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Aspirin Enteric-coated Tablets for Unstable angina pectoris Acute myocardial infarction
Aspirin Enteric-coated Tablets for Unstable angina pectoris Acute myocardial infarction
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Aspirin Enteric-coated Tablets
Asipilin Changrong Pian
A SI PI LIN CHANG RONG Pian
阿司匹林肠溶片
FUNCTION and INDICATIONS
Inhibition of platelet adhesion and aggregation in the following situations: - Unstable angina pectoris (heart pain due to disturbance of coronary blood flow); - Acute myocardial infarction; - Prevention of recurrent myocardial infarction; - Postoperative arterial vascular surgery (arterial surgery) After interventions, such as aortocoronary bypass grafting, PTCA); - to prevent transient decreased blood flow to the brain (TIA; transient ischemic attack) and the development of early symptoms (such as transient facial or arm muscle paralysis or Prevention of cerebral infarction after transient blindness).
INGREDIENTS
The main ingredient of this product is aspirin.
DESCPRIPTION
This product is white enteric-coated tablet,white after removing the coating.
SPECIFICATION AND PACKAGE
0.1g(100mg)*48 tablets/box.
USAGE AND DOSAGE
This product should be taken with warm water after meals, not on an empty stomach. When treating acute myocardial infarction, the first tablet should be mashed or chewed and taken. After aortocoronary vein bypass grafting (ACVB), the best time to start using aspirin enteric-coated tablets is 24 hours after surgery.
Dosage and frequency of taking:
- Unstable angina (heart pain caused by coronary blood flow disorder), the daily dose of aspirin is 75mg~300mg, and the recommended daily dose of aspirin is 100mg (equivalent to 1 aspirin enteric-coated tablet per day);
- In acute myocardial infarction, the daily dose of aspirin is 100mg~160mg, and the recommended daily dose is 100mg (equivalent to 1 aspirin enteric-coated tablet per day);
- When preventing the recurrence of myocardial infarction, the recommended daily dose of aspirin is 300 mg (equivalent to 3 aspirin enteric-coated tablets per day);
- After arterial vascular surgery (after arterial surgery or interventional surgery, such as aortocoronary bypass grafting, PTCA), the daily dose of aspirin is 100mg~300mg, the recommended daily dose is 100mg (equivalent to 1 aspirin enteric-coated tablet per day) );
- To prevent transient reduction of blood flow to the brain (TIA: transient ischemic attack and prevention of cerebral infarction after early symptoms have appeared), the daily dose of aspirin is 30mg~300mg, and the recommended daily dose is 100mg (equivalent to 1 tablet per day) aspirin enteric-coated tablets);
REFERENCES
ADVERSE REACTION
Common side effects are gastrointestinal reactions, such as abdominal pain and minor gastrointestinal bleeding, with occasional nausea, vomiting, and diarrhea. Stomach bleeding and gastric ulcers and allergic reactions (dyspnea and skin reactions), mainly in asthmatic patients, are rare. Liver and kidney dysfunction, hypoglycemia, and particularly severe skin lesions (erythema multiforme exudative) have been reported in individual cases. Low-dose aspirin can reduce the excretion of uric acid, which can cause gout attacks in susceptible individuals. Rarely, after long-term use of aspirin enteric-coated tablets, anemia occurs due to occult bleeding in the gastrointestinal tract, and melena (symptoms of severe stomach bleeding) occur. Dizziness and ringing in the ears (especially in children and the elderly) may be symptoms of severe poisoning. If any side effects not listed above occur, please inform your doctor or pharmacist of these side effects promptly.
In the event of side effects, the drug should be stopped immediately and the doctor should be notified so that the doctor can judge the extent of the side effects and take necessary measures.
CONTRAINDICATIONS
Aspirin enteric-coated tablets are contraindicated in the following cases:
-Patients with known hypersensitivity to this product and substances containing salicylic acid;
-Patients who have induced asthma, urticaria or allergic reactions after taking aspirin or other NSAIDs;
Aspirin enteric-coated tablets are contraindicated in the following cases:
- Patients with known hypersensitivity to this product and substances containing salicylic acid;
-Patients who have induced asthma, urticaria or allergic reactions after taking aspirin or other NSAIDs;
-Contraindicated in the treatment of perioperative pain during coronary artery bypass graft surgery (CABG);
-Patients with a history of gastrointestinal bleeding or perforation after the use of NSAIDs;
-Patients with active peptic ulcer/bleeding, or previous recurrence of ulcer/bleeding;
-Patients with severe heart failure..
Warning
Patients with asthma, hay fever, nasal polyps or chronic respiratory tract infections (especially allergic symptoms) and allergic to all types of analgesics, anti-inflammatory drugs and anti-rheumatic drugs, use aspirin enteric-coated tablets to cause asthma attacks risk (ie, analgesic intolerance/analgesic-induced asthma). Consult a doctor before taking medication. Patients who have allergic reactions to other substances such as skin reactions, itching, rubella should also consult their doctor before use. Please notify your doctor and dentist before taking aspirin enteric-coated tablets. Long-term high-dose use of aspirin enteric-coated tablets should be carried out under the guidance of a doctor.
-Avoid concomitant use with other NSAIDs, including selective COX-2 inhibitors.
- Use the lowest effective dose for the shortest duration of treatment as needed to control symptoms to minimize adverse reactions.
- Adverse effects of gastrointestinal bleeding, ulceration and perforation can occur at any time during treatment with all NSAIDs, with a potentially fatal risk. These adverse reactions may or may not be accompanied by warning symptoms, regardless of whether the patient has a history of gastrointestinal adverse reactions or a history of serious gastrointestinal events. Patients with a previous history of gastrointestinal disease (ulcerative colitis, Crohn's disease) should use NSAIDs with caution to avoid worsening the disease. The drug should be discontinued when patients develop gastrointestinal bleeding or ulcers while taking this drug. Elderly patients experience an increased frequency of adverse effects with NSAID use, especially gastrointestinal bleeding and perforation, with potentially fatal risks.
- In clinical trials of multiple COX-2 selective or non-selective NSAIDs for up to 3 years, this product may cause an increased risk of serious cardiovascular thrombotic adverse events, myocardial embolism and stroke, which may be fatal of. All NSAIDs, including COX-2 selective or non-selective drugs, may have similar risks. Patients with cardiovascular disease or risk factors for cardiovascular disease are at greater risk. Physicians and patients should be vigilant about the occurrence of such events even in the absence of previous cardiovascular symptoms. Patients should be informed of symptoms and/or signs of serious cardiovascular safety and steps to take if they occur.
Patients should be alert for symptoms and signs such as chest pain, shortness of breath, weakness, and slurred speech, and should seek medical help immediately if any of these symptoms or signs occur.
- Like all non-steroidal anti-inflammatory drugs (NSAIDs), this product can cause new-onset hypertension or exacerbate existing hypertension symptoms, either of which can lead to an increased frequency of cardiovascular events. When taking non-steroidal anti-inflammatory drugs (NSAIDs), it may affect how well these drugs work. Non-steroidal anti-inflammatory drugs (NSAIDs), including this product, should be used with caution in hypertensive patients. Blood pressure should be closely monitored during initiation of therapy with this product and throughout treatment.
-Use with caution in patients with a history of hypertension and/or heart failure (eg, fluid retention and edema).
-NSAIDs, including this product, may cause fatal and serious adverse skin 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 severe skin reactions, and the product should be discontinued at the first appearance of a skin rash or other signs of an allergic reaction.
-If you are allergic to other analgesics, anti-inflammatory drugs or anti-rheumatic drugs, or have other allergic reactions, you should consult your doctor and use this product with caution.
- If you are using anticoagulant drugs at the same time (such as coumarin derivatives, heparin, except for low-dose heparin treatment), you should consult your physician and use this product with caution.
- After taking less or forgetting aspirin enteric-coated tablets, do not take double the amount the next time you take the medicine, but continue to take it as prescribed and prescribed by your doctor.
【Pregnant and lactating women medication】
If you become pregnant while taking aspirin enteric-coated tablets, please notify your doctor. Pregnant women should use this product with caution in the first and second trimesters. This product is contraindicated in women in the last 3 months of pregnancy due to the increased risk of maternal and neonatal morbidity during childbirth.
Aspirin and its degradation products can pass into breast milk in small amounts and should be used with caution in lactating women. Breastfeeding should be discontinued when taking large doses (more than 150 mg per day).
【Medication for Children】
The rare but life-threatening Reye syndrome may occur in children and adolescents taking aspirin enteric-coated tablets.
【Drug overdose】
Overdose or intoxication manifestations, namely salicylic acid reaction (salicylism):
1.Mild: manifested as headache, dizziness, tinnitus, deafness, nausea, vomiting, diarrhea, drowsiness, mental disorder, sweating, shortness of breath, polydipsia, involuntary movements of hands and feet (more common in the elderly), visual impairment, etc.
2.Severe: hematuria, convulsions, hallucinations, severe mental disorders, dyspnea and nameless fever may occur; mental and respiratory disorders are more obvious in children; laboratory tests may show abnormal EEG, acid-base balance disorders (breathing) alkalosis and metabolic acidosis), hypoglycemia or hyperglycemia, ketonuria, hyponatremia, hypokalemia, and proteinuria. If you suspect an overdose of aspirin enteric-coated tablets, you should inform your doctor immediately, and the doctor can take necessary measures according to the degree of poisoning symptoms.
【Pharmacology and Toxicology】
Aspirin acetylates the cyclooxygenase (ie, prostate synthase) of platelets, thereby reducing the production of thromboxane A2 (TXA2) and irreversibly inhibiting TXA2-induced platelet aggregation; It also has inhibitory effect; it can inhibit the aggregation and release of platelets caused by low concentrations of collagen, thrombin, antigen-antibody complexes, some viruses and bacteria, and self-aggregation, thereby preventing the formation of thrombus. At high concentrations, aspirin can also inhibit PG synthase in the blood vessel wall and adhere to the synthesis of prostate (PG12), which is a physiological antagonist of TXA2, and its synthesis reduction can promote thrombosis.
【Pharmacokinetics】
After oral administration, aspirin is mainly absorbed in the upper part of the small intestine, and the plasma concentration reaches a peak at about 3.5 hours. After absorption, it is rapidly hydrolyzed into salicylic acid. Therefore, the plasma concentration of aspirin is low, the plasma half-life is 0.38 hours, and the average residence time is 3.9 hours. After hydrolysis, it is rapidly distributed to body tissues in the form of salicylate, and can also enter joints and cerebrospinal fluid, and can pass through the placenta. The binding rate of salicylic acid to plasma proteins is high, up to 80-90%. Salicylic acid is metabolized by the liver. The metabolites are mainly salicylic acid and glucuronic acid conjugates, and a small part is gentisic acid. Most of this product is excreted from the kidneys as bound metabolites and a small part as free salicylic acid. Urine pH has an effect on the excretion rate, and the excretion rate is accelerated in alkaline urine.
STORAGE
Hermetically sealed,keep in cool and dry places.
PERIOD OF VALIDITY
24 months.
CERTIFICATE NO
Stage Food and Drug Administration Approval number:H20065051.
Manufactured
SHENYANG AOJINA PHARMACEUTICAL CO.,LTD
Tips: Please read the directions for use in retail or directed by physician.
Part of the goods frequent replacement of packaging, such as goods and pictures are not exactly the same, please refer to the goods you receive.
General Cautions
Keep away from animals and children.This product has not been evaluated by the FDA. It is not intended to diagnose, treat, cure, or prevent any disease.We highly recommend that you consult with a Traditional Chinese Medical practitioner or physician before taking any products or if you have any questions regarding your health.