Pulmobreathe powder for oral suspension 2g x 20 sachets — Made in India — Free Delivery

Name: Pulmobreathe powder for oral suspension 2g x 20 sachets — Made in India — Free Delivery
Brand: Sava Healthcare Limited
Price: 29.9635 USD
Availability: InStock

Brand: Sava Healthcare Limited
Product Code: Pulmobreathe
Availability: In Stock

$29.96

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Description

Pharmacological properties

Pharmacodynamics. Ambroxol hydrochloride is a mucolytic and expectorant agent that has a pronounced expectorant, anti-inflammatory, immunomodulatory, antioxidant and slight antitussive effect. stimulates serous cells of the glands of the bronchial mucosa, increases the amount of mucous secretion and thus changes the disturbed ratio of serous and mucous components. this leads to the normalization of rheological parameters of sputum, reducing its viscosity and adhesive properties. directly stimulates the motor activity of the ciliated epithelium of the bronchi, prevents its adhesion and improves mucociliary evacuation of sputum. Ambroxol increases the content of surfactant in the lungs, and also prevents its destruction in pneumocytes. Ambroxol does not cause bronchial obstruction, but, on the contrary, improves the function of external respiration. it has been proven that the preparation reduces the hyperreactivity of bronchial muscles in patients with asthma. Ambroxol has anti-inflammatory effect, antioxidant properties, stimulates local immunity and renewal of the natural surfactant layer. when taking ambroxol, patients' complaints of cough and phlegm are significantly reduced according to the intensity of treatment.

Acetylcysteine is a mucolytic and expectorant agent. Due to the free sulfhydryl group, it breaks the bisulfide bonds of mucopolysaccharides of sputum, which leads to a decrease in the viscosity of bronchial secretions. Increases mucociliary clearance. It has an antioxidant effect due to its ability to bind free radicals. Increases the synthesis of glutathione, which is an important factor in detoxification; due to this property, acetylcysteine is used to treat acute poisoning with paracetamol, phenols, aldehydes and other substances.

Pharmacokinetics

Ambroxol hydrochloride. The absorption of ambroxol hydrochloride from oral forms of non-prolonged action is fast and fairly complete, with a linear dose dependence in the therapeutic range. Peak plasma levels are reached after 1–2.5 h with oral administration of rapid-release dosage forms.

Distribution. When taken orally, the distribution of ambroxol hydrochloride from the blood to the tissues is rapid and pronounced, with the maximum concentration of the active substance in the lungs.

Metabolism and excretion. About 30% of the dose after oral administration is excreted by first pass metabolism. Ambroxol hydrochloride is metabolized mainly in the liver by glucuronidation and cleavage to dibromantranilic acid (about 10% of the dose). After 3 days of oral administration, about 6% of the dose is excreted in the urine unchanged, about 26% of the dose is in the conjugated form.

T½ from blood plasma is about 10 hours.

In patients with impaired liver function, the excretion of ambroxol hydrochloride is less, which results in 1.3–2 times higher plasma levels.

Age and gender do not have a clinically significant effect on the pharmacokinetics of ambroxol hydrochloride, so dose adjustment is not required.

Food intake does not affect the bioavailability of Ambroxol hydrochloride.

Acetylcysteine. After oral administration, acetylcysteine is rapidly and completely absorbed and metabolized in the liver to form cysteine, a pharmacologically active metabolite, as well as diacetylcysteine, cystine, and further mixed disulfides. Bioavailability is very low - about 10%. Cmax in blood plasma is achieved within 1-3 hours after administration. Plasma protein binding is about 50%. Acetylcysteine is excreted by the kidneys as inactive metabolites (inorganic sulfates, diacetylcysteine).

T½ is determined mainly by rapid biotransformation in the liver and is about 1 hour. In the case of a decrease in liver function, T½ is extended to 8 hours.

Indications

Treatment of acute and chronic diseases of the respiratory tract, accompanied by impaired bronchial secretion and evacuation of secretions: including in acute and chronic bronchitis, hobl, pneumonia, bronchiectasis, BA, cystic fibrosis, laryngitis, tracheitis.

With shock lung syndrome in adults, for the prevention and treatment of complications after surgery on the lungs, when caring for a tracheostomy, before and after bronchoscopy.

Application

Dissolve the contents of 1 sachet in ½ glass of water and drink.

Doses for adults and children over the age of 12 years: 1 sachet 3 times a day.

Do not exceed the recommended dose.

The duration of treatment should not exceed 5 days without consulting a doctor.

Contraindications

Hypersensitivity to ambroxol, acetylcysteine or other components that make up the preparation. peptic ulcer of the stomach and duodenum in the acute stage. hemoptysis, pulmonary hemorrhage.

Side effects

From the immune system: hypersensitivity reactions, including anaphylactic reactions or even shock, rash, urticaria, reactions from the mucous membranes, angioedema, fever, dyspnea, itching, etc.

Skin and subcutaneous tissue disorders: erythema, eczema, severe skin lesions - Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome).

From the digestive system: dry mouth, salivation, heartburn, nausea, vomiting, dyspepsia, stomatitis, abdominal pain, diarrhea, constipation, bad breath.

On the part of the respiratory system: rhinorrhea, dry airways, bronchospasm (mainly in patients with hyperresponsiveness of the bronchial system, which is associated with asthma).

From the urinary system: dysuria.

From the side of the organ of hearing: ringing in the ears.

From the nervous system: headache.

From the side of the cardiovascular system: tachycardia, arterial hypotension.

With the use of acetylcysteine, bleeding was very rarely reported, which was most often associated with the development of hypersensitivity reactions; cases of anemia, hemorrhages. There have been cases of a decrease in platelet aggregation, but there is no clinical confirmation of this.

When taking the preparation in the form of a powder for oral suspension, it is possible to develop a mild laxative effect due to the content of mannitol (E421).

Special instructions

Several severe skin reactions (Stevens-Johnson and Lyell syndromes) have been reported that coincided with the use of ambroxol hydrochloride or acetylcysteine. in most cases, they could be explained by the severity of the underlying disease in patients with / or the simultaneous use of another preparation. also in the early stages of Stevens-Johnson syndrome or Lyell's syndrome, patients may have nonspecific flu-like symptoms such as fever, aches, rhinitis, cough, and sore throat. erroneously, with such nonspecific symptoms, symptomatic treatment with preparations for cough and cold can be used. therefore, if new lesions of the skin or mucous membranes appear, you should immediately seek medical attention and stop taking Ambroxol hydrochloride.

Since ambroxol can increase mucus secretion, the preparation should be used with caution in case of impaired bronchial motility and increased mucus secretion (for example, in such a rare disease as primary ciliary dyskinesia).

The use of acetylcysteine causes dilution of bronchial secretions. If the patient is unable to effectively cough up sputum, postural drainage and bronchoaspiration are necessary.

Use the preparation with caution in patients with asthma, with a history of gastric and duodenal ulcers.

Use with caution in patients with impaired renal function, severe liver disease (namely, the interval between use should be increased or the dose reduced); in patients with severe renal impairment, the accumulation of metabolites that are formed in the liver is expected.

Pulmobreathe, a powder for oral suspension, contains aspartame, which is a source of phenylalanine, so the preparation should not be used in patients with phenylketonuria.

Use during pregnancy and lactation. The preparation is not recommended for use in the first trimester of pregnancy.

There are no relevant data on the teratogenic effect of ambroxol hydrochloride and acetylcysteine on the fetus, therefore, the preparation can be used in the II – III trimesters of pregnancy only when the expected benefit to the mother outweighs the potential risk to the fetus.

Since ambroxol hydrochloride and acetylcysteine pass into breast milk, it is undesirable to take the preparation during breastfeeding. If necessary, the appointment of the preparation should stop breastfeeding.

The ability to influence the reaction rate when driving or working with other mechanisms. There is no data on the effect on the reaction rate when driving vehicles or other mechanisms.

Children. For use in children over 12 years of age.

Interactions

There is a synergism of acetylcysteine with bronchodilators.

Acetylcysteine reduces the hepatotoxic effect of paracetamol; can donate cysteine and increase glutathione levels, which helps detoxify free oxygen radicals and certain toxic substances in the body.

The use of ambroxol increases the concentration of antibiotics amoxicillin, cefuroxime, erythromycin and doxycycline in sputum and bronchopulmonary secretions.

The simultaneous use of the preparation and cough suppressants can lead to excessive accumulation of mucus due to inhibition of the cough reflex. Therefore, such a combination is possible only after a thorough assessment by the doctor of the ratio of the expected benefit and the possible risk of use.

With simultaneous use with antibiotics such as tetracycline (with the exception of doxycycline), ampicillin, amphotericin B, cephalosporins, aminoglycosides, their interaction with the thiol group of acetylcysteine is possible, which leads to a decrease in the activity of both preparations. Therefore, the interval between the use of these preparations should be at least 2 hours. This does not apply to cefixime and loracarbef.

Activated carbon reduces the effectiveness of acetylcysteine.

The simultaneous intake of nitroglycerin and acetylcysteine can lead to an increase in the vasodilating effect of nitroglycerin.

Acetylcysteine affects the metabolism of histamine, therefore, long-term therapy should not be prescribed to patients with histamine intolerance, as this can lead to symptoms of intolerance (headache, vasomotor rhinitis, itching).

The use of acetylcysteine may alter colorimetric assays and urine ketones.

When the powder for oral suspension comes into contact with metals or rubber, sulfides with a characteristic odor are formed, therefore, glassware should be used to dissolve the preparation.

Overdose

There are no data on cases of overdose of oral dosage forms of acetylcysteine.

Ambroxol is well tolerated after parenteral administration at doses up to 15 mg / kg / day and after oral administration up to 25 mg / kg / day. In the case of an overdose with ambroxol, no severe signs of intoxication were noted. Cases of short-term anxiety and diarrhea, hypersalivation have been reported. Children are at risk of hypersecretion.

Similar to preclinical studies, excessive overdose can lead to hypersalivation, nausea, vomiting, and low blood pressure.

Treatment. Urgent measures such as inducing vomiting and gastric lavage are generally not indicated and should be used in cases of acute intoxication. Symptomatic treatment is recommended.

Storage conditions

Keep out of the reach of children in the original packaging at a temperature not exceeding 25 ° C.

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