Dorner Beraprost Sodium Tablets

1. Indications and Usage
Chronic Arterial Occlusive Disease: Indicated for the improvement of ischemic sequelae, including intermittent claudication, ulcerative lesions, and cold sensitivity associated with chronic arterial occlusive disease.
2. Dosage and Administration
Standard Dose: The usual dosage for adults is 40 μg three times daily after meals.
Titration: A physician may increase the dose to 60 μg three times daily as necessary.
Administration: Tablets should be taken orally after meals with water.
Pediatric Use: Safety and efficacy in pediatric patients have not been established.
3. Mechanism of Action
Vasodilation: Beraprost sodium is a synthetic analog of prostacyclin (PGI₂). It binds to prostacyclin receptors on vascular smooth muscle cells, activating adenylate cyclase and increasing intracellular cAMP, which relaxes vascular smooth muscle and dilates blood vessels.
Antiplatelet Activity: It inhibits platelet aggregation and the generation of thromboxane A₂, helping to prevent the formation of arteriosclerotic thrombi.
4. Safety and Warnings
Contraindications: Contraindicated in pregnant or potentially pregnant women due to animal studies showing fetal resorption.
Bleeding Risk: Contraindicated in patients with active bleeding or high bleeding risk (e.g., hemorrhagic stroke, active gastrointestinal bleeding, hemophilia).
Serious Adverse Effects: May cause serious bleeding, shock, or interstitial pneumonia. Patients should be monitored for abnormal bruising, bleeding, or respiratory symptoms.
Special Populations: Use with caution in patients with hepatic or renal dysfunction, as well as the elderly.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Headache, dizziness, flushing, nausea, abdominal pain, and edema.
Hematological Effects: Anemia, thrombocytopenia, and increased bleeding time.
Clinical Findings: Clinical trials have demonstrated significant improvement in walking distance and relief from ischemic pain in patients with chronic arterial occlusive disease.
6. Drug Interactions
Anticoagulants and Antiplatelet Drugs: Concurrent use with warfarin, heparin, or aspirin may significantly increase the risk of bleeding.
Fibrinolytic Agents: Use with caution when combined with thrombolytic agents (e.g., urokinase).
Other Prostaglandins: Concurrent use may increase the risk of hypotension.
7. Pharmaceutical Information
Active Ingredient: Beraprost Sodium.
Strengths: Typically available as 20 μg and 40 μg tablets.
Appearance: White to off-white film-coated tablets.
Storage: Store in a tightly sealed container, protected from moisture and light, at room temperature (10°C–30°C).