Ameile Amezinamidi Mesylate Tablets

Brand Name: 阿美乐®(Ameile®)
Generic Name: Aumolertinib Mesilate
Strength: 55mg per tablet (calculated by C₃₀H₃₅N₇O₂), 20 tablets per box
Manufacturer: Jiangsu Haosen Pharmaceutical Group Co., LTD. (a subsidiary of Hansoh Pharmaceutical)
Marketing Authorization Holder: Jiangsu Haosen Pharmaceutical Group Co., LTD.
Approval Date in China: March 18, 2020
Registration Number: 国药准字 H20200004
Storage: Sealed, stored below 30℃, away from moisture and direct sunlight, keep out of reach of children

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1. Indications and Usage
Hemostatic Agent:
Indicated for the treatment of hemorrhage caused by hyperfibrinolysis (excessive breakdown of blood clots).
Clinical Scenarios:
Commonly used for surgical bleeding (e.g., prostate, thyroid, lung surgeries), obstetric and gynecologic bleeding, hemoptysis (coughing up blood) due to pulmonary tuberculosis, and hematuria (blood in urine).
2. Dosage and Administration
Route of Administration:
Oral administration.
Adult Dosage:
Single Dose: 0.25 g to 0.5 g per time.
Frequency: 2 to 3 times daily.
Maximum Daily Dose: Total daily dose should not exceed 2 g.
Duration:
Duration should be determined by the physician based on the severity of bleeding.
3. Mechanism of Action
Antifibrinolytic Activity:
Aminomethylbenzoic acid is a lysine analog. It acts by competitively inhibiting the binding of plasminogen to fibrin.
Physiological Effect:
This inhibition prevents the activation of plasminogen to plasmin, thereby protecting fibrin clots from degradation by plasmin and achieving hemostasis.
4. Safety and Warnings
Thrombosis Risk:
Long-term use or overdose may promote thrombus formation. Use with caution in patients with a history of thromboembolism or a tendency toward thrombosis (e.g., acute myocardial infarction).
Renal Impairment:
The drug is excreted via the kidneys. Dosage reduction is recommended for patients with chronic renal insufficiency to prevent accumulation.
Contraindications:
Contraindicated in patients with a history of thromboembolic disease or those who are hypersensitive to the drug.
5. Adverse Reactions
Common Symptoms:
Occasionally causes dizziness, headache, or abdominal discomfort.
Serious Risks:
Overdose or prolonged use can lead to thrombosis.
6. Drug Interactions
Hormonal Contraceptives & Estrogens:
Concurrent use with oral contraceptives or estrogen preparations may increase the risk of thrombosis.
Coagulation Factors:
Should not be used simultaneously with other coagulation factors (e.g., Factor IX) to avoid excessive thrombosis.
7. Pharmaceutical Information
Chemical Name:
Aminomethylbenzoic Acid.
Appearance:
White or off-white tablets.
Storage:
Store in a tightly closed container, protected from moisture.

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