Composition and release form
The drug is available in several dosage forms:
- syrup for oral administration;
- solution for nebulizers;
- pills;
- capsules;
- solution for injection (in medical institutions).
The tablets contain the main active ingredient – ambroxol, 0.3 g, as well as auxiliary components:
- lactose (Lactose monohydrate);
- corn starch (Maidis amylum);
- magnesium stearate (Magnesium stearate);
- silica.
The tablets have a score in the center. They are convex on both sides and white. Packaged in blisters, each containing 10 pcs. One cardboard package can contain several blisters: from 2 pcs. up to 5 pcs.
Capsules are a form with an increased duration of action, they contain 0.75 g of ambroxol, in addition:
- triethyl citrate;
- hypromellose;
- silicon dioxide
The capsule itself consists of gelatin, dyes and titanium dioxide. The part covering the capsule is painted brown. Inside there are white or yellowish granules. Capsules are packaged in blisters, 10 pcs. in everyone. There can be 1 or 2 blisters in 1 cardboard package.
100 ml of syrup contains a dose equal to 1 tablet - 0.3 g of ambroxol. Raspberry flavoring gives the clear liquid a pleasant aroma and taste. The bottle is made of dark glass, which protects the contents from sunlight, and is equipped with a nozzle that makes dosing easier. The syrup is supplied with a plastic measuring cup with marks on the body.
100 ml of solution for inhalation contains 0.75 g of ambroxol. The liquid is colorless and odorless. Packaged in glass bottles with a drip nozzle, which facilitates dosing when preparing solutions in a nebulizer. The packaging includes a plastic measuring cup with marks and a scale on the walls.
2 ml of solution for injection includes 0.15 g of ambroxol. Sold in ampoules, each with a volume of 2 ml, made of dark glass. 1 cardboard package contains 5 ampoules in 1 pallet.
Ambrobene syrup
Release form
Syrup: a clear, colorless to slightly yellow solution with a raspberry odor.
Compound
Active ingredients : ambroxol hydrochloride (0.30 g/100 ml).
Excipients : liquid sorbitol 70%; propylene glycol; raspberry flavor; saccharin; purified water .
Pharmacological group
Mucolytic and expectorant drug. Secretolytics and stimulants of motor function of the respiratory tract.
Action
Mucolytic agent with expectorant action. Ambroxol increases the secretion of the glands of the respiratory tract, stimulates the activity of the villi of the respiratory tract, and enhances the formation of surfactant in the lungs. Ambroxol is a metabolite of bromhexine.
Ambroxol - description of the substance
The effect occurs 30 minutes after administration and lasts 6-12 hours.
Indications
Acute and chronic diseases of the respiratory tract, accompanied by impaired formation and discharge of sputum.
Contraindications and restrictions
- Hypersensitivity to ambroxol or one of the excipients;
- Pregnancy (first trimester);
- Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
Carefully:
- impaired bronchial motor function and increased sputum production (with immotile cilia syndrome);
- pregnancy (II–III trimester), lactation period;
- peptic ulcer of the stomach and duodenum during an exacerbation;
- impaired renal function or severe liver disease.
Application and dosage
Inside , after meals, using the included measuring cup.
Children: up to 2 years old - 1/2 measuring cup (2.5 ml syrup) 2 times a day (15 mg ambroxol per day); from 2 to 6 years - 1/2 measuring cup (2.5 ml syrup) 3 times a day (22.5 mg ambroxol per day); from 6 to 12 years - 1 measuring cup (5 ml of syrup) 2-3 times a day (30-45 mg of ambroxol per day).
Adults and children over 12 years of age: in the first 2-3 days of treatment - 2 measuring cups (10 ml of syrup) 3 times a day (90 mg of ambroxol per day). If therapy is ineffective, adults can increase the dose to 4 measuring cups (20 ml of syrup) 2 times a day (120 mg of ambroxol per day). In the following days, you should take 2 measuring cups (10 ml of syrup) 2 times a day (60 mg of ambroxol per day).
It is not recommended to take Ambrobene for more than 4-5 days without a doctor's prescription.
The mucolytic effect of the drug occurs when taking large amounts of fluid, so drinking plenty of fluids is recommended during treatment.
Side effect
Rarely (from ≥0.1% to <1%) - allergic reactions (urticaria, skin rash, angioedema of the face, shortness of breath, itching), fever, weakness, headache; very rarely (<0.01%) - anaphylactic reactions, incl. anaphylactic shock. Rarely - nausea, abdominal pain, vomiting, diarrhea, constipation, dry mucous membrane of the oral cavity and respiratory tract, exanthema, rhinorrhea, dysuria.
special instructions
It should not be combined with antitussive drugs that impede the removal of sputum.
Severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, have been observed extremely rarely when using Ambrobene. If there is a change in the skin or mucous membranes, you must immediately consult a doctor and stop taking the drug.
In children under 2 years of age, the drug can only be used as prescribed by a doctor.
Caloric content is 2.6 kcal/g sorbitol. Sorbitol may have a mild laxative effect. One measuring cup (5 ml of syrup) contains 2.1 g of sorbitol, which corresponds to 0.18 XE.
Storage
At a temperature not exceeding 25 °C. Keep out of the reach of children. Shelf life - 5 years, after opening - 1 year.
Production
- Teva Pharmaceutical Enterprises Ltd (Israel);
- Merkle GmbH (Germany).
Package
100 ml with a measuring cup (cup) in a cardboard pack or in a dark glass bottle.
Recipe
Available without a prescription.
Contraindications
Allergic reactions or intolerance to any component of the drug are grounds for refusing therapy and prescribing an alternative remedy.
Tablets are not prescribed to people with:
- lactase deficiency;
- hypolactasia;
- children under 6 years old.
Due to the fact that Ambrobene syrup has a sweet taste, it is not prescribed to patients with:
- fructose intolerance;
- malabsorption of glucose, galactose, sucrose, isomaltose.
Use of the drug Ambrobene
The drug is taken after meals; tablets, capsules are washed down with a sufficient amount of warm liquid (tea, broth). Tablets for adults and children over 12 years of age in the first 2-3 days are prescribed 1 tablet 3 times a day, then 1 tablet 2 times a day or 1/2 tablet 3 times a day. Children aged 6 to 12 years are usually prescribed 1/2 tablet 2-3 times a day. Retard capsules are prescribed to adults and children over 12 years of age, 1 capsule daily. The solution for oral administration and for inhalation is dosed using the supplied dosing cup. Adults are prescribed orally in the first 2-3 days, 4 ml 3 times a day, then 4 ml 2 times or 2 ml 3 times a day. Children under 2 years of age are prescribed 1 ml 2 times a day; from 2 to 5 years - 1 ml 3 times a day; from 5 to 12 years - 2 ml 2-3 times a day. When performing inhalations, the solution is inhaled using an inhaler. Adults and children over 5 years of age are prescribed 1–2 inhalations per day, 2–3 ml; children under 5 years of age - 1-2 inhalations per day, 2 ml. The syrup is prescribed to adults in the first 2-3 days, 10 ml 3 times a day; then 10 ml 2 times or 5 ml 3 times a day. Children under 2 years of age (except newborns and premature infants) are prescribed 2.5 ml 2 times a day; from 2 to 5 years - 2.5 ml 3 times a day; from 5 to 12 years - 5 ml 2-3 times a day. The duration of treatment with Ambrobene depends on the characteristics of the disease. The doctor decides whether to use the drug for longer than 4–5 days.
Carefully
Patients with congenital syndrome of slow-moving cilia of the respiratory tract epithelium should take the drug strictly under the supervision of medical personnel. This is explained by the significantly reduced activity of the receptors responsible for the cough reflex, which makes it impossible to timely remove rapidly produced mucus, leading to complications.
Tablets, capsules and syrup are not prescribed to patients with acute gastric or duodenal ulcers.
People with reduced kidney and liver function during treatment should be under the supervision of specialists who are ready to provide timely assistance if necessary.
Side effects
Forms of the drug intended for systemic treatment, involving oral administration, may lead to the following symptoms:
- allergic skin reactions such as itching, urticaria, swelling of tissues on the face;
- fever;
- headache;
- nausea;
- weakness;
- gastrointestinal disorders.
The inhalation solution rarely causes impaired taste perception, as well as abdominal pain and anaphylactic reactions.
Ambrobene 7.5 mg/ml 40 ml oral solution
Instructions for medical use of the drug Ambrobene Trade name Ambrobene® International nonproprietary name Ambroxol Dosage form Solution 7.5 mg/ml, 40 and 100 ml Composition 100 ml solution contains the active substance: ambroxol hydrochloride 0.7500 g, excipients: potassium sorbate, hydrochloric acid 25% (for pH correction), water for injection Description Transparent, colorless to slightly yellowish-brown solution. Pharmacotherapeutic group Expectorants. Mucolytics. ATC code R05CB06 Pharmacological action Pharmacokinetics After oral administration, Ambroxol is almost completely absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma of the drug occurs after 1-3 hours. Binding to blood plasma proteins is about 85%. The half-life is approximately 22 hours. Excretion occurs through the kidneys 90% in the form of metabolites and 10% in the form of unchanged ambroxol. Pharmacodynamics Ambrobene® normalizes altered bronchopulmonary secretion, improves the rheological parameters of sputum, reducing its viscosity, and facilitates the removal of sputum from the bronchi. Ambrobene® promotes the activation of the surfactant system through a direct effect on type 2 pneumocytes in the alveoli and Clara cells, stimulates the formation and excretion of surface active material (surfactant) in the alveolar and bronchial region of the embryonic and adult lungs. In addition, the antioxidant effects of ambroxol have been established. After using Ambrobene®, the concentration of antibiotics in sputum and bronchial secretions increases. Indications for use Ambrobene® is used for the purpose of secretolytic therapy for acute and chronic bronchopulmonary diseases in which the production and expectoration of sputum is impaired: - acute and chronic bronchitis, pneumonia - bronchial asthma with difficulty in sputum discharge - bronchiectasis. Method of administration and dosage Ambrobene® solution for oral administration and inhalation is dosed using the supplied dosage cup. ORALLY (taken after meals with a sufficient amount of warm liquid, for example, with tea or broth): Adults and children over 12 years of age: in the first 2-3 days, 4 ml 3 times a day, then 4 ml 2 times or 2 ml 3 times a day. Children from 6 to 12 years: 2 ml 2-3 times a day. Children from 2-5 years: 1 ml 3 times a day. Children under 2 years of age: 1 ml 2 times a day INHALATION: the solution is inhaled using an inhaler. Children under 2 years of age: 1 ml 1-2 inhalations per day. Adults and children over 5 years of age: 2-3 ml, 1-2 inhalations per day. The duration of treatment depends on the characteristics of the disease. It is not recommended to use Ambrobene® without medical prescription for more than 4-5 days. Side effects Rarely - dry mouth, gastralgia, nausea, vomiting - weakness, headache - hypersensitivity reactions (skin rash, facial swelling, dyspnea, itching) - fever Very rarely - allergic reactions, including anaphylactic shock. Contraindications - hypersensitivity to ambroxol and/or other components of the drug - first trimester of pregnancy - phenylketonuria - peptic ulcer of the stomach and duodenum Drug interactions With the simultaneous use of Ambrobene® and antitussive drugs, it may be difficult to remove phlegm from the bronchi due to a decrease in the cough reflex. Special instructions If the functional capacity of the kidneys is limited and/or with severe liver diseases, Ambrobene® should be used with extreme caution, reducing the dose used and increasing the time between doses of the drug. Pregnancy and lactation There is no reliable data on the negative effect of Ambrobene® on the fetus and infants; use of the drug in the second and third trimesters of pregnancy and lactation is possible only after a thorough analysis of the benefit/risk ratio by the attending physician. Peculiarities of influence on the ability to drive a vehicle or potentially dangerous mechanisms. Does not affect the ability to drive a vehicle or potentially dangerous mechanisms. Overdose Symptoms: agitation, diarrhea, increased salivation, vomiting and hypotension Treatment: symptomatic therapy. Release form and packaging 40 and 100 ml of the drug in dark glass bottles complete with a pipette and measuring cap, together with instructions for medical use in the state and Russian languages, are placed in a cardboard pack. Storage instructions Store at a temperature not exceeding 25˚C. Keep out of the reach of children! Shelf life: 5 years Do not use after expiration date! Conditions for dispensing from pharmacies Without a prescription, Germany Holder of the registration certificate "ratiopharm GmbH", Germany, Graf Arko str. 3, 89079 Ulm Address of the organization that accepts claims from consumers on the quality of products (products) in the Republic of Kazakhstan: ratiopharm Kazakhstan LLP, 050000, Almaty, Al-Farabi Ave., 13, BC Nurly-Tau, 1B, office 305 , telephone/68/73/75, Fax Email address
Taking multiple drugs at the same time
Antibacterial therapy, supplemented with Ambrobene, increases the concentration of antibacterial substances in secreted sputum.
The simultaneous use of Ambrobene with antitussives is strictly contraindicated. The liquid sputum produced should immediately leave the lungs and bronchi, thanks to the cough reflex. By suppressing a cough with means such as Sinekod, the patient dooms himself to the development of pneumonia associated with stagnation of mucus from the lungs, where a favorable environment is formed for the proliferation of pathogenic bacteria.
Pharmacological properties of the drug Ambrobene
Mucolytic drug. It has a bronchosecretolytic and secretomotor (expectorant) effect. Ambrobene normalizes impaired bronchopulmonary secretion, improves the rheological parameters of sputum, reduces its viscosity and facilitates discharge from the bronchi. After oral administration, Ambrobene is almost completely absorbed from the gastrointestinal tract. The action begins after 30 minutes and lasts for 6–12 hours. Metabolized in the liver. The half-life is 8–10 hours. About 90% of the drug is excreted in the urine.
