Medication info

Aroxol Injection (Ambroxol Hydrochloride)

Prescription medicationInjections정맥
Ingredient · strength
Ambroxol Hydrochloride›15mg / 1 ampoule
Manufacturer / importer
(주)비씨월드제약
Appearance
A colorless, transparent solution in a brown ampoule for injection.
Packaging
50 ampoules/box [(2 milliliters/1 ampoule)]
Approval status
Active

MFDS item code 199302020 · Notified 1993.11.18 · Insurance code 653101191

Summary

Main use
Effectiveness in preventing respiratory diseases (chronic bronchitis, asthma) and pulmonary complications.
Who receives it
Adults · Children
Adult administration
As Ambroxol Hydrochloride, slowly inject 15 mg per dose, 2 to 3 times a day. In severe cases, the dosage can be increased to 30 mg per dose, and it can be administrated as an intravenous drip with saline injection or Ringer's solution. For those over 5 years old, administer 15 mg per dose, 2 to 3 times a day.
Child administration
For children, slowly administer 1.2 to 1.6 mg per kg of body weight as an intravenous injection. For ages 2 to 4 years, administer 7.5 mg per dose, 3 times a day. For under 2 years old, administer 7.5 mg per dose, 2 times a day. Respiratory distress syndrome.

Ingredients

Manufacturer
(주)비씨월드제약

Efficacy & effects

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

  • Mucus secretion disorder
  • acute and chronic respiratory diseases
  • chronic bronchitis
  • asthmatic bronchitis
  • acute attacks of bronchial asthma
  • respiratory distress syndrome
  • chronic obstructive pulmonary disease
  • pulmonary complications.
View approved original text

This injection is used for the treatment of acute and chronic respiratory diseases such as chronic bronchitis, asthmatic bronchitis, and acute attacks of bronchial asthma due to mucus secretion disorders. It also promotes the production of pulmonary surfactant in newborns and premature infants with respiratory distress syndrome, improving respiratory function. Furthermore, it is effective in preventing pulmonary complications in severe patients with chronic obstructive pulmonary disease before and after surgery. This medication aids in the treatment of respiratory diseases and the recovery of lung function.

How it is given

Adult administration

As Ambroxol Hydrochloride, slowly inject 15 mg per dose, 2 to 3 times a day. In severe cases, the dosage can be increased to 30 mg per dose, and it can be administrated as an intravenous drip with saline injection or Ringer's solution. For those over 5 years old, administer 15 mg per dose, 2 to 3 times a day.

Child administration

For children, slowly administer 1.2 to 1.6 mg per kg of body weight as an intravenous injection. For ages 2 to 4 years, administer 7.5 mg per dose, 3 times a day. For under 2 years old, administer 7.5 mg per dose, 2 times a day. Respiratory distress syndrome.

Precautions

Since this medication is in a glass ampoule injection, great care must be taken when cutting the container as glass fragments may mix in. Precaution is especially necessary when used in children and the elderly. This medication should not be used by individuals allergic to it or its components. Patients with poor kidney function, severe liver dysfunction, and infants under 2 years old should use this medication with caution. Rarely, serious adverse reactions such as severe skin damage may occur; if new damage to the skin or mucous membranes occurs, use should be stopped immediately, and treatment should be obtained. Gastrointestinal discomfort may occur, including indigestion, nausea, vomiting, heartburn, and dryness of the mouth, which can be seen occasionally. Rarely, there may be discomfort or bloating in the stomach or abdomen, abdominal pain, diarrhea, constipation, and loss of appetite. Skin rashes or severe allergic reactions, hives, facial swelling, and difficulty breathing have been reported rarely; if these symptoms occur, immediate consultation with a physician is required. Inflammation in the respiratory system may occur, and sensory abnormalities of the tongue, taste changes, and rarely, oral paralysis or arm paralysis may be observed in the nervous system. This medication may increase the concentration of antibiotics in bronchial and pulmonary secretions when used with certain antibiotics; thus, consultation with a physician is necessary when used in combination. This medication is not recommended during pregnancy, especially in the first three months, and should be administered cautiously in the later stages of pregnancy. For breastfeeding women, this medication may be transmitted through breast milk, so it should only be used if the benefits of treatment outweigh the risks. Elderly patients may have decreased physical function, and caution should be taken in reducing the dosage when using this medication. No specific symptoms have been reported in the case of overdose; however, treatment may be necessary for emerging adverse reactions. During injection, headaches, leg pain, and extreme fatigue may occur, so it is advisable to inject slowly. This medication should only be mixed with saline solution or Ringer's solution for intravenous drip administration, and the mixed solution should be used within 24 hours at room temperature. This medication should be stored in a secure place away from children's reach.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, severe acute anaphylactic reactions (including anaphylactic shock), angioedema, facial swelling, Stevens-Johnson syndrome, serious skin damage such as toxic epidermal necrolysis (Lyell's syndrome).

Mild side effects

  • Indigestion
  • nausea
  • vomiting
  • heartburn
  • dry mouth
  • discomfort in the stomach
  • abdominal bloating
  • abdominal pain
  • diarrhea
  • constipation
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  • loss of appetite
  • skin rash
  • hives-like erythema
  • itching
  • increased body temperature with chills
  • sensory abnormalities of the tongue
  • taste changes
  • oral paralysis sensations
  • arm numbness
  • headaches
  • leg pain
  • extreme fatigue.

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

Storage

This medication is sensitive to light, so it should be stored in a container that blocks light. Additionally, it is best to store the medication at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

A colorless, transparent solution in a brown ampoule for injection.

Package unit

50 ampoules/box [(2 milliliters/1 ampoule)]

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.