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Brand Name :
N/A
Synonyms :
berdazimer topical
Class :
Dermatologics, Other
Brand Name :
N/A
Synonyms :
berdazimer topical
Class :
Dermatologics, Other
Dosage Forms & Strengths
FDA approval for molluscum contagiosum therapy is pending.
FDA approval for molluscum contagiosum therapy is pending.
The FDA is now reviewing berdazimer 10.3% gel for the treatment of molluscum contagiosum
It is projected that the FDA will approve something in early 2024
Phase III trials are presently being conducted on berdazimer 3.4% gel to treat acne
Dose Adjustments
N/A
N/A
N/A
Actions and Spectrum:
Actions:
Berdazimer gel eliminates molluscum lesions by acting as an antiviral. It operates by generating nitric oxide, which regulates NF-κB, immunomodulation, inflammation, cytokine production, and, most likely, apoptosis via protein S-nitrosylation. Additionally, nitric oxide possesses cytotoxic properties that impact the reproduction of viruses by means of reactive oxygen and/or nitrogen molecules.
Spectrum:
N/A
N/A
Black Box Warning:
N/A
Contraindication
Caution
Contraindications
Cautions
N/A
Pregnancy consideration:
No data is available regarding the administration of the drug during pregnancy.
Breastfeeding warnings:
No data is available regarding the excretion of drug in breast milk.
Pregnancy category:
Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: No data is available for the drug under this category.
Pharmacology:
Topical nitric oxide (NO)-releasing product made of carboxymethyl cellulose hydrogel, which serves as a proton donor, and berdazimer.
Pharmacodynamics:
The human body naturally produces nitric oxide (NO), which serves a variety of purposes including immunological defense. Via protein nitrosylation, it functions as an antibacterial by influencing cytokine production, immunomodulation, apoptosis, and inflammation. Viral replication can be impacted by NO through the production of harmful reactive oxygen and nitrogen molecules.
Two parts of berdazimer work together to encourage the release of nitric oxide (NO):
Berdazimer sodium, the nitric oxide donor a hydrogel that supports the regulated release of NO and functions as a proton donor on the skin.
Pharmacokinetics:
Children aged 2 to 12 years old who received berdazimer once daily demonstrated low systemic absorption, according to measurements of the NO metabolite hMAP3.
Administration:
N/A
Patient information leaflet
Generic Name: berdazimer topical
Pronounced: ber-daz-i-mer TOH-pi-kal
Why do we use berdazimer topical?
A topical nitric oxide-releasing medication called berdazimer gel is being developed to treat molluscum contagiosum.
The molluscipoxvirus is the prevalent and contagious cause of molluscum contagiosum, a viral skin infection. Mollusca, which are tiny, elevated lesions that can occur anywhere on the body, are its defining feature.
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