DOVAS - Calcium Dobesilate Capsules

Composition w/v   Each capsule contains   Calcium Dobesilate Monohydrate BP 500 mg  Dosage form - Capsules Category - Vasoprotector Description Calcium dobesilate is a synthetic compound claimed to reduce capillary permeability. It is often recommended in diabetic retinopathy and venous disorders.  Calcium dobesilate is a vasoactive drug with presumed effects on endothelial integrity, capillary permeability, and blood viscosity. It is often recommended for venous disorders, but it is also prescribed for diabetic retinopathy and other microvascular disorders Mechanism of action Calcium dobesilate has a comprehensive mode of action. It increases endothelial nitric oxide levels by enhancing the activity of nitric-oxide synthase, decreasing capillary hyper-permeability. Calcium dobesilate shows anti-platelet and fibrinolytic activities by inhibiting platelet activation factor (PAF) and enhancing the release of tissue plasminogen activator (tPA), thereby improving the local blood flow to tissues, otherwise inhibited due to thrombosis. Calcium dobesilate also inhibits the two pathophysiological reactions in diabetes viz polyol pathway and glycation of proteins due to its inhibitory effects on aldose reductase.  Calcium dobesilate acts on the endothelial layer and basement membrane of the capillaries. It reduces histamine and bradykinin - induced hyperpermeability. It increases red blood cell membrane flexibility and reduces capillary fragility. Calcium dobesilate can reduce the platelet aggregation stimulated by collagen and thrombin, but not by arachidonic acid.  Calcium dobesilate may also inhibit the formation of sorbitol, thus providing another possible mechanism for its usefulness in diabetic retinopathy.  Glucose inhibits the formation of both type I and type II collagen formation. Calcium dobesilate does not affect type I inhibition by glucose but accelerates type II collagen fibrillogenesis, a major structural component of the arterial wall.  Calcium dobesilate has angioprotective action by reducing the permeability and fragility of microvessels, which should restrict fluid extravasation into the cardiac interstitium. Its antiplatelet effect should counteract thrombosis and its reduction of plasma viscosity should prevent stasis.  Dosage Doses of 1000 milligrams (mg) twice daily have demonstrated efficacy in the treatment of CHRONIC VENOUS INSUFFICIENCY. The manufacturers recommend a starting dose of calcium dobesilate of 500mg twice daily for 1 to 3 weeks, followed by 500mg once daily. For the treatment of DIABETIC RETINOPATHY, 1500 milligrams (mg) daily has demonstrated efficacy. Some recommend a dose of calcium dobesilate of 500 to 1000mg daily for 4 to 6 months, or 500mg once daily. For advanced retinopathy, the dose is 500mg three times daily for one month, 500mg twice daily for the second month, and 500mg once or twice daily for the third month. Calcium dobesilate 500mg three times daily for two years did not produce significant progression of pre-existing diabetic retinopathy compared to placebo in a study of 74 patients. In a placebo-controlled dose-response study of 52 patients with increased platelet aggregation, calcium dobesilate 1500mg/day for four days produced a 22% decrease in platelet aggregation, a 96.4% increase in reaction time and a 75% decrease in the platelet aggregation/reaction time quotient as compared to placebo. Doses of 500mg and 1000mg daily did not produce significant changes. Adverse Reactions Drug induced fever, epigastric pain, gastric irritation, pruritus, skin rashes and granulocytosis (rare). Indications A) Diabetic Retinopathy and Glaucoma Reduces blood hyperviscosity, retinal hemorrhages, visual field defects, and intraocular pressure. Enhances outflow facility. Inhibits the formation of sorbitol .  Calcium dobesilate has been shown to decrease blood hyperviscosity and intraocular pressure in patients with diabetic retinopathy and GLAUCOMA. In a randomized double-blind trial, 79 non-insulin dependent diabetics with early retinopathy or OPEN-ANGLE GLAUCOMA received 1500 milligrams daily for 6 months, or placebo. The treatment group experienced statistically significant decreases in intraocular pressure, visual field defects, surface area of retinal hemorrhage and blood viscosity. There were also significant decreases in albumin, prothrombin time, and platelet counts after 6months of treatment. B) Diabetic Microangiopathy 500 milligrams orally 3 times daily for six months to 1 year. Increases collagen formation thereby reducing vascular permeability. Reduces histaminic and bradykinin induced hyperpermeability of capillaries. Maintains flexibility of erythrocytes. Inhibits polyol pathway and sorbitol formation in diabetes. Enhances Tissue Plasminogen Activator (TPA) activity and potentiates fibrinolysis. Exhibits direct antioxidant properties and thereby maintains endothelial function. Inhibits Platelet Activating Factor (PAF) and reduces platelet aggregation. C) Chronic Venous Insufficiency Effective in the treatment of chronic venous insufficiency. Reduces volume in the foot and lower legs. Reduces ankle and calf circumferences. Decreases venous distensibility index. Decreases maximum venous outflow and capillary filtration index. Reduces ankle edema. 500 milligrams orally 3 times daily for 28 days was highly effective and well tolerated in an open, multicenter study of 373 patients with chronic VENOUS INSUFFICIENCY.  Contraindications Hypersensitivity to calcium dobesilate. Precautions Duodenal or peptic ulcer, recurrent gastritis. Incase of severe renal insufficiency requiring dialysis, the dose should be reduced. Pregnancy Calcium dobesilate shows no teratogenic effects as it does not cross the placental barrier. Hence, it may be used during, however the experience with same in clinical practise is limited in pregnancy. Lactation Exercise caution since safety for use in the nursing mothers has not been established. Children Not recommended. Storage Calcium dobesilate be stored in the original package protected from light and moisture. Presentation DOVAS is available in blister pack of 10 capsules.