Flumil: Formula, Presentation, Indications, Action Mechanism, Dosage and Side Effects

It is used orally for the symptomatic treatment of some pulmonary pathologies that occur with excess mucus.

Flumil is a mucolytic drug, which reduces nasal mucus.

It is known as symptomatic because it does not cure the disease, it only helps relieve symptoms.

The mucus is typical of many diseases, from a cold to bronchitis or pulmonary fibrosis, acetylcysteine helps relieve symptoms in all of them.

Chemical formula

  • The active substance in flumil is acetylcysteine.
  • C5H9NO3S.
  • (R) -2-Acetamido-3-sulfanylpropanoic acid.

Presentation

  • Granules for adults in 200 mg oral solution.
  • Child granulate for oral solution 100 mg.
  • Effervescent tablets (Flumil Forte) 600 mg.
  • Oral solution 20 mg / ml.
  • Oral solution 40 mg / ml.
  • Syrup.
  • Blisters

Indications

Flumil is indicated in cases of bronchial hyperviscosity , as a coadjuvant treatment in respiratory processes that present excessive mucous secretions.

For the treatment of ions such as acute and chronic bronchitis, chronic obstructive pulmonary diseases, pulmonary emphysema, common cold, influenza, atelectasis caused by mucous obstructions, pulmonary complications due to cystic fibrosis and other related pathologies.

It is also used as an antidote in the case of an overdose of paracetamol.

Flumil is indicated when treating a genetic disorder in which the physiological secretions appear much thicker than normal, thus obstructing the respiratory tract, the pancreatic or sperm ducts.

Mechanism of action

This compound is an N-acetylated derivative of a natural amino acid, cysteine.

This reduces the viscosity of bronchial secretions, favoring their elimination, probably due to the existence of a free thiol group.

This group of thiols is capable of fragmenting the disulfide bonds that are responsible for maintaining the structure of mucoproteins, which produces a fluidification of secretions.

On the other hand, acetylcysteine ​​also acts on the respiratory mucosa, allowing expectoration or expulsion of mucus.

In turn protecting the mucous cells from the irritations that excessive mucus can produce, due to its cytoprotective effect.

Dose

The recommended administration is orally, in doses distributed during the day or in a single dose.

Granulated Flumil

  • In adults and children over 7 years : The usual recommended dose is 600 mg per day, orally, can be administered in a single daily dose of 600 mg or in 3 doses per day of 200 mg each and every 8 hours.
  • In children between 2 and 7 years: The usual recommended dose is 300 mg per day orally, in 3 doses of 100 mg each and every 8 hours.

In cases of pulmonary complications of cystic fibrosis, the usual dose recommended for these cases is as follows:

  • In adults and children over 7 years: From 200 to 400 mg every 8 hours.
  • In children from 2 to 7 years old: 200 mg every 8 hours.

Blisters

The ampoules can be administered parenterally, intravenously, intramuscularly, by inhalation, by intratracheal instillation.

Syrup

  • In adults: The recommended dose is 10 ml (200 mg) every 8 hours or 30 ml (600 mg) every 24 hours in a single dose, preferably in the morning.
  • In adolescents from 12 years of age: 10 ml (200 mg) every 8 hours.
  • In children from 6 to 11 years old: The dose is 5 ml (100 mg) every 8 hours.
  • In children younger than 6 years: Their safety and effectiveness have not yet been evaluated.

Side effects

Adverse effects of flumil administration are uncommon. However, when they are presented they are very mild and transient. Among these are:

Digestive: In some occasions nausea, vomiting, diarrhea and gastric hyperacidity may appear. This type of effects appears especially when high doses are used.

Hepatic: Some cases of transaminase increases have been reported after administration of high doses of acetylcysteine, which were reversed within a few days after stopping treatment.

Neurological and psychological: In some cases there has been headache and drowsiness.

Respiratory: These effects are usually exclusive of administration by inhalation. Bronchitis, hemoptysis , rhinorrhea, tracheitis and bronchial spasms may occur .

Eyepieces: Effects such as blurred vision occur.

Ear disorders: In the special case of the labyrinth, such as tinnitus.

Dermatological allergies: After administering flumil, side effects can occur after 30 to 60 minutes as hypersensitivity reactions to the component, which present generalized urticarias , moderate fevers, rash, pruritus , angioedema , dyspnea and hypotension .

These reactions occur more frequently and with a greater degree of severity in cases of parenteral administration, which can be fatal in some cases, whereas when administered orally or inhalationally, these effects are very rare.

In case of allergic reactions, the temporary suspension of the treatment and the administration of antihistamines H1 are recommended, and if necessary, the adrenaline application. If this allergic reaction happens again it should be stopped immediately and not be administered again in the patient.

General: Flumil can cause excessive sweating.

Warnings and contraindications

Sufficient fluid: It is advisable to drink plenty of fluids during treatment with flumil.

Alcohol and drugs: It should not be administered in conjunction with alcohol or drugs.

Children: Flumil is recommended for children from 2 years of age.

Pregnancy: The use of flumil during pregnancy is contraindicated, although no research has been done to show that this drug causes fetal damage.

Lactation: Its administration should be avoided during lactation.

Allergies: Acetylcysteine, which is the active ingredient in flumil, is a derivative of an amino acid called cysteine. For this reason, its use is contraindicated in case of allergies or hypersensitivity to compounds linked to cysteine. In the first manifestation of an allergic reaction to this drug must be removed.

Drowsiness: Flumil causes drowsiness, so you should avoid driving vehicles and operate machinery or equipment during your administration.

Severe hepatic insufficiency and liver cirrhosis: The metabolism of this medicine is hepatic and its elimination is renal.

Therefore, special care must be taken and the patient must be closely monitored in case of presenting pathologies in some of these organs, due to the risk of presenting adverse reactions and in that case it is necessary to adjust the dose or search for an alternative treatment.

Peptic ulcer: Flumil is contraindicated especially in cases of gastrointestinal ulcers. Acetylcysteine ​​can sometimes cause nausea and vomiting, especially at high doses, so there is an increased risk of gastric bleeding.

In addition, it has also been reported that acetylcysteine ​​produces an increase in the fluidity of gastric mucus, causing a decrease in the protective action of the mucous membranes. It is recommended to weigh the precautions in those patients who suffer from peptic ulcers.

Asthma: In patients with asthma problems, who suffer from severe respiratory insufficiency or in those cases of diseases that present bronchial spasms, an increase in fluidity in the secretions can cause a blockage of the respiratory tract if adequate expectoration does not occur.

Therefore, in these cases, extreme caution is recommended. In patients who receive acetylcysteine ​​by oral inhalation or intratracheal instillation, bronchospasm may occur.

In case this happens, it is recommended to include a broncho dilator in the liquid that is going to be used to make the nebulizations, and if the bronchospasm persists, the treatment should be stopped immediately.

When treatment is started, an increase in expectorations may occur, caused by increased fluidity in the secretions. This effect is reduced after a few days of treatment. If these symptoms continue or become worse after five days of treatment, it is advisable to reevaluate this clinical situation.

Interactions

It should not be co-administered with antitussive drugs, such as codeine and other cough medicines.

Neither with drugs inhibiting bronchial secretions such as anticholinergic or antihistamine H1, tricyclic antidepressants, antiparkinsonian, inhibitors of monoamine oxidase, neuroleptics.

They can antagonize the effects of acetylcysteine ​​and could cause the accumulation of a fluid mucus.

In addition, due to its hepatic metabolism can interact when high doses are administered with other drugs, in these cases should consult the doctor about possible drug interactions.

In the case of antibiotics, acetylcysteine ​​may be incompatible with amphotericin B, ampicillin sodium, cephalosporins, erythromycin lactobionate or some tetracyclines.

It is recommended to take the separate shots at least with an interval of two hours, among them.

When taken together with nitroglycerin, acetylcysteine ​​may potentiate the vasodilatory effects of nitroglycerin and cause adverse reactions at very high doses (100 mg / kg).

With the salts of metals, acetylcysteine ​​could have certain chelating effects of some metals such as gold, calcium or iron, so it could decrease its absorption.

It is advisable to separate the intake of mineral supplements and acetylcysteine ​​with at least two hours of difference between one and another.