These Highlights Do Not Include All The Information Needed To Use Avaclyr Safely And Effectively. See Full Prescribing Information For Avaclyr.

Risk Summary

A prospective epidemiologic registry of acyclovir use from 1984 to 1999 indicated that the occurrence rate of birth defects in women exposed to systemically administered acyclovir during the first trimester of pregnancy (period of organogenesis) approximated that found in the general population. Likewise, oral and subcutaneous administration of acyclovir to pregnant mice, rats, and rabbits during organogenesis did not produce teratogenicity at clinically relevant doses (see Animal Data).

Overdosage of topical application of acyclovir 3% is unlikely because of minimal absorption.

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 C₈H₁₁N₅O₃ and a molecular weight of 225.2. The maximum solubility in water at 25°C is 1.41 mg/mL. The pka's of acyclovir are 2.52 and 9.35.

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.

Acyclovir is a synthetic purine nucleoside analogue that is phosphorylated intracellularly by the viral encoded thymidine kinase (TK) of HSV into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In a biochemical reaction, acyclovir triphosphate inhibits replication of herpes viral DNA by competing with nucleotides for binding to the viral DNA polymerase and by incorporation into and termination of the growing viral DNA chain. The cellular thymidine kinase of normal, uninfected cells does not use acyclovir effectively as a substrate, hence toxicity to mammalian host cells is low.

Safety and efficacy of Acyclovir ophthalmic ointment in pediatric patients below the age of two years has not been established.

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

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.

AVACLYR is contraindicated for patients who develop sensitivity to acyclovir or valacyclovir.

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.

No clinically significant interactions have been identified resulting from topical administration of other drugs concomitantly with AVACLYR.

It has not been possible to detect acyclovir concentrations in the blood by existing bioanalytical methods after topical application to the eye. Trace quantities are detectable in the urine but are not therapeutically relevant.

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.

Acyclovir is an antiviral drug [see Microbiology (12.4)].

This product is sterile when packaged. Patients should be advised to not allow the tip of the container to touch any surface, as this may contaminate the ointment. If pain develops, or if redness, itching, or inflammation becomes aggravated, the patient should be advised to consult a physician.

• AVACLYR is indicated for topical ophthalmic use. (5.1)
• Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with AVACLYR. (5.2)

AVACLYR is indicated for topical ophthalmic use.

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.

AVACLYR is an ophthalmic ointment containing 3% acyclovir.

Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with AVACLYR.

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).

FERA

NDC 48102-028-35

Avaclyr®

(Acyclovir

Ophthalmic

Ointment) 3%

Each gram contains:

acyclovir USP 30 mg

in an ointment base

of white petrolatum.

For Topical

Ophthalmic Use.

Sterile

3.5g Net Wt. Rx only

Lot:

FERA

NDC 48102-028-35

Avaclyr®

(Acyclovir

Ophthalmic

Ointment) 3%

For

Topical

Ophthalmic

Use.

STERILE

3.5g Net Wt. Rx only

Risk Summary

A prospective epidemiologic registry of acyclovir use from 1984 to 1999 indicated that the occurrence rate of birth defects in women exposed to systemically administered acyclovir during the first trimester of pregnancy (period of organogenesis) approximated that found in the general population. Likewise, oral and subcutaneous administration of acyclovir to pregnant mice, rats, and rabbits during organogenesis did not produce teratogenicity at clinically relevant doses (see Animal Data).

Overdosage of topical application of acyclovir 3% is unlikely because of minimal absorption.

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 C₈H₁₁N₅O₃ and a molecular weight of 225.2. The maximum solubility in water at 25°C is 1.41 mg/mL. The pka's of acyclovir are 2.52 and 9.35.

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.

Acyclovir is a synthetic purine nucleoside analogue that is phosphorylated intracellularly by the viral encoded thymidine kinase (TK) of HSV into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In a biochemical reaction, acyclovir triphosphate inhibits replication of herpes viral DNA by competing with nucleotides for binding to the viral DNA polymerase and by incorporation into and termination of the growing viral DNA chain. The cellular thymidine kinase of normal, uninfected cells does not use acyclovir effectively as a substrate, hence toxicity to mammalian host cells is low.

Safety and efficacy of Acyclovir ophthalmic ointment in pediatric patients below the age of two years has not been established.

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

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.

AVACLYR is contraindicated for patients who develop sensitivity to acyclovir or valacyclovir.

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.

No clinically significant interactions have been identified resulting from topical administration of other drugs concomitantly with AVACLYR.

It has not been possible to detect acyclovir concentrations in the blood by existing bioanalytical methods after topical application to the eye. Trace quantities are detectable in the urine but are not therapeutically relevant.

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.

Acyclovir is an antiviral drug [see Microbiology (12.4)].

This product is sterile when packaged. Patients should be advised to not allow the tip of the container to touch any surface, as this may contaminate the ointment. If pain develops, or if redness, itching, or inflammation becomes aggravated, the patient should be advised to consult a physician.

• AVACLYR is indicated for topical ophthalmic use. (5.1)
• Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with AVACLYR. (5.2)

AVACLYR is indicated for topical ophthalmic use.

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.

AVACLYR is an ophthalmic ointment containing 3% acyclovir.

Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with AVACLYR.

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).

FERA

NDC 48102-028-35

Avaclyr®

(Acyclovir

Ophthalmic

Ointment) 3%

Each gram contains:

acyclovir USP 30 mg

in an ointment base

of white petrolatum.

For Topical

Ophthalmic Use.

Sterile

3.5g Net Wt. Rx only

Lot:

FERA

NDC 48102-028-35

Avaclyr®

(Acyclovir

Ophthalmic

Ointment) 3%

For

Topical

Ophthalmic

Use.

STERILE

3.5g Net Wt. Rx only