Ambrobene pills 30 mg №20

Active ingredient and dosage form

1 tab. contains Ambroxol hydrochloride 30 mg;
Excipients: lactose; corn starch, Magnesium stearate, silicon dioxide highly dispersed;
10 pieces. in a blister; in box 2 blisters

1 cap, - ambroxol hydrochloride 75 mg;
Excipients: MCC; MCC and sodium carboxymethyl cellulose; methyl hydroxypropyl cellulose; Eudragit RS 30D; triethyl citrate; precipitated colloidal silicon; gelatin; titanium dioxide; iron oxide (yellow, red, black);
10 pieces. in a blister, in a box of 1 or 2 blisters.

1 ml- ambroxol hydrochloride 7.5 mg;
Excipients: potassium sorbate, hydrochloric acid, purified water;
40 or 100 ml in dark-glass dropper bottles, complete with a measuring cup; in the box 1 set.

1 ampoule - Ambroxol hydrochloride 15 mg;
Excipients: citric acid monohydrate; sodium chloride; disodium monohydrogenphosphate heptahydrate; water for injections;
2 ml in an ampoule, in a blister pack of 5 pcs., In a box 1 pack.

5 ml contains ambroxol hydrochloride 15 mg;
Excipients: sorbitol liquid (not crystallized); propylene glycol; raspberry flavoring; saccharin; purified water;
100 ml in dark glass bottles complete with a measuring cup; in the box 1 set.

- tab - P No. 014731 / 01-2003 01/23/03
- caps. retard - P No. 014731 / 05-2003 01/23/03
- rr d / ingestion and ingal. - P No. 014731 / 02-2003 01/23/03
- syrup - P No. 014731 / 04-2003 01/23/03
- rr d / injection. - P No. 014731/03-2003. January 23, 2003

Mechanism of action

A mucolytic drug that has, along with a bronchosecretolytic drug, is also a secretomotor (expectorant) effect. Stimulates the formation of surfactant, normalizes the changed bronchopulmonary secretion, improves the rheological parameters of sputum, reduces its viscosity and adhesive properties, increases mucociliary transport, facilitating the excretion of sputum from the bronchi.

Suction
After oral administration, Ambroxol is almost completely absorbed from the gastrointestinal tract. C_max is achieved approximately 2 hours after ingestion of all oral dosage forms, with the exception of retard capsules (for them, this figure averages 9 hours).
Metabolism
Ambroxol is extensively metabolized in the liver.
Removal
T_1/2 is 9-10 hours. Ambroxol is mainly excreted (about 90%) in the urine.

Indications and usage

 
- acute and chronic bronchitis, pneumonia;
- bronchial asthma with the difficulty of sputum discharge;
- bronchiectasis;
- to stimulate the synthesis of surfactant in respiratory distress syndrome in premature babies and newborns (as part of complex therapy).

Contraindications

 
- gastric ulcer and duodenal ulcer;
- I trimester of pregnancy;
- Hypersensitivity to the drug.

Dosage and administration

For adults in the first 2-3 days appoint 1 tab. 3 times / day, then 1 tab. 2 times or 1/2 tab. 3 times / day Children aged 5 to 12 years appoint 1/2 tab. 2-3 times / day. Capsules retard prescribe adults and children over 12 years old 1 pc. daily.
Solution for oral administration and inhalation dispensed using the supplied measuring cup. Inside for adults designate in the first 2-3 days 4 ml 3 times / day, then 4 ml 2 times or 2 ml 3 times / day. Children under 2 years old appoint 1 ml 2 times / day; from 2 to 5 years - 1 ml 3 times / day; from 5 to 12 years - 2 ml 2-3 times / day. When conducting inhalation Ambrobene solution is inhaled with an inhaler. Adults and children over 5 years appoint 1-2 inhalations per day, 2-3 ml; children under 5 years old - 1-2 inhalations per day, 2 ml.
Syrup prescribe for adults in the first 2-3 days, 10 ml 3 times / day; then 10 ml 2 times or 5 ml 3 times / day. Children under 2 years old appoint 2.5 ml 2 times / day; from 2 to 5 years - 2.5 ml 3 times / day; from 5 to 12 years - 5 ml 2-3 times / day.
Tablets, capsules retard, Ambrobene solution and syrup taken orally after eating, drinking plenty of warm liquid (tea, broth).
Injection enter in / m, p / k or / in (slowly jet or drip). The solvent used is 0.9% sodium chloride solution, 5% glucose solution, levulose, Ringer-Locke solution or other basic solution with a pH not higher than 6.3. For adults appoint 2 ml (in severe cases - 4 ml) 2-3 times a day. For children the drug is prescribed in a daily dose at the rate of 1.2-1.6 mg per 1 kg of body weight. Usually children under 2 years old enter 1 ml 2 times; from 2 to 5 years - 1 ml 3 times; older than 5 years - 2 ml 2-3 times / day.
At Respiratory Distress Syndrome in Premature Babies and Newborns Ambrobene increases the daily dose to 10 mg / kg (in severe cases, to 30 mg / kg), spreading over 3-4 injections.

Adverse reactions

Seldom: weakness, headache, gastralgia, nausea, vomiting, diarrhea, rash.
In some cases: with rapid on / in the introduction of the drug - severe headache, severe weakness, weakness.

Pregnancy and breastfeeding

Ambrobene is contraindicated for use in the first trimester of pregnancy.
If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.

Special notes

Parenterally, the drug is used until complete relief of the symptoms of the disease or the transition to the appointment of other dosage forms Ambrobene.
The drug in the form of a syrup can be prescribed to patients with diabetes mellitus (5 ml of syrup contain the amount of sorbitol and saccharin, corresponding to 0.18 XE).

Overdosage

To date, no cases of intoxication with Ambrobene have been noted.

Drug Interactions

The simultaneous use of Ambrobene with drugs that have antitussive activity (for example, containing codeine) is not recommended because of the difficulty of removing sputum from the bronchi against the background of a decrease in cough.

Ambrobene solution for injection is incompatible in the same syringe or dropper with other drugs, the pH value of which exceeds 6.3, since it has acidic properties.

Tablets, retard capsules, oral solution and injection should be stored in a dark place at temperatures not above 25 ° C.
Syrup should be stored in a dark place at a temperature of 8 ° to 25 ° C.

The drug in the form of tablets, capsules, retard, oral solution and syrup is approved for use as a means of non-prescription.
The drug in the form of a solution for injection is released by prescription.