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New FDA Drug Approvals - April 2024


berdazimer

Zelsuvmi

Pharmaceutical company: LNHC, Inc.

Pharmacologic classification: Nitric oxide-releasing agent

Therapeutic classification: Antiviral

AVAILABLE FORMS

Gel: 10.3% berdazimer supplied as two tubes (Tube A contains 14 g berdazimer and Tube B contains 17 g hydrogel)

INDICATIONS AND DOSAGES

Molluscum contagiosum

Adults and children age 1 and older: Mix 0.5-mL gel from Tube A and 0.5-mL gel from Tube B on the manufacturer-provided dosing guide. Immediately apply as an even, thin layer once daily to each molluscum contagiosum lesion for up to 12 weeks.

CONTRAINDICATIONS AND CAUTIONS

  • Application site reactions, including allergic contact dermatitis, have occurred.
  • Safety and effectiveness in children younger than 1 year haven't been established.
  • Dialyzable drug: Unknown

PREGNANCY-LACTATION-REPRODUCTION

  • There are no adequate studies during pregnancy. Fetal risk is unknown.
  • It isn't known whether drug appears in human milk. Before use during breastfeeding, consider the patient's need for therapy and the potential effects on the infant.

INTERACTIONS

None reported by the manufacturer.

ADVERSE REACTIONS

CNS: fever.
GI: vomiting.
Respiratory: upper respiratory infection.
Skin: application site pain, erythema, stinging, burning, pruritis, exfoliation, dermatitis, swelling, erosion, discoloration, vesicles, irritation, infection.

Reactions in bold italics are life-threatening.
 

Released: April 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer


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