Ambroxol, loratadine

Pharmacological properties

Pulmolor has a pronounced expectorant effect, softens and soothes dry cough, facilitates breathing, normalizes the secretion of bronchial mucus, improves sputum discharge, and reduces inflammation of the respiratory tract. it has an antiexudative effect, reduces spasm of the smooth muscles of the bronchi and swelling of tissues, including the mucous membranes of the nose, throat, maxillary sinuses and respiratory tract, reduces capillary permeability, reduces nasal congestion, lacrimation, sneezing, itchy palate and nose, and eye hyperemia.

Ambroxol hydrochloride is a secretolytic and secretory agent. It has a pronounced expectorant and slight antitussive effect. It stimulates the serous cells of the glands of the bronchial mucosa, increases the amount of mucous secretion and thus normalizes the ratio of serous and mucous components. This helps to normalize the rheological parameters of sputum, reduce its viscosity and adhesive properties. Directly stimulates the mobile 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. As a mucolytic agent and as an exporant, Ambroxol improves the function of external respiration. The drug reduces the hyperreactivity of the muscles of the bronchi in AD. Ambroxol exhibits anti-inflammatory effect, antioxidant properties, stimulates local immunity and the renewal of the natural layer of surfactant. When taking Ambroxol, patient complaints of cough and sputum are significantly reduced according to the intensity of treatment. Ambroxol hydrochloride increases the concentration of antibiotics in the lungs and thus improves the course of respiratory diseases with bacterial infections of the lungs.

Loratadine - a selective peripheral H blocker₁long-acting histamine receptors. It does not have a central sedative effect. It has anti-allergic properties, weakens the spasm of the smooth muscles of the bronchi, reduces the sensitivity of the bronchi to histamine, eliminates the dry cough of allergic etiology, reduces the permeability of capillaries, reduces swelling of the tissues, rhinorrhea, lacrimation, sneezing, itchy palate and nose, redness of the eyes. It prevents the development and facilitates the course of allergic reactions. Its action is carried out by competitive blocking of N₁-histamine receptors on effector cells due to inhibition of calcium flow into cells, inhibition of histamine release (membrane-stabilizing function), inhibition of chemotaxis of eosinophils and their accumulation in the mucous membrane. The antihistamine effect of loratadine is manifested 1-3 hours after administration, reaches a maximum after 8-12 hours and lasts 24 hours. After 28 days of using loratadine, addiction is not observed.

Indications

Symptomatic therapy of acute and chronic respiratory diseases with spastic and allergic components associated with impaired bronchial secretion and weakened mucus progression. prescribed for acute and chronic bronchitis, hobl, pneumonia, in conditions that are accompanied by bronchial hyperreactivity.

In ENT practice, in order to dilute the secret and reduce edema, it is prescribed for rhinitis, including allergic, in the complex treatment of sinusitis and otitis.

Application

Tablets. used in adults and children over the age of 12 years, inside, 1 tablet 2 times a day.

Tablets should be taken after meals and washed down with water. The duration of treatment is up to 14 days.

Powder for suspension. Children aged 6-12 years: 2.5 ml.

2-3 times a day.

Adults and children over the age of 12 years: 5 ml 2 times a day.

Suspension preparation.To prepare the suspension, boiled chilled water is added to the bottle to the mark, then shaken. Take after meals. Shake well before each use.

The duration of treatment is up to 14 days. Consult a physician if after 14 days the symptoms do not disappear and / or intensify.

Contraindications

Hypersensitivity to any component of the drug.

Side effects

Usually the drug is well tolerated.

On the part of the skin: alopecia.

On the part of the immune system: hypersensitivity reactions, including rash, urticaria, pruritus, anaphylactic reactions (including anaphylactic shock), angioedema, shortness of breath (as a symptom of a hypersensitivity reaction), erythema; severe skin lesions: Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyells syndrome).

Since the tablets contain methylparaben and propylparaben, allergic reactions (possibly delayed) and bronchospasm are possible.

Due to the sodium content of metabisulfite in the powder for oral suspension, the development of hypersensitivity reactions and bronchospasm.

From the nervous system: dysgeusia (taste disorder), dizziness, cramps, headache, nervousness, fatigue, drowsiness, insomnia.

From the digestive tract: nausea, decreased sensitivity in the oral cavity, vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth and throat, constipation, salivation, gastritis.

From the respiratory system: rhinorrhea.

From the hepatobiliary system: impaired liver function.

From the cardiovascular system: tachycardia, palpitation.

From the urinary system: dysuria.

Common disorders: fever, reactions from the mucous membranes, increased appetite.

special instructions

Before conducting skin tests for reactivity, you should stop taking the drug for 48 hours.

The drug contains lactose, so patients with rare hereditary galactose intolerance, Lapp lactase deficiency or impaired absorption of glucose and galactose should not take this drug.

Only a few reports have been received of severe skin lesions: Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyells syndrome) associated with the use of expectorants, such as Ambroxol hydrochloride. For the most part, they could be explained by the severity of the underlying disease in patients and the simultaneous use of another drug. Also at the initial stage of Stevens-Johnson syndrome or Lyell syndrome, patients may have non-specific symptoms similar to signs of the onset of the flu, such as fever, aches, rhinitis, cough and sore throat. Erroneously, with such nonspecific symptoms similar to signs of the onset of influenza, symptomatic treatment with cough and cold preparations can be used. Therefore, when new lesions of the skin or mucous membranes appear, you should immediately seek medical help and stop treatment with Ambroxol hydrochloride.

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

Patients with impaired renal or hepatic function (eg, jaundice, hepatitis, hepatonecrosis) should take the drug only after consulting a doctor; the drug should be used with caution (namely, the interval between use should be increased or the dose reduced). In patients with severe renal failure, the accumulation of metabolites that form in the liver is expected.

5 ml of the finished suspension contain 0.75 g of sucrose, which should be taken into account in the total amount of sucrose consumed per day for patients with diabetes mellitus and subject to a diet low in sugar.

Use during pregnancy and lactation. Since the experience of using the drug in pregnant women is insufficient, it is not recommended to take it during pregnancy. Since the drug passes into breast milk, it is not recommended to use it during lactation.

Children. Tablets should not be prescribed to children under the age of 12 years.

Powder for the preparation of the suspension should not be prescribed to children under the age of 6 years.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. In general, the drug does not affect the reaction rate when driving vehicles or working with other mechanisms. The patient must be informed that drowsiness is very rare, which can affect the ability to drive vehicles or work with other mechanisms.

Interactions

The simultaneous administration of pulmolor with antibiotics has an advantage over the appointment of only an antibiotic. pulmolor increases the concentration of antibiotics in the lungs and, thus, improves the course of respiratory diseases in bacterial infections of the lungs.

The drug does not potentiate the effects of alcohol.

Do not take concomitantly with cough medications, which make it difficult to remove sputum.

Potential interaction is possible with all known CYP 3A4 or CYP 2D6 inhibitors, which leads to increased levels of loratadine, and this, in turn, can cause an increase in the incidence of adverse reactions.

In controlled studies, an increase in the concentration of loratadine in blood plasma after simultaneous use with ketoconazole, erythromycin and cimetidine was reported, which was not accompanied by clinically significant changes (including ECG).

Other drugs that suppress liver function should be prescribed with caution while using it.

Overdose

Drowsiness, tachycardia, headache, nausea, vomiting, diarrhea, decreased hell.

Treatment. In case of an overdose, symptomatic and supportive treatment is recommended. Conduct standard measures for the removal of a drug that is not absorbed in the stomach: gastric lavage, the use of crushed activated carbon with water.

Loratadine is not excreted by hemodialysis. It is also unknown whether it is excreted by peritoneal dialysis. After emergency care, the patient should remain under medical supervision.

Storage conditions

Suspension - in the original packaging at a temperature not exceeding 25 ° C. after preparation, the suspension is stored for 14 days at a temperature of 2–8 ° C.

Tablets - in the original packaging at a temperature not exceeding 25 ° C.

Keep out of the reach of children.