Aspirin

[Drug name]

Common name: Aspirin Enteric-coated Tablets

English name: Aspirin Enteric-coated Tablets

Chinese Pinyin: Asipilin Changrong Pian

[Ingredients]

The main ingredient is aspirin

Molecular formula: C9H8O4

Molecular weight: 180.16.

[Characteristics]

This product is a white enteric-coated tablet, which turns white after the coating is removed.

[Indications]

Inhibit platelet aggregation, prevent thrombosis, treat and prevent transient ischemic attacks, cerebral thrombosis, coronary heart disease, myocardial infarction, migraine, artificial heart valves, arteriovenous leakage and other post-operative thrombosis, thromboangiitis obliterans, etc.

[Usage and Dosage]

This product should be taken with warm water after meals and not on an empty stomach. This product is an enteric-coated tablet and must be taken whole. When treating myocardial infarction, the first tablet should be crushed or chewed before taking.

Dosage and frequency

1. For unstable angina pectoris, it is recommended to take one aspirin tablet per day. 2. For acute myocardial infarction, it is recommended to take 1 aspirin tablet per day. 3. To prevent recurrent myocardial infarction, it is recommended to take 3 aspirin tablets per day. 4. To prevent transient reduction of blood flow in the brain and to prevent cerebral infarction after early symptoms have appeared, it is recommended to take one aspirin tablet per day.

[Adverse reactions]

The dosage generally used for antipyretic and analgesic rarely causes adverse reactions. Long-term use of large amounts of drugs (such as the treatment of rheumatic fever), especially when the blood concentration of the drug is >200 μg/ml, is more likely to cause adverse reactions. The higher the blood drug concentration, the more obvious the adverse reactions will be.

(1) Gastrointestinal reactions (incidence 3% to 9%) such as nausea, vomiting, upper abdominal discomfort or pain (due to direct stimulation of the gastric mucosa by this product) are common, and most of them disappear after stopping the drug. Long-term or high-dose use may cause gastrointestinal bleeding or ulcers.

(2) Central nervous system: reversible tinnitus and hearing loss occur, usually after taking a certain course of treatment and the blood concentration reaches 200-300 g/L.

(3) Allergic reaction: occurs in 0.2% of patients, manifesting as asthma, urticaria, angioedema or shock. Mostly susceptible

[Contraindications]

1. It is prohibited for those who are allergic to this product;

2. The following situations should be prohibited:

① Gastrointestinal bleeding caused by active ulcer disease or other reasons;

② Hemophilia or thrombocytopenia;

③ People with a history of allergy to aspirin or other NSAIDs, especially those with asthma, neuroangioedema, or shock.

[Precautions]

(1) Fork allergic reaction. People who are allergic to this product may also be allergic to another salicylate or another non-salicylic acid NSAID. But not absolutely. One must be alert to the possibility of cross-allergy.

(2) Interference with diagnosis:

1) When the daily dosage exceeds 2.4g during the period, false positives may occur in the copper sulfate urine glucose test. Glucose enzyme urine sugar test may cause false negatives;

2) Can interfere with urine ketone body test;

3) When the blood drug concentration exceeds 130μg/ml, the colorimetric method to measure blood uric acid may give a false high value, but the uricase method is not affected;

4) The determination of urinary 5-hydroxyindoleacetic acid (5-HIAA) by fluorescence method may be interfered by this product;

5) The determination of urinary vanillylmandelic acid (VMA), due to different methods, the results may be high or low;

6) Because this product inhibits platelet aggregation, it can prolong bleeding time. Doses as small as 40 mg/day can also affect platelet function, but there have been no clinical reports of bleeding caused by small doses (<150 mg/day);

7) Liver function tests, when the blood drug concentration is >250 μg/ml, abnormal changes in alanine aminotransferase, aspartate aminotransferase and serum alkaline phosphatase may occur, and political parties can be restored when the dose is reduced;

8) High-dose application, especially when the blood concentration is >300 μg/ml, prothrombin time can be prolonged;

9) Serum cholesterol will be low if the daily dosage exceeds 5g;

10) Since this product acts on the renal tubules, potassium excretion increases, which may lead to a decrease in blood potassium;

11) When large doses of this product are used, lower results can be obtained by measuring serum thyroxine (T4) and triiodothyronine (T3) using radioimmunoassay; 12) Due to the competition between this product and phenolsulfonphthalein for excretion in the renal tubules, the excretion of phenolsulfonphthalein is reduced (ie, PSP excretion test)

(3) The following situations should be used with caution:

1) When there are asthma and other allergic reactions;

2) People with glucose-6-phosphate dehydrogenase deficiency (this product occasionally causes hemolytic anemia);

3) Gout (this product can affect the action of other uricosuric drugs and may cause uric acid retention in small doses);

4) Decreased liver function can aggravate hepatotoxic reactions and bleeding tendencies, and patients with hepatic insufficiency and cirrhosis are prone to renal adverse reactions;

5) Cardiac insufficiency or hypertension, which may cause heart failure or pulmonary edema when used in large quantities;

6) Renal insufficiency is at risk of aggravating renal toxicity;

7) Thrombocytopenia.

(4) When taking large amounts of medicine for a long time, hematocrit, liver function and serum salicylic acid content should be checked regularly.

[Medicine for Special Populations]

Children’s Precautions:

Pediatric patients, especially those with fever and dehydration, are prone to toxic reactions. The use of this product in children with acute febrile diseases, especially influenza and chickenpox, may be related to the occurrence of Reye's syndrome, which is rare in China.

Precautions during pregnancy and lactation:

This product easily passes through the placenta. Animal experiments show that application of this product in the first 3 months of pregnancy can cause teratogenesis, such as spina bifida, cranial cleft, facial cleft, leg deformity, and underdevelopment of the central nervous system, internal organs and bones. Fetal defects have also been reported in humans after the use of this product. In addition, long-term and large-scale use of this product in the third month after pregnancy can prolong the pregnancy period and increase the risk of postpartum syndrome and prepartum hemorrhage. Use in the last 2 weeks of pregnancy can increase the risk of fetal bleeding or neonatal hemorrhage. Long-term use in late pregnancy may also cause contraction of the fetal ductus arteriosus or early atresia, leading to persistent pulmonary hypertension and heart failure in newborns. There have been reports of an increased incidence of stillbirth or neonatal death (possibly due to ductus arteriosus atresia, antepartum hemorrhage, or low body weight) due to overdose or abuse of this product during the third trimester. However, the above adverse reactions have not been found using general therapeutic doses. This product can be excreted in breast sweat. Breastfeeding women take 650 mg orally orally. The drug concentration in breast milk can reach 173-483 μg/ml 5 to 8 hours later. Therefore, babies may have adverse reactions when taking high-dose medication for a long time.

Precautions for the elderly:

Elderly patients are prone to toxic reactions when taking this product due to decreased renal function.

[Drug Interactions]

(1) The efficacy is not enhanced when used together with other non-steroidal anti-inflammatory analgesics, because this product 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 is also increased. Long-term use of large amounts of this product together with acetaminophen may cause renal lesions including renal papillary necrosis, renal cancer or bladder cancer.

(2) When used together with any drug that can cause hypoprothrombinemia, thrombocytopenia, reduced platelet aggregation function, or gastrointestinal ulcer bleeding, there may be a risk of aggravating coagulation disorders and causing bleeding.

(3) Use together with anticoagulants (dicumarin, heparin, etc.) and thrombolytic drugs (streptokinase, urokinase) may increase the risk of bleeding.

(4) Urinary alkalinizing drugs (sodium bicarbonate, etc.) and antacids (used in large quantities for a long time) can increase the excretion of this product in the urine and reduce the blood drug concentration. However, when the blood concentration of this product has reached a stable state and the alkaline drug is stopped, the blood concentration of this product may increase to a toxic level. Carbonic anhydrase inhibitors can alkalinize urine, but can cause metabolic acidosis, which not only reduces blood concentration but also increases the amount of this product penetrating into brain tissue, thereby increasing toxic reactions.

(5) Uric acidifying drugs can reduce the excretion of this product and increase its blood concentration. The addition of uric acidifying drugs to patients whose blood concentration of this product has reached a stable state may lead to an increase in the blood concentration of this product and increased toxic reactions.

(6) Glucocorticoids (hormones for short) can increase the excretion of salicylates. In order to maintain the blood concentration of this product when used together, the dose of this product should be increased if necessary. This product is used together with hormones for a long time. Especially when used in large quantities, there is an increased risk of gastrointestinal ulcers and bleeding. For this reason, clinical use of these two drugs at the same time is currently not recommended.

(7) The hypoglycemic effect of insulin or oral hypoglycemic drugs can be enhanced and accelerated by being used together with this product.

(8) When used together with methotrexate (MTX), it can reduce the binding of methotrexate to protein, reduce its excretion from the kidneys, increase the blood concentration of the drug, and increase toxic reactions.

(9) The uricosuric effect of probenecid or sulfinpyrazone can be reduced by simultaneous application of this product; it is significantly reduced when the blood concentration of salicylate is 50 μg/ml, and even more so when it is >100-150 μg/ml. In addition, probenecid may decrease the renal clearance of salicylates, thereby increasing plasma concentrations of salicylates.

[Pharmacological effects]

① Analgesic effect: Mainly by inhibiting the synthesis of prostaglandins and other substances that can make pain sensitive to mechanical or chemical stimulation (such as bradykinin, histamine), it is a peripheral analgesic. However, the possibility of central analgesia (which may act on the hypothalamus) cannot be ruled out;

② Anti-inflammatory effect: The exact mechanism is not yet clear, but it may be due to the fact that this product acts on inflammatory tissues and exerts anti-inflammatory effects by inhibiting the synthesis of prostaglandins or other substances that can cause inflammatory reactions (such as histamine). Inhibiting the release of lysosomal enzymes and leukocyte chemotaxis may also be related to it;

③ Antipyretic effect: It may act on the hypothalamus thermoregulatory center to cause peripheral blood vessel dilation, increase skin blood flow, sweating, and increase heat dissipation, thereby acting as an antipyretic. This central effect may be related to the inhibition of the synthesis of prostaglandins in the hypothalamus;

④ Anti-rheumatic effect: The anti-rheumatic effect of this product, in addition to its antipyretic and analgesic effects, is mainly anti-inflammatory;

⑤ Inhibition of platelet aggregation: It works by inhibiting platelet cyclooxygenase and reducing the production of prostaglandins.

[Storage]

Sealed. Store below 25`C. It should be taken immediately after removal.

[Specifications]

50mg

[Packaging specifications]

50mg*100s

[Validity period]

60 months, do not use after the validity period.