Medication info

Okosol Injection (Ambroxol Hydrochloride)

Prescription medication정맥
Ingredient · strength
Ambroxol Hydrochloride›7.5mg / 1mL
Manufacturer / importer
(주)오스코리아제약
Appearance
Brown ampoule filled with a colorless liquid
Packaging
2 mL/ampoule X 100
Approval status
Active

MFDS item code 201604659 · Notified 2016.07.28 · Insurance code 629701141

Summary

Main use
Improvement of respiratory diseases (chronic bronchitis, asthma, etc.), increase of surfactant production, prevention of pulmonary complications
Who receives it
Adults · Children
Adult administration
As Ambroxol Hydrochloride, slowly administer 15 mg per dose, 2 to 3 times a day via intravenous injection. In severe cases, the dosage can be increased up to 30 mg per dose and can be administered via drip intravenous injection along with saline or Ringer's solution. Ages 5 and older: 15 mg per dose, 2 to 3 times a day.
Child administration
For this medication, slowly administer 1.2 to 1.6 mg per kg of body weight daily via intravenous injection. Ages 2 to 4: 7.5 mg per dose, 3 times a day Under 2 years: 7.5 mg per dose, 2 times a day In case of respiratory distress syndrome.

Ingredients

Manufacturer
(주)오스코리아제약

Efficacy & effects

Improvement of respiratory diseases (chronic bronchitis, asthma, etc.), increase of surfactant production, prevention of 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 effective for acute and chronic respiratory diseases caused by mucus secretion disorders, such as chronic bronchitis, asthmatic bronchitis, and acute attacks of bronchial asthma. Additionally, it helps improve respiratory function by enhancing surfactant production in newborns and preterm infants with respiratory distress syndrome. It is also used to prevent pulmonary complications in severely ill patients with chronic obstructive pulmonary disease before and after surgery. This efficacy contributes to the overall enhancement of respiratory health.

How it is given

Adult administration

As Ambroxol Hydrochloride, slowly administer 15 mg per dose, 2 to 3 times a day via intravenous injection. In severe cases, the dosage can be increased up to 30 mg per dose and can be administered via drip intravenous injection along with saline or Ringer's solution. Ages 5 and older: 15 mg per dose, 2 to 3 times a day.

Child administration

For this medication, slowly administer 1.2 to 1.6 mg per kg of body weight daily via intravenous injection. Ages 2 to 4: 7.5 mg per dose, 3 times a day Under 2 years: 7.5 mg per dose, 2 times a day In case of respiratory distress syndrome.

Precautions

This medication is provided in the form of glass ampoules and should be cut very carefully since glass pieces may mix in during use. Caution is especially needed when administering to children or the elderly. This drug must not be administered to patients with allergies to this medication or its components. Use with caution in patients with impaired kidney function, severe liver disease, or in children under two years of age. Very rarely, serious skin damage such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur with this drug; discontinue immediately and seek medical attention if any skin or mucous membrane abnormalities arise. Mild gastrointestinal symptoms such as dyspepsia, nausea, vomiting, heartburn, dry mouth may occur, and rarely, discomfort in the stomach or abdomen, diarrhea, constipation, and loss of appetite may also happen. Allergic reactions such as skin rash, hives, facial swelling, and breathing difficulties may occur rarely, and any such symptoms should be reported to a healthcare professional immediately. In terms of respiratory symptoms, purulent rhinitis may develop, and in the nervous system, unusual tongue sensations, taste changes, and rarely, numbness in the mouth or arm numbness have been reported. Caution is needed when using this drug together with certain antibiotics as it may increase antibiotic concentrations in the bronchi and lungs. Use during pregnancy, especially in the first three months, is not recommended. breastfeeding women must only use this medication when absolutely necessary, as it can be transmitted through breast milk. Elderly patients may have reduced physiological function, so dosage should be adjusted and administered with caution. No specific symptoms have been reported in the event of overdose, but appropriate treatment may be required if abnormal symptoms appear. This medication may cause headaches, leg pain, and severe fatigue when administered, so it should be injected slowly and only mixed with saline or Ringer's solution. After mixing, it should be administered within 24 hours for safety. Finally, this medication should be stored out of the reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema, facial swelling), chest tightness, difficulty breathing, cold sweat, pallor → severe acute anaphylaxis reaction (including anaphylactic shock), high fever with severe rash, blisters, skin peeling, pain in mucous membranes of mouth/eyes → serious skin damage such as Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell's syndrome), sudden and severe headaches, seizures, confusion, visual disturbances.

Mild side effects

Dyspepsia, nausea, vomiting, heartburn, dry mouth, discomfort in the stomach, abdominal bloating, abdominal pain, diarrhea, constipation, loss of appetite, skin rash, hives-like erythema, itching, facial swelling, fever accompanied by chills, leukocytosis associated with purulent rhinitis, abnormal sensations in the tongue, taste changes, numbness in the mouth, 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 and should be stored in an opaque, sealed container. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius room temperature. Storing it this way can help preserve the medication's effectiveness.

Appearance and packaging

Appearance

Brown ampoule filled with a colorless liquid

Package unit

2 mL/ampoule X 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.