Sinil Ambroxol Hydrochloride Injection

Adult administration

Adult: Administer slowly by intravenous injection 15 mg once, 2 – 3 times a day of Ambroxol Hydrochloride. In severe cases, this can be increased to 30 mg once and administered by slow intravenous infusion with normal saline injection or Ringer's solution.

Child administration

Pediatric: Administer slowly by intravenous injection 1.2 – 1.6 mg per kg body weight per day. Dosage by age: Over 5 years: 15 mg once, 2 – 3 times a day 2 – 4 years: 7.5 mg once, 3 times a day

This medication is in a glass ampoule injection form, and care should be taken as glass fragments may mix when opening the container. Extra caution is needed when used in children or the elderly. It should not be used in patients with an allergy to this medication or its components. This medication should be used cautiously in patients with poor kidney function, severely impaired liver function, and children under 2 years of age. Although rare, serious skin diseases may occur while using this medication, so if any abnormalities on the skin or mucous membranes appear, use should be stopped immediately, and consultation with a healthcare professional is necessary. Gastrointestinal side effects like dyspepsia, nausea, vomiting, heartburn, and dry mouth may occur occasionally, and rarely abdominal pain, diarrhea, or constipation may appear. Skin rashes or allergic reactions, and in severe cases, acute reactions like anaphylactic shock may occur; therefore, if any unusual symptoms appear, inform a healthcare professional right away. Inflammatory rhinitis may appear as a respiratory side effect, and neurological symptoms such as altered sensation of the tongue or taste changes, and rarely paralysis sensations in the arms have been reported. Care should be taken when using with antibiotics, as antibiotic concentrations may increase in the bronchial and pulmonary secretions. Its use is not recommended, especially during the first three months of pregnancy, and should be carefully considered during breastfeeding. In the elderly, caution must be exercised such as reducing the dosage due to declining body functions. No specific symptoms have been reported in cases of overdose; however, treatment may be necessary corresponding to the symptoms if adverse reactions occur. The injection speed should be slow, and headaches, leg pain, or severe fatigue may occur. It can only be mixed with normal saline injection or Ringer's solution for infusion and must be used within 24 hours after mixing. Keep this medication out of reach of children.

Serious side effects

Urticaria, angioedema, dyspnea, severe acute anaphylactic reactions (including anaphylactic shock), Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome)

Mild side effects

Dyspepsia, nausea, vomiting, heartburn, dry mouth, abdominal discomfort, abdominal bloating, abdominal pain, diarrhea, constipation, loss of appetite, skin rash, urticarial-like erythema, itching, facial swelling, chills, fever, purulent rhinitis accompanied by leukocytosis, altered taste sensation, taste changes, oral paralysis sensation, arm paralysis sensation, headache, leg pain, extreme fatigue

This medication should be stored in a container that blocks light since it may degrade in light. Additionally, it should be kept in a sealed container to avoid contact with air, and it is important to maintain a storage temperature between 1°C and 30°C.

Appearance

Brown ampoules containing a colorless solution for injection

Package unit

2 mL/ampoule X 50