Cadosil500 mg

Cadosil is a vasoprotective (angioprotective) agent used in the symptomatic treatment of the following conditions:

Established / Widely Approved Uses

• Chronic venous insufficiency (CVI): Cadosil is used to relieve symptoms such as leg pain, heaviness, swelling (edema), night cramps, and discomfort associated with varicose veins and chronic venous disease of the lower limbs.

Guideline-Supported / Regionally Approved Adjunct Uses

• Hemorrhoidal disease: Cadosil is used as an adjunct to relieve symptoms (pain, bleeding, discomfort) of acute hemorrhoidal episodes, generally alongside standard local measures and other treatments.
• Diabetic retinopathy (background/non-proliferative): In some countries, Cadosil is used as an adjunct to reduce capillary hyperpermeability and slow progression of early-stage diabetic retinopathy. Evidence for this use is more limited and regionally variable compared to established first-line therapies (e.g., glycemic control, laser photocoagulation, anti-VEGF therapy), and Cadosil should not replace standard diabetic eye care.

Note: Cadosil is not approved by the US FDA and is not marketed in the United States; its use is based on approvals and clinical practice in Europe, Latin America, and parts of Asia.

Calcium Dobesilate is available as oral solid dosage forms, most commonly:

• Calcium Dobesilate 500 mg capsule/tablet
• Calcium Dobesilate 250 mg capsule (in some markets)

Each unit contains Calcium Dobesilate as the active pharmaceutical ingredient, along with standard pharmaceutical excipients.

Cadosil is a synthetic angioprotective (capillary-protective) drug belonging to the venotonic/vasoprotective class of medicines. It is used mainly for the symptomatic management of chronic venous insufficiency and related microvascular conditions, and in some markets for hemorrhoids and early diabetic retinopathy.

Cadosil works by improving capillary resistance and reducing abnormal capillary permeability, which helps reduce fluid leakage, edema, and the discomfort associated with venous and microvascular disorders.

Vasoprotective / Angioprotective agent (capillary-protecting and venotonic drug); Cadosil is classified with agents used for chronic venous insufficiency.

Calcium Dobesilate is an angioprotective agent whose exact mechanism of action is not completely established, but several actions have been described:

• Reduction of capillary hyperpermeability: Calcium Dobesilate normalizes increased capillary permeability, reducing plasma leakage into surrounding tissue and thereby reducing edema.
• Increase in capillary resistance: It strengthens capillary walls, reducing fragility.
• Decrease in blood viscosity and platelet aggregation: Calcium Dobesilate has mild antiplatelet and rheological effects that may improve microcirculatory blood flow.
• Antioxidant effect: Calcium Dobesilate scavenges free radicals, which may contribute to protecting the retinal microvasculature in diabetic retinopathy.

These combined effects underlie the use of Calcium Dobesilate in conditions involving increased capillary fragility and permeability, such as chronic venous insufficiency and diabetic microangiopathy.

Cadosil is taken orally. Capsules/tablets should be swallowed whole with a glass of water.

• Cadosil may be taken with or without food, preferably with meals to minimize gastrointestinal discomfort.
• Doses should be spaced evenly through the day as directed by the physician.
• Do not crush or chew the capsule/tablet unless specifically advised.

Clinically significant interactions with Cadosil include:

• Anticoagulants and antiplatelet agents (e.g., warfarin, aspirin, clopidogrel): Cadosil has mild antiplatelet activity; concurrent use may theoretically increase the risk of bleeding. Monitor patients on combined therapy.
• Other drugs associated with blood dyscrasias: Because rare cases of agranulocytosis have been reported with Cadosil (see Precautions and Warnings), caution is advised when co-administering other medicines known to affect bone marrow function, due to potential additive hematologic risk.

No other well-established, clinically significant drug interactions with Cadosil have been documented. Patients should inform their physician of all medicines they are taking before starting Cadosil.

Cadosil is generally well tolerated at recommended doses. Reported side effects include:

Common

• Nausea
• Diarrhea or other mild gastrointestinal upset
• Headache

Uncommon

• Skin rash
• Dizziness
• Fever

Rare but Serious

• Agranulocytosis: Rare but serious reports of agranulocytosis (a severe drop in white blood cells) have been associated with Cadosil use. Patients should seek prompt medical attention if they develop fever, sore throat, mouth ulcers, or other signs of infection while taking Cadosil (see Precautions and Warnings).
• Elevated liver enzymes (rare, reversible on discontinuation)

Safety data for Cadosil use during pregnancy and lactation are limited. Cadosil should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus. It is advisable to avoid Cadosil during the first trimester unless specifically directed by a physician.

It is not established whether Cadosil passes into breast milk. Use during breastfeeding should only occur after consulting a physician, who will weigh the benefits of treatment against any potential risk to the infant.

The following precautions should be observed with Cadosil:

• Agranulocytosis risk: Rare but serious cases of agranulocytosis have been reported with Cadosil. Patients should be advised to report any signs of infection, unexplained fever, or sore throat promptly to their physician. If agranulocytosis is suspected, Cadosil should be discontinued immediately and appropriate medical care sought.
• Limited efficacy evidence for diabetic retinopathy: The evidence supporting use of Cadosil in diabetic retinopathy is more limited and variable compared to established first-line therapies. Cadosil should be used as an adjunct only, and patients should continue standard diabetic eye care and monitoring.
• Bleeding risk: Use with caution in patients on anticoagulant or antiplatelet therapy (see Interactions).
• Hepatic monitoring: Periodic monitoring of liver function may be considered with prolonged use, given rare reports of elevated liver enzymes.

Limited data are available on overdose with Cadosil. In the event of a suspected overdose, seek immediate medical attention or contact a poison control center. Treatment of overdose with Cadosil should be symptomatic and supportive, managed by qualified medical personnel; there is no specific antidote for Cadosil. Do not attempt to manage an overdose at home.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Renal impairment: There is limited specific dosing data for Cadosil in renal impairment; use with caution and physician supervision.

Hepatic impairment: Use Cadosil with caution in patients with hepatic impairment, given rare reports of liver enzyme elevation; monitor liver function if used long-term.

Elderly: No specific dose adjustment of Cadosil is established for elderly patients, but they should be monitored for tolerability.

Pediatric patients: Safety and efficacy of Cadosil have not been established in children; its use in this population is not recommended (see Pediatric Uses).

The duration of treatment with Cadosil depends on the condition being treated and the patient's response. For chronic venous insufficiency, courses of several weeks to a few months are typical, with re-evaluation by the physician to assess continued need. For acute hemorrhoidal episodes, shorter courses are generally used. Treatment should not be continued indefinitely without periodic medical review.

Angioprotective agents; Vasoprotectives and venotonics; capillary-protecting drugs (the class to which Calcium Dobesilate belongs).

Calcium Dobesilate acts by reducing capillary hyperpermeability and increasing capillary resistance, decreasing blood viscosity and platelet aggregation, and exerting antioxidant (free-radical scavenging) effects. Together, these actions reduce microvascular leakage and improve microcirculatory function, which underlies the therapeutic effects of Calcium Dobesilate in venous and capillary disorders.

The safety and efficacy of Cadosil have not been established in pediatric patients. Cadosil is not recommended for use in children, and no pediatric dosing regimen has been established.