Product Overview
[Drug Name]
Generic Name: Isosorbide Mononitrate Sustained-Release Tablets
Trade Name: Zaijia
English Name: Isosorbide Mononitrate Sustained-Release Tablets
Chinese Pinyin: Dangxiaosuan Yishanlizhi Huanshi Pian
[Ingredients]
Ingredient: Isosorbide mononitrate.
[Properties]
This product is a film-coated tablet. After removing the film coating, it is a white or off-white double-layer tablet.
[Indications]
Prevention of long-term treatment of angina pectoris. Treatment after myocardial infarction. Adjunctive treatment of severe myocardial insufficiency in combination with digitalis glycosides and/or diuretics. Pulmonary hypertension.
[Dosage and Administration]
Oral: Take one tablet daily in the morning. For severe cases, take two tablets daily in the morning. If headache occurs, the initial dose can be reduced to half a tablet daily. The whole or half tablet should be kept intact before taking and swallowed with half a glass of water. Do not chew or crush.
[Adverse Reactions]
1. Side effects such as skin flushing (a sign of vasodilation) are generally mild.
2. Allergic reactions, fatigue, nausea, and vomiting may occasionally occur, but these symptoms generally resolve spontaneously after discontinuation of the drug.
[Contraindications]
This product is contraindicated in patients with the following conditions: 1. Hypersensitivity to the active ingredient of this product or similar drugs (nonsteroidal anti-inflammatory drugs, NSAIDs); 2. Asthma; 3. Cerebral hemorrhage; 4. Bleeding or coagulation disorders; 5. Children under 16 years of age; 6. Head injury; 7. Heart attack due to other cardiac causes; 8. Hypotension; 9. Decreased blood volume; 10. Peptic ulcer; 11. Severe anemia; 12. Severe cerebral insufficiency; 13. Acute myocardial infarction with decreased left ventricular filling pressure; 14. Evidence suggests that sildenafil can enhance the antihypertensive effect of nitrates; therefore, their combined use is contraindicated.
[Precautions]
1. This drug may sometimes exacerbate angina pectoris caused by hypertrophic cardiomyopathy. Patients with early myocardial infarction require close examination and clinical monitoring when using this drug. 2. Use with caution in patients with hypovolemia or low blood pressure who are taking diuretics or certain antihypertensive medications. 3. Alcohol can synergistically worsen hypotension with isosorbide mononitrate, which can be life-threatening. Therefore, alcohol consumption is strictly prohibited while taking this drug. 4. Because aspirin is irritating to the stomach, it should be used with caution in patients with gastric or duodenal ulcers. 5. Avoid use during pregnancy.
[Special Use]
Precautions for Children:
Children under 16 years of age;
Precautions for Pregnancy and Lactation:
Use with caution in pregnant and lactating women.
Precautions for Elderly:
Unknown.
[Drug Interactions]
Unknown.
[Pharmacological Actions]
This drug contains two active ingredients: isosorbide mononitrate and aspirin. Isosorbide mononitrate is the primary active metabolite of isosorbide dinitrate. It can reduce myocardial oxygen consumption by dilating peripheral blood vessels, particularly increasing venous blood volume, reducing venous return, and lowering cardiac preload and postload. It can also promote myocardial blood flow redistribution and improve blood supply to the ischemic area. Isosorbide mononitrate may exert its anti-ischemic effects through these two aspects. Aspirin acetylates platelet cyclooxygenase (i.e., prostaglandin synthase), thereby reducing thromboxane A2 (TXA2) production. It irreversibly inhibits TXA2-induced platelet aggregation and also inhibits phase II aggregation induced by ADP or epinephrine. It can also inhibit platelet aggregation and release reactions induced by low concentrations of collagen, thrombin, antibody-antigen complexes, certain viruses, and bacteria, as well as spontaneous aggregation, thereby preventing thrombus formation. At high concentrations, aspirin can also inhibit prostacyclin synthase in the blood vessel wall, reducing the synthesis of prostacyclin (PGI2). PGI2 is a physiological antagonist of TXA2, and its reduced synthesis may promote thrombosis.
[Storage]
Store in a dark, airtight container.
[Specifications]
60mg
[Packaging]
Compound film packaging, 10 tablets/box
[Expiry Period]
24 months
[Approval Number]
National Medicine Standard No. H20010247
[Manufacturer]
Company Name: Nanjing Chengong Pharmaceutical Co., Ltd.
