacology: Mechanism of Action: N-acetylcysteine (NAC) is a derivative of the naturally occurring amino acid, cysteine. N-acetylcysteine exerts an intensive mucolytic-fluidifying action on mucous and mucopurulent secretions through its free sulfhydryl group in the molecule by cleaving the intra- and intermolecular disulfide bonds in glycoprotein aggregates. Thus, by depolymerizing of the mucoprotein complexes and the nucleic acids which confer viscosity to the vitreous and purulent component of the sputum and of the secretions. Furthermore, it presents antiphlogistic effects and enhances mucous regeneration.
N-acetylcysteine exerts a direct antioxidant action, being provided with a free thiol (-SH) nucleophilic group which is able to interact directly with the electrophilic group of the oxidant radicals. Of particular interest is the recent demonstration that NAC protects α₁ antitrypsin, enzyme-inhibiting elastase from inactivation due to the action of hypochlorous acid (HOCl), a reactive oxidant agent produced by the myeloperoxidase enzyme of activated phagocytes. Through its molecular structure, NAC can easily cross the cellular membranes. Inside the cell, NAC is deacetylized to L-cysteine, an amino acid indispensable for the glutathione synthesis (GSH). GSH is a 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 the most important protective, endocellular mechanism against oxidant radical, either of external or internal nature, as well as toward numerous cytotoxic substances. N-acetylcysteine plays a role of primary importance in the maintenance of adequate GSH levels that contributes 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 specific antidote in acetaminophen poisoning. In the course of a cyclophosphamide treatment and hemorrhagic cystitis, it provides SH-groups necessary to inactivate acrolein, a toxic metabolite that is reported to be responsible for uropathy during the chemotherapy. Acetylcysteine can also protect the respiratory tract by opposing the harmful effect of the oxidant agents.
Granules: 600 mg: Fluimucil 600 mg granule contains active substance Acetylcysteine 600 mgwhich is able is to thin and dissolve thick phlegm stuck in the respiratory tract, making it easierto be expelled.
Pharmacokinetics: Capsule/Dry Syrup: N-acetylcysteine is rapidly absorbed after oral administration and distributed to the body tissues including the lung. It is well-tolerated by intestine.

Acute and chronic bronchial and pulmonary disease associated with thick mucous secretions eg, acute/chronic bronchitis and acute exacerbation, pulmonary emphysema, mucoviscidosis, bronchiectasis.
Granules: 600 mg: Fluimucil 600 mg granule is indicated for treatment of respiratory tract disease characterized by thick and viscous hypersecretion, such as: acute bronchitis, chronic & recurrent acute bronchitis, pulmonary emphysema, mucovisidosis (Cystic fibrosis), bronchiectasis (chronic dilatation of airway).
Fluimucil 600 mg granule is also used for antidotes therapy: Voluntary or accidental intoxication of paracetamol.

Capsule: Adults and children >14 years: 1 capsule 2-3 times daily; 6-14 years: 1 capsule 2 times daily.
Mucoviscidosis: Children 6 years: 1 capsule 3 times daily.
Effervescent tablet: 1 tablet daily.
Pediatric granules for oral solution: Children: 100 mg 2-4 times daily.
Granules for oral solution: Adults: 200 mg 2-3 times daily.
Respiratory tract infection: Children: 10-20 mg/kg daily.
600 mg: Unless prescribed differently, common dose of Fluimucil 600 mg granule is: For treatment of respiratory tract disease: 1 sachet 600 mg once daily (preferably in the evening).
For voluntary or accidentally paracetamol intoxication: Initial dose 140 mg/kg body weight orally should be taken immediately within 10 hrs after ingestions, to be followed by single dose of 70 mg/kg body weight to be taken 4 hourly for 1 to 3 days.
Dry syrup: Adults: 10 mL 2-3 times daily.
Children: 5 mL 2-4 times daily; >4 years: 300 mg/day; 2-4 years: 200 mg/day; <2 years: 100 mg/day.
Solution for inhalation: Nebulize 1 ampule 1-2 times daily.
Method of administration: Granules: 600 mg: Dissolve the contents of one sachet Fluimucil 600 mg granule in a glass containing a little water, then stir well. If needed, given in measure spoon to obtain a suitable solution for drinking.

Capsule: In the cases of accidental or non-accidental overdose, it may cause irritation eg, pyrosis, stomachache, nausea, vomiting and diarrhea. There are no serious side effects or toxic symptoms reported, even in patients treated with very high doses of NAC. However, it is advisable to consult the physician in any case of overdoses.
Granules: 600 mg: No cases of overdose have been reported with respect to oral administration of acetylcysteine.
Symptoms: Overdose can cause gastrointestinal symptoms such as nausea, vomiting and diarrhea.
Treatment: There are no specific antidotic treatments; overdose therapy is based on symptomatic treatment.
Solution for inhalation: No particular toxic signs and symptoms have been observed, even in patients treated with high doses of NAC by systemic route. Very high doses of NAC by topical administration could produce an excessive and massive liquefaction of the mucopurulent secretions, particularly in subjects with inadequate coughing reflex of expectoration, in whom it may be necessary to use mechanical methods of bronchial suction.

Hypersensitivity. Patients with diabetes or under low-calorie diet.
Granules: 600 mg: Fluimucil 600 mg granule is contraindicated in patients with hypersensitivity to active substances or any excepients & other chemical content of the drug, and is contraindicated for children & adolescents, and patients with phenylketonuria. Fluimucil 600 mg is contraindicated in pregnancy & nursing women.

Capsule/Granules/Dry syrup: Patients suffering from bronchial asthma should be monitored. Should bronchospasm occur, the treatment must be immediately suspended.
Capsule/Dry syrup: Fluimucil should be taken after meals in patients with a history of gastritis.
Granules/Dry syrup: In patients with diabetes or receiving low-calorie diet, sugar content of Fluimucil should be considered.
Granules: 600 mg: Patients with asthma should be closely monitored during treatment; Patients with bronchial asthma must be closely monitored during therapy, if bronchospasm occurs, the treatment must be stopped immediately. The use of the medicinal product in patients with peptic ulcer or with a history of peptic ulcer need particular attention, especially in the case of concomitant use of other drugs with a known gastric-damaging effect. The administration of acetylcysteine, especially at the beginning of the treatment, can thin the phlegm and at the same time increase their volume.
Acetylcysteine should be used with caution for long-term treatment in patients with histamine intolerance as the intolerance symptoms may occur (headache, sneezing, nasal congestion, itching).
Important information about some of the ingredients: Fluimucil 600 mg granule contains sorbitol, dextrose, and lactose. Therefore, patients with glucose or fructose intolerance is not recommended to take the drug. Fluimucil 600 mg granule contains phenylalanine source which may harrmful for patients with phenylketonuria.
The possible presence of a sulphurous odor does not indicate alteration of the product but it is related to the specific properties of acetylcysteine.
Dry syrup: The possible presence of sulfurous odor does not indicate an alteration of Fluimucil but is due to NAC contained in the preparation.
It is not recommended for patients with diabetes mellitus, however, it may be given if the blood glucose level is under control.
The administration of Fluimucil, especially at the beginning of treatment, may liquefy the bronchial secretions and simultaneously increase the volume.
Solution for inhalation: The administration of NAC, particularly by aerosol, can at the beginning of treatment, liquefy the bronchial secretions and simultaneously increase the volume. If the patient is unable to properly expectorate, it is necessary to clear the airways by postural drainage or eventually by bronchosuction to avoid retention of secretions. Patients suffering from bronchial asthma must be closely monitored as bronchospasm may occur during the treatment. In such event, the treatment must be immediately suspended.
N-acetylcysteine aerosol may worsen cough in patients suffering from acute bronchial asthma.
The presence of sulfurous odor upon opening of the ampule does not affect the quality of Fluimucil. N-acetylcysteine solution, stored opened ampules or transferred to the aerosol equipment may assume a pink color but it does not affect the efficacy and safety of Fluimucil.
Ability to operate the machinery: Granules: 600 mg: There are no evidence shown that the drug may affect the concentration while driving.
Use in pregnancy & lactation: In either animal or human, studies shown that the administration of NAC does not cause teratogenic effect or other side effects, however, the administration of Fluimucil during pregnancy and lactation should be done under the supervision of physicians.
In some cases, the physicians should evaluate the risk and benefit ratio.
Use in children: In pediatric patients <1 year and breastfed infants, Fluimucil should be given only in life-threatening cases and always under strict medical supervision. Fluimucil should not be given to children <6 years.
Granules: 600 mg: The safety and efficacy of the drug in children ≥2 years old & adolescents has not been established.

The use of Fluimucil granule during pregnancy and lactation is contraindicated.
In either animal or human, studies shown that the administration of NAC does not cause teratogenic effect or other side effects, however, the administration of Fluimucil during pregnancy and lactation should be done under the supervision of physicians.
In some cases, the physicians should evaluate the risk and benefit ratio.
Granules: 600mg: Pregnancy: There is a limited clinical data related to acetylcysteine use in pregnant women. It is advisable to avoid using of Fluimucil granule 600 mg during pregnancy. Ask the doctor or pharmacist for advice before taking the drug.
Lactation: It is not known whether acetylcysteine or its metabolites are found in breast milk. Ask the doctor's or pharmacist's advice before taking the drug.
Fertility: If the patients is planning to become pregnant, ask the doctor or pharmacist before taking the drug.

Capsule/Granules/Dry syrup: The rare possible adverse reactions related to the use of Fluimucil are pyrosis, nausea, vomiting and diarrhea. Stomatitis, dizziness and tinnitus has been reported in such limited cases.
Occasionally, allergic reactions eg, itching, urticaria, cutaneous eruption (exanthema, rash), bronchospasm, tachycardia and reduced blood pressure occur following NAC administration.
Occasionally, mild gastrointestinal disturbances.
Solution for inhalation: Use of Fluimucil by systemic route may occasionally be followed by hypersensitivity reactions eg, urticaria and rarely, bronchospasm. During administration by aerosol, nasopharyngeal and gastrointestinal irritation eg, rhinorrhea, stomatitis, nausea and vomiting may also be experienced.

Granules: 600 mg: Like all medicines, Fluimucil may cause side effects, although not everybody gets them.
The possible side effects: Uncommon side effects (affecting less than 1 in 100 people) such as allergic reactions (hypersensitivity); headache; a ringing sound in the ears (tinnitus); increased heart rate (tachycardia); vomiting; diarrhea; inflammation of mouth cavity (stomatitis); abdominal pain; nausea; urticaria, rash; swelling of facial, lips, mouth, tongue or throat which may cause swallowing or breathing difficulties (angioedema); itching; fever (pyrexia) and lowered blood pressure.
Rare (affecting less than 1 in 1,000 people) such as tighten the airway muscle (bronchospasm); breathing difficulties (dyspnea) and indigestion (dyspepsia).
Very rare (affecting 1 in 10,000 people) such as severe allergic reaction (anaphylactic shock, anaphylaxis/anaphylactoid reactions); bleeding (haemorrhage).
Unknown (the frequency of cases cannot be estimated from the available information): Facial swelling (edema).
In very rare cases, there has been the appearance of serious skin reactions (such as Stevens-Johnson syndrome or Lyell's syndrome). If the patient notice any mucocutaneous alterations, it is advisable to stop taking the drug and contact the doctors. Also, contact the doctor if any prolonged bleeding time.

Capsule: Concomitant use of Fluimucil capsule with antitussive may cause mucus stasis since they suppress the cough reflex. Therefore, these combinations should be used with caution.
The use of tetracycline HCl should be taken separately with interval of at least 2 hrs.
Concomitant use of Fluimucil capsule with glycerol trinitrate (nitroglycerin) may cause increased vasodilatation effect and blood flow.
Granules: 600 mg: Study of drug interaction is only performed in adult patients.
Antitussive drugs and acetylcysteine should not be concomitantly administered as the reduction of cough reflex may lead to mucus accumulation. Activated-charcoal may reduce the effect of acetylcysteine. The interaction between antibiotic and acetylcysteine may occur, so it is advisable to take at least 2 hourly interval between oral antibiotics and acetylcysteine consumption. Concomitant use of nitroglycerin and acetylcysteine may cause headache. If concomitant administration of nitroglycerin and acetylcysteine is deemed necessary, patient should be monitored.
Concomitant use of acetylcysteine and carbamazepine may reduce the effectiveness of carbamazepine.
Solution for inhalation: Fluimucil may be administered concurrently with common bronchodilators, vasoconstrictors, etc. When local treatment with NAC and antibiotic is necessary, it is advisable to administer the 2 drugs separately since incompatibility between NAC and certain antibiotic may exist.

Store at room temperature (25°-30°C).
Granules: 600 mg: Store at temperature below 30°C.

Cough & Cold Preparations

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

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