O-(beta-hydroxyethyl)-rutosides

Registered South African indications:

• Heavy, painful and swollen legs
• Oedema of the ankles
• Paraesthesia
• Nocturnal cramp
• Pain and oedema associated with varicose veins
• Lower limb venous insufficiency
• Superficial thrombophlebitis
• Trophic disturbances of venous insufficiency (dermatitis and ulcers)
• Sclerotherapy and excision of varicose veins (as adjuvant)
• Haemorrhoids

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Cardiac disease
• Leg oedema due to cardiac, renal or hepatic disease
• No improvement or worsening of leg pain and swelling
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: cap

Heavy, painful and swollen legs 
Oedema of the ankles 
Paraesthesia
- Pins and needles in the limbs at night and on waking
Nocturnal cramp 
Pain and oedema associated with varicose veins
Lower limb venous insufficiency 
Superficial thrombophlebitis 
Trophic disturbances of venous insufficiency
- Dermatitis and ulcers 
Sclerotherapy and excision of varicose veins (as adjuvant)
Haemorrhoids 

• Oral (cap): Initial: 250mg, 6-8hrly; Maintenance: 250-500mg, 24hrly

Oedema associated with chronic venous insufficiency

• Oral (cap): 500mg, 12hrly

To be taken with meals

Not established for use in children below 18 years

Pregnancy

• First trimester: Caution; not recommended
• Second and third trimester: Caution
• Data on a limited number of exposed pregnancies indicate no adverse effects of O-(beta-hydroxyethyl)-rutosides on pregnancy or on the health of the foetus/ new-born child
• Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development
• Nevertheless, according to generally accepted safety recommendations, O-(beta-hydroxyethyl)-rutosides should not be used during the first three months of pregnancy

Breastfeeding

• Caution 
• In animal studies, traces of O-(beta-hydroxyethyl)-rutosides were found in the foetuses and in the milk of breastfeeding dams. These minor amounts of O-(beta-hydroxyethyl)-rutosides are of no clinical significance

Fertility

• Animal studies did not indicate effects on fertility following administration of O-(beta-hydroxyethyl)-rutosides

Renal impairment

• Caution; no information available
  Patients who have oedema of the lower limbs due to renal disease should not use this product as the effect of O-(beta-hydroxyethyl)-rutosides have not been shown in this indication

Hepatic impairment

• Caution; no information available
  Patients who have oedema of the lower limbs due to hepatic disease should not use this product as the effect of O-(beta- hydroxyethyl)-rutosides have not been shown in this indication

Elderly

• Caution; no dose adjustment recommended

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness
• Headache
• Fatigue

Gastrointestinal Disorders

• Flatulence
• Diarrhoea
• Abdominal pain
• Stomach discomfort
• Dyspepsia

Musculoskeletal Disorders

• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Urticaria
• Photosensitivity
• Alopecia
• Flushing

Immune, Blood and Lymphatic System Disorders

• Anaphylactoid reactions
• Hypersensitivity reactions

None known

None routine

At the cellular level, the capability of O-(beta-hydroxyethyl)-rutosides to protect the vascular wall from oxidative attack of activated blood cells and its affinity to the endothelium of capillaries and venoles is shown. O-(beta-hydroxyethyl)-rutosides demonstrate a reduction of the capillary permeability, restoration of the veno-arteriolar reflex, increase of the venous refilling time and increase of the transcutaneous oxygen tension. All these effects are compatible with the primary effect being on the microvascular endothelium, with a resultant diminution of oedema.

Capsule 250mg

• Paroven (GSK)