Product Overview
[Drug Name]
Generic Name: Beraprost Sodium Tablets
Trade Name: Dana
[Ingredients]
Beraprost Sodium
[Properties]
This product is a white to pale yellowish film-coated tablet that appears white after removal of the coating.
[Indications]
It is used to improve symptoms such as ulcers, intermittent claudication, pain, and cold sensation caused by chronic arterial occlusive disease.
[Dosage and Administration]
Adults: Orally take 40 μg three times daily after meals.
[Adverse Reactions]
Among 7,515 treated patients, 370 (4.9%) reported adverse reactions, including abnormal laboratory values. These adverse reactions primarily included headache in 91 cases (1.2%), facial flushing in 60 cases (0.8%), hot flashes in 39 cases (0.5%), diarrhea in 29 cases (0.4%), and nausea in 20 cases (0.3%). 1. Serious adverse reactions (1) Bleeding tendency [cerebral hemorrhage (less than 0.1%), gastrointestinal hemorrhage (less than 0.1%), pulmonary hemorrhage (less than 0.1%)]: Closely observe. If abnormalities occur, discontinue the drug and give appropriate treatment. (2) Shock (less than 0.1%), syncope (less than 0.1%), unconsciousness (less than 0.1%): There have been reports of shock, syncope, and unconsciousness. Close observation should be given. If symptoms such as low blood pressure, increased heart rate, pale face, and nausea occur, discontinue the drug and give appropriate treatment. (3) Interstitial pneumonia (incidence unknown): There have been reports of interstitial pneumonia. Close observation should be given. If abnormalities occur, discontinue the drug and give appropriate treatment. (4) Impaired liver function (incidence unknown): There have been reports of jaundice and increased GOT and GPT. Close observation should be given. If abnormalities occur, discontinue the drug and give appropriate treatment. (5) Angina pectoris (incidence unknown): There have been reports of angina pectoris. If abnormalities occur, the drug should be discontinued and appropriate treatment should be given. (6) Myocardial infarction (incidence unknown): There have been reports of myocardial infarction. If abnormalities occur, the drug should be discontinued and appropriate treatment should be given. (7) Other adverse reactions: There is a possibility of the following adverse reactions. Close observation should be made and appropriate treatment should be given. (8) Bleeding tendency: Bleeding tendency, subcutaneous hemorrhage (incidence less than 0.1%), epistaxis (incidence unknown). (9) Blood: Anemia, eosinophilia (incidence less than 0.1%), thrombocytopenia, leukopenia (incidence unknown). (10) Allergy: Rash (incidence 0.1-5%), eczema, itching (incidence less than 0.1%). (11) Mental and nervous system: Headache, dizziness (incidence 0.1-5%), vertigo, drowsiness, drowsiness, numbness (incidence less than 0.1%). (12) Digestive system: nausea, diarrhea, abdominal pain, loss of appetite (incidence 0.1-5%), gastric ulcer, vomiting, gastric dysfunction, thirst, heartburn (incidence 0.1-5%). (13) Liver: increased GOT, increased GPT, increased γ-GTP, increased LDH (incidence 0.1-5%), increased bilirubin, increased Al-P (incidence less than 0.1%), jaundice (incidence unknown). (14) Kidney: increased BUN (incidence 0.1-5%), hematuria (incidence less than 0.1%), frequent urination (incidence unknown). (15) Circulatory system: facial flushing, fever, dizziness, palpitations, skin flushing (incidence 0.1-5%), decreased blood pressure, increased heart rate (incidence less than 0.1%). 16. Others: increased triglycerides (incidence 0.1-5%), edema, pain, chest pain, joint pain, chest tightness, tinnitus, fatigue, fever, sweating (incidence less than 0.1%), back pain, hair loss, cough (incidence unknown).
[Contraindications]
The following conditions are contraindicated: 1. Women who are pregnant or may become pregnant should not take this product (the safety of the drug during pregnancy has not been determined). 2. Patients with bleeding (such as hemophilia, capillary fragility, upper gastrointestinal bleeding, urinary tract bleeding, hemoptysis, fundus hemorrhage, etc., may experience increased bleeding if taking this product).
[Precautions]
1. The following patients should take this drug with caution: (1) Patients who are taking anticoagulants, antiplatelet drugs, and thrombolytics. (2) Women during menstruation. (3) Patients with bleeding tendency and its factors.
[Use in Special Populations]
Precautions for Children:
The safety of this medication for children has not been established (no experience).
Precautions for Pregnancy and Lactation:
1. This drug should not be taken by women who are pregnant or may become pregnant (the safety of this medication during pregnancy has not been established).
2. Lactating women should avoid taking this drug. If necessary, breastfeeding should be discontinued (animal studies in rats have shown that this drug can be distributed in breast milk).
Precautions for Elderly:
The dosage should be carefully considered when taking this medication for elderly patients (physiological functions are generally reduced in the elderly).
[Drug Interactions]
1. It may interact synergistically with the following drugs: anticoagulants, such as warfarin; antiplatelet drugs, such as aspirin and ticlopidine; thrombolytics, such as urokinase.
2. It may increase bleeding tendency; close observation is recommended. If abnormalities are detected, appropriate measures should be taken, such as reducing the dose or discontinuing the concomitant medication.
3. It may interact synergistically with prostaglandin I2 preparations. Concomitant use may cause a decrease in blood pressure; close blood pressure monitoring is required.
[Pharmacological Action]
1. Antiplatelet Effect (1) Oral administration of this product to patients with peripheral circulatory disorders and healthy adults can inhibit platelet aggregation and platelet adhesion. (2) It can inhibit the aggregation of human platelets caused by aggregation-inducing substances and has a dissolving effect on human platelet aggregates (in vitro experiments). 2 Vascular dilation and blood flow increase effect (1) Oral administration of this product to healthy adults increases skin blood flow. (2) Oral administration of this product to patients with peripheral circulatory disorders can increase the partial pressure of oxygen in tissues at rest and shorten the ischemic recovery time of limb ischemia tests. The increase in skin blood flow can be measured by laser Doppler method. (3) In addition, it shows a dilation effect on various isolated arteries such as the dog femoral artery and mesenteric artery that are contracted by K and PGF2&alpha (in vitro experiments), increasing the blood flow of the blood vessels of various organs of the dog. Effects on Pathological Models: 1. Chronic Arterial Occlusive Disease Model: In models of lauric acid-induced rat hindlimb circulatory impairment, ergotamine-epinephrine-induced rat tail circulatory impairment, and electrical stimulation-induced rabbit arterial thrombosis, it inhibited the progression of ischemic lesions and thrombosis. 2. Thrombosis Model: It inhibited thrombosis in rat arterial thrombosis and rat venous thrombosis. 3. Skin Ulcer Model: It promoted the healing of acetic acid-induced skin ulcers in rats. Similar to prostacyclin, this drug activates adenylate cyclase through prostacyclin receptors on platelets and vascular smooth muscle, increasing intracellular cAMP concentrations and inhibiting Ca2+ influx and thromboxane A2 production, resulting in antiplatelet and vasodilatory effects. Toxicology: 1. Acute Toxicity Test: The LD50 of this drug in mice and rats was 11.6-48.3 mg/kg when administered orally. No mortality occurred in dogs when administered orally at 5, 10, and 20 mg/kg. 2. Antigenicity Test: This product was not found to be antigenic in antigenicity tests conducted with guinea pig and rat sera.
[Storage] Store tightly closed at room temperature.
[Strength] 20 μg (as beraprost sodium)
[Packaging] 20 μg x 10 tablets
[Expiry Date] 36 months
[Approval Number] National Medical Standard HJ20181058
