Ambrobene - Instruction, Use For Children, Syrup, Solution For Inhalation

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Ambrobene

Ambrobene: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Ambrobene

ATX code: R05CB06

Active ingredient: Ambroxol hydrochloride (Ambroxol hydrochloride)

Manufacturer: Ratiopharm GmbH, Merckle (Germany), Teva (Israel)

Description and photo update: 2019-13-08

Prices in pharmacies: from 102 rubles.

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Ambrobene is a mucolytic agent that has a secretolytic, secretomotor and expectorant effect.

Release form and composition

Ambrobene is produced in the following forms:

• Capsules;
• Pills;
• Injection;
• Solution for inhalation and oral administration;
• Syrup.

As part of all forms of the drug, the active ingredient is ambroxol hydrochloride.

Ambrobene capsules contain the following excipients:

• Methylhydroxypropylcellulose;
• MCC and sodium carboxymethylcellulose;
• Colloidal silicon precipitated;
• Triethyl citrate;
• Iron oxide (black, yellow, red);
• Gelatin;
• Titanium dioxide.

The capsules are available in blisters. One blister contains 10 pieces. The package contains 1 or 2 blisters.

Auxiliary components in Ambrobene tablets are highly dispersed silicon dioxide, corn starch, lactose and magnesium stearate. One carton contains 2 blisters of 10 tablets.

Ambrobene solution for injection contains as auxiliary substances:

• Disodium monohydrogen phosphate heptahydrate;
• Citric acid monohydrate;
• Water for injection;
• Sodium chloride.

Ambrobene solution for injection is available in 2 ml ampoules in a cell package. One package contains 5 pieces.

Ambrobene solution for inhalation and oral administration, in addition to the active ingredient, contains purified water, potassium sorbate and hydrochloric acid. It is sold in 40 ml or 100 ml dark glass dropper bottles. A measuring cup is included with them.

Ambrobene syrup contains liquid sorbitol, raspberry flavor, purified water, propylene glycol and saccharin. It is sold in 100 ml dark glass bottles. They also come with a measuring cup.

Pharmacological properties

Pharmacodynamics

Ambroxol belongs to the benzylamine group and is a metabolite of bromhexine. It differs from the latter in the presence of a hydroxyl group located in the para-trans position of the cyclohexyl ring and in the absence of a methyl group. The active component of Ambrobene is characterized by expectorant, secretolytic and secretomotor action.

Preclinical studies prove that ambroxol stimulates the serous cells of the glands located on the bronchial mucosa. By activating the cells of the ciliated epithelium and reducing the viscosity of sputum, it improves mucociliary transport.

Ambroxol provides a more intense formation of surfactant, directly acting on type 2 alveolar pneumocytes and Clara cells located in the small airways.

In vivo studies involving animals and experiments on cell cultures indicate that ambroxol activates the synthesis and secretion of surfactant, which demonstrates activity on the surface of the bronchi and alveoli in both the adult and the embryo. Also, preclinical studies have confirmed the antioxidant effect of Ambroxol. When Ambrobene is taken together with some antibiotics (doxycycline, amoxicillin, erythromycin and cefuroxime), their content in sputum and bronchial secretions increases.

Pharmacokinetics

When administered parenterally, ambroxol penetrates into the tissues quickly enough; when taken orally, it is completely absorbed from the gastrointestinal tract. The maximum concentration of this substance is found in the lungs and is reached within 1-3 hours after administration / ingestion. The substance binds to plasma proteins by about 80-90% (on average 85%). Plasma half-life is 7-12 hours. The total half-life of ambroxol and its metabolites is approximately 22 hours.

Less than 10% of ambroxol is excreted unchanged through the kidneys, 90% of the administered dose is excreted as metabolites in the same way. Since ambroxol is largely bound to plasma proteins, has a large volume of distribution and is slowly redistributed from tissues to blood, dialysis or forced diuresis does not significantly affect its excretion.

In patients with severe liver dysfunctions, ambroxol clearance is reduced by 20-40%. The substance penetrates the placental barrier and into the cerebrospinal fluid, and is also excreted in breast milk.

Indications for use

According to the instructions, Ambrobene is prescribed for the following diseases:

• Pneumonia;
• Chronic and acute bronchitis;
• Bronchiectasis;
• Chronic obstructive pulmonary disease, including bronchial asthma with difficult sputum discharge;

Ambrobene can also be used as part of complex therapy for respiratory distress syndrome in newborns and premature infants to stimulate surfactant synthesis.

Contraindications

• Hypersensitivity;
• Epileptic syndrome;
• Peptic ulcer of the stomach and duodenum;
• Breastfeeding period;
• First trimester of pregnancy.

Ambrobene is prescribed with caution when:

• Severe liver disease;
• Renal dysfunction;
• Large volumes of secreted secretions;
• Impaired bronchial motility.

Instructions for use Ambrobene: method and dosage

The method of using Ambrobene depends on the form of release:

• Capsules (1 capsule - 75 mg ambroxol hydrochloride). In this form, Ambrobene is indicated for children over 12 years of age and adults in a dose corresponding to 1 capsule per day;
• Tablets (1 tablet - 30 mg ambroxol hydrochloride). For adults, the dosage regimen is as follows: 1 tablet 3 times a day (the first 2-3 days), then the frequency of doses is reduced to 2 times a day, or a single dose is reduced to 1/2 tablet while maintaining 3 doses;
• Ambrobene solution for injection (1 ampoule - 15 mg of ambroxol hydrochloride). Adults with a frequency of 2-3 doses are usually prescribed 1 ampoule, however, in severe cases, an increase in a single dose is possible. The daily dose for children is calculated according to the following scheme: 1.2-1.6 mg of ambroxol chloride is multiplied by the child's weight in kg. Ambrobene's instructions indicate the following doses: 1/2 ampoule for children under 2 years old (2 times a day) and children from 2 to 5 years old (3 times a day), and children 5-12 years old are prescribed 1 ampoule, with a frequency of use 2-3 times a day. In the treatment of suffocation syndrome in newborns and premature infants, Ambrobene is prescribed in 3-4 doses, and the daily dose is calculated by multiplying 10 mg of ambroxol hydrochloride by the weight of the child in kg. In severe cases, with caution, the daily dose can be increased by 3 times;
• Ambrobene solution for inhalation and oral administration (1 ml contains 7.5 mg of ambroxol hydrochloride). The first 2-3 days for adults, the drug is prescribed 4 ml, while the frequency of receptions is 3 times, then the frequency is reduced to 2 times while maintaining a single dose, or the dose is reduced to 2 ml, but taken 3 times a day. Children under 2 years of age should be given a single dose of 1 ml 2 times a day; increasing the number of doses up to 3 times while maintaining a single dose is necessary for children 2-5 years old; 2-3 times a day, a single dose (2 ml) is prescribed for children 5-12 years old;
• Ambrobene syrup (5 ml - 15 mg of ambroxol hydrochloride). For ease of use, a measuring cup is attached to the preparation, one division on which corresponds to 1 ml of syrup. For adults, a single dose is 10 ml, which are taken in 3 doses for the first 2-3 days, with a subsequent decrease to 2 times. Also, after 2-3 days of treatment, it is possible to reduce the dose to 5 ml while maintaining a threefold dose. For children under 2 years old, the drug is prescribed in a volume of 2.5 ml 2 times a day, for children 2-5 years old, the same dose is prescribed 3 times a day, for children 5-12 years old, syrup should be given 5 ml 2 or 3 times a day.

After using Ambrobene inside, the drug begins to act in half an hour, the effect lasts for 6-12 hours.

Ambrobene is excreted in breast milk, penetrates the blood-brain and placental barriers.

Side effects

According to the instructions, Ambrobene can cause the following undesirable body reactions:

• Hives;
• Skin rash;
• Angioneurotic edema;
• Extremely rare - allergic contact dermatitis, anaphylactic shock;
• Diarrhea;
• Constipation;
• Dry mouth;
• Rhinorrhea;
• Headache.

Long-term use of Ambrobene can cause nausea, vomiting, gastralgia. Rapid administration of the drug can cause adynamia, a feeling of numbness, a decrease in blood pressure, intense headache, hyperthermia, shortness of breath and chills.

In case of overdose, diarrhea, vomiting, dyspepsia are possible, which are eliminated by gastric lavage or vomiting, and the intake of fat-containing foods can also help.

Overdose

With an overdose of Ambrobene, symptoms of intoxication are practically not manifested. In some cases, reported increased nervous excitement and diarrhea. When the drug is taken orally in a daily dose not exceeding 25 mg / kg, Ambroxol is well tolerated. When using Ambrobene in very high doses, a decrease in blood pressure, nausea, vomiting, and increased salivation are sometimes observed.

In case of extremely severe overdose, intensive care methods are used as treatment, including induction of vomiting. Gastric lavage is most effective only in the first 1-2 hours after taking the drug. Symptomatic therapy is also prescribed.

special instructions

It is not recommended to combine the remedy with antitussive drugs, which make it difficult to remove sputum.

In rare cases, the use of Ambrobene can cause severe skin reactions (Lyell's syndrome and Stevens-Johnson syndrome). If changes in the mucous membranes or skin are observed after taking the drug, stop taking the drug and immediately consult a doctor.

Influence on the ability to drive vehicles and complex mechanisms

The effect of ambroxol on the ability to drive vehicles and work with moving mechanisms has not been sufficiently studied at the moment.

Application during pregnancy and lactation

There is currently insufficient information regarding the use of ambroxol during the first 28 weeks of pregnancy to determine the safety and efficacy of treatment with the drug in this category of patients. Prescribing a drug in the II and III trimesters of pregnancy is possible only after consulting a specialist and determining the ratio of the potential benefits of therapy to the mother and the likely risks to the fetus.

The use of Ambrobene during lactation has not been sufficiently studied, therefore, only a doctor should prescribe it after a careful assessment of the ratio of the possible benefits of treatment for the mother and the potential risks for the infant.

Experimental studies carried out on animals do not indicate the presence of a teratogenic effect, but prove that ambroxol is excreted in breast milk.

Pediatric use

Ambrobene in the form of a solution for injection and tablets should not be used in children under 6 years of age. Capsules are contraindicated for use in children under 12 years of age.

Treatment of children under 2 years of age must be carried out exclusively under the supervision of a physician.

With impaired renal function

Ambrobene is recommended to be used with caution in case of renal dysfunction, increasing the interval between doses of the drug and decreasing the dose. Treatment should be carried out under the supervision of a specialist.

For violations of liver function

The drug should be used with caution in patients with severe liver dysfunctions, reducing the dose and increasing the time interval between Ambrobene doses. The course of treatment is carried out only under the supervision of a physician.

Drug interactions

When ambroxol is combined with antitussives, due to inhibition of the cough reflex, secretion stagnation may develop. For this reason, such combinations must be selected with care.

The combined reception of Ambrobene and antibiotics (doxycycline, amoxicillin, erythromycin and cefuroxime) leads to an increase in the concentration of the latter in bronchial secretions and sputum.

Analogs

The following drugs are Ambrobene analogs: Ambrolan; Bronchoxol; Ambrosan; Dephlegmin; Bronchorus; Remebrox; Halixol; Flavamed.

Terms and conditions of storage

Ambrobene must be stored in a dry, dark place, out of the reach of children, at a temperature not exceeding 25 ° C.

The shelf life of the drug is 4 years.

Terms of dispensing from pharmacies

Available without a prescription.

Reviews about Ambroben

Numerous reviews about Ambroben, regardless of its dosage form, are mostly positive. On specialized forums, rather high ratings of the drug are often found among patients who underwent a course of treatment with it: 4.5-4.8 in accordance with a five-point scale.

The main advantages of the remedy include a variety of dosage forms, which allows you to choose the appropriate one according to the individual characteristics of the patient, the effectiveness, the ability to use Ambrobene for children from the first months of life, fast response, pleasant taste for children, ease of use. However, occasionally there are negative and neutral reviews, where the lack of treatment results is mentioned.

Price for Ambroben in pharmacies

The approximate price for Ambroben in the form of tablets is 143-157 rubles (the package includes 20 pcs.). The syrup can be purchased for approximately 118-133 rubles (for a bottle of 100 ml). The solution for injection will cost about 156-197 rubles (for 5 ampoules), and the solution for inhalation and ingestion - about 119-131 rubles (for a bottle of 40 ml) or 176-190 rubles (for a bottle of 100 ml). The cost of Ambrobene capsules is approximately 188–207 rubles (the package includes 10 pieces) or 257–288 rubles (the package includes 20 pieces).

Ambrobene: prices in online pharmacies

Drug name Price Pharmacy

Ambrobene 15 mg / 5 ml syrup 100 ml 1 pc. 102 RUB Buy

Ambrobene solution for inhalation and inside 7.5mg / ml 40ml n1 RUB 104 Buy

Ambrobene 7.5 mg / ml solution for oral administration and inhalation 40 ml 1 pc. RUB 104 Buy

Ambrobene 7.5 mg / ml solution for injection 2 ml 5 pcs. 105 RUB Buy

Ambrobene Stopussin 4mg + 100mg / ml drops for oral administration 10 ml 1 pc. 118 RUB Buy

Ambrobene 7.5 mg / ml solution for oral administration and inhalation 100 ml 1 pc. 119 RUB Buy

Ambrobene tablets 30mg 20 pcs. 125 RUB Buy

Ambrobene 30 mg tablets 20 pcs. 125 RUB Buy

Ambrobene stoptussin cap. for oral administration 10 ml 126 RUB Buy

Ambrobene syrup 15mg / 5ml 100ml 127 RUB Buy

Ambrobene solution for inhalation and inside 7.5mg / ml 100ml n1 152 RUB Buy

Ambrobene solution for intravenous injection 7.5mg / ml 2ml 5 pcs. 187 r Buy

Ambrobene Stopussin 4mg + 100mg / ml drops for oral administration 25 ml 1 pc. 189 r Buy

Ambrobene stopussin cap. for oral administration 25 ml 203 RUB Buy

Ambrobene Stopussin 4mg + 100mg / ml drops for oral administration 50 ml 1 pc. 272 r Buy

Ambrobene 75 mg sustained-release capsules 20 pcs. 283 r Buy

Ambrobene stopussin drops for oral administration 4mg + 100mg / ml fl. with cap. 50ml 310 RUB Buy

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, 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!