Acyclovir (Acyclovir)

Trade Name : Acyclovir

Teva Pharmaceuticals, Inc.

CREAM

Strength 50 mg/g

Storage and handling for Acyclovir

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]

Disclaimer

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

Acyclovir (Acyclovir) 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

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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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.

About GNH

No data

Acyclovir 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.
Acyclovir 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. ()

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.

Each gram of Acyclovir Cream 5% contains 50 mg of acyclovir.

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

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No data

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, 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 Acyclovir Cream. Due to minimal systemic absorption of Acyclovir Cream, systemic drug interactions are unlikely.

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No data

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

Acyclovir is a synthetic nucleoside 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-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 225.20. The maximum solubility in water at 37u00b0C is 2.5 mg/mL. The pKau2019s of acyclovir are 2.27 and 9.25.
Each gram of Acyclovir Cream 5% contains 50 mg of acyclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, purified water, sodium lauryl sulfate, 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 Acyclovir 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 Acyclovir Capsules, Tablets, and Suspension and Acyclovir for Injection.

No data

Each gram of Acyclovir Cream 5% contains 50 mg acyclovir in an aqueous cream base. Acyclovir 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 Acyclovir Cream is a prescription topical cream for the treatment of cold sores (recurrent herpes labialis) that occur on the face and lips. Acyclovir Cream is not a cure for cold sores. Patients should be instructed that Acyclovir Cream is intended for cutaneous use only for herpes labialis of the lips and around the mouth. Patients should be advised that Acyclovir 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 Acyclovir Cream.
Do not use if you are allergic to Acyclovir Cream or any of the ingredients in Acyclovir Cream. Before you use Acyclovir 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 Acyclovir Cream topically 5 times per day for 4 days. Patients should be instructed to topically apply a quantity of Acyclovir 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 Acyclovir Cream. Keep out of reach of children.
Possible Side Effects
Common skin-related side effects that occurred when Acyclovir Cream was applied include application site reactions. Acyclovir Cream has the potential for irritation and contact sensitization.

Manufactured For:n n North Wales, PA 19454
Revised March 2019
9673500n

Important information: Acyclovir Cream is for use on cold sores on the lips and around the mouth only.
What is Acyclovir Cream?
Who should not use Acyclovir Cream?
Do not use Acyclovir Cream if you are:
What should I tell my healthcare provider before using Acyclovir Cream?
Before using Acyclovir 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 Acyclovir Cream?
What are the possible side effects of Acyclovir Cream?
The most common side effects of Acyclovir 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 Acyclovir 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 Acyclovir Cream?
General information about the safe and effective use of Acyclovir Cream
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Acyclovir Cream for a condition for which it was not prescribed. Do not give Acyclovir 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 Acyclovir Cream that is written for health professionals.
What are the ingredients in Acyclovir Cream?
Active ingredient:
Inactive ingredients:
Manufactured in Canada By:Bausch Health Companies Inc.Laval, Quebec H7L 4A8, Canada
Manufactured For:n n North Wales, PA 19454
For more information, call 1-800-321-4576.n This Patient Information has been approved by the U.S. Food and Drug Administration.Revised: 03/20199673500n

ACYCLOVIR CREAM 5%
NDCn- 3630n- Net Wt. 5 g
Each gram contains
USE ONLY FOR COLD SORES.n- FOR CUTANEOUS USE ONLY.
Rx only

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