Orvis Broncho
Orvis Broncho: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. In case of impaired renal function
- 11. For violations of liver function
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Orvis Broncho
ATX code: R05CB06
Active ingredient: ambroxol (Ambroxol)
Manufacturer: Evalar, CJSC (Russia)
Description and photo update: 2019-08-07
Prices in pharmacies: from 157 rubles.
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Orvis Broncho Ambroxol Evalar is a mucolytic and expectorant drug.
Release form and composition
Dosage form - solution for oral administration and inhalation: from colorless to brownish, transparent, has a weak characteristic odor (in a cardboard box 1 glass bottle of 50 or 100 ml with or without a measuring cup included and instructions for use of Orvis Broncho).
Composition of 1 ml solution:
- active substance: ambroxol hydrochloride - 7.5 mg;
- auxiliary components: sodium hydrogen phosphate dihydrate - 4.35 mg; citric acid monohydrate - 2 mg; sodium chloride - 6.22 mg; benzalkonium chloride - 0.225 mg; purified water - 989.705 mg.
Pharmacological properties
Pharmacodynamics
The active substance of Orvis Broncho is ambroxol - an active N-demethylated metabolite of bromhexine. It has a secretomotor, secretolytic and expectorant effect. Thanks to its use, the work of the bronchial glands is stimulated, the motor activity of the ciliated epithelium increases, which is ensured by the effect on pneumocytes of the second type and Clara cells (in the alveoli and bronchioles, respectively). There is also an increase in the formation of endogenous surfactant - a surfactant that provides a slip in the airway lumen of bronchial secretions.
Ambroxol contributes to an increase in the proportion of the serous component in the bronchial secretion, this leads to an improvement in its structure, a decrease in viscosity and, as a consequence, to dilution of sputum. The combination of these effects is manifested by an improvement in mucociliary transport (mucociliary clearance). Due to the increased mucociliary clearance, there is an improvement in the excretion of sputum from the bronchial tree and relief of coughing.
When taking Orvis Broncho inside, the therapeutic effect develops on average after 30 minutes, the duration of the effect depends on the dose and ranges from 6 to 12 hours.
Pharmacokinetics
After oral administration, Ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract. With max (maximum concentration of the substance) in the blood plasma is achieved in 1-3 hours. The V d (volume of distribution) is 552 liters. Plasma protein binding in a therapeutic concentration range of 80 to 90%.
The highest concentrations of ambroxol are recorded in the lungs. The substance penetrates the blood-brain and placental barriers, is excreted in breast milk. About 30% of an oral dose of Ambroxol is exposed to the effect of primary passage through the liver.
According to studies carried out on human liver microsomes, the predominant isoform responsible for the metabolism of ambroxol to dibromantranilic acid is the isoenzyme CYP3A4. The rest of the substance is metabolized in the liver by conjugation with the formation of metabolites that do not have pharmacological activity.
Terminal T 1/2 (half-life) of a substance from blood plasma - 10 hours. The total T 1/2 of ambroxol and its metabolites is approximately 22 hours. Excretion is carried out by the kidneys: in the form of metabolites - 90% of the dose, unchanged - 10%.
No clinically significant effect of the patient's gender and age on the pharmacokinetic parameters of ambroxol was found, so there is no reason for dose adjustment.
Indications for use
Orvis Broncho is prescribed for the treatment of acute and chronic respiratory diseases with the release of viscous sputum:
- bronchial asthma with difficulty in sputum discharge;
- chronic obstructive pulmonary disease;
- bronchiectasis;
- acute and chronic bronchitis;
- pneumonia.
Contraindications
Absolute:
- I trimester of pregnancy and lactation;
- individual intolerance to the components of the drug.
Relative (Orvis Broncho is prescribed under medical supervision):
- severe liver failure;
- renal failure;
- exacerbation of gastric ulcer and duodenal ulcer;
- impaired bronchial motility and increased mucus secretion (in patients with immobile cilia syndrome);
- II – III trimester of pregnancy.
Orvis Broncho, instructions for use: method and dosage
1 ml of Orvis Broncho corresponds to 25 drops.
Oral intake
The solution should be taken after meals by adding it to water, tea, fruit juice or milk.
Recommended dosage regimen:
- adults and children from 12 years old: 3 times a day, 4 ml, after 2-3 days the frequency of administration is reduced to 2 times a day; maximum - 90 mg per day;
- children 6–12 years old: 2-3 times a day, 2 ml; maximum - 45 mg per day;
- children 2-6 years old: 3 times a day, 1 ml; the maximum is 22.5 mg per day;
- children under 2 years old: 2 times a day, 1 ml (under medical supervision); the maximum is 15 mg per day.
To enhance the mucolytic action of Orvis Broncho during the period of therapy, you need to consume a lot of liquid.
Inhalation
Recommended dosage regimen:
- adults and children from 6 years old: 1-2 inhalations of 2-3 ml of solution per day;
- children under 6 years of age: 1-2 inhalations of 2 ml of solution per day.
Orvis Broncho can be used using any modern inhalation equipment (except for steam inhalers).
In order to achieve optimal hydration during inhalation, Orvis Broncho must be mixed with 0.9% sodium chloride solution in a 1: 1 ratio.
Taking a deep breath during inhalation therapy can provoke a cough, so inhalations should be carried out in a normal breathing mode. It is recommended to warm the solution to body temperature before the procedure.
In case of bronchial asthma, patients should be inhaled after using bronchodilators, this will avoid nonspecific irritation of the respiratory tract and their spasm.
If after 4-5 days of therapy the symptoms of the disease persist, you should consult your doctor.
Side effects
Possible adverse reactions (> 10% - very often;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare; with an unknown frequency - it is not possible to set the frequency unwanted reactions):
- immune system: rarely - angioedema, urticaria, skin rash, hypersensitivity reactions, itching; in isolated cases - anaphylactic reactions (including anaphylactic shock);
- digestive system: often - nausea, decreased sensitivity in the pharynx or mouth; infrequently - abdominal pain, dyspepsia, diarrhea, vomiting; rarely - dryness of the mucous membrane of the pharynx and oral cavity; with an unknown frequency - constipation, heartburn;
- nervous system: often - dysgeusia;
- respiratory system: rarely - rhinorrhea, dryness of the mucous membrane of the respiratory tract;
- skin and subcutaneous tissues: very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome);
- others: with an unknown frequency - fever, weakness.
Overdose
In humans, the specific symptoms of ambroxol overdose have not been described.
The main symptoms: vomiting, nausea, diarrhea, abdominal pain, dyspepsia (correspond to the known side reactions of Ambroxol, which is used in the recommended doses).
Therapy: in the first 1–2 hours after taking Orvis Broncho, artificial vomiting, gastric lavage are effective, later, the intake of fat-containing products and symptomatic treatment are indicated.
special instructions
The combined use of Orvis Broncho with antitussives, in which there is difficulty in excreting sputum, is not recommended.
In order to maintain a secretolytic effect during the period of therapy with Orvis Broncho, it is necessary to ensure the intake of a sufficient amount of fluid into the body.
Ambroxol against the background of bronchial asthma can lead to increased coughing.
1 ml of Orvis Broncho contains 10 mg of sodium, which should be taken into account by patients following a hyponatric diet.
The preparation contains benzalkonium chloride as a preservative, which in sensitive patients with increased airway reactivity during inhalation can lead to bronchial spasm.
It is not recommended to mix Orvis Broncho with alkaline solutions and cromoglycic acid.
Patients with severe renal insufficiency (with creatinine clearance less than 30 ml / min) should take into account the likelihood of accumulation of ambroxol metabolites.
There is information about isolated cases of development of Stevens-Johnson syndrome and Lyell's syndrome during treatment with ambroxol. A causal relationship between these phenomena has not been confirmed. Most often, these disorders could be explained by the severity of the underlying disease and / or concomitant treatment.
Against the background of Stevens-Johnson syndrome or Lyell's syndrome in the early phase, it is possible to develop symptoms such as fever, rhinitis, pain in the body and throat, and cough. When carrying out symptomatic treatment, it is possible to erroneously prescribe drugs with mucolytic action, including ambroxol. With the development of these syndromes, it is recommended to stop using Orvis Broncho and immediately seek medical help.
Application during pregnancy and lactation
- I trimester of pregnancy and lactation: the use of Orvis Broncho is contraindicated;
- II – III trimesters of pregnancy: therapy can be carried out only after assessing the ratio of the expected benefits and possible risks.
With impaired renal function
Against the background of renal failure, therapy should be carried out with caution.
For violations of liver function
Orvis Broncho in severe liver failure should be used with caution.
Drug interactions
Possible interactions:
- drugs with antitussive action: it is difficult to discharge sputum, which is associated with the suppression of the cough reflex;
- amoxicillin, cefuroxime, doxycycline, erythromycin: the concentration of these drugs in the bronchial secretions increases.
Analogs
Orvis Broncho analogs are: Lazolvan, Ambrosan, AmbroGEXAL, Bronchoxol, Flavamed, Remebrox, Suprima-kof, Halixol, Ambroxol, Bronchorus, Ambrolor, Deflegmin, Ambrobene, etc.
Terms and conditions of storage
Store at temperatures up to 25 ° C. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Available without a prescription.
Reviews about Orvis Broncho
Reviews about Orvis Broncho are mostly positive. It is noted that against the background of therapy, sputum begins to pass away faster, which speeds up recovery. The cost is assessed as affordable.
The price of Orvis Broncho in pharmacies
The approximate price for Orvis Broncho Ambroxol Evalar (100 ml bottle) is 182 rubles.
Orvis Broncho: prices in online pharmacies
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Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!