Composition
Each tablet contains: 30mg Ambroxol hydrochloride.
Uses (Indications)
Halixol is indicated for use in the following cases:
- Treatment of acute and chronic obstructive airway diseases such as bronchial asthma and bronchitis, bronchiectasis caused by excessive production of mucus and phlegm.
- Enhance the dissolution of mucus in inflammatory diseases of the nose and throat.
Usage - Dosage
The medicine should be taken with plenty of water after eating. Drinking plenty of fluids during treatment will help increase the mucus-dissolving effects of ambroxol.
Dosage:
- Adults and children over 12 years old: The recommended daily dose in the first 2-3 days is 1 tablet x 3 times/day, the next days take a dose of 1 tablet x 2 times/day or ½ tablet x 3 times/day. day.
- Children 5-12 years old: The usual dose is ½ tablet x 2-3 times/day.
* In patients with severe renal impairment, it is necessary to reduce the dose or increase the interval between dosing.
Do not use in the following cases (Contraindications)
Halixol is contraindicated in the following cases:
- Hypersensitivity to ambroxol, bromhexine or to any of the ingredients.
- Gastrointestinal ulcers.
- Pregnant and lactating women.
Precautions for use (Warnings and cautions)
- The possibility of hypersensitivity reactions must be taken into account when using Halixol.
- Particular care should be taken when administering Halixol to patients with tracheal dysfunction or patients with excessive sputum.
- Care should be taken when administering the drug to patients with lactose intolerance because each Halixol tablet contains 84 mg of lactose.
Undesirable effects (Side effects)
When using Halixol, you may experience unwanted effects (ADRs).
Rarely, ADR < 1/1000
- Nervous: Headache.
- Digestive: Diarrhea, vomiting, digestive disorders.
- Skin and subcutaneous tissue: Skin rash.
- Body as a whole: Weak and tired.
Instructions on how to handle ADR
Inform your doctor about any unwanted side effects you may experience while using the drug
Interactions with other drugs
When used concomitantly with other antibiotics (eg, amoxicillin, cefuroxime, erythromycin, doxycycline), ambroxol increases the concentration of antibiotics in the lung parenchyma. Halixol and antitussives (e.g. codeine) should not be used concurrently, as this may interfere with the secretion of sputum dissolved by ambroxol.
Driving and operating machinery
There is no evidence that the drug affects the ability to drive and use machines.
Pregnancy and lactation
Pregnancy period
- Preclinical data: To date, no teratogenic effects have been observed in preclinical studies.
- In humans: Halixol should not be used in pregnant women.
Breastfeeding period
Halixol should not be used by nursing women.
Storage
Store protected from light, below 30°C.
Due date
60 months from date of manufacture.
Pharmacodynamic
- Ambroxol, the active ingredient of Halixol, is a metabolite of bromhexine and belongs to the benzylamine group of mucolytic compounds.
- Ambroxol increases the production of lysosomes and enhances the effect of hydrolytic enzymes in mucus-secreting cells, thereby promoting the resolution of bronchial secretions, cutting acid mucopolysaccharides. At the same time, the serous glands are stimulated, making the secretions less dense. In inflammatory diseases of the respiratory tract, ambroxol stimulates the production of surfactants and has a strengthening effect on the cleansing of mucous membranes.
Pharmacokinetics
- Ambroxol is almost completely absorbed from the gastrointestinal tract. The drug is extensively metabolised by primary metabolism in the liver. The absolute bioavailability of ambroxol when administered orally is approximately 60%.
- Approximately 80% of the drug in the blood is bound to plasma proteins.
- Approximately 80% of the dose is excreted in the urine as unchanged and as glucuronide conjugates of the oxidized metabolites. Metabolism is biphasic and the apparent half-lives of the two phases are 1.3 and 8.8 hours, respectively.
Patients with Severe Renal Impairment: The half-life of ambroxol is increased in patients with severe renal impairment, thus requiring a dose reduction or increased dosing interval in these patients.
- According to preclinical studies, ambroxol crosses the placental barrier and the concentration of the drug in fetal serum is 2-4 times higher than that in the mother's body.
- Ambroxol is also found in breast milk and cerebrospinal fluid.