Doxium Calcium Dobesilate Capsules

Brand Name: 导升明®(Doxium®)
Generic Name: Calcium Dobesilate
Strength: 0.5 g (500 mg) per capsule, 20 capsules per box
Manufacturer: Klocke Pharma Service GmbH
Marketing Authorization Holder: Vifor Pharma Österreich GmbH
Approval Date in China: 2014
Registration Number: 国药准字H20140641
Storage: Store tightly sealed in a cool, dry place protected from light; keep out of reach of children, follow full storage specifications in the package insert

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1. Indications and Usage
Diabetic Microangiopathy: Treatment of diabetic retinopathy and glomerulosclerosis.
Chronic Venous Insufficiency: Adjunctive therapy for varicose syndrome, post-thrombotic syndrome, leg ulcers, stasis dermatitis, and peripheral edema.
Microvascular Damage: Treatment of conditions associated with increased capillary permeability and fragility, such as cyanosis of the extremities.
2. Dosage and Administration
Diabetic Retinopathy: 0.5 g three times daily (typically for 4-6 months), then reduced to 0.5 g twice daily for maintenance.
Other Microangiopathy: 0.5 g three times daily for 1-2 months, then reduced to 0.5 g twice daily as symptoms improve.
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: Take the capsule whole during meals with water. Do not crush or chew.
3. Mechanism of Action
Microvascular Protection: Increases vascular wall resistance and reduces pathological high permeability of the microvasculature.
Hemodynamic Improvement: 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.
Pregnancy and Lactation: Safety has not been established; use only if the potential benefit outweighs the risk. The drug is excreted in breast milk in trace amounts.
Laboratory Interference: May interfere with creatinine assays (phosphotungstic acid method), resulting in falsely low values.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Gastrointestinal disturbances (e.g., nausea, vomiting, abdominal pain, diarrhea) and skin reactions (e.g., pruritus, flushing, urticaria).
Rare Adverse Reactions: Severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome), liver enzyme elevation, headache, and joint pain.
Clinical Research: Clinical trials 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 additive effects on coagulation, although specific interactions have not been definitively established.
Laboratory Tests: As noted in Safety and Warnings, inform healthcare providers to ensure accurate creatinine monitoring.
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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