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Brand Name :
Zelsuvmi
Synonyms :
berdazimer sodium
Class :
Dermatologics
Brand Name :
Zelsuvmi
Synonyms :
berdazimer sodium
Class :
Dermatologics
Dosage Forms & Strengths
Topical gel
10.3%
14g of berdazimer sodium gel- Tube A (blue label)
17g of hydrogel- Tube B (yellow label)
10.3
percent
Gels
Topically applied
once a day
12
weeks
Apply the gel topically as a thin layer over the affected area one time a day for about 12 weeks.
Apply the gel topically as a thin layer over the affected area one time a day for about 12 weeks.
Dosage Forms & Strengths
Topical gel
10.3%
14g of berdazimer sodium gel- Tube A (blue label)
17g of hydrogel- Tube B (yellow label)
10.3
percent
Gels
Topical
once a day
12
weeks
Apply the gel topically as a thin layer over the affected area one time a day for about 12 weeks.
For children of the age 1 year and above:
Apply the gel topically over the affected area one time a day for about 12 weeks.
Refer to adult dosing
Actions and spectrum:
Actions:
The body makes nitric oxide for immune defense and fights microbes by influencing cytokines, apoptosis, and inflammation through protein nitrosylation. It can also hinder viral replication by generating reactive oxygen and nitrogen molecules.
Spectrum:
Berdazimer sodium treats apoptosis, acts as an antibacterial, and has immunomodulatory and anti-inflammatory actions.
>10%
Pain at the site of application (12.3%)
1-10%
Erythema at application site (6%)
Exfoliation at application site (2.8%)
Dermatitis at application site (2.8%)
Pruritis at application site (3.9%)
<1%
Irritation (0.4%)
Pyrexia (0.7%)
Infections of the upper respiratory tract (0.7%)
Vomiting (0.5%)
Black Box Warning
None
Contraindication/Caution:
Contraindication:
None
Caution:
Allergic contact dermatitis
Pregnancy consideration:
Data not available
Lactation:
Data not available
Pregnancy category:
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
Category B: There was a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.
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: There is no data available for the drug under this category.
Pharmacology:
Berdazimer sodium is a new topical gel releasing nitric oxide, potentially with antiviral effects by interfering with viral enzymes & viral reproduction.
Pharmacodynamics:
It releases nitric oxide where applied, possibly inhibiting viral replication by interacting with viral enzymes, hindering virus spread due to its small size.
Pharmacokinetics:
Limited data is available
Administration:
Apply berdazimer sodium gel one time a day on affected skin lesions and wash hands thoroughly afterward.
Patient information leaflet
Generic Name: berdazimer sodium
Why do we use berdazimer sodium?
Berdazimer sodium is the first drug approved for treating Molluscum contagiosum and acne vulgaris.
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