Ambroxol HCl Syrup (1 box and 1 bottle)
Ambroxol HCl Syrup (1 bottle)
Ambroxol HCl Syrup (box of 1 bottle)
Ambroxol HCl Syrup (1 box and 1 bottle)
Ambroxol HCl Syrup (1 bottle)
Ambroxol HCl Syrup (box of 1 bottle)
*Packaging color may differ according to distribution region.

Ambroxol Syrup

AmbroCare™
Ambroxol HCl Syrup is a mucolytic prescribed for a productive cough associated with respiratory diseases. This pharmaceutical drug has been manufactured by AdvaCare Pharma at one of its GMP/ISO-certified facilities.

Dosage

Packaging

What is Ambroxol HCl?

Therapeutic Class:

Active Ingredients: Ambroxol HCl

Ambroxol Syrup is a drug used to treat the symptoms of both acute and chronic pulmonary diseases that produce excessive amounts of phlegm or mucus. It is indicated for the treatment of tracheobronchitis, emphysema, bronchiectasis, bronchitis with bronchospasm, and inflammatory pulmonary conditions.

This expectorant can be used alongside antibiotics in order to treat symptoms associated with bacterial respiratory infections. Along with anti-inflammatory properties, ambroxol also acts as a local numbing agent, which can help to relieve sore throat and ease cough.

Ambroxol Syrup typically begins to work in about 30 minutes. It is a well-tolerated cough medicine that is suitable for use by adults and children.

Ambroxol is currently being studied for use in the treatment of Parkinson's disease; however, clinical trials are still underway.

Ambroxol belongs to the class of medicines called mucolytics. It is a metabolite of bromhexine and displays similar secretolytic and secretomotoric activity. Ambroxol works by stimulating fluid secretion and reducing the viscosity of mucus, resulting in less thick mucus and phlegm. This action improves both mucus flow and transport, allowing the individual to cough out the excess mucus and breathe more easily.

Ambroxol Syrup is produced with a dosage of 3mg/ml or 6mg/ml. It is available in 2 different-sized bottles: 100ml and 200ml.

AdvaCare Pharma is a producer and exporter of Ambroxol HCl Syrup. This medication is manufactured in our GMP-certified facilities in China, India, and the USA.

Why choose us as your Ambroxol Syrup manufacturer?

AdvaCare Pharma is a reputable manufacturer of Ambroxol Syrup, and other pharmaceutical syrups, with a presence in 65 countries. We have implemented a "vested supplier-distributor relationship" business model that differentiates us from other large-scale medical manufacturers, facilitating a closer partnership with our pharmaceutical distributors. With a range of more than 500 GMP-approved medicines, including 55+ treatments in oral liquid dosage form, we are an Ambroxol Syrup manufacturer that doctors trust and patients rely on.

Uses

What is Ambroxol Syrup used for?

It is used to clear congestion and treat a productive cough that is associated with both acute and chronic respiratory diseases. It is used to treat conditions such as:

  • the common cold
  • influenza
  • tracheobronchitis
  • bronchiectasis
  • chronic bronchitis
  • bronchitis with bronchospasm
  • emphysema with bronchitis pneumoconiosis
  • chronic inflammatory pulmonary conditions

Is Ambroxol Syrup used for treating a dry cough?

This medicine is not recommended for the treatment of a dry cough. Since it thins and loosens phlegm, Ambroxol is more effective at treating a wet cough.

How should Ambroxol HCl Syrup be used?

This medication is manufactured as a liquid, which is intended to be administered orally. The bottle should be shaken before each use. Do not use a regular spoon to measure the liquid. It is recommended to take Ambroxol Syrup with a glass of water, and the medicine works best when taken after meals. During treatment, it is advised to drink plenty of liquids throughout the day.

How should Ambroxol Syrup be stored?

It is recommended to keep Ambroxol Syrup in a dark, dry location at room temperature (below 35°C). Keep the bottle out of direct sunlight. The bottle should be stored in an upright position when not in use. Discard any expired medicine. Do not store Ambroxol Syrup or any medication within the reach of children or pets.

What happens if a dose is missed?

The forgotten dose should be taken as soon as possible. If it is nearly time for the next dose, the forgotten dose should be skipped. Two doses should not be taken at the same time. If a patient often forgets to take their medication, alternative treatment plans should be considered.

What dose should be taken?

Adult Dosing For respiratory diseases associated with abnormal mucus secretion:

  • For Ambroxol Syrup 3mg/ml, the usual dosage is 10ml, given 2-3 times per day for the first 2-3 days. Then 10ml, given twice per day.
  • For Ambroxol Syrup 6mg/ml, the usual dose is 5ml, given 2-3 times per day for the first 2-3 days. Then 5ml, given twice per day.

Renal Dosing For patients with renal impairment, consult a doctor for appropriate dose adjustments.

Hepatic Dosing Consult a doctor for appropriate dosing if you have hepatic impairment.

Pediatric Dosing For respiratory diseases associated with abnormal mucus secretion, the usual doses for Ambroxol Syrup 6mg/ml are as follows:

  • Adolescents and children over 12 years old: 5ml given 2-3 times per day. Then 5ml, given twice per day.
  • Children from 6 to 12 years old: 2.5ml given 3 times per day.
  • Children from 2 to 5 years old: 1.25ml, 3 times a day.

For Ambroxol Syrup 3mg/ml, the pediatric doses are as follows:

  • Adolescents and children over 12 years old: 10 ml given 2-3 times per day. Then 10ml, given twice per day.
  • Children from 6 to 12 years old: 5ml given 2-3 times per day.
  • Children from 2 to 5 years old: 2.5ml, 3 times a day

Refer to a doctor or pharmacist for guidelines on dosage. Dosage recommendations may vary between regions and individual products. Always consult the packaging insert before taking this medication.

Who can use Ambroxol?

Ambroxol Syrup can be given to adults and children, but caution is advised for specific groups of patients.

Pregnant It is not advised to use this medication within the first 3 months of pregnancy. There have been no adequate human studies to assess the risk in this population. Ambroxol should only be used if safer alternatives are not acceptable or not tolerated.

Breastfeeding Ambroxol is known to be excreted in milk, though no adverse effects have been reported, it is recommended to consult with a doctor before taking Ambroxol Syrup. The benefits must be weighed against the risks before use.

Children There is limited data available to properly assess the efficacy and safety in children. This medicine is not recommended for children younger than 2 years old due to an increased risk of bronchial obstruction. The benefits must be weighed against the risks before treating infants, babies, and children under 2 years old.

Geriatric Studies have not shown reduced tolerability, safety, or efficacy in this population.

Other warnings

For patients with severe kidney insufficiency or liver insufficiency, this medication should be used with great caution, as there is an increased risk of accumulation. It may be necessary to adjust the dosage, such as reducing the dose or increasing the interval between dosing.

For patients with gastric damage or gastric ulceration, this medication must be used cautiously. Mucolytics are associated with gastric damage and the disruption of the gastric protective barrier.

Ambroxol has been associated with the appearance of severe skin reactions. Treatment should be immediately discontinued if severe skin reactions occur.

Side Effects

As with all pharmaceuticals, some unwanted effects can occur from the use of Ambroxol HCl Syrup.

This medicine is typically well tolerated and causes mild side effects. Some common side effects include, but may not be limited to:

  • gastrointestinal effects (diarrhea, nausea, upset stomach, vomiting)
  • altered taste
  • dry mouth
  • fever
  • runny nose
  • heartburn

Seek immediate medical attention if the following symptoms occur:

  • signs of allergic reactions, such as hives, swelling, or difficulty breathing
  • severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis)

For a comprehensive understanding of all potential side effects, consult a medical professional.

If any symptoms persist or worsen, or you notice any other symptoms, please call your doctor.

Precautions

Do NOT use Ambroxol Syrup if: • You are allergic to ambroxol or any of the other ingredients.

Before treatment, consult your doctor regarding any medications you are taking to address potential drug interactions.Ambroxol may be associated with increased concentrations of some types of antibiotics, such as amoxicillin, cefuroxime, doxycycline, and erythromycin. Antitussives should not be used while undergoing treatment with Ambroxol Syrup.

This medication may not be suitable for people with certain conditions. It is important to consult with a doctor if you have any health conditions, including:

  • first trimester of pregnancy
  • history of gastric ulcers (peptic or duodenal ulcers)
  • asthma or severe asthma attacks
  • liver or kidney dysfunction
  • primary ciliary dyskinesia

This medicine is not expected to affect the ability to drive or operate a machine.

It is recommended to avoid the use of alcohol during treatment with Ambroxol Syrup.

Ambroxol Syrup is contraindicated for children under 2 years old unless under the supervision and recommendation of a doctor.

Do not use Ambroxol Syrup for longer than 14 days unless under the guidance of a doctor. If symptoms do not improve after 5 days, it is advised to consult a doctor. Consult a doctor if symptoms do not improve after 3 days in children under 6 years old.

It is advised to inform laboratory staff that you are taking Ambroxol Syrup before any test. Ambroxol HCl may cause interference in laboratory testing. It has been associated with false positives on certain types of urine-based testing. It has been associated with false positives for lysergic acid diethylamide.

Some formulations of Ambroxol Syrup may contain sorbitol. Consult the ingredients list, as these formulations should not be taken by those with hereditary fructose intolerance.

Benzoic acid may be added as an excipient in some formulations of this medicine. It should be noted that this chemical increases the risk of jaundice in newborns.

Ambroxol 15mg/5ml: Why the most common dose?

Ambroxol 15mg/5ml is commonly used for its mucolytic effect, helping to clear mucus from the respiratory tract in conditions like bronchitis. It balances effectiveness with patient tolerance and can be adjusted as needed.

References

An overview of efficacy and safety of ambroxol for the treatment of acute and chronic respiratory diseases with a special regard to children

Ambroxol is an over-the-counter product that is a mucoactive agent and has been used widely to treat both acute and chronic respiratory diseases since 1978.

This study focuses on providing evidence of the use of ambroxol in children with acute and chronic respiratory diseases. Different databases were used to collect data and it included almost 1,300 patients with strong clinical outcomes after consuming ambroxol.

Most of the studies revealed that ambroxol is well tolerated in children and can be used as a secretolytic therapy in acute and chronic bronchopulmonary disorders that lead to abnormal mucus secretion and impaired mucus transport.

The conclusion of this research is that ambroxol is well tolerated in children and has numerous benefits in patients with chronic and acute respiratory diseases.

*Regulatory compliance may vary according to production standard, import requirements and/or manufacturing origin.
Dolores Carrillo Profile
Medically reviewed by Dolores Carrillo, Pharm.D., MDB
October 14, 2024

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