Ambroxol Hydrochloride Injection , USP
BROX-A 15 Content:
Each ampoule contains 15mg of ambroxol hydrochloride and other ingredients.
BROX-A 15 Character:
It is a clear, colourless to slightly yellow liquid.
Brox-A 15 Pack:
It comes in 2 ml x 5 ampoules in a plastic tray, 1 tray per box.
1. What BROX-A 15 is and what it is used for
BROX-A 15 contains the active substance ambroxol hydrochloride which belongs to mucolytic and expectorant drugs, it is the active metabolite of bromhexine improves the rheological properties of sputum, reduces its viscosity and adhesive properties, facilitating its removal from the respiratory tract. Ambroxol stimulates the activity of the serous cells of bronchial glands of the shell, the formulation of enzymes that break down the relationship between polysaccharides of sputum, the formation of surfactant and direct the activity of the cilia of the bronchi, preventing them from sticking together.
BROX-A 15 is indicated for:
1) Acute, chronic respiratory diseases caused by respiratory mucosa-secretion disturbance, such as chronic bronchitis, asthmatic bronchitis and bronchial asthma.
2) Diﬃcult breathing syndrome in premature infants and neonates.
3) In pre- and post-operation, prevention and treatment of pulmonary complication.
2. What you need to know before you take BROX-A 15
The patients with hypersensitivity to this drug.
Should be administered cautiously to the following patients
The patients with severe renal disorder or severe hepathopathy. As for any medication with hepatic metabolism followed by renal elimination, accumulation of the metabolites of ambroxol generated in the liver can be expected in the presence of severe renal insuﬃciency.
The simultaneous use of Ambroxol hydrochloride with drugs, possessing antitussive activity (such as those containing codeine), is not recommended because of diﬃculties removing phlegm from the bronchial tubes in the background to reduce coughing.
The simultaneous use of Ambroxol hydrochloride with antibiotics (including amoxicillin, cefuroxime, erythromycin, doxycycline) improves the flow of antibiotics into the pulmonary route.
Such interaction with doxycycline is widely used for therapeutic purposes.
Use in pregnancy and nursing mother
As the safety during pregnancy has not yet been established, this drug should be used during pregnancy or suspected pregnancy only if the potential benefits overweigh the possible risks. (especially should not be administered during the first trimester of pregnancy)
Use in the elderly
Should be administered cautiously to the elderly.
1) Headache, leg pain, extreme fatigue may occur, so inject slowly.
2) When the injection is intravenously administered, should be injected slowly.
3) As precipitation of the injection may occur, this drug should not be mixed with other injectable solutions of more than pH 6.3.
4) Do not allow the injection to be mixed with other medicine in the same container. Pay attention to the compatibility of the medicines.
1.How to take BROX-A 15
BROX-A 15 Can be administrated intravenously.
Adult and children over 12 years: 15mg at once, 2 to 3 times a day. In severe symptoms, this dose may be increased to 30mg at once.
Children between 6 to 12 years: 15mg at once, administered 2 to 3 times a day.
Children between 2 to 6 years: 7.5mg at once, 3 times a day.
Children under 2 years: 7.5mg at once, 2 times a day.
All the intravenous injection should be slow.
For the treatment of infantile respiratory distress syndrome(IRDS), 30mg per kg bodyweight as ambroxol HCl is slowly IV-injected in 4 divided doses. The injection time is at least 5 minutes.
Contents of the pack and other information
1.What BROX-A 15 contains
• Each ampoule contain 15mg of ambroxol hydrochloride as the active ingredient.
• The other ingredients are anhydrous disodium hydrogen phosphate, citric acid monohydrate, sodium chloride and water for injections.
2.What BROX-A 15 looks like and contents of the pack
BROX-A 15 is a clear, colourless to slightly yellow liquid which comes in a glass ampoule containing 2 ml of solution. 5 ampoules in a plastic tray, 1 tray per box.
How to store BROX-A 15
BROX-A 15 must not be used after the expiry date ‘EXP’ shown on the container.
Keep out of the reach and sight of children. Store below 30℃, protect from light.