Fibro-Vein 3%
Fibro-Vein 3% Uses, Dosage, Side Effects, Food Interaction and all others data.
Sodium tetradecyl sulfate is an anionic surface-active agent which is used for its wetting properties in the industry and is also used in medicine as a blood vessel irritant and sclerosing agent for hemorrhoids and varicose veins .
Sodium tetradecyl sulfate has been widely used since the 1950s, and in 1978 the first successful report of injecting a 1% solution into spider angiomas in 144 patients was made. Also noted was an unspecified number of episodes of epidermal necrosis without significant long-term effects and a 30% incidence of post-sclerosis pigmentation that resolved within a few months .
Telangiectasias or varicose veins occur in about 33% of adult women and about 15% of adult men. Sclerotherapy with sotradecol is widely used in the treatment of varicose veins .
| Trade Name | Fibro-Vein 3% |
| Generic | Tetradecyl hydrogen sulfate (ester) |
| Tetradecyl hydrogen sulfate (ester) Other Names | Tetradecyl hydrogen sulfate |
| Type | |
| Formula | C14H30O4S |
| Weight | Average: 294.45 Monoisotopic: 294.18648062 |
| Groups | Approved |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Fibro-Vein 3% is an anionic surfactant used to treat small uncomplicated varicose veins.
Sotradecol (sodium tetradecyl sulfate injection) is indicated in the treatment of small, uncomplicated varicose veins of the legs showing simple dilation, with competent valves .
Sodium tetradecyl sulfate has been designated as an orphan drug by the FDA for the treatment of gastrointestinal bleeding due to esophageal varices .
Fibro-Vein 3% is also used to associated treatment for these conditions: Gastrointestinal Bleeding, Uncomplicated competent valves, simple dilation varicose veins of legs
How Fibro-Vein 3% works
When injected directly into a vein, sodium tetradecyl sulfate causes intimal inflammation and venous thrombus formation, which then results in occlusion of the vein. Following this sequence of events, fibrous tissue forms and causes partial to complete obliteration of the vein, which may be temporary or permanent. An important role of this drug, as well as other sclerosing agents, is to control active hemorrhage and encourage hemostasis. This may be due to the esophageal and vascular smooth muscle spasm induced by the sclerosing agent .
During acute and active bleeding, the sodium tetradecyl sulfate injected directly into the esophageal varices may dissipate rapidly, as the varices have a much higher blood volume/flow rate and no functioning valves .
The mechanical compression effect of submucosal edema, created by the injection of sclerosing agents, may also be responsible for acute hemostasis .
Toxicity
The intravenous LD50 of sodium tetradecyl sulfate in mice is 90 ± 5 mg/kg .
In the rat, the acute intravenous LD50 of sodium tetradecyl sulfate is estimated at 72 mg/kg and 108 mg/kg .
Adverse events are below:
Deep venous thrombosis
Because of the risk of deep vein thrombosis, patients must be evaluated for valvular competency and deep venous patency before treatment is initiated and slow injections of a small volume (< 2 mL) should be injected. It is recommended that patients be monitored post-treatment for both deep vein thrombosis and pulmonary embolism .
Air embolism
Stroke, transient ischemic attack, myocardial infarction, and impaired cardiac function have been associated with tetradecyl sulfate administration. Such sequelae may be caused by air embolism .
Local reaction
Local reactions including pain, itching or ulceration at the site of injection with permanent discoloration may remain along the path of the treated/sclerosed vein segment. Sloughing and/or necrosis of surrounding tissue may occur following extravasation from the injection site .
Allergic reactions
Hives, asthma, hay fever and anaphylactic shock have been reported with use of this drug .
*Mild systemic reactions *
Headache, nausea and vomiting .
Death A minimum of 6 deaths have reported with the use of Sotradecol. Four incidences of anaphylactic shock resulting in death have been reported in patients who received this drug .
One death has been reported in a patient who received Sotradecol while receiving an anti-ovulatory agent
Another death (from lethal pulmonary embolism) has been reported in a 36-year-old female treated with sodium tetradecyl acetate and was not taking oral contraceptive therapy
Food Interaction
No interactions found.Volume of Distribution
In humans, a large proportion (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 entry into the deep veins of the calf .
In rats, at 72 hours after intravenous dosing of radiolabelled sodium tetradecyl sulfate, tissue levels of radiolabelled matter found in sample tissues (liver, kidney, lipid and skeletal muscle) were measured as very low. Although there was some evidence of radiolabel associated with the injection site, the levels were negligible .
Elimination Route
After an intravenously administered radiolabelled dose, 70% of the drug was recovered in the urine of rats within 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 .
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