Instructions Respiks spray oral solution 10 mg/0.2 ml bottle 13 ml
Composition
active ingredient: ambroxol;
1 ml of solution contains 50 mg of ambroxol hydrochloride;
1 jet of solution (0.2 ml of solution) contains 10 mg of ambroxol hydrochloride;
excipients: trometamol, macrogol hydroxystearate, glycerin, acesulfame potassium, xylitol, sodium benzoate (E 211), levomenthol, ammonium glycyrrhizate, ethanol 96%, sodium hydroxide, purified water.
Dosage form
Oral solution.
Main physicochemical properties: colorless or yellowish cloudy solution. With a faint odor of menthol.
Pharmacotherapeutic group
Mucolytics. ATX code R05C B06.
Pharmacological properties
Pharmacodynamics
Ambroxol, a substituted benzylamine, is a metabolite of bromhexine.
It differs from bromhexine in the absence of a methyl group and an additional hydroxyl group at 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 for 6–12 hours, depending on the dose used.
In preclinical studies, ambroxol increased the amount of serous bronchial secretion. It was found that ambroxol increases mucociliary transport by stimulating the ciliary motility of the bronchial epithelium and reducing mucus viscosity.
Ambroxol causes activation of the surfactant system by directly affecting the type II pulmonocytes of the alveoli and the secretory cells of the bronchioles (the final section of the respiratory tract).
Ambroxol stimulates the formation and secretion of surfactant in the alveolar and bronchial areas of the lungs of fetuses and adult patients.
The local anesthetic effect of ambroxol hydrochloride was observed in a rabbit eye model, which may be explained by its sodium channel blocking properties. In vitro studies have shown that ambroxol hydrochloride blocks neuronal sodium channels; binding was reversible and concentration-dependent.
According to the results of a clinical study, the use of Respiks® Spray showed a decrease in the intensity of sore throat in patients with uncomplicated respiratory diseases.
Pharmacokinetics
After oral administration, ambroxol is almost completely absorbed, reaching peak plasma concentrations after 1–3 hours. Absolute bioavailability after oral administration is reduced by one third during the first phase of metabolism. Metabolites subject to renal secretion include dibromantranilic and glucuronic acid compounds.
Ambroxol is highly bound to plasma proteins (80–90%). The plasma half-life is 7 to 12 hours. The total plasma half-life of ambroxol and its metabolites is approximately 22 hours.
Ambroxol penetrates the cerebrospinal fluid of the central nervous system. It crosses the placental barrier and also penetrates into breast milk.
Approximately 90% of the ambroxol dose is excreted by the kidneys in the form of metabolites formed in the liver. Less than 10% of ambroxol is excreted unchanged.
Due to the high ability to bind to serum proteins, the large volume of distribution and the slow release from tissues with return to the blood, dialysis or forced diuresis do not affect the level of ambroxol excretion.
Severe hepatic impairment may reduce the metabolism of ambroxol by 20–40%. Severe renal impairment may lead to accumulation of metabolites formed in the liver.
Indication
Treatment of acute and chronic bronchopulmonary diseases accompanied by impaired mucus formation and excretion.
Relief of severe sore throat in uncomplicated respiratory diseases in adults.
Contraindication
Hypersensitivity to the active substance or to any of the excipients in Respiks® 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. Concomitant use of Respiks® Spray with antitussives may lead to accumulation of large amounts of bronchial secretions due to decreased cough reflex. Such drug combinations should be used with caution.
Antibiotics. Simultaneous use of ambroxol with some antibiotics, such as amoxicillin, cefuroxime, erythromycin, doxycycline, leads to an increase in the concentration of antibiotics in bronchopulmonary secretions and sputum.
Histamine. Ambroxol affects the metabolism of histamine, therefore, long-term use of Respiks® Spray should be avoided in patients with established hypersensitivity to histamine.
Ethyl alcohol. Respic® Spray contains a small amount of ethanol (ethyl alcohol) less than 100 mg per single dose.
Application features
Patients with established bronchomotor depression should avoid the use of mucolytic agents unless under medical supervision due to the risk of possible accumulation of large amounts of mucus.
In patients with moderate to severe renal/hepatic impairment, a slower rate of excretion may lead to accumulation of ambroxol and/or its metabolites formed in the liver. In such cases, Respiks® Spray should be used only with extreme caution, by extending the intervals between administrations or reducing the dose.
Use during pregnancy or breastfeeding
Ambroxol crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonal/fetal development, parturition or the postnatal period. Its use is not recommended in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the drug can be used only after careful assessment of the potential benefit of treatment and the associated risk. Ambroxol is excreted in breast milk, therefore its use during breastfeeding is not recommended.
Ability to influence reaction speed when driving vehicles or other mechanisms
Respiks® Spray may sometimes have a slight effect on the ability to drive and use machinery in sensitive individuals. The drug contains 96% ethanol, which should be taken into account by drivers of vehicles.
Method of administration and doses
Treatment of acute and chronic bronchopulmonary diseases accompanied by impaired mucus formation and excretion
Dosage regimen for adults and children over 12 years of age
The standard dose is 3 sprays 3 times a day, which corresponds to 90 mg of ambroxol hydrochloride per day. 1 spray is equivalent to 0.2 ml of solution and contains 10 mg of ambroxol hydrochloride.
Relief of severe sore throat in uncomplicated respiratory diseases in adults
3 sprays 4 times a day, which is equal to 120 mg of ambroxol hydrochloride per day.
Patients over 60 years of age. The drug is not used to relieve severe sore throat in uncomplicated respiratory diseases in patients over 60 years of age due to the lack of clinical data.
Patients with renal and hepatic insufficiency. In cases of moderate to severe renal/hepatic impairment, a doctor should be consulted regarding dose adjustment of Respiks® Spray.
Method of application
Respiks® Spray is intended for oral use.
Before using the spray for the first time, prime the pump by pressing it three times. Remove the protective cap before each use.
The recommended dose is obtained from the bottle using the included spray pump. The medicine is sprayed directly into the mouth and then swallowed.
Respics® Spray should be taken with or after food. The mucolytic activity of Respics® Spray is supported by drinking plenty of fluids.
Duration of treatment
Without consulting a doctor, treatment should last no more than 4–5 days.
If used to relieve severe sore throat in uncomplicated respiratory diseases without consulting a doctor, use for no more than 3 days.
Children
For the treatment of acute and chronic bronchopulmonary diseases accompanied by impaired mucus formation and excretion, it is used in children over 12 years of age.
The drug is not used to relieve severe sore throat in uncomplicated respiratory diseases in children under 18 years of age due to the lack of clinical data.
Overdose
Symptoms of overdose
There are no reports of severe intoxication after 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.
Following significant overdose, salivation, nausea, vomiting and a drop in blood pressure were observed in preclinical studies.
Overdose treatment
In general, emergency measures such as induction of vomiting or gastric lavage are not indicated and should only be used in very severe overdose. Therefore, symptomatic and supportive treatment should be used in all cases of suspected overdose.
Side effects
The frequency of undesirable effects is given as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (< 1/10,000); unknown (cannot be estimated from the available data).
On the part of the digestive tract: infrequent - heartburn, nausea, vomiting, stomach pain, decreased sensitivity in the oral cavity and pharynx, dry mouth and throat, dysgeusia.
Allergic reactions: infrequent - hypersensitivity reactions (skin 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 and Lyell's syndrome (toxic epidermal necrolysis).
In sensitive patients, hypersensitivity reactions (including shortness of breath) may be caused by levomenthol.
3 years
The shelf life after first use is 1 month.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25º C. Do not refrigerate or freeze.
Packaging
13 ml of solution in a bottle with a dosing device; 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
ITC Farma SRL, Italy.
Location of the manufacturer and address of its business
Via Pontina KM 29 – 00071 Pomezia (RM), Italy.
