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Vecin

Vecin

Manufacturer:

MacroPhar

Distributor:

MacroPhar Lab

Marketer:

MacroPhar Lab
Full Prescribing Info
Contents
Aescin.
Description
White, round, biconvex enteric-coated tablet, engraved with "
Click on icon to see table/diagram/image
" on one side and plain on the other.
Each enteric coated tablet contains aescin 20 mg.
Excipients/Inactive Ingredients: Lactose monohydrate, Povidone, Croscarmellose sodium, Magnesium stearate, Metacrylic acid/ethyl acrylate copolymer, Polyethylene glycol, Talc, Titanium dioxide.
Action
Pharmacotherapeutic group: Capillary-stabilizing agents. ATC code: CO5CX03.
Pharmacology: Pharmacodynamics: The target site of aescin is the vascular wall. In pathologically raised permeability, aescin inhibits exudation by reducing the extravasations of fluid into the tissue and accelerating the subsidence of edema. The mode of action is based on changes in the permeability of the affected capillary walls. In addition, aescin raises capillary resistance, inhibits inflammatory processes and improves microcirculation.
Pharmacokinetics: The metabolism of oral administered aescin was studied in rats and mice. After oral administration of tritium-marked aescin, the administered activity absorbed from the gastrointestinal tract averaged 12% to 16%. Excretion occurs by both bile and urine. The rate of metabolism is bigger following oral administration than with intravenous application. The organ distribution of aescin is insignificant in the excretion organs liver and kidneys, compared to the increased blood level.
Absorption: Aescin is rapidly absorbed after oral administration with an absorption half-life of approximately 1 hour; however, it undergoes a significant first-pass effect, resulting in only a 1.5% bioavailability.
Distribution: Total protein binding: 86% to 94%.
Metabolism: Aescin undergoes first-pass metabolism in liver.
Excretion: Aescin has a total plasma clearance of 21.8 milliliters/minute (ml/min).
Approximately 0.1% of an oral dose is excreted unchanged in the urine.
Terminal half-life of 10 hours after oral administration.
Indications/Uses
Localized swelling following injury, varicose veins, and hemorrhoids.
Dosage/Direction for Use
Recommended dose: As an initial dose, adults and adolescents over 14 years should take 2 tablets 3 times daily after meal.
In milder cases, or as a maintenance dose, they should take 1 tablet 3 times daily after meal.
Children between 7 and 14 years of age should take 1 tablet 2 or 3 times daily after meal.
For children less than 7 years of age are not indicated.
Mode of Administration: Oral administration.
Overdosage
Cases of overdose have not been reported.
Contraindications
Contraindicated in patient with hypersensitivity to aescin or any component of the formulation (See Description).
Contraindicated in patient with renal insufficiency/renal failure or renal diseases.
Special Precautions
Patients suffering from hereditary galactose intolerance, fructose intolerance, lactose deficiency, saccharase-isomaltase deficiency or glucose-galactose malabsorption should not take this medicine.
Use In Pregnancy & Lactation
Pregnancy: There are no adequate data from the use of aescin in pregnant women. Animal studies are insufficient with respect to effects on pregnancy or fetal/embryonal development. Aescin should not be used during pregnancy.
Nursing mothers: As it is unknown to which extent aescin passes into breast milk, should not be taken during lactation.
Adverse Reactions
Immune system disorders: Very rare (1 or less than 1 of 10,000 patients): hypersensitivity reactions, e.g. urticaria.
Gastrointestinal disorders: Uncommon (>1 of 1,000 patients): disorders of the gastrointestinal tract.
If hypersensitivity reactions occur, the administration should be discontinued.
Other possible adverse effects: Headache, vertigo, pruritus (The frequency is unknown).
Drug Interactions
Aescin may enhance the effects of anticoagulants.
The concomitant administration of antibiotics of the aminoglycoside type (e.g. gentamicin) should be avoided, since it cannot totally be ruled out that their nephrotoxicity may be enhanced.
The binding of aescin to plasma proteins may be affected by antibiotics. Cephalotin and ampicillin, e.g. cause a rise in the concentration of free serum aescin.
Storage
Keep in tight container, store below 30°C.
MIMS Class
Phlebitis & Varicose Preparations
ATC Classification
C05CX - Other capillary stabilizing agents ; Used as capillary stabilizing agents.
Presentation/Packing
Form
Vecin EC tab 20 mg
Packing/Price
10 × 10's
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