Avaclyr (Acyclovir)

Generic Name

Acyclovir

Brand Names

Avaclyr, Zovirax, Xerese

FDA approval date: March 29, 1982

Classification: Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor

Form: Injection, Ointment, Cream, Tablet, Suspension, Capsule

What is Avaclyr (Acyclovir)?

Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster . Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox . CLOSE.

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:

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