Keyuan Calcium Dobesilate Capsules

Brand Name: 可元®(Keyuan®)
Generic Name: Calcium Dobesilate
Strength: 0.5 g per capsule, 2×10 capsules per box
Manufacturer: Shanghai Zhaohui Pharmaceutical Co., Ltd.
Marketing Authorization Holder: Shanghai Zhaohui Pharmaceutical Co., Ltd.
Approval Date in China: 2003
Registration Number: 国药准字H20030088
Storage: Seal tightly, store in a cool and dry place protected from light; keep out of reach of children, comply with full storage instructions in the package insert

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1. Indications and Usage
Microvascular Diseases: Treatment of diabetic retinopathy and glomerulosclerosis.
Microvascular Damage: Treatment of conditions associated with increased capillary permeability and fragility, such as cyanosis of the extremities.
Chronic Venous Insufficiency: Adjunctive therapy for varicose syndrome, post-thrombotic syndrome, leg ulcers, stasis dermatitis, and peripheral edema.
2. Dosage and Administration
Diabetic Retinopathy: 0.5 g three times daily for 4-6 months, then reduced to 0.5 g twice daily for maintenance.
Other Microangiopathy: 0.5 g twice daily for 1-2 months. If clinical symptoms improve, discontinue the third daily dose.
Chronic Venous Insufficiency: 0.5 g twice daily for 1-3 weeks. If symptoms improve, the dose may be reduced to 0.5 g daily to consolidate the therapeutic effect.
Administration: Swallow the capsule whole during meals with water.
3. Mechanism of Action
Microvascular Wall: Increases vascular wall resistance and reduces pathological high permeability.
Hemodynamics: Decreases blood and plasma viscosity, inhibits platelet aggregation, and prevents thrombus formation.
Symptom Relief: Alleviates clinical signs of microvascular disease, including edema, capillary bleeding, and sensations of heaviness and pressure in the lower limbs.
4. Safety and Warnings
Agranulocytosis: Rare cases of agranulocytosis, neutropenia, and leukopenia have been reported. Immediate discontinuation and complete blood count (CBC) monitoring are required if fever, sore throat, or signs of infection occur.
Severe Hypersensitivity: Discontinue immediately if severe skin reactions (e.g., erythema, maculopapular rash, blistering, angioedema) develop.
Laboratory Interference: May interfere with creatinine assays (phosphotungstic acid method), resulting in falsely low values.
Renal Impairment: Use with caution in patients with severe renal impairment requiring dialysis.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Gastrointestinal disturbances (e.g., nausea, vomiting, abdominal pain, diarrhea), headache, and pruritus.
Rare Adverse Reactions: Severe cutaneous adverse reactions, liver enzyme elevation, and hematologic abnormalities.
Clinical Research: Clinical trials and post-marketing surveillance have demonstrated efficacy in improving microcirculation and reducing symptoms associated with chronic venous insufficiency and diabetic microangiopathy.
6. Drug Interactions
Anticoagulants/Antiplatelets: Concomitant use should be approached with caution to avoid potential additive effects on coagulation.
Laboratory Tests: Inform healthcare providers if the patient is undergoing creatinine monitoring using the phosphotungstic acid method.
7. Pharmaceutical Information
Active Ingredient: Calcium Dobesilate.
Appearance: White or almost white capsules.
Storage: Store in a tightly closed container, protected from light and moisture.

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