Respix Spray oral solution 10 mg/0.2 ml, 13 ml — Made in Italy — Free Delivery

Pharmacological properties.

Pharmacodynamics.

Ambroxol, substituted with benzylamine, is a metabolite of bromhexine.

It differs from bromhexine in the absence of a methyl group and an additional hydroxyl group in the 4 (trans) -position of the cyclohexyl ring. Although the exact mechanism of action is not fully established, various studies have shown secretolytic and secretomotor effects.

After oral administration, the effect appears on average after 30 minutes and lasts 6-12 hours depending on the dose.

In preclinical studies, ambroxol increased the amount of serous bronchial secretion. It was found that ambroxol increases mucociliary transport by stimulating the mobility of the eyelashes of the bronchial epithelium and reducing the viscosity of mucus.

Ambroxol causes the activation of the surfactant system by direct action on the type II pulmocytes of the alveoli and the secretory cells of the bronchioles (the final section of the airways).

Ambroxol stimulates the formation and release of surface active substances in the alveolar and bronchial areas of the lungs of the fetus and adult patients.

Pharmacokinetics.

After oral administration, Ambroxol is almost completely absorbed, reaching a maximum plasma concentration after 1-3 hours. Bioavailability after oral administration is reduced by one third during the first phase of metabolism. The metabolites subject to renal secretion include the compounds of dibromantranilic and glucuronic acids.

Ambroxol easily binds to plasma proteins (80 - 90%). The half-life is from 7 to 12:00. The total plasma half-life of ambroxol and its metabolites is approximately 22 hours.

Ambroxol penetrates into the cerebrospinal fluid of the central nervous system, it passes the placental barrier and also penetrates into breast milk.

Approximately 90% of the dose of ambroxol is excreted by the kidneys as metabolites formed in the liver. Less than 10% of ambroxol is excreted unchanged.

Due to the high ability of binding to blood plasma proteins, a large volume of distribution and slow release from tissues with return to the blood, dialysis or forced diuresis do not affect the level of Ambroxol withdrawal.

Severe liver dysfunctions can reduce the metabolism of ambroxol by 20 - 40%. Severe renal impairment can lead to the accumulation of metabolites formed in the liver.

Clinical characteristics.

Indications.

Treatment of acute and chronic bronchopulmonary diseases, accompanied by a violation of the formation and excretion of mucus.

Contraindications

Hypersensitivity to the active substance or to any of the excipients in the Resix® spray.

Children under 12 years of age - due to the high content of the active substance in the solution.

Interaction with other medicinal products and other types of interactions.

Antitussives. the simultaneous use of Resix® spray with antitussives can lead to the accumulation of large amounts of bronchial secretions due to a decrease in the cough reflex. such preparation combinations should be used with caution.

Antibiotics The simultaneous use of ambroxol with certain antibiotics, such as amoxicillin, cefuroxime, erythromycin, doxycycline, leads to an increase in the concentration of antibiotics in bronchopulmonary secretions and in sputum.

Histamine. Ambroxol affects the metabolism of histamine, therefore, prolonged use of Respix® Spray should be avoided in patients with established hypersensitivity to histamine.

Ethanol. Respix® Spray contains a small amount of ethanol (ethyl alcohol) less than 100 mg per single dose.

Structure:

Active substance: solutio ambroxoli hydrochloridi;

1 ml ambroxol hydrochloride 50 mg

1 stream of solution (0.2 ml) contains ambroxol hydrochloride 10 mg

excipients: trometamol, macrogol hydroxystearate, glycerin, potassium acesulfame, xylitol, sodium benzoate (E 211), levomenthol, ammonium glycyrizate, ethanol 96%, sodium hydroxide, purified water.

Features of the application.

With ambroxol, there have been very rare reports of serious skin reactions like Stevens-Johnson and Lyell's syndromes. in case of changes in the skin or mucous membranes, you should immediately stop using Ambroxol and consult a doctor.

Patients with established bronchomotor suppression should avoid the use of mucolytic agents, unless they are under medical supervision, due to the risk of possible accumulation of large amounts of mucus.

In patients with moderate to severe impaired renal / hepatic function, a slowdown in the rate of excretion may lead to the accumulation of ambroxol and / or its metabolites produced in the liver. In such cases, Respix® Spray can only be taken with extreme caution, lengthening the intervals between doses or reducing the dose.

Application during pregnancy or lactation.

Ambroxol crosses the placental barrier. animal studies have not revealed a direct or indirect harmful effect on the course of pregnancy, embryo / fetal development, childbirth or the postnatal period. in the i trimester of pregnancy, its use is not recommended. in the ii and iii trimesters of pregnancy, the preparation can be used subject to a careful assessment of the possible benefits of treatment and the associated risk. Ambroxol passes into breast milk, so its use during breastfeeding is not recommended.

The ability to influence the reaction rate when driving or driving other mechanisms.

Respix spray sometimes in sensitive individuals may have a slight effect on the ability to drive vehicles and work with technical equipment. the preparation contains 96% ethanol, this should be taken into account by vehicle drivers.

Method of administration and dosage.

Dosage regimen in adults and children over 12 years of age

The standard dose is 3 sprays three times a day, which corresponds to 90 mg of Ambroxol hydrochloride per day. 1 spray spray is equivalent to 0.2 ml of solution and 10 mg of ambroxol hydrochloride.

Patients with renal and hepatic impairment

In case of moderate to severe renal / hepatic impairment, consult your doctor regarding dose adjustment of Respix® Spray.

Mode of application

Respix® Spray is intended for oral use.

Before using the spray for the first time, the pump should be pumped by pressing it three times. Remove the protective cap before each use.

From the vial, the recommended dose is obtained using a metering spray pump, which is added, the preparation directly enters the oral cavity, and then swallow.

Respix® Spray must be taken with food or after meals. The mucolytic activity of Respix® Spray is supported by the consumption of large amounts of liquid.

Duration of treatment

Without consulting a doctor, treatment should last no more than 4-5 days.

Children.

Applied to children over 12 years of age.

Overdose.

Overdose symptoms

There is no evidence of severe intoxication after an overdose with ambroxol. The reported manifestations are short-term agitation and diarrhea.

In general, daily oral doses up to 25 mg / kg / day are very well tolerated.

After a significant overdose, according to the results of preclinical studies, salivation, nausea, vomiting and a drop in blood pressure were observed.

Overdose treatment

In general, urgent measures such as induction of vomiting or gastric lavage are not indicated, they can only be used in very severe overdose. Thus, in all cases of suspected overdose, symptomatic and supportive therapy should be used.

Adverse reactions.

The incidence of side effects is given as follows: very common (≥ 1/10); often (≥ 1/100,

From the digestive tract: infrequently - heartburn, nausea, vomiting, stomach pain, decreased sensitivity in the oral cavity and pharynx, dry mouth and throat, dysgeusia.

Allergic reactions: infrequently - hypersensitivity reactions (rash, angioedema, shortness of breath, urticaria), fever, allergic contact dermatitis; rare - severe acute anaphylactic reactions, including shock, severe skin lesions such as Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis).

In sensitive patients, hypersensitivity reactions (including shortness of breath) may be caused by levomenthol.

Shelf life.

3 years. shelf life after first use - 1 month.

Storage conditions.

Keep out of the reach of children at a temperature not exceeding 25 ° C. do not refrigerate, do not freeze.