Ambroxol hydrochloride injection(Children)
Generic name:Ambroxol Hydrochloride Injection
Active ingredient:Ambroxol Hydrochloride
Excipient:Citric acid, disodium hydrogen phosphate, sodium chloride and water for injection
Molecular formula:C13H18Br2N2O·HCl
Molecular weight:414.57
Description:A colorless clear liquid.
Indications
This product is indicated for acute and chronic lung diseases accompanied by abnormal secretion of sputum and poor sputum function, the expectorant treatment for chronic bronchitis exacerbation, asthmatic bronchitis and bronchial asthma for example.It can also be used for prevention of pulmonary complications after surgery and treatment of infant respiratory distress syndrome (IRDS) in preterm and neonates.
Strength
1ml:7.5mg
Dosage and administration
Prevention and treatment：Children aged 2-6: 3 times a day, 7.5 mg each time; children under 2 years: 2 times a day, 7.5mg each time. All are slow intravenous infusion.
Treatment of infant respiratory distress syndrome (IRDS):The total daily dose is calculated based on infant weight and 30 mg/kg is administered in 4 divided doses.
Syringe pumps should be used for administration with at least 5 minutes of intravenous injection duration.
The injection can also be used intravenously with glucose, fructose, saline or Ringer's solution.
Adverse effects
The incidence of adverse reactions is defined as follows.
Very common
≥1/10
Common
≥1/100,
while＜1/10
Uncommon
≥1/1000,
while＜1/100
Rare
≥1/10000,
while＜1/1000
Very rare
＜1/10000
Unknown
Existing data cannot assess its frequency
1. Immune system, skin and mucosa tissues diseases: = 1\*GB3 eq \o\ac(○,1)1Uncommon: erythema, =2\*GB3;eq \o\ac(○,2)2Unknown: Allergic reactions (including anaphylactic shock), angioneurotic edema, rash, urticaria, pruritus, and other hypersensitivity reactions. The relationship between the reported severe acute allergic reactions and the drug is not yet clear, and these patients are also often allergic to other substances.
2. Gastrointestinal diseases: = 1\*GB3 eq \o\ac(○,1)1Uncommon: dry mouth, constipation, runny nose and dry throat, = 2\*GB3 eq \o\ac(○,2)2Unknown: Stomach burning, nausea, vomiting, diarrhea, indigestion and abdominal pain.
3. Respiratory system, thorax and mediastinal diseases: uncommon, runny nose, dyspnea (one of the hypersensitivity symptoms).
4. Kidney and urinary system diseases: uncommon, difficulty urinating.
5. Systemic diseases and localized abnormalities in administration: uncommon, elevated body temperature, chills, and mucous membrane reactions.
Contraindication
It is known that allergy to ambroxol hydrochloride or other formulation ingredients should not be used.
Precaution
1, Warning There was a report of severe anaphylactic shock on this product in the post-market safety monitoring, therefore, it should be used with caution in patients with a special population, allergies, and hypersensitivity (such as the airway hyperresponsiveness of bronchial asthma).If an allergic reaction occurs after medication, the drug should be discontinued immediately and given symptomatic treatment according to the severity of the reaction. Once anaphylactic shock occurs, first aid should be given immediately.
2, Use caution The following conditions should be treated with caution:= 1\*GB3 eq \o\ac(○,1)1Liver, renal insufficiency patients;= 2\*GB3 eq \o\ac(○,2)2Gastric ulcer patients; = 3\*GB3 eq \o\ac(○,3)3Patients with impaired bronchial cilia motor function and a large amount of secretions in the respiratory tract (Patients with malignant cilia syndrome may have a risk of secretions blocking the airways); = 4\*GB3 eq \o\ac(○,4)4Glaucoma patients.
3, General precautions
(1)It is forbidden to mix this product with other drugs in the same container. Pay attention to the compatibility of the drug. Special care should be taken to avoid compatibility with cephalosporin antibiotics and Chinese medicine injections.
(2)Do not mix this product (pH 5.0) with other alkaline solutions with a pH greater than 6.3, as the increase in pH will cause precipitation of free base.
(3)If the injection speed is too fast during intravenous administration, very few patients may experience headaches, fatigue, exhaustion, and heavy lower limbs.
(4)In rare cases, severe skin reactions have occurred, such as Stevens-Johnson syndrome and Lyell’s syndrome (toxic epidermal necrolysis; TEN), and the appearance of these symptoms is related to the state of the patient at the time of use. Most of the above cases are caused by underlying diseases or concomitant medications. If a patient develops new skin or mucosal damage after use, stop using the product and promptly report to the doctor.
Pregnant and lactating women medication
Preclinical testing and extensive clinical experience after 28 weeks of gestation show no adverse effects on pregnancy. However, drugs should be used with caution during pregnancy, especially during the first trimester of pregnancy. The drug can enter the milk, but the therapeutic dose should have no effect on the baby.
Children medication
Refer to dosage and administration.
Elderly medication
No special precautions.
Medicine interactions
Combination therapy of this product and antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) in can increase the concentration of antibiotics in lung tissue.
Overdose
So far there have been no reports of symptoms on overdose of this medicine.
Pharmacokinetics
The distribution of this product from the blood to the tissue is fast and significant, and the lung is the main target organ. Plasma half-life is 7-12 hours and there is no cumulative effect. Ambroxol hydrochloride is mainly metabolized in the liver and approximately 90% is cleared by the kidneys.
Pharmacology and toxicology
Pharmacological effects: This product is a metabolite of bromhexine in the body and has the property of promoting the elimination of mucocele and dissolving secretions. It can promote the elimination of viscous secretions in the respiratory tract and reduce the retention of mucus, thus significantly promoting drainage and improving breathing. When the product is used, the patient's mucus secretion can be restored to normal conditions. Cough and sputum levels are usually significantly reduced, and the surface active substances in the respiratory mucosa can thus exert their normal protective functions.
Toxicological effects: Ambroxol hydrochloride has a very low toxicity index in acute toxicity tests. Ames test and micronucleus test showed that ambroxol hydrochloride had no mutagenicity. Carcinogenicity studies in mice and rats showed that ambroxol hydrochloride is not carcinogenic.
Storage
Sealed and kept under 30oC.
Packaging
Brown glass ampoules, 5 ampoules/box, 10 ampoules/box and 20 ampoules/box.
Shelf life
24 months
Specification
YBH02352010
Approval number
GUOYAOZHUNZI H20153028
Active ingredient:Ambroxol Hydrochloride
Excipient:Citric acid, disodium hydrogen phosphate, sodium chloride and water for injection
Molecular formula:C13H18Br2N2O·HCl
Molecular weight:414.57
Description:A colorless clear liquid.
Indications
This product is indicated for acute and chronic lung diseases accompanied by abnormal secretion of sputum and poor sputum function, the expectorant treatment for chronic bronchitis exacerbation, asthmatic bronchitis and bronchial asthma for example.It can also be used for prevention of pulmonary complications after surgery and treatment of infant respiratory distress syndrome (IRDS) in preterm and neonates.
Strength
1ml:7.5mg
Dosage and administration
Prevention and treatment：Children aged 2-6: 3 times a day, 7.5 mg each time; children under 2 years: 2 times a day, 7.5mg each time. All are slow intravenous infusion.
Treatment of infant respiratory distress syndrome (IRDS):The total daily dose is calculated based on infant weight and 30 mg/kg is administered in 4 divided doses.
Syringe pumps should be used for administration with at least 5 minutes of intravenous injection duration.
The injection can also be used intravenously with glucose, fructose, saline or Ringer's solution.
Adverse effects
The incidence of adverse reactions is defined as follows.
Very common
≥1/10
Common
≥1/100,
while＜1/10
Uncommon
≥1/1000,
while＜1/100
Rare
≥1/10000,
while＜1/1000
Very rare
＜1/10000
Unknown
Existing data cannot assess its frequency
1. Immune system, skin and mucosa tissues diseases: = 1\*GB3 eq \o\ac(○,1)1Uncommon: erythema, =2\*GB3;eq \o\ac(○,2)2Unknown: Allergic reactions (including anaphylactic shock), angioneurotic edema, rash, urticaria, pruritus, and other hypersensitivity reactions. The relationship between the reported severe acute allergic reactions and the drug is not yet clear, and these patients are also often allergic to other substances.
2. Gastrointestinal diseases: = 1\*GB3 eq \o\ac(○,1)1Uncommon: dry mouth, constipation, runny nose and dry throat, = 2\*GB3 eq \o\ac(○,2)2Unknown: Stomach burning, nausea, vomiting, diarrhea, indigestion and abdominal pain.
3. Respiratory system, thorax and mediastinal diseases: uncommon, runny nose, dyspnea (one of the hypersensitivity symptoms).
4. Kidney and urinary system diseases: uncommon, difficulty urinating.
5. Systemic diseases and localized abnormalities in administration: uncommon, elevated body temperature, chills, and mucous membrane reactions.
Contraindication
It is known that allergy to ambroxol hydrochloride or other formulation ingredients should not be used.
Precaution
1, Warning There was a report of severe anaphylactic shock on this product in the post-market safety monitoring, therefore, it should be used with caution in patients with a special population, allergies, and hypersensitivity (such as the airway hyperresponsiveness of bronchial asthma).If an allergic reaction occurs after medication, the drug should be discontinued immediately and given symptomatic treatment according to the severity of the reaction. Once anaphylactic shock occurs, first aid should be given immediately.
2, Use caution The following conditions should be treated with caution:= 1\*GB3 eq \o\ac(○,1)1Liver, renal insufficiency patients;= 2\*GB3 eq \o\ac(○,2)2Gastric ulcer patients; = 3\*GB3 eq \o\ac(○,3)3Patients with impaired bronchial cilia motor function and a large amount of secretions in the respiratory tract (Patients with malignant cilia syndrome may have a risk of secretions blocking the airways); = 4\*GB3 eq \o\ac(○,4)4Glaucoma patients.
3, General precautions
(1)It is forbidden to mix this product with other drugs in the same container. Pay attention to the compatibility of the drug. Special care should be taken to avoid compatibility with cephalosporin antibiotics and Chinese medicine injections.
(2)Do not mix this product (pH 5.0) with other alkaline solutions with a pH greater than 6.3, as the increase in pH will cause precipitation of free base.
(3)If the injection speed is too fast during intravenous administration, very few patients may experience headaches, fatigue, exhaustion, and heavy lower limbs.
(4)In rare cases, severe skin reactions have occurred, such as Stevens-Johnson syndrome and Lyell’s syndrome (toxic epidermal necrolysis; TEN), and the appearance of these symptoms is related to the state of the patient at the time of use. Most of the above cases are caused by underlying diseases or concomitant medications. If a patient develops new skin or mucosal damage after use, stop using the product and promptly report to the doctor.
Pregnant and lactating women medication
Preclinical testing and extensive clinical experience after 28 weeks of gestation show no adverse effects on pregnancy. However, drugs should be used with caution during pregnancy, especially during the first trimester of pregnancy. The drug can enter the milk, but the therapeutic dose should have no effect on the baby.
Children medication
Refer to dosage and administration.
Elderly medication
No special precautions.
Medicine interactions
Combination therapy of this product and antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) in can increase the concentration of antibiotics in lung tissue.
Overdose
So far there have been no reports of symptoms on overdose of this medicine.
Pharmacokinetics
The distribution of this product from the blood to the tissue is fast and significant, and the lung is the main target organ. Plasma half-life is 7-12 hours and there is no cumulative effect. Ambroxol hydrochloride is mainly metabolized in the liver and approximately 90% is cleared by the kidneys.
Pharmacology and toxicology
Pharmacological effects: This product is a metabolite of bromhexine in the body and has the property of promoting the elimination of mucocele and dissolving secretions. It can promote the elimination of viscous secretions in the respiratory tract and reduce the retention of mucus, thus significantly promoting drainage and improving breathing. When the product is used, the patient's mucus secretion can be restored to normal conditions. Cough and sputum levels are usually significantly reduced, and the surface active substances in the respiratory mucosa can thus exert their normal protective functions.
Toxicological effects: Ambroxol hydrochloride has a very low toxicity index in acute toxicity tests. Ames test and micronucleus test showed that ambroxol hydrochloride had no mutagenicity. Carcinogenicity studies in mice and rats showed that ambroxol hydrochloride is not carcinogenic.
Storage
Sealed and kept under 30oC.
Packaging
Brown glass ampoules, 5 ampoules/box, 10 ampoules/box and 20 ampoules/box.
Shelf life
24 months
Specification
YBH02352010
Approval number
GUOYAOZHUNZI H20153028
