Contents Indications

N-acetylcysteine Capsule/Granule/Dry Syrup: : As a mucolytic therapy in acute, chronic bronchial and pulmonary disease associated with thick mucous secretions eg, acute bronchitis, chronic bronchitis and acute exacerbation, pulmonary emphysema, mucoviscidosis and bronchiectasis. Ampule: Treatment of respiratory infection characterized by thick and viscous hypersecretions. 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 2 times daily. Capsule should be taken after meals with amount of water. Duration of Therapy: 5-10 days. Granule: Adults: 1 sachet of Fluimucil granule 200 mg 2-3 times daily.Children: 1 sachet of Fluimucil Pediatric 100 mg 2-4 times daily. Duration of Therapy: 5-10 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. Duration of therapy: 5-10 days. Administration: Ampule: Aerosol: Nebulize 1 ampule 1-2 times daily for 5-10 days. Should be taken with food 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. Ampule: 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. Granule: Pregnancy and lactation. Pediatric Sachet: Since Fluimucil Pediatric contains saccharose; therefore, it should not be used in the case of hereditary fructose intolerance, glucose-galactose malabsorption syndrome and sucrose-isomaltase deficiency. Capsule/Granule/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. Granule/Dry Syrup: In patients with diabetes or receiving low-calorie diet, sugar content of Fluimucil should be considered. 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. Ampule: 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.

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Contraindications

Special Precautions

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. 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. Adverse Drug Reactions Capsule/Granule/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. Ampule: 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. Click to view ADR Monitoring Form 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. Ampule: 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. View more drug interactions with Fluimucil

Drug Interactions

Pregnancy Category (US FDA) Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies st in women in the 1 trimester (and there is no evidence of a risk in later trimesters). Storage Mechanism of Action Store at room temperature (25-30C). 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 1 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. 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. MIMS Class Indications Cough & Cold Preparations Acute & chronic resp tract infections w/ abundant mucus secretions due to acute bronchitis, chronic bronchitis & its exacerbations, pulmonary emphysema, mucoviscidosis & bronchiectasis. Effervescent tab/Oral soln Adult 600 mg daily (preferably in the evening) or 200 mg bidtid. Childn 100 mg bid-qid according to age. Dissolve the tab or content of sachet in a glass of water (75 mL). Inhalant Nebulize 1 amp once-bid for 5-10 days. IM inj 1 amp oncebid. Small childn adult dose.IV Adult 1 amp bid up to 2-3 amp bid-tid. Childn 1-1 amp bid-tid. It is recommended to dilute IV inj w/ 0.9% NaCl soln or a 5% glucose soln. Should be taken with food. Effervescent tab/Oral soln: Phenylketonurics. Asthmatic patients. Patients w/ history of peptic ulceration. Rarely, urticaria, bronchospasm, nausea, vomiting. Inhalant: Rhinitis, stomatitis. View ADR Monitoring Website

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Administration Contraindications Special Precautions Adverse Drug Reactions Pregnancy Category (US FDA)

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters). MIMS Class ATC Classification Cough & Cold Preparations R05CB01 - acetylcysteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough. V03AB23 - acetylcysteine ; Belongs to the class of antidotes. Used to neutralize paracetamol overdose.