Avaclyr
Generic Formulation: ACYCLOVIR
Regulatory Registrant: Fera Pharmaceuticals, LLC
Related NDC Products
| NDC Code | Dosage Form | Route | Category |
|---|---|---|---|
| 48102-028 | OINTMENT | OPHTHALMIC | NDA |
Indications & Usage
1 INDICATIONS 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. 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
2 DOSAGE 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. 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
5 WARNINGS AND 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.
Side Effects
6 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
7 DRUG INTERACTIONS No clinically significant interactions have been identified resulting from topical administration of other drugs concomitantly with AVACLYR.