Optium

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မြန်မာ

Composition

Active Principle : Calcium Dobesilate

Capsule : Calcium Dobesilate 500mg

DESCRIPTION

Calcium Dobesilate : Chemically it is known as 2,5-dihydroxy benzene sulfonic acid calcium salt. Molecular formula of calcium dobesilate is C₁₂H₁₀CaO₁₀S₂. Molecular weight is 418.41 and meeting point is 300ºC.

Calcium dobesilate acts on the capillary walls by regulating their impaired physiological flexibility, inhibits platelet hyperaggregation and in diabetic retinopathy, it reduces plasma and blood hyperviscosity, thus improving blood rheological properties and tissue irrigation. These effects allow to correct capillary dysfunctions either of functional origin or caused by constitutional or acquired metabolic disorders. Calcium dobesilate contributes to reduce oedema.

INDICATIONS

Microangiopathies, in particular diabetic retinopathy.

Clinical signs of chronic venous insufficiency in the lower limbs (pain, cramps, paresthesia, oedema stasis dermatosis), as adjuvant in superficial thrombophlebitis, Haemorrhoidal syndrome, microcirculation disorders of arteriovenous origin.

DOSAGE AND ADMINISTRATION

Generally 500 to 1000 mg – 1 capsule once or twice a day – to be taken with the main meals.

Treatment duration, which is generally between a few weeks and several months, depends on the disease and its evolution. Dosage should be adapted individually according to the severity of the case.

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CONTRAINDICATIONS

Hypersensitivity towards calcium dobesilate and or / sulfites.

Pregnancy and lactation

Pregnancy category C:

Studies in pregnant women or animals are not available. As it is not known whether calcium dobesilate crosses the placental barrier in humans, the drug should only e administered if the potential benefit justifies the potential risk to the foetus.

Calcium dobesilate enters the maternal milk in very low quantities (0.4 µg/ml after intake of 3 x 500mg. As a precaution, either the treatment or the breast-feeding should be stopped.

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ADVERSE EFFECTS

Rarely gastrointestinal disorders including nausea and diarrhea, skin reactions and fever have been reported.

In case of gastrointestinal disorders, the dosage should be reduced or the treatment temporarily withdrawn. In case of skin reactions and fever, the treatment must be stopped and the treatment physician informed as this may constitute an allergic reaction.

Optium tablets contain sodium bisulfite as antioxidant which may cause allergic reactions, nausea and diarrhea in predisposed patients. These allergic reactions may lead to anaphylactic shock and life-threatening asthma attacks. The prevalence in the general population is not known, but is probably low. However, sulfite hypersensitivity is observed more frequently in asthmatics than in non-asthmatics (see ” Contraindications”). In case of hypersensitivity reactions, the intake of Optium tablets must be stopped immediately.

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