Medication info

Sputam Injection 10% (Acetylcysteine)

Prescription medication근육 · 정맥
Ingredient · strength
Acetylcysteine›100mg / 1mL
Manufacturer / importer
명인제약(주)
Appearance
A brown ampoule filled with a colorless to pale purple transparent liquid.
Packaging
10 ampoules/box [3 ml/ampoule x 10 units], 10 ampoules/box [6 ml/ampoule x 10 units]
Approval status
Active

MFDS item code 199901137 · Notified 1999.06.03 · Insurance code 651901371,651904881

Summary

Main use
Improvement of mucus discharge difficulty in bronchial diseases (acute and chronic bronchitis, bronchiectasis) and detoxification effects in acetaminophen overdose.
Who receives it
Adults · Children
Adult administration
1. Mucolytic Action 1) Intravenous Injection For adults, acetylcysteine should be administered intravenously at a dose of 600 to 900 mg once, 2 to 3 times a day. 2) Intramuscular Injection For adults, this medication should be administered intramuscularly at a dose of 300 mg once, 1 to 2 times a day. 2. Detoxification of Acetaminophen Overdose Dilute 150 mg per kg body weight in 200 mL of 5% dextrose solution for intravenous drip within the first 15 minutes. After that, dilute 50 mg per kg body weight in 500 mL of 5% dextrose solution.
Child administration
1. Mucolytic Action 1) Intravenous Injection For children, this medication should be administered intravenously at a dose of 300 to 450 mg once, 2 to 3 times a day. 2) Intramuscular Injection For children, this medication should be administered intramuscularly at a dose of 150 mg once, 1 to 2 times a day.

Ingredients

Manufacturer
명인제약(주)

Efficacy & effects

Improvement of mucus discharge difficulty in bronchial diseases (acute and chronic bronchitis, bronchiectasis) and detoxification effects in acetaminophen overdose.

  • Thick and viscous phlegm
  • difficulty in expectoration symptoms
  • acute and chronic bronchitis
  • bronchiectasis
  • asthma-like bronchitis
  • pharyngitis
  • sinusitis
  • cystic fibrosis
  • postoperative pulmonary complications.
View approved original text

This medication helps facilitate the discharge of mucus in various bronchial diseases caused by thick and viscous phlegm, such as acute and chronic bronchitis, bronchiectasis, asthma-like bronchitis, pharyngitis, sinusitis, cystic fibrosis, and postoperative pulmonary complications. Additionally, it is effective as an antidote for acetaminophen overdose, improving symptoms of poisoning. Therefore, this medication is used for both respiratory diseases and acetaminophen poisoning treatment.

How it is given

Adult administration

1. Mucolytic Action 1) Intravenous Injection For adults, acetylcysteine should be administered intravenously at a dose of 600 to 900 mg once, 2 to 3 times a day. 2) Intramuscular Injection For adults, this medication should be administered intramuscularly at a dose of 300 mg once, 1 to 2 times a day. 2. Detoxification of Acetaminophen Overdose Dilute 150 mg per kg body weight in 200 mL of 5% dextrose solution for intravenous drip within the first 15 minutes. After that, dilute 50 mg per kg body weight in 500 mL of 5% dextrose solution.

Child administration

1. Mucolytic Action 1) Intravenous Injection For children, this medication should be administered intravenously at a dose of 300 to 450 mg once, 2 to 3 times a day. 2) Intramuscular Injection For children, this medication should be administered intramuscularly at a dose of 150 mg once, 1 to 2 times a day.

Precautions

This medication is in a glass ampoule injection form, and caution should be taken when opening the container, as glass fragments may mix with the solution. Extra care is particularly required when used in children or the elderly. This medication should not be used by individuals who are allergic to it or its components. Patients with bronchial asthma or poor respiratory function should be cautious, as this medication may cause bronchospasm; if abnormal symptoms occur, administration should be stopped immediately and appropriate treatment should be obtained. It is preferable not to use this medication in neonates unless it is a severe condition. Occasionally, gastrointestinal symptoms such as nausea, vomiting, decreased appetite, and diarrhea may occur with this medication. Rarely, hypersensitive reactions such as urticaria, itching, rash, headache, tinnitus, and bronchospasm may occur. Additionally, there may be rare instances of increased heart rate or elevated blood pressure, and very rarely a severe allergic reaction known as anaphylaxis may occur. When used as an antidote, administering large doses intravenously may cause symptoms similar to hypersensitivity and severe hypertension, so caution is necessary and administration should be stopped immediately if abnormal symptoms arise. While using this medication, bronchial secretions may increase; therefore, careful monitoring of the patient's condition is essential, and appropriate measures such as mechanical suction or positional changes should be taken as needed. For intramuscular injection, deep injection is recommended. When used as an antidote, it is effective if administered within 10 hours after poisoning. This medication may interact chemically with certain drugs, so caution should be exercised when mixing or administering with other medications. There is insufficient research on the safety of this medication during pregnancy, so it should only be used when necessary. Nursing women should also use this medication with caution, as it is unclear whether it passes into breast milk. Elderly patients may have diminished bodily functions, so careful monitoring and cautious administration are advised.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • bronchospasm
  • anaphylaxis
  • respiratory distress
  • angioedema

Mild side effects

  • Nausea
  • vomiting
  • decreased appetite
  • diarrhea
  • itching
  • rash
  • headache
  • tinnitus
  • tachycardia
  • hypertension

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

Storage

This medication may be sensitive to light and should be stored in a container that does not allow light penetration. Additionally, it is important to store the medication at room temperature, maintaining a temperature between 1 degree and 30 degrees Celsius. This will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

A brown ampoule filled with a colorless to pale purple transparent liquid.

Package unit

10 ampoules/box [3 ml/ampoule x 10 units], 10 ampoules/box [6 ml/ampoule x 10 units]

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.