Optium

Optium

calcium dobesilate

Manufacturer:

Zifam Pinnacle

Distributor:

Pyrex
Full Prescribing Info
Contents
Calcium dobesilate.
Description
Calcium dobesilate is 2,5-dihydroxy benzene sulfonic acid calcium salt. Molecular formula of calcium dobesilate is C12H10CaO10S2. Molecular weight is 418.41 and melting point is 300°C. Color changes to pink upon exposure to air. Very soluble in water and alcohol, practically insoluble in ether, benzene, chloroform. Therapeutic Category: Vasotropic.
Action
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/Uses
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/Direction for Use
Generally 1 cap once or twice a day (500-1000 mg) 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.
Overdosage
The clinical signs of a possible overdosage are not known.
Contraindications
Hypersensitivity towards calcium dobesilate and/or sulfites.
Special Precautions
Dosage should be reduced in case of severe renal insufficiency requiring dialysis.
In very rare cases (0.32/1,000,000 patients), incidence estimated on the basis of spontaneous reports, the intake of calcium dobesilate may induce agranulocytosis, probably linked to a hypersensitivity reaction. This condition may be expressed by symptoms eg, high fever, oral cavity infections (tonsillitis), sore throat, anogenital inflammation and accompanying symptoms that are often signs of an infection. The patient should be told that any sign of infection must immediately be reported to the physician. In that case, it is essential to control without delay the blood formula and leucogram and to discontinue the treatment.
Use in pregnancy & 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, it should only be administered if the potential benefit justifies the potential risk to the foetus.
Calcium dobesilate enters the maternal milk in very low quantities (0.4 mcg/mL after intake of three 500-mg capsules. As a precaution, either the treatment or the breastfeeding should be stopped.
Use In Pregnancy & 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, it should only be administered if the potential benefit justifies the potential risk to the foetus.
Calcium dobesilate enters the maternal milk in very low quantities (0.4 mcg/mL after intake of three 500-mg capsules. As a precaution, either the treatment or the breastfeeding should be stopped.
Side 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 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.
Drug Interactions
No interaction is known.
Incompatibilities: No incompatibility is known.
Storage
Store at temperature below 25°C. Protect from sunlight.
ATC Classification
C05BX01 - calcium dobesilate ; Belongs to the class of other sclerosing agent used in antivaricose therapy.
Presentation/Packing
Cap 500 mg x 10 x 10's.
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