Medication info

Myungmoon Ambroxol Hydrochloride Injection

Prescription medicationSolution정맥
Ingredient · strength
Ambroxol Hydrochloride›7.5mg / 1mL
Manufacturer / importer
명문제약(주)
Appearance
Brown ampule containing a colorless liquid,
Packaging
100 ampules/box[(2mL×100)]
Approval status
Active

MFDS item code 200202717 · Notified 2002.02.08 · Insurance code 649801361

Summary

Main use
Effectiveness in preventing respiratory diseases (chronic bronchitis, asthma) and pulmonary complications
Who receives it
Adults · Children
Adult administration
As ambroxol hydrochloride, administer slowly by intravenous injection at a dose of 15 mg once, 2 to 3 times a day. In severe cases, the dose may be increased to 30 mg per administration and can be administered by drip intravenous infusion with normal saline or Ringer's solution. Ages over 5 years: 15 mg once, 2 to 3 times a day
Child administration
Administer slowly by intravenous injection at a dose of 1.2 to 1.6 mg per kg of body weight per day. Ages 2 to 4 years: 7.5 mg once, three times a day Under 2 years: 7.5 mg once, twice a day For neonates with respiratory distress syndrome

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

Effectiveness in preventing respiratory diseases (chronic bronchitis, asthma) and pulmonary complications

  • Mucus secretion disorders
  • acute bronchitis
  • chronic bronchitis
  • asthmatic bronchitis
  • acute attacks of bronchial asthma
  • respiratory distress syndrome
  • chronic obstructive pulmonary disease
View approved original text

This injection is used to treat acute and chronic respiratory diseases caused by mucus secretion disorders, such as chronic bronchitis and acute attacks of bronchial asthma. Additionally, in cases of respiratory distress syndrome in neonates and premature infants, it promotes the production of pulmonary surfactant, aiding in easier breathing. It is also effective in preventing pulmonary complications before and after surgery in patients with chronic obstructive pulmonary disease. This medication plays an important role in improving respiratory issues and enhancing lung function.

How it is given

Adult administration

As ambroxol hydrochloride, administer slowly by intravenous injection at a dose of 15 mg once, 2 to 3 times a day. In severe cases, the dose may be increased to 30 mg per administration and can be administered by drip intravenous infusion with normal saline or Ringer's solution. Ages over 5 years: 15 mg once, 2 to 3 times a day

Child administration

Administer slowly by intravenous injection at a dose of 1.2 to 1.6 mg per kg of body weight per day. Ages 2 to 4 years: 7.5 mg once, three times a day Under 2 years: 7.5 mg once, twice a day For neonates with respiratory distress syndrome

Precautions

Since this drug is a glass ampule injection, great care must be taken to ensure that glass fragments do not enter the container when opening it. Extra caution is needed when using it in children or the elderly. This drug should not be administered to patients who are allergic to it or to any of its components. Use of this drug should be done cautiously in patients with poor kidney function, severe liver dysfunction, or in infants under 2 years of age. Serious side effects, such as severe skin damage, may rarely occur when using this drug, so if any new skin or mucosal damage arises, the use of the drug should be stopped immediately, and medical attention should be sought. Gastrointestinal symptoms such as heartburn, nausea, vomiting, and dyspepsia may occur rarely, and constipation and diarrhea may also occur infrequently. Using this drug may cause allergic reactions such as skin rashes or hives, and in severe cases, acute allergic shock such as respiratory distress or facial edema may occur. Respiratory issues such as purulent rhinitis may develop, and neurological issues may include altered sensations of the tongue or taste changes, and rarely, paralysis sensations in the arms or around the mouth have been reported. When used in combination with certain antibiotics, this drug may increase the concentration of the antibiotic in bronchial or pulmonary secretions and sputum, so caution is necessary when used together. The use during pregnancy, especially within the first 3 months, is not recommended, and it should be administered cautiously during pregnancy as it passes through the placenta. Furthermore, breastfeeding women should only use this drug when the benefits of treatment outweigh the risks, as it may be excreted in breast milk. Elderly individuals may have decreased body functions, so dosage should be reduced or used with caution. No specific symptoms have been reported in cases of overdose, but if any adverse reactions occur, appropriate treatment should be sought. This drug may cause headaches, leg pain, and extreme fatigue when injected, therefore it should be administered slowly and should only be mixed with normal saline or Ringer's solution. It should be administered within 24 hours after mixing and should not be mixed with other solutions. Finally, this drug should be stored in a safe place out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, respiratory distress, severe acute anaphylactic reactions (including anaphylactic shock), Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)

Mild side effects

  • Dyspepsia
  • nausea
  • vomiting
  • heartburn
  • dry mouth
  • discomfort in the stomach
  • abdominal bloating
  • stomach pain
  • diarrhea
  • constipation
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  • loss of appetite
  • skin rashes
  • hives-like erythema
  • itching
  • facial edema
  • fever with chills
  • altered sensations of the tongue
  • taste changes
  • oral paralysis sensations
  • paralysis sensations in the arms
  • headaches
  • leg pain
  • extreme fatigue

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

Storage

This drug is sensitive to light, so it should be stored in a light-blocking, sealed container. Additionally, the medication should be stored at room temperature, specifically between 1 and 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Brown ampule containing a colorless liquid,

Package unit

100 ampules/box[(2mL×100)]

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.

Questions about this medicine

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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.