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Brand Name :
VivaGel BV
Synonyms :
astodrimer
Class :
Vaginal preparations
Brand Name :
VivaGel BV
Synonyms :
astodrimer
Class :
Vaginal preparations
Adult Dosing
Dosage Forms & Strengths
Bacterial Vaginosis The advised regimen is one full applicator (containing 5 g) inserted vaginally once a day, ideally at bedtime, for a total of seven days. Make sure to complete the entire course, even if symptoms improve before finishing treatment.
Pediatric Dosing
Not applicable
Geriatric Dosing
Refer to adult dosing
Action:
Astodrimer belongs to the class of dendrimers, which are highly branched polymers composed of a central core, internal branching layers, and terminal surface groups designed for specific biological interactions. Its surface carries multiple negatively charged groups, allowing it to engage with various molecular targets. In the case of HIV, these groups attach to the viral gp120 proteins, thereby preventing the virus from binding to CD4 receptors on host cells and blocking infection.
Frequency Not Defined
Burning around the vaginal area
Urinary tract infection
Candidiasis (thrush)
Itching
Headache
Black Box Warning
Avoid using Fleurstat BVgel if you are allergic or have previously shown sensitivity to astodrimer sodium, hydroxybenzoates, or any of the other components in the product.
Contraindication/Caution:
Hypersensitivity reactions Allergy
Pregnancy Warnings:
Pregnancy category: N/A
Lactation: Excretion in human breastmilk is unknown Pregnancy categories:
Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester.
Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women.
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women.
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.
Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women. Category N: There is no data available for the drug under this category.
Pharmacology:
Astodrimer sodium (VivaGel), the active component in Fleurstat BVgel, acts by forming a protective barrier that prevents harmful bacteria associated with bacterial vaginosis (BV) from adhering to the vaginal surface. This action supports the restoration and growth of healthy vaginal bacteria.
Pharmacokinetics:
Absorption:
Preclinical and clinical studies indicate that astodrimer sodium (VivaGel), when applied topically in the vagina, does not enter systemic circulation.
Administration:
The drug is administered intravaginally.
Patient information leaflet
Generic Name: astodrimer
Why do we use astodrimer?
Fleurstat BVgel is a transparent vaginal gel used for managing bacterial vaginosis (BV). It provides relief from common symptoms such as unusual vaginal odor and discharge, while also supporting the restoration of normal vaginal pH and healthy microbial balance.
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