Approval Date:
Date of revision:
Aminoblast Hydrochloride Capsules Instructions
Please read the instructions carefully and use under the guidance of a physician
[Drug Name]
Generic Name: Ambroxol Hydrochloride Capsules
English Name:Ambroxol Hydrochloride Capsules
Hanyu Pinyin:Yansuan Anxiusuo Jiaonang
[Ingredients]
The main ingredient of this product is Ambroxol Hydrochloride.
The chemical name is: trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride
Chemical structure formula:
Molecular Formula:C13H18Br2N2O
– HCl
Molecular weight:414.57
[Properties] The contents of this product are white or off-white granules or powder.
[Indications]
For acute and chronic respiratory diseases, such as acute and chronic Bronchitis, bronchial asthma, bronchial dilatation, tuberculosis, etc., which cause sticky sputum and difficult coughing.
[Specifications]30[Specifications]30 family:equivocal”>mg
[dosage]
To be taken orally with meals in adults and12children over the age of 30mg per dose(1capsule) daily3times, which can be reduced to 2times per day for long-term users.
[Adverse Reactions]
Sometimes rash, nausea, stomach upset, lack of appetite, abdominal pain, diarrhea.
Other allergic reactions, including anaphylaxis, angioedema, urticaria, and pruritus.
Other gastrointestinal reactions such as gastrointestinal dysfunction including vomiting and dyspepsia.
Other neurological reactions, including headache and dizziness.
Rare severe skin reactions, including erythema multiforme, Stevens-Johnson syndrome (SJS)/Toxic Epidermal Necrolysis Loosening Disease (TEN) ) and acute generalized eruptive pustulosis.
If serious adverse reactions occur, discontinue treatment with this product immediately.
[Contraindicated]
Not recommended for those with known hypersensitivity to Ambroxol Hydrochloride or other ingredients of this product.
During the first3 months of pregnancy Prohibited for women.
[Caution]
1. Use with caution in pregnant and lactating women. .
2. Please consult your physician or pharmacist for dosage for children. .
3. Concomitant use with central cough suppressants (e.g., dextromethorphan) should be avoided to avoid blockage of the airway by diluted sputum.
4. This product is a mucus regulator and is only useful for coughing up sputum symptoms. If you do not see improvement after using7days, you should seek medical advice promptly.
5. If overdose or serious adverse reactions occur, seek immediate medical attention. .
6. Discontinue if allergic to this product; use with caution in allergic individuals. 6.
7. Not to be used if there is any change in the properties of this product. .
8. Keep this product out of the reach of children. .
9. Must be used by children under adult supervision. .
10. Consult your physician or pharmacist before using this product if you are using other medications. .
11. A few cases of severe skin damage have been reported, such as Stevens-Johnson syndrome and toxic epidermolysis bullosa, associated with the duration of expectorant medication (e.g., amiloride hydrochloride). Most of these cases can be explained by the severity of the patient’s underlying disease and/ or combined medications. In addition, in the early stages of Stevens-Johnson syndrome or toxic epidermolysis bullosa, patients may first present with nonspecific flu-like prodromal symptoms, such as fever, body aches, rhinitis, cough and sore throat. These non-specific flu-like prodromal symptoms can be misleading and may start with symptomatic treatment with cough and cold medications. Therefore, if new skin or mucosal lesions develop, seek immediate medical attention and, as a precautionary measure, discontinue the use of amiloride hydrochloride.
12. For patients with impaired renal function and severe liver disease, use this product only after consultation with a physician.
13. This product contains lactose per capsule90mg. The maximum recommended daily dose contains540mg of lactose. With rare hereditary galactose intolerance,Lapplactase deficiency or glucose-galactose malabsorption should not be taken by patients with this product.
14. This product has no effect on driving or mechanical ability.
[For pregnant and lactating women]
Pregnancy
Animal studies have not revealed any teratogenic effects. There are no teratogenic effects in animals and no teratogenic effects in humans are expected. In fact, studies of teratogenic effects in humans have been demonstrated in two species to date.
There are insufficient clinical data to evaluate the teratogenic effects and fetal toxicity of amiloride hydrochloride during pregnancy.
Therefore, try not to use Ambroxol hydrochloride during pregnancy.
Lactation
This product is not recommended for use during breastfeeding.
[For Children]
See [Dosage].
[Geriatric Use]
No dose adjustment is required in elderly patients.
[Drug Interactions]
1. Concomitant administration of this product with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) may result in increased antibiotic concentrations in lung Tissue concentrations are elevated.
2. Drug interactions may occur if used concurrently with other drugs; consult your physician or pharmacist for details.
[Overdose]
Medication overdose cases should be treated symptomatically.
[Pharmacology and Toxicology]
This product is a mucolytic agent, which can increase the secretion of respiratory mucosal plasma glands and decrease the secretion of mucus glands, thus reducing the viscosity of sputum, promoting the secretion of lung surface active substances, increasing the movement of bronchial cilia, and making sputum easy to cough up.
[Pharmacokinetics]
Ambroxol hydrochloride is rapidly absorbed in the intestine after oral administration. It has a hepatic first-pass effect with a bioavailability of approximately 70%. Peak plasma concentrations occur about 2hours after dosing. The increase in blood concentration is directly proportional to the dose. At therapeutic doses, plasma protein binding is approximately 90%. The large volume of distribution of this product demonstrates that it is widely distributed in the blood vessels, especially in the lungs. The elimination half-life is 6 to 12 hours. There was no drug accumulation after multiple repeated doses. The two major metabolites are glucuronide conjugates, which are excreted primarily in the urine (83% of the administered dose). The metabolizing enzyme of amiloride hydrochloride is CYP3A4.
No dose adjustment is required in elderly patients and patients with hepatic impairment. No data are available for patients with renal impairment.
[storage]
Store under shade and seal.
[Packaging]
Polyvinyl chloride solid pharmaceutical hard tablets and pharmaceutical aluminum foil:10grain/plateplate×3board/boxes.
[Expiration date] 18months.
[Implementation Standard]
[Approval Number]
State Drug CertificateH20000282
[Manufacturer]
Company Name: Shanghai Xinyi Tianping Pharmaceutical Co.
Manufacturing Address: Jindu Road, Minhang District, Shanghai4598 family:equals”>No.
Postal Code:201108
Phone Number:021-54428899
Fax Number:021-54425880