Halixol Sires 15mg/5ml Treatment of bronchial asthma and bronchitis (100ml)

Dosage form Syrup
Specifications Bottle x 100ml
Ingredient Ambroxol
Indication Acute bronchitis, bronchiectasis, bronchial asthma
Contraindication Pregnancy, peptic ulcer

Ingredient

Thành phần cho 5ml

Composition information	Content
Ambroxol	15mg

Uses

indications

Halixol Siro drugs are indicated in the following cases:

Acute and chronic respiratory obstructive diseases such as bronchial asthma and bronchitis, bronchiectasis related to mucus secretion and abnormal sputum. Enhance the dissolution of mucus in nasopharyngitis.

ATC code: R05C B06.

ambroxol, the active ingredient of halixol, is the metabolic substance of bromhexine and belongs to the benzylamine group of mucus dilution compounds.

Ambroxol increases the production of lysosomes and enhances the effects of hydrolyzed enzymes in mucus cells, thereby promoting bronchial secretion, cutting mucopolysaccharides. At the same time, the fluids are also stimulated to make the secretion less dense. In respiratory infections, ambroxol stimulates the production of surfactants because it affects alveolar cells group 2 and claria cells in the respiratory tract and has been shown to enhance mucus clearance.

As a result, the viscosity of mucus decreases and the effectiveness of airways cleaning of mucus clearance becomes more efficient.

Clinical pharmacological studies also show that mucus removal increases.

Mucus is thinner and improved mucus removal effects facilitate sputum.

Use ambroxol hydrochloride (6 months) significantly reduces the number of exacerbations in patients with chronic pulmonary obstruction (COPD) after two months of treatment. Patients were treated with Ambroxol Hydrochloride significantly reduced the number of sick leave and shortened antibiotic treatment time. Compared to placebo, patients treated with ambroxol hydrochloride significantly improve symptoms (difficulty sputum, cough, shortness of breath and blow).

The local anesthetic effect of Ambroxol Hydrochloride is observed on the rabbit face model that can be explained by sodium channel blockers: on Vitro In Vitro, Ambroxol Hydrochloride Neurological Sodium channel blocked; This cohesion can recover and depend on the concentration.

On Vitro, Ambroxol Hydrochloride significantly reduces the release of cytokine from single and multi -core cells in the blood and from single -core and multi -core cells with tissue.

Observed a significant decrease in pain and throat redness in clinical studies in sore throat.

These pharmacological properties are suitable for the additional results obtained in studies on clinical effectiveness when using ambroxol to treat upper respiratory symptoms, giving rapid pain relief results and discomfort related to pain in the ear - nose - trachea with aerosol.

After using Ambroxol Hydrochloride, antibiotic concentration (amoxicillin, cefuroxime, erythromycin and doxycycline) in bronchial fluid - lung and sputum increased.

pharmacokinetics

absorption:

Amboroxol is quickly and completely absorbed from the digestive tract, the absorption is linear with the dose in the treatment range.

The drug is strongly metabolized through the initial metabolism in the liver. Absolute bioavailability after taking an ambroxol hydrochloride tablet 30 mg is 79%.

distribution:

The distribution of ambroxol hydrochloride from the blood into the tissue is very fast and clear, the highest active ingredient concentration in the lungs. The distribution of oral use is 552 L. In the treatment range, about 90% of the blood in the blood is linked to plasma proteins.

transformation:

About 30% of the oral dosage of Ambroxol Hydrochloride is eliminated through the initial metabolism. Ambroxol hydrochloride is metabolized mainly in the liver by glucuronide and partly cutting into dibromanthanilic acid (about 10% of the dose) in addition to some small -rated metabolites. Studies on human liver microsomes have shown that CYP3A4 enzyme participated in the conversion of ambroxol hydrochloride into dibromanthanilic acid.

excretion:

Within 3 days after oral taken, about 6% of the dosage of the drug is found in the form of free, while about 26% of the dose existed in the form of an incompatible urine. Ambroxol Hydrochloride is eliminated with a half -life. The total clearance is 660 ml/min, with the renal clearance accounting for about 8% of the total clearance.

Special patient groups:

In patients with liver dysfunction, the excretion of ambroxol hydrochloride is reduced, leading to plasma concentrations about 1.3 to 2 times higher. Due to the wide range of therapy of Ambroxol Hydrochloride, the dose adjustment is not needed.

Other factors:

Age and gender does not affect the pharmacokinetics of Ambroxol Hydrochloride and therefore there is no need to adjust the dosage mode of the drug.

According to preclinical studies, Ambroxol passes through the placenta and the concentration of the drug in the fetal serum 2-4 times higher than the concentration of the drug in the mother's body.

Ambroxol is also found in breast milk and cerebrospinal fluid.

Food does not affect the bioavailability of ambroxol hydrochloride.

Before taking Halixol Sires 15mg/5ml Treatment of bronchial asthma and bronchitis (100ml)

How to use

Take medicine with lots of water, can be the same or not with food. Drink plenty of water during treatment helps increase the mucus dissolving effect of ambroxol.

In acute respiratory disorders, see a doctor if symptoms do not improve or worsen during treatment.

In patients with kidney failure or severe liver disease, it is necessary to be very cautious when using ambroxol hydrochloride.

Do not use Ambroxol hydrochloride syrup that lasts more than 45 days without a doctor's recommendation.

Consult your doctor or pharmacist if you feel that halixol syrup works too strong or too weak.

Dosage

recommended dose of halixol syrup as follows:

Adults and children over 12 years: 10 ml x 3 times/day.

Children from 6 to 12 years: 5 ml x 2-3 times/day. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

When using the drug overdose, the first thing to do is vomit and add drinking water (milk or tea). If the drug is overdose for 1-2 hours earlier, the stomach should be carried out. Activated carbon can be used and treated symptoms after detoxification. Need to continue monitoring the circulatory system.

Consult your doctor immediately if suspected of overdose.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using Halixol 15mg/5ml, you may experience unwanted effects (ADR).

Very common (≥ 1/10).

Common (≥ 1/100 to

Less (≥ 1/1000 to

Rare (≥ 1/10000 to

Very rare (

Do not know the frequency (not estimated from existing data).

immune system disorders:

Rare: Hypersensitivity reactions.

Common: Change taste.

Rare: Weakness, headache.

Common: Reducing the feeling of pharyngeal.

Common: Nausea, reduce the sensation of the mouth.

Rare: rash, urticaria.

Rare: urination disorders.

Very rare: difficulty urinating.

Uncommon: fever, mucosal reaction.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Halixol 15mg/5ml contraindications in the following cases:

Hypersensitivity to Ambroxol, Bromhexine or any other ingredient of the drug.

Be cautious when using

need to take into account the possibility of hypersensitivity reactions when using Halixol.

There have been reports that have severe skin reactions such as diverse erythema, Stevens-Johnson syndrome (SJS)/ toxic skin necrosis (ten) and acute all-body pustules (AGEP) related to the use of ambroxol hydrochloride. If symptoms or signs of progressive skin rash appear (sometimes blisters or mucosal lesions), it is necessary to stop treating with ambroxol hydrochloride immediately and consult a doctor.

If a patient has a renal function or a severe liver disease, only halixol syrup should be used after consulting a doctor. Just like any drug metabolized in the liver is then eliminated through the kidneys, the accumulation of ambroxol metabolites in the liver may occur when severe kidney failure. In the case of impaired renal function or severe liver disease, especially cautious when using ambroxol hydrochloride.

Due to the risk of clogging bronchial secretions, it is necessary to be especially cautious when using halixol for patients with bronchodial dysfunction or patients with too many sputum (for example in the rare Mao Nguyen Phat Hair Disorder Syndrome).

It is necessary to assess the benefits and risks when taking drugs for patients with gastrointestinal ulcers.

Children under 2 years of age using Ambroxol Hydrochloride syrup should be monitored continuously by medical experts.

excipients:

Each 5 ml of preparations contains 1.2 g of sorbitol. When taking the drug as recommended, each dose contains 0.6 - 2.4 g of sorbitol. It should be paid attention to the amount of sorbitol when using halixol syrup for diabetic patients.

It is necessary to take into account the resonance effect when using simultaneous products containing sorbitol (or fructose) and the amount of sorbitol (or fructose) in the diet. Sorbitol content in oral drugs can affect the bioavailability of other drugs taken simultaneously. Patients with non -intolerance fructose (HFI) should not use this drug. Sorbitol can cause discomfort in the digestive tract and have a light laxative effect.

This drug contains 3.6 mg of alcohol (ethanol) in 5 ml of syrup. The amount of alcohol in 5 ml of these drugs is equivalent to less than 1 ml of beer or 1 ml of wine. A small amount needed in this drug will not cause any effect to note.

This drug contains 7.43 mg of propylene glycol in 5 ml of syrup. Simultaneous use of this drug with any substrate of Alcohol Dehydrogenase such as ethanol can cause serious side effects in newborns.

This drug contains 5 mg of sodium benzoate salt in 5 ml of syrup. Benzoate salt can increase jaundice (jaundice and eyes) in newborns (until 4 weeks of age).

This drug contains less than 1 mmol sodium (23 mg) in 5 ml, which can be considered "non -sodium".

The effect of drugs on driving and operating machinery

There is no evidence that Ambroxol affects the ability to drive and operate machinery.

Use drugs for women during pregnancy and lactation

Prelise clinical data:

So far has not been observed to see the monster effects in preclinical studies.

Pregnancy:

Ambroxol hydrochloride through the placenta fence. Animal studies do not show direct or indirect effects on pregnancy, embryo/ fetal development, birth or postpartum development.

Deeply clinical experiences after 28 weeks of pregnancy shows no evidence of harmful effects on the fetus. However, be careful when using drugs for pregnant women. Especially in the first 3 months of pregnancy, it is recommended to use halixol syrup.

breastfeeding period:

Ambroxol Hydrochloride is secreted into breast milk.

Although there is no adverse effects in breastfeeding, it is not recommended to use halixol syrup for breastfeeding women.

affect fertility:

Pre -clinical studies do not show any harmful effects on fertility.

Drug interactions

Unbelievable use of Halixol and anti -themine drugs (e.g. codeine) because it can hinder the excretion of sputum diluted by ambroxol.

When used simultaneously with other antibiotics (for example, Amoxicillin, Cefuroxime, Erythromycin, Doxycycline), Ambroxol promotes antibiotic penetration into bronchial fluid.

There has not been unfavorable interaction reports with other drugs clinically.

Storage

Avoid light, store at temperatures below 30 ° C.

Expiry date: 60 months from the date of production. Take the drug within 4 weeks after opening.

Do not use overdue drugs indicated on the packaging.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.