Product Overview
[Drug Name]
Generic Name: Aspirin Enteric-coated Tablets
Trade Name: Xinhui
English Name: Aspirin Enteric-coated Tablets
Chinese Pinyin: Asipilin Pian
[Ingredients]
Aspirin. Chemical Name: 2-(Acetoxy)benzoic acid, Molecular Formula: C9H8O4, Molecular Weight: 180.2
[Properties]
This product is an enteric-coated tablet that appears white after removal of the coating.
[Indications]
Inhibits platelet aggregation and prevents thrombosis. It is used to treat and prevent transient ischemic attacks, cerebral thrombosis, coronary artery disease, myocardial infarction, migraines, prosthetic heart valves, arteriovenous fistulas, thrombosis after other surgeries, and thromboangiitis obliterans.
[Dosage and Administration]
Oral. Children aged 4 to 8 years, 0.5 tablets at a time; children aged 8 to 14 years, 1 tablet at a time; children over 14 years old and adults, 1 to 2 tablets at a time; if fever or pain persists, the drug can be repeated once every 4 to 6 hours, and no more than 4 times in 24 hours.
[Adverse Reactions]
The doses generally used for antipyretic and analgesic rarely cause adverse reactions. Long-term and large-scale use (such as treatment of rheumatic fever), especially when the drug blood concentration is > 200 μg/ml, is more likely to cause adverse reactions. The higher the blood drug concentration, the more obvious the adverse reactions. (1) Common gastrointestinal reactions include nausea, vomiting, upper abdominal discomfort or pain (caused by direct stimulation of the gastric mucosa by this product) (incidence rate 3% to 9%), which usually disappear after discontinuation of the drug. Long-term or large-dose use may cause gastrointestinal bleeding or ulcers. (2) Central nervous system: reversible tinnitus and hearing loss occur, which usually occur after a certain course of treatment and a blood drug concentration of 200 to 300 g/L. (3) Allergic reaction: This occurs in 0.2% of patients and manifests as asthma, urticaria, angioedema, or shock. Most of these reactions occur in susceptible individuals, who quickly develop breathing difficulties after taking the drug. Severe cases can lead to death, a condition called aspirin asthma. Some cases present with a triad of aspirin allergy, asthma, and nasal polyps, often related to genetic and environmental factors. (4) Damage to liver and kidney function is dose-dependent, especially when the dose is excessive and the blood concentration reaches 250 μg/ml. These damages are reversible and can be reversed after discontinuation of the drug. However, there have been reports of renal papillary necrosis. (5) Symptoms of overdose or poisoning: ① Mild, namely salicylic acid reaction (salicylism), which is more common in patients with rheumatism treated with this product, and manifests as headache, dizziness, tinnitus, deafness, nausea, vomiting, diarrhea, drowsiness, mental disorder, sweating, deep and rapid breathing, thirst, involuntary movements of hands and feet (more common in the elderly) and visual impairment; ② Severe, may cause hematuria, convulsions, hallucinations, severe mental disorder, dyspnea and unexplained fever; mental and respiratory disorders are more obvious in children; laboratory tests in case of overdose may show abnormal EEG, changes in acid-base balance (respiratory alkalosis and metabolic acidosis), hypoglycemia or hyperglycemia, ketonuria, hyponatremia, hypokalemia and proteinuria. 【Contraindications】
1. This product is contraindicated in patients who are allergic to it. 2. This product should be contraindicated in the following cases: ① Active ulcer disease or gastrointestinal bleeding caused by other reasons; ② Hemophilia or thrombocytopenia; ③ Patients with a history of allergy to aspirin or other non-steroidal anti-inflammatory drugs, especially those with asthma, angioedema or shock.
[Precautions]
(1) Cross-allergic reaction. When allergic to this product, you may also be allergic to another salicylate drug or another non-salicylate non-steroidal anti-inflammatory drug. However, this is not absolute. Be vigilant about the possibility of cross-allergy. (2) Interference with diagnosis: 1) When the daily dose exceeds 2.4g, the copper sulfate urine glucose test may show a false positive. 1) False negatives may occur in the glucose test using glucose enzyme; 2) It may interfere with the urine ketone body test; 3) When the blood drug concentration exceeds 130μg/ml, falsely high values may be obtained when measuring blood uric acid using the colorimetric method, but the uricase method is not affected; 4) The determination of urinary 5-hydroxyindoleacetic acid (5-HIAA) using the fluorescence method may be interfered with by this product; 5) The determination of urinary vanillylmandelic acid (VMA) may give high or low results depending on the method used; 6) Because this product inhibits platelet aggregation, it may prolong bleeding time. Doses as low as 40 mg/day can also affect platelet function, but there have been no reports of low doses (<150 mg/day) causing bleeding in clinical practice; 7) Liver function tests: when the blood concentration is >250 μg/ml, alanine aminotransferase, aspartate aminotransferase and serum alkaline phosphatase may show abnormal changes, which can be restored when the dose is reduced; 8) High doses, especially when the blood concentration is >300 μg/ml, can prolong the prothrombin time; 9) Daily doses exceeding 5 g can cause low serum cholesterol; 10) Because this product acts on the renal tubules, it increases potassium excretion, which can lead to decreased blood potassium; 11) When this product is used in large doses, lower results can be obtained by measuring serum thyroxine (T4) and triiodothyronine (T3) by radioimmunoassay; 12) Because this product competes with phenolsulfonphthalein for excretion in the renal tubules, it reduces the excretion of phenolsulfonphthalein (i.e., PSP excretion test) (3) It should be used with caution in the following situations: 1) 1) Patients with asthma and other allergic reactions; 2) Glucose-6-phosphate dehydrogenase deficiency (this product may occasionally cause hemolytic anemia); 3) Gout (this product may affect the effects of other uricosuric drugs and may cause uric acid retention at low doses); 4) Patients with impaired liver function may aggravate liver toxicity and bleeding tendency. Patients with impaired liver function and cirrhosis are prone to adverse renal reactions; 5) Patients with heart failure or hypertension may develop heart failure or pulmonary edema when taking large amounts of the drug; 6) Patients with renal insufficiency may have a risk of aggravated renal toxicity; 7) Patients with thrombocytopenia. (4) When taking large amounts of the drug for a long time, the hematocrit, liver function and serum salicylic acid level should be checked regularly.
[Use in Special Populations]
Precautions for Use in Children:
Pediatric patients, especially those with fever and dehydration, are susceptible to toxic reactions. Use of this drug in children with acute febrile illnesses, especially influenza and chickenpox, may be associated with the development of Reye's syndrome, a rare condition in China.
Precautions for Pregnancy and Lactation:
This drug readily crosses the placenta. Animal studies have shown that use of this drug in the first trimester of pregnancy can cause teratogenic effects, such as spina bifida, skull clefts, facial clefts, leg deformities, and hypoplasia of the central nervous system, internal organs, and skeleton. Fetal defects have also been reported in humans following use of this drug. Furthermore, long-term, high-dose use of this drug in the last three months of pregnancy can prolong pregnancy and increase the risk of post-term labor syndrome and antepartum hemorrhage. Use in the last two weeks of pregnancy can increase the risk of fetal or neonatal hemorrhage. Long-term use in late pregnancy can also cause constriction or premature closure of the fetal ductus arteriosus, leading to persistent pulmonary hypertension and heart failure in the newborn. There have been reports that excessive use or abuse of this drug in late pregnancy has increased the incidence of stillbirth or neonatal death (possibly due to ductus arteriosus occlusion, antepartum hemorrhage or low birth weight). However, the above adverse reactions have not been found when using general therapeutic doses. This drug can be excreted in breast milk. After oral administration of 650 mg to lactating women, the drug concentration in breast milk can reach 173-483 μg/ml 5-8 hours later. Therefore, long-term high-dose use may cause adverse reactions in infants.
Precautions for the elderly: Elderly patients are prone to toxic reactions when taking this drug due to decreased renal function.
[Drug Interactions]
(1) The efficacy of this drug is not enhanced when used with other non-steroidal anti-inflammatory analgesics because this drug can reduce the bioavailability of other non-steroidal anti-inflammatory drugs. In addition, gastrointestinal side effects (including ulcers and bleeding) are increased; in addition, due to the enhanced inhibitory effect on platelet aggregation, the risk of bleeding in other parts of the body may also be increased. Long-term and large-scale use of this drug with acetaminophen may cause kidney diseases including renal papillary necrosis, renal cancer or bladder cancer. (2) When used together with any drug that can cause hypoprothrombinemia, thrombocytopenia, decreased platelet aggregation function or gastrointestinal ulcer bleeding, there is a risk of aggravating coagulation disorders and causing bleeding. (3) When used together with anticoagulants (dicoumarol, heparin, etc.) and thrombolytic drugs (streptokinase, urokinase), the risk of bleeding may be increased. (4) Urine alkalinizing drugs (sodium bicarbonate, etc.) and antacids (long-term and large-scale use) can increase the excretion of this product in the urine, causing the blood concentration to decrease. However, when the blood concentration of this product has reached a stable state and the alkaline drug is discontinued, the blood concentration of this product may rise to a toxic level. Carbonic anhydrase inhibitors can alkalinize the urine, but can cause metabolic acidosis, which not only reduces the blood concentration but also increases the amount of this product that penetrates into the brain tissue, thereby increasing toxic reactions. (5) Uric acidifying drugs can reduce the excretion of this product, causing its blood concentration to increase. Patients whose blood concentration of this product has reached a stable state may experience an increase in blood concentration of this product and an increase in toxic reactions after adding uricosuric drugs. (6) Glucocorticoids (hormones) can increase the excretion of salicylates. When used together, the dose of this product should be increased if necessary to maintain the blood concentration of this product. Long-term use of this product with hormones, especially when used in large quantities, increases the risk of gastrointestinal ulcers and bleeding. For this reason, the simultaneous use of these two drugs is not recommended clinically. (7) The hypoglycemic effect of insulin or oral hypoglycemic drugs can be enhanced and accelerated by the concomitant use of this product. (8) When used together with methotrexate (MTX), it can reduce the binding of methotrexate to proteins, reduce its excretion from the kidneys, increase blood concentrations and increase toxic reactions. (9) The uricosuric effect of probenecid or sulfinpyrazone can be reduced by the simultaneous use of this drug; when the blood concentration of salicylate is 50μg/ml, it is significantly reduced, and it is even more severe when it is >100-150μg/ml. In addition, probenecid can reduce the clearance rate of salicylate from the kidney, thereby increasing the blood concentration of the latter.
[Pharmacological Actions]
① Analgesic effect: It mainly inhibits the synthesis of prostaglandins and other substances that can make pain sensitive to mechanical or chemical stimulation (such as bradykinin and histamine), and is a peripheral analgesic. However, the possibility of central analgesia (possibly acting on the hypothalamus) cannot be ruled out; ② Anti-inflammatory effect: The exact mechanism is still unclear. It may be because this drug acts on inflamed tissues and inhibits the synthesis of prostaglandins or other substances that can cause inflammatory reactions (such as histamine) to exert an anti-inflammatory effect. Inhibition of lysosomal enzyme release and leukocyte chemotaxis may also be involved. ③ Antipyretic effect: This may occur by acting on the hypothalamic thermoregulatory center, causing peripheral vasodilation, increased skin blood flow, sweating, and increased heat dissipation, leading to an antipyretic effect. This central effect may be related to inhibition of prostaglandin synthesis in the hypothalamus. ④ Antirheumatic effect: In addition to its antipyretic and analgesic effects, this product's antirheumatic mechanism primarily lies in its anti-inflammatory properties. ⑤ Platelet aggregation inhibition: This occurs by inhibiting platelet cyclooxygenase, reducing prostaglandin production.
[Storage] Store in a cool, dark place (below 20°C).
[Specification] 50mg x 100 tablets
[Expiry Date] 24 months
[Manufacturer] Company Name: Hunan Xinhui Pharmaceutical Co., Ltd.
