Registered Rwanda · Rwanda FDA

DOBESIL

Calcium Dobesilate Monohydrate Capsules

Rwanda FDA-HMP-MA-1807 Capsules 500 mg

What it does

Dobesilate is a medication that helps improve blood flow and reduce swelling.

Commonly used for: varicose veins, chronic venous insufficiency, diabetic retinopathy

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-1807
Registration date
17/08/2024
Expiry date
16/08/2029
Status
Registered
Active ingredient
Calcium Dobesilate Monohydrate Capsules
Dosage form
Capsules
Strength
500 mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Aurochem Pharmaceuticals
Applicant / LTR
OCHOA LABORATORIES
Country of origin
INDIA
Manufacturer location
No. 430, Gundecha Industrial Complex, Akurli Rd, Kandivali, Akurli Industry Estate, Kandivali East, Mumbai, Maharashtra 400101, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:04 · updated 2026-09-21 02:30:19

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Dobesilate is a medication that helps improve blood flow and reduce swelling.

What it treats

  • varicose veins
  • chronic venous insufficiency
  • diabetic retinopathy

How it works

It works by strengthening blood vessels and improving circulation.

Who it's for

This medicine is for adults who have issues with blood circulation, particularly related to veins.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: dobesilate

BNF-referenced

Dobesilate is a sulfonic acid derivative with properties that include vasoprotection and anti-inflammatory effects. It is primarily used in the management of microangiopathies, particularly in diabetic retinopathy and chronic venous insufficiency. The drug is thought to improve endothelial function and reduce vascular permeability, thus helping to stabilize capillaries and prevent complications associated with microvascular damage.

Indications

  • Diabetic retinopathy
  • Chronic venous insufficiency
  • Microangiopathies

Dosage

Children: Paediatric dosing information is not provided, refer to the BNF for Children for appropriate guidance.

Adults: The typical adult dosage is 500 mg taken orally, three times daily. The duration of treatment and specific indications should be guided by clinical judgment and individual patient response.

Mechanism of action

Dobesilate is believed to exert its effects by stabilizing capillary membranes and reducing their permeability to plasma proteins. It also inhibits the release of inflammatory mediators from activated endothelial cells, leading to a reduction in edema and inflammation. This action contributes to its therapeutic effects in microangiopathies and vascular disorders.

Pharmacodynamics

Dobesilate exhibits vasoprotective properties, which involve actions on the vascular endothelium, providing protection against damage and reducing leakage of plasma proteins. Its anti-inflammatory effects may also contribute to reducing the progression of diseases associated with microcirculation disturbances. The drug has also shown to have positive effects on blood flow in microcirculation by improving the rheological properties of blood.

Pharmacokinetics

Dobesilate is absorbed after oral administration, though the specifics of its bioavailability are not well established. It undergoes hepatic metabolism, and its elimination half-life is approximately 3-4 hours. The drug is primarily excreted via the kidneys, and dose adjustments may be necessary in patients with renal impairment to avoid accumulation.

Contra-indications

  • Hypersensitivity to dobesilate or any of its components
  • Severe renal impairment

Adverse effects

  • Gastrointestinal disturbances
  • Skin rashes
  • Headache
  • Dizziness
  • Fatigue
  • Nausea

Precautions

  • Use with caution in patients with renal impairment
  • Monitor for signs of hypersensitivity

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Dobesilate should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether dobesilate is excreted in human milk. Caution should be exercised when administering to nursing mothers.

Storage

Store below 25 degrees Celsius, in a dry place, protected from light.

Formulations

  • Capsules
  • Tablets
  • Oral suspension

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: dobesilate

PubChem CID 17507

Molecular formula: C6H6O5S

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.