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Acyclovir (Zovirax)

Trade Name : Zovirax

Bausch Health Americas, Inc.

CREAM

Strength 50 mg/g

ACYCLOVIR DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]

Delivery Process

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Product information is meant for

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Acyclovir (Zovirax) which is also known as Zovirax and Manufactured by Bausch Health Americas, Inc.. It is available in strength of 50 mg/g per ml. Read more

Acyclovir (Zovirax) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • ZOVIRAX Cream is a herpes simplex virus (HSV) nucleoside 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.
  • ZOVIRAX Cream is a herpes simplex virus (HSV) nucleoside 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. ()
  • 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.
  • Each gram of ZOVIRAX Cream 5% contains 50 mg of acyclovir.
  • u2022
  • 3
  • ZOVIRAX Cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation.
  • u2022
  • 4
  • No data
  • To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 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.
  • u2022
  • 7
  • No data
  • Overdosage by topical application of ZOVIRAX Cream is unlikely because of minimal systemic exposure [see ]. There is no information available for overdose.
  • ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside 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-purin-6-one; it has the following structural formula:
  • Acyclovir is a white, crystalline powder with the molecular formula CHNO and a molecular weight of 225. The maximum solubility in water at 37u00b0C is 2.5 mg/mL. The pKa's of acyclovir are 2.27 and 9.25.
  • Each gram of ZOVIRAX Cream 5% contains 50 mg of acyclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water and white petrolatum.
  • No data
  • Systemic exposure following topical administration of acyclovir is minimal. Dermal carcinogenicity studies were not conducted. Results from the studies of carcinogenesis, mutagenesis and fertility are not included in the full prescribing information for ZOVIRAX Cream due to the minimal exposures of acyclovir that result from dermal application. Information on these studies is available in the full prescribing information for ZOVIRAX Capsules, Tablets, and Suspension and ZOVIRAX for Injection.
  • No data
  • Each gram of ZOVIRAX Cream 5% contains 50 mg acyclovir in an aqueous cream base. ZOVIRAX Cream is supplied as follows:
  • Store at or below 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • 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. Patients should be instructed to wash hands prior to application and ensure the face and/or lips are clean and dry. Patients should be advised to apply ZOVIRAX Cream topically 5 times per day for 4 days. Patients should be instructed to topically apply a quantity of ZOVIRAX Cream sufficient to cover the affected area, including the outer margin. Patients should be advised to avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. Patients should be instructed 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.
  • Manufactured for:
  • Bridgewater, NJ 08807 USA
  • By:
  • Laval, Quebec H7L 4A8, Canada
  • Zovirax is a trademark of GlaxoSmithKline LLC used under license.
  • u00a9 Valeant Pharmaceuticals North America LLC
  • 9462202n
  • Important information: ZOVIRAX Cream is for use on cold sores on the lips and around the mouth only.
  • What is ZOVIRAX Cream?
  • Who should not use ZOVIRAX Cream?
  • Do not use ZOVIRAX Cream if you are:
  • 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:
  • Tell your healthcare provider about all the medicines you take,
  • How should I use ZOVIRAX Cream?
  • 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?
  • 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:
  • Inactive ingredients:
  • Manufactured for:n- By:
  • ZOVIRAXn n- (ACYCLOVIR) CREAM 5%
  • NDCn- Net Wt. 5 g
  • Each gram contains
  • USE ONLY FOR COLD SORES.n- FOR CUTANEOUS USE ONLY.
  • Ortho Dermatologics
  • Rx only

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