Generic Name
Acyclovir
Brand Names
Zovirax, Xerese
FDA approval date: March 29, 1982
Classification: Corticosteroid
Form: Injection, Ointment, Cream, Tablet, Suspension, Capsule
What is Zovirax (Acyclovir)?
Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.
Save this treatment for later
Not sure about your diagnosis?
Tired of the same old research?
Related Clinical Trials
A Phase I Pharmacokinetic and Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus Disease
Summary: This is a Phase 1 single-arm open-label study of letermovir in neonates with symptomatic congenital Cytomegalovirus (CMV) disease. There will be two groups enrolled. Group 1 will be comprised of 4 subjects. Following documentation study inclusion and signing of informed consent, Group 1 subjects will receive one dose of oral letermovir (Study Day 0), using the dose bands. A full pharmacokinetics (...
Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)
Summary: To learn if the combination of pirtobrutinib (also called LOXO-305), venetoclax, and obinutuzumab is safe and effective when given to patients with chronic lymphocytic leukemia (CLL) or Richter transformation (RT) who have not previously received treatment.
Historical Controlled, Single Center Open Label Pilot Comparing the Effectiveness and Tolerability of De-novo Initiation of Letermovir Versus Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
Summary: This study is being done to compare the effectiveness of de novo Letermovir versus valganciclovir in preventing the development of cytomegalovirus viremia or symptomatic disease in African American kidney transplant recipients within the first year after transplantation. There are two arms in the study: Arm 1: Prophylaxis: This group includes freshly transplanted high risk (CMV D+/R-) African Amer...
Related Latest Advances
Brand Information
Zovirax (acyclovir)
1INDICATIONS AND USAGE
ZOVIRAX 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.
2DOSAGE AND ADMINISTRATION
ZOVIRAX 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.
3DOSAGE FORMS AND STRENGTHS
Each gram of ZOVIRAX Cream contains 50 mg (equivalent to 5% w/w) of acyclovir.
4CONTRAINDICATIONS
ZOVIRAX Cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation.
5DRUG INTERACTIONS
Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with ZOVIRAX Cream. Due to minimal systemic absorption of ZOVIRAX Cream, systemic drug interactions are unlikely.
6OVERDOSAGE
Overdosage by topical application of ZOVIRAX Cream is unlikely because of minimal systemic exposure
7DESCRIPTION
ZOVIRAX is the brand name for acyclovir, a synthetic deoxynucleoside analogue active against herpes viruses. ZOVIRAX Cream 5% is a formulation for topical administration.
The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy) methyl]-6
Acyclovir is a white, crystalline powder with the molecular formula C
Each gram of ZOVIRAX 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.
8HOW SUPPLIED/STORAGE AND HANDLING
Each gram of ZOVIRAX Cream contains 50 mg (equivalent to 5% w/w) of acyclovir in an aqueous cream base. ZOVIRAX Cream is supplied as follows:
NDC 0187-0994-45: 5 g tubes
Store at or below 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
General
Patients should be informed that ZOVIRAX Cream is a prescription topical cream for the treatment of cold sores (recurrent herpes labialis) that occur on the face and lips. ZOVIRAX Cream is not a cure for cold sores. Patients should be instructed that ZOVIRAX Cream is intended for cutaneous use only for herpes labialis of the lips and around the mouth. Patients should be advised that ZOVIRAX Cream should not be used in the eye, inside the mouth or nose, or on the genitals. Patients should be instructed to avoid applying other topical products to the affected area while using ZOVIRAX Cream.
Do not use if you are allergic to ZOVIRAX Cream or any of the ingredients in ZOVIRAX Cream. Before you use ZOVIRAX Cream, tell your doctor if you are pregnant, planning to become pregnant, or are breast-feeding.
Instructions for Use
Treatment should be initiated at the earliest sign or symptom of recurrence. Instruct patients to wash hands prior to application and ensure the face and/or lips are clean and dry. Advise patients to apply ZOVIRAX Cream topically 5 times per day for 4 days. Instruct patients to topically apply a quantity of ZOVIRAX Cream sufficient to cover the affected area, including the outer margin. Advise patients to avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. Instruct patients to wash their hands with soap and water after using ZOVIRAX Cream. Keep out of reach of children.
Possible Side Effects
Common skin-related side effects that occurred when ZOVIRAX Cream was applied include application site reactions. ZOVIRAX Cream has the potential for irritation and contact sensitization.
10PATIENT INFORMATION
ZOVIRAX (zho-vahy-rex)
Important information: ZOVIRAX Cream is for use on cold sores on the lips and around the mouth only. ZOVIRAX Cream should not be used in your eyes, mouth, nose, or on your genitals.
What is ZOVIRAX Cream?
- ZOVIRAX Cream is a prescription medicine used to treat cold sores (herpes labialis) that are recurring in adults and children 12 years of age and older, and who have normal immune systems.
- ZOVIRAX Cream is not a cure for cold sores.
It is not known if ZOVIRAX Cream is safe and effective in children less than 12 years of age.
Do not use ZOVIRAX Cream if you are allergic to acyclovir, valacyclovir, or any of the ingredients in ZOVIRAX Cream. See the end of this leaflet for a complete list of ingredients in ZOVIRAX Cream.
What should I tell my healthcare provider before using ZOVIRAX Cream?
Before using ZOVIRAX Cream, tell your healthcare provider about all of your medical conditions, including if you:
- become sick very easily (have a weak immune system).
- are pregnant or plan to become pregnant. It is not known if ZOVIRAX Cream will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if ZOVIRAX Cream passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ZOVIRAX Cream.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use ZOVIRAX Cream?
- Use ZOVIRAX Cream exactly as your healthcare provider tells you to use it.
- Use ZOVIRAX Cream as soon as you have the first symptoms of a cold sore such as itching, redness, burning or tingling, or when the cold sore appears.
- Wash your hands with soap and water before and after applying ZOVIRAX Cream.
- The affected area should be clean and dry before applying ZOVIRAX Cream.
- Apply ZOVIRAX Cream to the affected area 5 times each day for 4 days, including the outer edge.
- You should not apply other skin products to the affected area during treatment with ZOVIRAX Cream.
- Avoid unnecessary rubbing of the cold sore because this may cause the cold sore to spread to other areas around your mouth or make your cold sore worse.
What are the possible side effects of ZOVIRAX Cream?
The most common side effects of ZOVIRAX Cream are skin reactions at the treatment site and may include: dry or cracked lips, peeling, flaking or dryness of the skin, a burning or stinging feeling, and itching.
These are not all the possible side effects of ZOVIRAX Cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ZOVIRAX Cream?
- Store ZOVIRAX Cream at room temperature between 68° to 77°F (20° to 25°C).
Keep ZOVIRAX Cream and all medicines out of reach of children.
General information about the safe and effective use of ZOVIRAX Cream.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZOVIRAX Cream for a condition for which it was not prescribed. Do not give ZOVIRAX Cream to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ZOVIRAX Cream that is written for health professionals.
What are the ingredients in ZOVIRAX Cream?
Active ingredient: acyclovir
Inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water, and white petrolatum
Inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water, and white petrolatum
Distributed by: Bausch Health US, LLC
Bridgewater, NJ 08807 USA
Bridgewater, NJ 08807 USA
Manufactured by: Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada
Zovirax is a trademark of GlaxoSmithKline LLC used under license.
© 2021 Bausch Health Companies Inc. or its affiliates
For more information, call 1-800-321-4576.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 02/2021
9462203
11PRINCIPAL DISPLAY PANEL - 5g Tube Carton
ZOVIRAX
(ACYCLOVIR) CREAM 5%
(ACYCLOVIR) CREAM 5%
NDC 0187-0994-45
Net Wt. 5 g
Net Wt. 5 g
Each gram contains:
50 mg (equivalent to 5%
w/w) acyclovir, cetostearyl
alcohol, mineral oil,
poloxamer 407, propylene
glycol, sodium lauryl
sulfate, water and
white petrolatum.
50 mg (equivalent to 5%
w/w) acyclovir, cetostearyl
alcohol, mineral oil,
poloxamer 407, propylene
glycol, sodium lauryl
sulfate, water and
white petrolatum.
USE ONLY FOR COLD SORES.
FOR CUTANEOUS USE ONLY.
FOR CUTANEOUS USE ONLY.
Ortho Dermatologics
Rx only
