Acyclovir

Acyclovir Cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. Acyclovir Cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. (1)

Acyclovir Cream should be applied 5 times per day for 4 days. Therapy should be initiated as early as possible following the onset of signs or symptoms of herpes labialis, i.e. during the prodrome or when lesions appear. For adolescents 12 years of age and older, the dosage is the same as in adults. Apply 5 times a day for 4 days. (2) Administer immediately following the onset of cold sore lesions. (2)

Each gram of Acyclovir Cream contains 50 mg (equivalent to 5% w/w) of acyclovir. Cream, 50 mg (equivalent to 5% w/w) acyclovir. (3)

Acyclovir Cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation. Acyclovir Cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir or any component of the formulation. (4)

Only for topical use of recurrent HSV lesions on the external aspect of lips and the face. Acyclovir Cream should not be applied on mucous membranes including in the eye or inside the mouth or nose. (5.1) There is a potential for irritation and contact sensitization. (5.2)

5.1General Acyclovir

Cream should only be applied on the affected external aspects of the lips and face in patients with herpes labialis. Because no data are available, application to human mucous membranes is not recommended. Acyclovir Cream is intended for cutaneous use only and should not be used in the eye or inside the mouth or nose. 5.2 Contact Sensitization Acyclovir Cream has a potential for irritation and contact sensitization [see Adverse Reactions (6.1)]. The effect of Acyclovir Cream has not been established in immunocompromised patients.

Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Acyclovir Cream. Due to minimal systemic absorption of Acyclovir Cream, systemic drug interactions are unlikely. Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Acyclovir Cream. Due to minimal systemic absorption of Acyclovir Cream, systemic drug interactions are unlikely. (7)

Risk Summary Acyclovir is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the Acyclovir Cream [see Clinical Pharmacology (12.3)]. Experience with topical acyclovir use in pregnant women over several decades, based on published literature including observational studies, has not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies with systemic exposure of acyclovir have been conducted. Refer to acyclovir prescribing information for additional details. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

An open-label, uncontrolled trial with Acyclovir Cream was conducted in 113 patients aged 12 to 17 years with recurrent herpes labialis. In this trial, therapy was applied using the same dosing regimen as in adults and subjects were followed for adverse events. The safety profile was similar to that observed in adults. Safety and effectiveness in pediatric patients less than 12 years of age have not been established.

Clinical studies of acyclovir cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Systemic absorption of acyclovir after topical administration is minimal [see Clinical Pharmacology (12.3)].

Overdosage by topical application of Acyclovir Cream is unlikely because of minimal systemic exposure [see Clinical Pharmacology (12.3)]. There is no information available for overdose.

Acyclovir is a synthetic deoxynucleoside analogue active against herpes viruses. Acyclovir Cream 5% is a formulation for topical administration. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy) methyl]-6 H -purin-6-one; it has the following structural formula: Acyclovir is a white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pKa’s of acyclovir are 2.27 and 9.25. Each gram of Acyclovir Cream contains 50 mg (equivalent to 5% w/w) of acyclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water and white petrolatum. chemstructure

Acyclovir is an antiviral drug active against α-herpesviruses [see Microbiology (12.4)].

Each gram of Acyclovir Cream contains 50 mg (equivalent to 5% w/w) of acyclovir in an aqueous cream base. Acyclovir Cream is supplied as follows: 5 g tubes NDC 0093-3630-20 Store at or below 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Store at or below 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].