BROVAN [Ambroxol] 15 mg/5 ml Syrup for oral administration
BROVAN
instructions for
the medical use of the medicinal product
Tradename
Brovan, Брован
International non-proprietary name or generic name
Ambroxol, Амброксол
Composition
Each film-coated
tablet contains:
Active substance: ambroxol hydrochloride 30 mg.
Excipients: lactose monohydrate, starch,
talc, magnesium stearate, PVP K-30.
Each 5 ml of syrup contains:
Active substance: ambroxol hydrochloride 15 mg.
Excipients: sodium
methylparaben, sodium propylparaben, sodium hydroxide, sugar, glycerin,
strawberry essence, distilled water.
Each 5 ml of syrup contains:
Active substance: амброксола гидрохлорид 30 мг.
Excipients: sodium
methylparaben, sodium propylparaben, sodium hydroxide, sugar, glycerin,
strawberry essence, distilled water.
Tablets.
Syrup for oral administration.
Mucolytic
agent.
Pharmacodynamics
Mucolytic agent, stimulates prenatal lung
development (increases synthesis, secretion of surfactant and blocks its
breakdown). It has a secretomotor, secretolytic and expectorant effect:
stimulates serous cells of the glands of the bronchial mucosa, increases the
content of mucous secretions and the release of surfactant (surfactant) in the
alveoli and bronchi; normalizes the disturbed ratio of serous and mucous
components of sputum. By activating hydrolyzing enzymes, and enhancing the
release of lysosomes from Clara cells, it reduces the viscosity of sputum.
Increases the motor activity of the ciliated epithelium, increases mucociliary
transport.
After oral administration, the action occurs
after 30 minutes, and lasts for 6-12 hours. Absorption is high (for any route
of administration). The time to reach the maximum concentration is 2 hours, the
connection with plasma proteins is 80%. Penetrates through the blood-brain
barrier, placental barrier, excreted in breast milk. Metabolism - in the liver,
forms dibromantranilic acid and glucuronic conjugates. The half-life is 7-12
hours. It is excreted by the kidneys: 90% in the form of water-soluble
metabolites, unchanged - 5%. The half-life increases with severe chronic renal
failure, does not change with impaired liver function.
Diseases of the bronchopulmonary system, accompanied by the formation of
difficult sputum: acute and chronic bronchitis, tracheitis, laryngitis, chronic
obstructive pulmonary disease, pneumonia, bronchial asthma, bronchiectasis.
Treatment and prevention of respiratory distress syndrome.
Hypersensitivity to any component of the drug,
gastric ulcer and duodenal ulcer, in the form of tablets for children under 6
years of age.
Method of administration and dosage
Tablets
Inside, after meals without chewing, drinking plenty of liquid.
Children 6-12 years old: ½ tablet 2-3 times a day (equivalent to 30-45
mg of ambroxol hydrochloride per day);
Adults and children over 12 years of age: 1 tablet 3 times during the
first 2-3 days (equivalent to 90 mg of ambroxol hydrochloride per day).
Continue treatment with 1 tablet 2 times a day (equivalent to 60 mg of ambroxol
hydrochloride per day).
If necessary, the therapeutic effect for adults and children over 12
years of age can be enhanced by the use of 2 tablets 2 times a day (equivalent
to 120 mg of ambroxol hydrochloride per day).
The tablets should not be used for more than 4-5 days without consulting
a doctor.
Syrop
Inside, after meals, drink plenty of fluids.
Children under 2 years of age: 15 mg / day in 2 divided doses
(equivalent to 7.5 mg of ambroxol hydrochloride 2 times a day).
Children 2-5 years old: 22.5 mg / day in 3 divided doses (equivalent to
7.5 mg of ambroxol hydrochloride 3 times a day).
Children 5-12 years old: 30-45 mg / day in 2-3 doses (equivalent to 15
mg of ambroxol hydrochloride 2-3 times a day).
Adults and children over 12 years old: 30 mg 2-3 times / day for the
first 2-3 days, then 30 mg 2 times / day.
Treatment of children under 2 years of age should be carried out only
under the supervision of a physician.
The duration of treatment is selected individually, depending on the
course of the disease.
Special instructions and precautions
Care must be taken when prescribing to patients with
renal or hepatic impairment.
It should be used with caution
in patients with a weakened cough reflex or impaired mucociliary transport due
to the possibility of sputum accumulation.
It should not be taken
simultaneously with antitussive drugs that can inhibit the cough reflex, for
example, with codeine, as this can make it difficult to remove the liquefied
sputum from the bronchial tree.
Application during pregnancy
and during breastfeeding
Application during pregnancy is possible only in cases where the
intended benefit to the mother outweighs the potential risk to the fetus.
If necessary, use during lactation should stop breastfeeding.
Interaction with other medicinal
products
The combined use of ambroxol hydrochloride with atropine and other drugs
with anticholinergic effects, such as amantadine, tricyclic antidepressants,
haloperidol, histamine H1 receptor blockers, and procainamide, excluding
ipratropium, suppressing the activity of the ciliated epithelium and reducing
mucociliary clearance, can lead to mucociliary secretion.
The use of antitussive drugs with increased doses leads to the suppression
of the cough reflex, therefore, it becomes difficult to remove bronchial
secretions, which are formed in large quantities under the influence of
ambroxol hydrochloride.
From the digestive system: nausea,
vomiting, diarrhea.
Allergic reactions: skin
rash, itching, urticaria, angioedema.
With prolonged use - gastralgia, nausea,
vomiting, intense headaches, decreased blood pressure, shortness of breath,
hyperthermia, chills.
If any of the side effects indicated in the
instructions are aggravated, or you notice any other side effects not listed in
the instructions, inform your doctor.
Symptoms: nausea, vomiting,
gastralgia.
Treatment: artificial vomiting,
gastric lavage in the first, 1-2 hours after taking the drug, taking
fat-containing products. The liquefied sputum should be aspirated.
Tablets
Store in a dry cool and dry place, at a temperature not exceeding 30°C.
Syrup
Store in a dry and dark place at a temperature not exceeding 30°C.
Keep out of the reach of children!
Shelf life
2 years. Do not use after the expiration date printed on the package.
Vacation conditions
Dispensed by prescription.
Release form
Tablets
10 tablets in an aluminum foil blister. 2 blisters together with
instructions for use in a cardboard box.
Syrup
1 bottle 100 ml
with syrup 15 mg / 5 ml. Bottle, measuring spoon with instructions for use in a
cardboard box.
1 bottle 100 ml with syrup 30 mg / 5 ml. Bottle, measuring spoon with instructions for use in a cardboard box.