Medication info

Ambroxol Syrup

Prescription medicationSolution경구Approval withdrawn
Ingredient · strength
Ambroxol Hydrochloride›150mg / 100mLClenbuterol Hydrochloride›0.1mg / 100mL
Manufacturer / importer
조아제약(주)
Appearance
(For domestic use) Colorless liquid with added strawberry flavor in a plastic container (For export) Colorless or slightly yellow syrup with a unique flavored sweetener in a plastic container
Packaging
500 milliliters/bottle
Approval status
Approval withdrawn

MFDS item code 200003487 · Notified 2000.11.14

This product's status changed to Approval withdrawn on 2025.03.07. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of bronchospasm and excessive mucus secretion
Who takes it
Adults · Children
Adult dose
Adults and children (12 years and older): 20 ml once, twice a day. After significant improvement of symptoms, it can be reduced to 10 ml once, 2-3 times a day. For patients with severe breathing difficulties, 20 ml can be taken 3 times a day for the first 2-3 days.
Child dose
Children (under 12 years): 2.5-15 ml once, twice a day, depending on age and weight. Recommended dosage Ages 6-12 (22-35 kg): 15.0 ml Ages 4-5 (16-22 kg): 10.0 ml

Ingredients

Manufacturer
조아제약(주)

Efficacy & effects

Relief of bronchospasm and excessive mucus secretion

  • Bronchospasm
  • excessive mucus secretion
  • bronchial asthma
  • emphysema
  • bronchitis
View approved original text

This medication is used to relieve bronchospasm and excessive mucus secretion associated with respiratory diseases such as bronchial asthma, emphysema, and bronchitis.

How to take

Adult dose

Adults and children (12 years and older): 20 ml once, twice a day. After significant improvement of symptoms, it can be reduced to 10 ml once, 2-3 times a day. For patients with severe breathing difficulties, 20 ml can be taken 3 times a day for the first 2-3 days.

Child dose

Children (under 12 years): 2.5-15 ml once, twice a day, depending on age and weight. Recommended dosage Ages 6-12 (22-35 kg): 15.0 ml Ages 4-5 (16-22 kg): 10.0 ml

Precautions

This medication should not be administered to patients with hypertrophic cardiomyopathy. It should be used with caution in patients with hyperthyroidism, hypertension, heart failure or arrhythmias, diabetes, and severe renal impairment. When taking this medication, side effects related to the nervous system such as headache, tremors, muscle stiffness, drowsiness, anxiety, dizziness, nervousness, insomnia, agitation, and limb numbness may occur. Additionally, cardiovascular symptoms such as rapid or irregular heartbeat, fluctuations in blood pressure, hypertension, and arrhythmias may occur. If hypersensitivity reactions such as rash, itching, angioedema, hives, bronchospasm, hypotension, or collapse occur, use should be discontinued immediately. Other side effects such as elevated liver function tests, generalized malaise, swelling, and gastrointestinal disturbances may also occur. Care should be taken as excessive or prolonged use of this medication may increase the risk of cardiac arrhythmias or cardiac arrest. The prescribed routes and dosages should be adhered to, and if no improvement is observed, it should be judged as unsuitable and discontinued. Particularly when administering to children, instructions for use should be provided accurately and observations of progress should be well-maintained. This medication can lower blood potassium levels, and this effect may be exacerbated when used with xanthine drugs, steroids, and diuretics, requiring caution in severe asthma patients. In states of hypoxemia, reduced potassium levels may have a greater impact on cardiac rhythm, so regular monitoring of blood potassium levels is advisable. This medication should not be used together with catecholamines such as epinephrine or isoproterenol due to the risk of cardiac arrhythmias or cardiac arrest. Caution is advised for patients taking MAO inhibitors or tricyclic antidepressants as the vascular effects may become more pronounced. Combinations with non-selective beta-blockers such as propranolol should be avoided. Patients receiving multiple sympathetic stimulants should also use this medication with caution. Animal studies during late pregnancy have demonstrated that it can suppress uterine contractions, potentially delaying labor, and it may cross the placenta or be transmitted through breast milk, so caution is necessary, especially in the first three months of pregnancy. Elderly patients may require caution due to decreased physiological function and may require dosage reductions. Symptoms of overdose usually resolve upon discontinuation of the medication, and cardiac-selective beta-blockers may be used as an antidote, although caution is necessary in patients with a history of bronchospasm. Finally, rare allergic rashes may occur with dosage changes, and some patients with specific sensitivities may experience systemic allergic reactions.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema (severe swelling), bronchospasm (difficulty breathing), hypertension, arrhythmias (potentially classified as severe swelling or urinary difficulties), systemic allergic reactions

Mild side effects

  • Headache
  • tremors
  • muscle rigidity
  • drowsiness
  • anxiety
  • dizziness
  • nervousness
  • insomnia
  • agitation
  • limb numbness
Show 16 more
  • palpitations
  • tachycardia
  • fluctuations in blood pressure
  • hypertension
  • arrhythmias
  • rash
  • itching
  • angioedema
  • bronchospasm
  • hypotension
  • collapse
  • elevated ALT
  • elevated AST
  • generalized malaise
  • swelling
  • gastrointestinal disturbances

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container that protects it from air and moisture, at a safe temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

(For domestic use) Colorless liquid with added strawberry flavor in a plastic container (For export) Colorless or slightly yellow syrup with a unique flavored sweetener in a plastic container

Package unit

500 milliliters/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.