ACTION AND MECHANISM

Vasoprotective and antivaricose flavonoid. Hydrosmine is a standard mixture (mainly 5 and 3'-mono-O-(beta-hydroxyethyl)-diosmin and 5,3'-di-O-(beta-hydroxyethyl)-diosmin) whose mechanism of action has not been fully understood, although it could be related to the inhibition of catecholamine degradation (inhibition of catechol-O-methyltransferase). Main pharmacological actions: a) Reduces capillary permeability induced by various agents (histamine, bradykinin, etc.) and reduces capillary fragility induced by a deficiency diet; b) Increases the deformability of red blood cells and decreases blood viscosity; c) Induces a sustained and gradual contraction of the smooth muscle of the venous wall; d) It produces dilation of the lymphatic collectors and an increase in the speed of lymphatic conduction, thus improving lymphatic flow. It has an intrinsic activity on the consequences of venous stasis secondary to varicose dilation of the veins of the lower extremities, producing a short-term improvement in the clinical symptoms of peripheral venous insufficiency (pain, heaviness, edema, etc.) that is significantly different from that which can be produced by placebo.

CONTRAINDICATIONS

- Hypersensitivity to hidrosmine.

PREGNANCY

There are no clinical data available on pregnant women exposed to hidrosmine. Animal studies have not revealed direct or indirect harmful effects on pregnancy, fetal development, delivery, or postnatal development. Extreme caution should be exercised when using hidrosmine during pregnancy, and the potential benefit of this medication should be carefully assessed.

PHARMACOKINETICS

Oral administration: In healthy volunteers, the plasma concentration-time curve is biphasic: an initial peak at 15 minutes, then a slight decline; a further increase in levels is observed 4 hours later; a stabilization phase occurs 5–8 hours post-dose; the levels subsequently decline, and plasma levels are practically undetectable at 24 hours. Elimination: Quite rapid, with 90% of the dose excreted within 48 hours. Excretion via feces (80% of the administered dose) and urine (16–18%).

INDICATIONS

- [VENOUS INSUFFICIENCY], [EDEMA]: Short-term relief (2 to 3 months) of edema and symptoms related to chronic venous insufficiency.

LACTATION

It is not known whether hidrosmine is excreted in breast milk, so its use during breastfeeding is not recommended.

POSOLOGY

- Oral route: usual dose: 200 mg/8 h.

PRECAUTIONS RELATED TO EXCIPIENTS

- This medicine contains sunset yellow S as an excipient. It may cause allergic-type reactions including [ASTHMA], especially in patients with [SALICYLATE ALLERGY].

ADVERSE REACTIONS

Generally well tolerated. The most frequently observed adverse reactions are: -Digestive: [NAUSEA], [EPIGASTRIC PAIN]. -Neurological/psychological: [HEADACHE], [DIZZINESS]. -Allergic/dermatological: [EXANTHEMATOUS ERUPTIONS], [PRURITUS].

COMPOSITION

HYDROSMINE: 200 MILLIGRAMS
ORANGE YELLOW S (E-110) (EXCIPIENT): 0