Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: STD Pharmaceutical Products Ltd, Plough Lane, Hereford, HR4 0EL, United Kingdom
Pharmacotherapeutic group: Vasoprotectives, Sclerosing agents for local injections
ATC code: C05BB04
Sodium tetradecyl sulfate is a sclerosing agent. Intravenous injection causes intima inflammation and thrombus formation. This usually occludes the injected vein. Subsequent formation of fibrous tissue results in partial or complete vein obliteration that may or may not be permanent.
Published clinical series have shown that Fibrovein converted to a foam is very effective at treating larger varicose veins e.g. great saphenous vein and tributaries. The foam is able to displace the blood and the sclerosant has more time to act on the endothelium compared to the liquid form. Some adverse events are more frequent following foam sclerotherapy than liquid sclerotherapy e.g. headache, migraine and visual disturbances. Adverse neurological events may also occur, but these are rare.
Fibrovein containing sodium tetradecyl sulfate is administered directly into the lumen of the isolated segment of vein/venule.
In humans, the majority (75%) of an injected dose of radiolabelled 3% sodium tetradecyl sulfate rapidly disappeared from the empty varicose vein injection site into communicating blood vessels with rapid passage into the deep calf veins.
In rats, at 72 hours after intravenous dosing of radiolabelled sodium tetradecyl sulfate, tissue levels of radiolabel found in the sampled tissues (liver, kidney, lipid and skeletal muscle) were extremely low. Although there was some evidence of radiolabel associated with the injection site, the levels were very low.
The metabolism of sodium tetradecyl sulfate has not been confirmed.
Of an intravenously administered radiolabelled dose, 70% was recovered in the urine of rats within the first 24 hours post-dosing. At the end of the 72 hour post-dose period, 73.5% of the radiolabel had been recovered from the urine and 18.2% recovered from the faeces.
No pharmacokinetics studies have been performed in patients with hepatic or renal impairment.
There are no additional data of relevance to the prescriber other than those already mentioned in other sections of the SmPC.
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