Neonatal Herpes Treatments

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Generic Name

Acyclovir

Brand Names
Avaclyr, Zovirax, Xerese
FDA approval date: March 29, 1982
Classification: Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor
Form: Ointment, Injection, Cream, Tablet, Suspension, Capsule

What is Avaclyr (Acyclovir)?

Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.

Approved To Treat

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Brand Information

    Avaclyr (ACYCLOVIR)
    1INDICATIONS AND USAGE
    AVACLYR is a sterile topical antiviral indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus.
    2DOSAGE AND ADMINISTRATION
    The recommended dosing regimen is to apply a 1 cm ribbon of ointment in the lower cul-de-sac of the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals and then a 1 cm ribbon 3 times per day for 7 days.
    3DOSAGE FORMS AND STRENGTHS
    AVACLYR is an ophthalmic ointment containing 3% acyclovir.
    4CONTRAINDICATIONS
    AVACLYR is contraindicated for patients who develop sensitivity to acyclovir or valacyclovir.
    5ADVERSE REACTIONS
    The most common adverse reactions (2-10%) reported in patients were eye pain (stinging), punctate keratitis and follicular conjunctivitis. Rare reports of blepharitis and very rare reports of immediate hypersensitivity reactions including angioedema and urticaria have been observed post-marketing in patients taking AVACLYR.
    6DRUG INTERACTIONS
    No clinically significant interactions have been identified resulting from topical administration of other drugs concomitantly with AVACLYR.
    7OVERDOSAGE
    Overdosage of topical application of acyclovir 3% is unlikely because of minimal absorption.
    8DESCRIPTION
    Acyclovir is a synthetic herpes simplex virus nucleoside analog DNA polymerase inhibitor. The drug substance is a white crystalline powder with the molecular formula of C
    The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]6H-purin-6-one, it has the following chemical structure:
    Chemical Structure
    AVACLYR is a sterile ointment for topical administration in eyes. Each gram of ointment contains 30 mg of acyclovir in a white petrolatum base.
    9CLINICAL STUDIES
    In five randomized, double masked studies which enrolled a total of 238 subjects with dendritic herpetic keratitis, acyclovir ophthalmic ointment, 3% was either superior or as effective as idoxuridine ophthalmic ointment 0.5% or 1% in subjects with dendritic ulcers. Clinical resolution (healed ulcers) at Day 7 averaged 83% for acyclovir and 50% for idoxuridine.
    10HOW SUPPLIED/STORAGE AND HANDLING
    AVACLYR is available in a 3.5 g aluminum tube with a white high density polyethylene cap as a clear, colorless, sterile ophthalmic ointment for topical use containing 3% acyclovir active drug. Each tube is packaged in an individual carton.
    3.5 g tube (NDC 48102-028-35)
    Store at 15°C to 25°C (59°F to 77°F).
    11Principal Display Panel - 30 mg Carton Label
    FERA
    NDC 48102-028-35
    Avaclyr®
    (Acyclovir
    For
    STERILE
    3.5g Net Wt. Rx only
    Principal Display Panel - 30 mg Carton Label
    12Principal Display Panel - 30 mg Tube Label
    FERA
    NDC 48102-028-35
    Avaclyr®
    (Acyclovir
    Each gram contains:
    acyclovir USP 30 mg
    For Topical
    Sterile
    3.5g Net Wt. Rx only
    Lot:
    Principal Display Panel - 30 mg Tube Label