FLUIMUCIL Acetylcysteine 100 mg / mL Solution for Inhalation 3mL 5's
RXDRUG-DR-XY25655
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Treatment of respiratory affections characterized by thick and viscous hypersecretions due to acute bronchitis, chronic bronchitis and its exacerbation, pulmonary emphysema, mucoviscidosis and bronchiectasis.
Dosage/Direction for Use
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 Acetylcysteine (Fluimucil) 200 mg sachet is recommended.
Children: 1 sachet of Acetylcysteine (Fluimucil) 100 mg, 2 to 4 times a day, according to age.
The duration of treatment should be 5 to 10 days in the acute phase. It may be continued in the chronic state for several months according to the advice of the physician.
Acetylcysteine (Fluimucil) is contraindicated in children below 2 years of age.
Modality of Use: Dissolve the tablets or granules in a glass containing a small quantity of water. Mix if necessary, with a spoon.
The solution can be drunk directly from the glass or in the case of children, it may be given with the use of a teaspoon or in a feeding bottle.
1 Acetylcysteine (Fluimucil) 600 mg effervescent tablet daily (preferably in the evening).
For the prevention of exacerbation, the use of Acetylcysteine (Fluimucil) 200 mg sachet is recommended.
Children: 1 sachet of Acetylcysteine (Fluimucil) 100 mg, 2 to 4 times a day, according to age.
The duration of treatment should be 5 to 10 days in the acute phase. It may be continued in the chronic state for several months according to the advice of the physician.
Acetylcysteine (Fluimucil) is contraindicated in children below 2 years of age.
Modality of Use: Dissolve the tablets or granules in a glass containing a small quantity of water. Mix if necessary, with a spoon.
The solution can be drunk directly from the glass or in the case of children, it may be given with the use of a teaspoon or in a feeding bottle.
Overdosage
Healthy volunteers received 11.2 g of acetylcysteine daily for three months without any serious undesirable effects. Oral doses of up to 500 mg of acetylcysteine/kg body weight were tolerated without any symptoms of poisoning.
Symptoms: Overdose may lead to gastrointestinal symptoms such as nausea, vomiting and diarrhea.
Treatment: There is no specific antidote for acetylcysteine and treatment is symptomatic.
Symptoms: Overdose may lead to gastrointestinal symptoms such as nausea, vomiting and diarrhea.
Treatment: There is no specific antidote for acetylcysteine and treatment is symptomatic.
Administration
Should be taken with food: Dissolve effervescent tab or granules in a glass of water. Mix if necessary. Drink directly from the glass, or in case of childn, it may be given w/ a tsp or in a feeding bottle.
Contraindications
Known hypersensitivity to acetylcysteine or to any of the excipients. Acetylcysteine (Fluimucil) granules and tablets are contraindicated in patients suffering from phenylketonuria due to the aspartame content.
Children below 2 years of age.
Children below 2 years of age.
Special Precautions
Mucolytic agents can induce respiratory obstruction in children under 2 years of age. Due to the physiological characteristics of the airways in this age group, the ability to expectorate may be limited. Therefore, mucolytic agent should not be used in children under 2 years of age. (See Contraindications.)
It should be used with caution in asthmatic patients and patients with a history of peptic ulceration especially in case of concomitant administration of other medicines with a known irritating effect on the gastric mucosa.
Patients suffering from bronchial asthma must be strictly monitored during the therapy. Should bronchospasm occurs, the treatment must be discontinued immediately and appropriate treatment must be initiated.
The administration of acetylcysteine, mainly at the start of treatment might fluidify bronchial secretion and increase their volume. If the patient is not able to effectively expectorate, postural drainage and bronchoaspiration should be performed.
Acetylcysteine may moderately affect histamine metabolism, therefore caution should be used when administering the product for long-term therapy in patients with histamine intolerance, since symptoms of intolerance can occur (headache, vasomotor rhinitis, itching).
The possible presence of sulfurous smell is not indicative of product alterations but is a characteristic of the active ingredient contained in this preparation.
It is preferred not to mix other drugs with Acetylcysteine (Fluimucil) solution.
Acetylcysteine (Fluimucil) Granules contain sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Acetylcysteine (Fluimucil) Effervescent Tablet contains 6.8 mmol (or 156.9 mg) sodium per tablet. This must be taken into consideration by patients on a controlled sodium diet.
Acetylcysteine (Fluimucil) Granules and Acetylcysteine (Fluimucil) Effervescent Tablet contain aspartame, a source of phenylalanine. May be harmful for people with phenylketonuria.
Effects on the Ability to Drive and Use Machines: Acetylcysteine has no known influence on the ability to drive and use machines.
It should be used with caution in asthmatic patients and patients with a history of peptic ulceration especially in case of concomitant administration of other medicines with a known irritating effect on the gastric mucosa.
Patients suffering from bronchial asthma must be strictly monitored during the therapy. Should bronchospasm occurs, the treatment must be discontinued immediately and appropriate treatment must be initiated.
The administration of acetylcysteine, mainly at the start of treatment might fluidify bronchial secretion and increase their volume. If the patient is not able to effectively expectorate, postural drainage and bronchoaspiration should be performed.
Acetylcysteine may moderately affect histamine metabolism, therefore caution should be used when administering the product for long-term therapy in patients with histamine intolerance, since symptoms of intolerance can occur (headache, vasomotor rhinitis, itching).
The possible presence of sulfurous smell is not indicative of product alterations but is a characteristic of the active ingredient contained in this preparation.
It is preferred not to mix other drugs with Acetylcysteine (Fluimucil) solution.
Acetylcysteine (Fluimucil) Granules contain sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Acetylcysteine (Fluimucil) Effervescent Tablet contains 6.8 mmol (or 156.9 mg) sodium per tablet. This must be taken into consideration by patients on a controlled sodium diet.
Acetylcysteine (Fluimucil) Granules and Acetylcysteine (Fluimucil) Effervescent Tablet contain aspartame, a source of phenylalanine. May be harmful for people with phenylketonuria.
Effects on the Ability to Drive and Use Machines: Acetylcysteine has no known influence on the ability to drive and use machines.
Use In Pregnancy & Lactation
Pregnancy: There is limited clinical data relating to women exposed to acetylcysteine during pregnancy. Animal studies do not suggest any direct or indirect harmful effects on the pregnancy, embryo/fetal development, birth or postnatal development.
As a precautionary measure, it is preferable to avoid use of Acetylcysteine (Fluimucil) during pregnancy. Prior to use in pregnancy, the potential risks should be weighed against the potential benefits.
Lactation: There is no available information on the excretion in breast milk. A risk to the child cannot be excluded. The product should only be used during pregnancy and lactation after the benefit/risks have been weighed up carefully. A decision must be made whether to discontinue breast feeding or to discontinue/abstain from Acetylcysteine (Fluimucil) therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the mother.
Fertility: No data are available on the effect of acetylcysteine on human fertility. Animal studies do not indicate harmful effects with respect to fertility for humans at the recommended doses.
As a precautionary measure, it is preferable to avoid use of Acetylcysteine (Fluimucil) during pregnancy. Prior to use in pregnancy, the potential risks should be weighed against the potential benefits.
Lactation: There is no available information on the excretion in breast milk. A risk to the child cannot be excluded. The product should only be used during pregnancy and lactation after the benefit/risks have been weighed up carefully. A decision must be made whether to discontinue breast feeding or to discontinue/abstain from Acetylcysteine (Fluimucil) therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the mother.
Fertility: No data are available on the effect of acetylcysteine on human fertility. Animal studies do not indicate harmful effects with respect to fertility for humans at the recommended doses.
Adverse Reactions
Summary of the safety profile: The most frequent adverse events associated with the oral administration of acetylcysteine are gastrointestinal in nature. Hypersensitivity reactions including anaphylactic shock, anaphylactic/anaphylactoid reaction, bronchospasm, angioedema, rash and pruritus have been reported less frequently.
Tabulated list of adverse reactions: In the table as follows, adverse reactions are listed by system organ class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions reported after use of N-acetylcysteine oral formulations are shown as follows: See table.
Description of selected adverse reactions: In very rare cases, the occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome has been reported in temporal connection with the administration of acetylcysteine. In most cases, at least one co-suspect drug, more probably involved in triggering the reported mucocutaneous syndrome could be identified.
Seek immediate medical advice if any new changes to the skin or mucous membrane occur. Acetylcysteine must be discontinued immediately.
A decrease in platelet aggregation in the presence of acetylcysteine has been confirmed by various investigations. The clinical significance has not yet been established.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Tabulated list of adverse reactions: In the table as follows, adverse reactions are listed by system organ class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions reported after use of N-acetylcysteine oral formulations are shown as follows: See table.
Description of selected adverse reactions: In very rare cases, the occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome has been reported in temporal connection with the administration of acetylcysteine. In most cases, at least one co-suspect drug, more probably involved in triggering the reported mucocutaneous syndrome could be identified.
Seek immediate medical advice if any new changes to the skin or mucous membrane occur. Acetylcysteine must be discontinued immediately.
A decrease in platelet aggregation in the presence of acetylcysteine has been confirmed by various investigations. The clinical significance has not yet been established.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Drug Interactions
Drug-Drug Interactions: Drug interaction studies have been performed in adults only.
Antitussive drugs and mucolytic agents like acetylcysteine should not be concurrently administered because the reduction in cough reflex could lead to accumulation of bronchial secretions.
Concurrent administration of nitroglycerin and Acetylcysteine has been shown to cause significant hypotension and enhance temporal artery dilation. If concurrent nitroglycerin and Acetylcysteine therapy is necessary, patients should be monitored for hypotension, which can be severe, and warned of the possibility of headaches.
Concurrent use of acetylcysteine and carbamazepine may result in subtherapeutic carbamazepine levels.
Dissolution of acetylcysteine formulations concomitantly with other drugs is not recommended.
Reports of an inactivation of antibiotics resulting from acetylcysteine so far only relate to in-vitro tests in which the relevant substances were mixed directly. Nevertheless, when other oral drugs or antibiotics are required, it is advisable to administer the drugs 2 hours apart from acetylcysteine. This does not relate to loracarbef.
Activated charcoal may reduce the effect of acetylcysteine.
Drug-Lab Modifications: Acetylcysteine may interfere with colorimetric assay method for salicylate measurement. Acetylcysteine may interfere with urine ketone test.
Antitussive drugs and mucolytic agents like acetylcysteine should not be concurrently administered because the reduction in cough reflex could lead to accumulation of bronchial secretions.
Concurrent administration of nitroglycerin and Acetylcysteine has been shown to cause significant hypotension and enhance temporal artery dilation. If concurrent nitroglycerin and Acetylcysteine therapy is necessary, patients should be monitored for hypotension, which can be severe, and warned of the possibility of headaches.
Concurrent use of acetylcysteine and carbamazepine may result in subtherapeutic carbamazepine levels.
Dissolution of acetylcysteine formulations concomitantly with other drugs is not recommended.
Reports of an inactivation of antibiotics resulting from acetylcysteine so far only relate to in-vitro tests in which the relevant substances were mixed directly. Nevertheless, when other oral drugs or antibiotics are required, it is advisable to administer the drugs 2 hours apart from acetylcysteine. This does not relate to loracarbef.
Activated charcoal may reduce the effect of acetylcysteine.
Drug-Lab Modifications: Acetylcysteine may interfere with colorimetric assay method for salicylate measurement. Acetylcysteine may interfere with urine ketone test.
Storage
Store at temperatures not exceeding 25°C.
Action
Pharmacology: Pharmacodynamics: Acetylcysteine, active ingredient of FLUIMUCIL, exerts an intensive mucolytic-fluidifying action on the 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 other secretions.
Furthermore, acetylcysteine exerts a direct antioxidant action, having 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 finding that acetylcysteine protects α1-antitrypsin enzyme inhibiting elastase from the inactivation by hypochlorous acid (HOCl), 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 mucous and mucopurulent secretions. In addition, due to its molecular structure, acetylcysteine can easily cross the cellular membranes. Inside the cell, acetylcysteine is deacetylated to L-cysteine, an amino acid indispensable for the glutathione synthesis (GSH).
GSH is a highly reactive tripeptide found ubiquitously in the various tissues of animal and is essential for the maintenance of functional capacity as well as cellular morphological integrity. It represents the most important protective endocellular mechanism against oxidant radicals, either of external or internal nature, as well as toward numerous cytotoxic substances.
Acetylcysteine 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 the case of paracetamol poisoning.
Due to this mechanism of action, acetylcysteine is also indicated as a specific antidote in paracetamol poisoning and in the course of treatment of cyclophosphamide-induced hemorrhagic cystitis, in the latter case, it provides the -SH groups necessary to inactivate acrolein, a toxic metabolite that affects the urinary mucosa, whilst not interfering with chemotherapy.
Pharmacokinetics: Absorption: In humans, acetylcysteine is completely-absorbed after oral administration. Because of the gut wall metabolism and first pass effect, the bioavailability of acetylcysteine taken orally is very low (approximately 10%). No differences were reported for the various pharmaceutical forms. In patients with various respiratory or cardiac diseases, the maximum plasma concentration is obtained between two and three hours after administration and the levels remained high over a period of 24 hours.
Distribution: Acetylcysteine is distributed both in the non-metabolized (20%) and the metabolized (active) (80%) form, and can mainly be found in the liver, kidneys, lungs, and bronchial secretions. The volume of distribution of acetylcysteine ranges from 0.33 to 0.47 L/kg. Protein binding is about 50% four hours after the dose and decreases to 20% at 12 hours.
Biotransformation: Acetylcysteine undergoes rapid and extensive metabolism in the gut wall and liver following oral administration. The resulting compound, cysteine, is considered to be an active metabolite. Following this stage of transformation, acetylcysteine and cysteine share the same metabolic route.
Elimination: Renal clearance may account for about 30% of the total body clearance. Following oral administration the terminal half-life of total acetylcysteine is 6.25 (4.59-10.6).
Furthermore, acetylcysteine exerts a direct antioxidant action, having 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 finding that acetylcysteine protects α1-antitrypsin enzyme inhibiting elastase from the inactivation by hypochlorous acid (HOCl), 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 mucous and mucopurulent secretions. In addition, due to its molecular structure, acetylcysteine can easily cross the cellular membranes. Inside the cell, acetylcysteine is deacetylated to L-cysteine, an amino acid indispensable for the glutathione synthesis (GSH).
GSH is a highly reactive tripeptide found ubiquitously in the various tissues of animal and is essential for the maintenance of functional capacity as well as cellular morphological integrity. It represents the most important protective endocellular mechanism against oxidant radicals, either of external or internal nature, as well as toward numerous cytotoxic substances.
Acetylcysteine 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 the case of paracetamol poisoning.
Due to this mechanism of action, acetylcysteine is also indicated as a specific antidote in paracetamol poisoning and in the course of treatment of cyclophosphamide-induced hemorrhagic cystitis, in the latter case, it provides the -SH groups necessary to inactivate acrolein, a toxic metabolite that affects the urinary mucosa, whilst not interfering with chemotherapy.
Pharmacokinetics: Absorption: In humans, acetylcysteine is completely-absorbed after oral administration. Because of the gut wall metabolism and first pass effect, the bioavailability of acetylcysteine taken orally is very low (approximately 10%). No differences were reported for the various pharmaceutical forms. In patients with various respiratory or cardiac diseases, the maximum plasma concentration is obtained between two and three hours after administration and the levels remained high over a period of 24 hours.
Distribution: Acetylcysteine is distributed both in the non-metabolized (20%) and the metabolized (active) (80%) form, and can mainly be found in the liver, kidneys, lungs, and bronchial secretions. The volume of distribution of acetylcysteine ranges from 0.33 to 0.47 L/kg. Protein binding is about 50% four hours after the dose and decreases to 20% at 12 hours.
Biotransformation: Acetylcysteine undergoes rapid and extensive metabolism in the gut wall and liver following oral administration. The resulting compound, cysteine, is considered to be an active metabolite. Following this stage of transformation, acetylcysteine and cysteine share the same metabolic route.
Elimination: Renal clearance may account for about 30% of the total body clearance. Following oral administration the terminal half-life of total acetylcysteine is 6.25 (4.59-10.6).
MedsGo Class
Cough & Cold Preparations
Features
Brand
FLUIMUCIL
Full Details
Dosage Strength
100 mg / mL
Drug Ingredients
- Acetylcysteine
Drug Packaging
Solution for Inhalation 3ml x 5's
Generic Name
Acetylcysteine
Dosage Form
Solution for Inhalation
Registration Number
DR-XY25655
Drug Classification
Prescription Drug (RX)
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