Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW 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).; Principal Display Panel - 30 mg Carton Label FERA NDC 48102-028-35 Avaclyr® (Acyclovir Ophthalmic Ointment) 3% For Topical Ophthalmic Use. STERILE 3.5g Net Wt. Rx only Principal Display Panel - 30 mg Carton Label; Principal Display Panel - 30 mg Tube Label 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: Principal Display Panel - 30 mg Tube Label
- 16 HOW 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).
- Principal Display Panel - 30 mg Carton Label FERA NDC 48102-028-35 Avaclyr® (Acyclovir Ophthalmic Ointment) 3% For Topical Ophthalmic Use. STERILE 3.5g Net Wt. Rx only Principal Display Panel - 30 mg Carton Label
- Principal Display Panel - 30 mg Tube Label 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: Principal Display Panel - 30 mg Tube Label
Overview
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 8 H 11 N 5 O 3 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. Chemical Structure
Indications & 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. AVACLYR (acyclovir ophthalmic ointment) 3%, a herpes simplex virus nucleoside analog DNA polymerase inhibitor, is indicated in the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus.
Dosage & 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. Apply a 1 cm ribbon in the lower cul-de-sac of the affected eye 5 times per day until healed then 3 times per day for 7 days. ( 2 )
Warnings & Precautions
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 ) 5.1 Topical Ophthalmic Use AVACLYR is indicated for topical ophthalmic use. 5.2 Avoidance of Contact Lenses Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with AVACLYR. 5.3 Risk of Contamination 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.
Contraindications
AVACLYR is contraindicated for patients who develop sensitivity to acyclovir or valacyclovir. AVACLYR is contraindicated in patients with a known hypersensitivity to acyclovir or valacyclovir.
Adverse 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. The most common adverse reactions (2 to 10%) reported in patients were eye pain (stinging), punctate keratitis and follicular conjunctivitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fera Pharmaceuticals, LLC at (414) 434-6604 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
No clinically significant interactions have been identified resulting from topical administration of other drugs concomitantly with AVACLYR.
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