YABAO Enteric-coated Aspirin Tablets For Cerebrovascular Disease 25mg*60

[Drug Name]
Generic Name: Enteric-Coated Aspirin Tablets
Trade Name: Yabao Enteric-Coated Aspirin Tablets 25mg x 60 Tablets

[Main Ingredients]
The main ingredient of this product is aspirin. Chemical name: 2-(Acetoxy)benzoic acid. Molecular formula: C9H8O4. Molecular weight: 180.16

[Properties]
This product is an enteric-coated tablet that appears white after removal of the coating.

[Indications/Main Functions]
This product is a nonsteroidal anti-inflammatory drug. It is clinically indicated for the following conditions: 1. Antithrombotic: This product inhibits platelet aggregation and can prevent thrombosis. It is clinically used to prevent thrombosis following transient ischemic attack, myocardial infarction, atrial fibrillation, prosthetic heart valves, arteriovenous fistula, or other surgical procedures. It can also be used to treat unstable angina. 2. Analgesic and Antipyretic: It can relieve mild to moderate pain, such as headaches, toothaches, neuralgia, muscle pain, and menstrual pain. It is also used to reduce fever in colds and flu. This product only relieves symptoms and does not treat the underlying cause of pain and fever, so other medications must be used to treat the underlying condition. 3. Anti-inflammatory and Anti-rheumatic: It is commonly used to treat rheumatic fever. It can reduce fever, improve joint symptoms, and lower erythrocyte sedimentation rate, but it cannot eliminate the underlying pathological changes of rheumatic fever, nor can it treat or prevent heart damage or other complications. 4. Arthritis: In addition to rheumatoid arthritis, this product is also used to treat rheumatoid arthritis, improving symptoms, but the underlying cause must be treated simultaneously. It is also used to relieve skeletal muscle pain in osteoarthritis, ankylosing spondylitis, juvenile arthritis, and other non-rheumatic inflammatory conditions. However, its use in these conditions has been limited in recent years. 5. In pediatrics, it is used to treat mucocutaneous lymph node syndrome (Kawasaki disease).

[Specifications]
25mg*60 tablets (Yabao)

[Dosage and Administration]
1. Oral dosage for adults. ① For antipyretics and analgesia, take 0.3-0.6g orally three times daily, or every four hours if necessary. For anti-rheumatic use, take 3-6g orally daily, divided into four doses. For platelet inhibition, use a lower dose, such as 80-300mg once daily. ④ For the treatment of biliary ascariasis, take 1g orally two or three times daily for two or three days. Discontinue use 24 hours after paroxysmal colic stops, and then proceed with deworming. 2. Oral dosage for children: ① For antipyretics and analgesia, take 1.5g/m² daily, divided into four or six doses, or 5-10mg/kg per dose, or 60mg per year, divided into four or six hours if necessary. ② For rheumatism: 80-100 mg/kg daily based on body weight, divided into 3-4 doses. If no effect is seen within 1-2 weeks, the dosage can be adjusted based on blood concentrations. In some cases, the dosage may need to be increased to 130 mg/kg daily. For small infants with mucocutaneous lymphadenopathy (Kawasaki disease), the initial dosage is 80-100 mg/kg daily based on body weight, divided into 3-4 doses. After 2-3 days of fever subsidence, the dosage should be increased to 30 mg/kg daily, divided into 3-4 doses. This dosage can be continued for 2 months or longer. During periods of thrombocytosis and hypercoagulability, the dosage can be 5-10 mg/kg once daily.

[Adverse Reactions]
Adverse reactions are rare at doses typically used for antipyretics and analgesia. However, long-term, high-dose use (e.g., for rheumatic fever), especially when the blood concentration is above 200 μg/ml, is more likely to cause adverse reactions. The higher the blood concentration, the more pronounced the adverse reactions. 1. Common gastrointestinal reactions (incidence 3%-9%) include nausea, vomiting, and upper abdominal discomfort or pain (caused by direct irritation of the gastric mucosa), which generally resolve after discontinuation of the drug. Long-term or high-dose use may cause gastrointestinal bleeding or ulcers. 2. Central nervous system: Reversible tinnitus and hearing loss may occur, often occurring after a certain course of treatment and when blood concentrations reach 200-300 μg/mL. 3. Allergic reactions: These occur in 0.2% of patients and manifest as asthma, urticaria, angioedema, or shock. These reactions usually occur in susceptible individuals, leading to rapid onset of respiratory distress and, in severe cases, death. This is known as aspirin asthma. Some cases present with a triad of aspirin allergy, asthma, and nasal polyps, often linked to genetic and environmental factors. 4. Hepatic and renal impairment: This is dose-dependent, particularly when excessive doses reach blood concentrations of 250 μg/mL. These impairments are reversible and resolve after discontinuation of the drug. However, there have been reports of renal papillary necrosis.

[Contraindications]
1. Patients with known hypersensitivity to this drug; 2. Patients with asthma, urticaria, or other allergic or anaphylactic reactions induced by aspirin or other NSAIDs; 3. Contraindicated for the treatment of perioperative pain following coronary artery bypass grafting (CABG); 4. Patients with a history of gastrointestinal bleeding or perforation after NSAID use; 5. Patients with active peptic ulcers/bleeding, or a history of recurrent ulcers/bleeding; 6. Patients with severe heart failure.

[Drug Interactions]
1. Concomitant use with other NSAIDs does not enhance efficacy because this drug may reduce the bioavailability of other NSAIDs. Furthermore, gastrointestinal side effects (including ulcers and bleeding) may be increased. Furthermore, due to the enhanced inhibitory effect on platelet aggregation, the risk of bleeding at other sites may be increased. Long-term, high-dose concomitant use of this drug with acetaminophen may cause renal disease, including renal papillary necrosis, renal cancer, or bladder cancer. 2. Concomitant use with any medication that can cause hypoprothrombinemia, thrombocytopenia, decreased platelet aggregation, or gastrointestinal ulcer bleeding may aggravate coagulopathy and cause bleeding. 3. Concomitant use with anticoagulants (such as dicoumarol and heparin) or thrombolytics (such as streptokinase and urokinase) may increase the risk of bleeding. 4. Urine alkalinizing drugs (such as sodium bicarbonate) and antacids (when used in large quantities over a long period of time) may increase the urinary excretion of this drug, reducing blood concentrations. However, discontinuation of alkalinizing drugs after the blood concentration has stabilized may increase blood concentrations to toxic levels. Carbonic anhydrase inhibitors can alkalinize the urine but can cause metabolic acidosis, which not only reduces blood concentrations but also increases the amount of this drug penetrating into brain tissue, thereby increasing toxic reactions. 5. Uric acidifying drugs may reduce the excretion of this drug, increasing blood concentrations. For patients whose blood concentration of this drug has reached a stable state, the addition of uricosuric agents may result in elevated blood concentrations and increased toxic reactions. 6. Glucocorticoids (also known as corticosteroids) can increase salicylate excretion. To maintain this drug's blood concentration, the dose should be increased if necessary when used concomitantly. Long-term concomitant use of this drug with corticosteroids, especially at high doses, increases the risk of gastrointestinal ulcers and bleeding. Therefore, the concomitant use of these two drugs is currently not recommended clinically. 7. The hypoglycemic effect of insulin or oral hypoglycemic agents may be enhanced and accelerated when used concomitantly with this drug. 8. Concomitant use with methotrexate (MTX) may reduce protein binding of methotrexate, decreasing its renal excretion, leading to elevated blood concentrations and potentially increased toxic reactions. 9. The uricosuric effect of probenecid or sulfinpyrazone may be reduced by concomitant use of this drug; this reduction is significant when the blood concentration of salicylate is >50 μg/ml, and even more so when it is >100-150 μg/ml. In addition, probenecid can reduce the clearance of salicylates from the kidneys, thereby increasing the plasma concentration of the latter.

[Precautions]
1. Avoid concomitant use with other NSAIDs, including selective COX-2 inhibitors. 2. Use the lowest effective dose for the shortest treatment duration necessary to control symptoms to minimize adverse reactions. 3. Gastrointestinal bleeding, ulceration, and perforation are possible adverse reactions at any time during treatment with all NSAIDs, and the risk of these reactions can be fatal. These adverse reactions may be accompanied by or without warning symptoms, regardless of the patient's history of gastrointestinal adverse reactions or serious gastrointestinal events. NSAIDs should be used with caution in patients with a history of gastrointestinal conditions (ulcerative colitis, Crohn's disease) to avoid exacerbating their condition. If gastrointestinal bleeding or ulceration occurs while taking this drug, the drug should be discontinued. Elderly patients experience an increased frequency of adverse reactions with NSAIDs, particularly gastrointestinal bleeding and perforation, which can be fatal. 4. Clinical trials of multiple COX-2 selective and non-selective NSAIDs for up to three years have shown that this product may increase the risk of serious cardiovascular thrombotic adverse events, myocardial infarction, and stroke, which may be fatal. All NSAIDs, including COX-2 selective and non-selective drugs, may have similar risks. Patients with cardiovascular disease or risk factors for cardiovascular disease are at greater risk. Even in the absence of prior cardiovascular symptoms, physicians and patients should remain vigilant for the occurrence of such events. Patients should be informed of the symptoms and/or signs of serious cardiovascular safety and the steps to take if they occur. Patients should be alert to symptoms and signs such as chest pain, shortness of breath, weakness, and slurred speech, and should seek medical attention immediately if any of these symptoms or signs occur. 5. Like all nonsteroidal anti-inflammatory drugs (NSAIDs), this product may cause new-onset hypertension or worsen existing hypertension, any of which may increase the incidence of cardiovascular events. Patients taking thiazide or myeloid diuretics while taking nonsteroidal anti-inflammatory drugs (NSAIDs) may experience decreased efficacy of these drugs. Nonsteroidal anti-inflammatory drugs (NSAIDs), including this product, should be used with caution in patients with hypertension. Blood pressure should be closely monitored at the initiation and throughout treatment with this product. 6. Use with caution in patients with a history of hypertension and/or heart failure (e.g., fluid retention and edema). 7. NSAIDs, including this product, may cause life-threatening and serious skin adverse reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). These serious events can occur without warning. Patients should be informed of the signs and symptoms of serious skin reactions, and this product should be discontinued at the first appearance of a skin rash or other signs of an allergic reaction.

[Pediatric Use]
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 condition not commonly seen in China.

[Use in Elderly Patients]
Elderly patients are more susceptible to toxic reactions due to decreased renal function.

[Overdose]
Manifestations of overdose: 1. Mild, known as salicylic acid reaction, is more common in patients treated with this drug for rheumatic conditions and can include headache, dizziness, tinnitus, deafness, nausea, vomiting, diarrhea, drowsiness, mental confusion, sweating, rapid breathing, thirst, involuntary movements of the hands and feet (mostly in the elderly), and visual impairment. 2. Severe, including hematuria, convulsions, hallucinations, severe mental disturbances, dyspnea, and unexplained fever. Mental and respiratory disturbances are more pronounced in children.

[Pharmacology and Toxicology]
Pharmacology: ① Analgesic effect: This drug primarily acts by inhibiting the synthesis of prostaglandins and other substances that sensitize pain to mechanical or chemical stimuli (such as bradykinin and histamine), making it a peripheral analgesic. However, the possibility of central analgesia (possibly through the hypothalamus) cannot be ruled out. ② Anti-inflammatory effect: The exact mechanism is unclear, but it may be due to its action on inflamed tissues, inhibiting the synthesis of prostaglandins and other substances that can cause inflammatory reactions (such as histamine). Inhibition of lysosomal enzyme release and leukocyte chemotaxis may also be involved. ③ Antipyretic effect: This antipyretic effect may occur by acting on the hypothalamic thermoregulatory center, causing peripheral vasodilation, increased skin blood flow, sweating, and increased heat dissipation. This central effect may be related to the inhibition of prostaglandin synthesis in the hypothalamus; ④ Anti-rheumatic effect: The anti-rheumatic mechanism of this product, in addition to antipyretic and analgesic effects, mainly lies in its anti-inflammatory effect; The effect of inhibiting platelet aggregation: It works by inhibiting platelet cyclooxygenase and reducing the production of prostaglandins.