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Acyclovir (Acyclovir)

Trade Name : Acyclovir

NorthStar Rx LLC

OINTMENT

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]

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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 (Acyclovir) which is also known as Acyclovir and Manufactured by NorthStar Rx LLC. 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

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
  • Acyclovir, USP, is a synthetic nucleoside analogue active against herpes viruses. Acyclovir ointment, USP 5% is a formulation for topical administration. Each gram of acyclovir ointment, USP 5% contains 50 mg of acyclovir, USP in a polyethylene glycol (PEG) base.
  • Acyclovir, USP 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 pkau2019s of acyclovir, USP are 2.27 and 9.25.
  • The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6-purin-6-one; it has the following structural formula:
  • VIROLOGY
  • Mechanism of Antiviral Action: n- in vitron- in vivo
  • The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. , acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK.
  • Antiviral Activities: n- in vitro
  • Drug Resistance:
  • Two clinical pharmacology studies were performed with acyclovir ointment 5% in immunocompromised adults at risk of developing mucocutaneous Herpes simplex virus infections or with localized varicella zoster infections. These studies were designed to evaluate the dermal tolerance, systemic toxicity, and percutaneous absorption of acyclovir.
  • Inu00a0one of these studies, which included 16 inpatients, the complete ointment or its vehicle were randomly administered in a dose of 1-cm strips (25 mg acyclovir) 4 times a day for 7 days to an intact skin surface area of 4.5 square inches. No local intolerance, systemic toxicity, or contact dermatitis were observed. In addition, no drug was detected in blood and urine by radioimmunoassay (sensitivity, 0.01 mcg/mL).
  • The other study included 11 patients with localized varicella zoster infections. In this uncontrolled study, acyclovir was detected in the blood of 9 patients and in the urine of all patients tested. Acyclovir levels in plasma ranged from <0.01 to 0.28 mcg/mL in 8 patients with normal renal function, and from <0.01 to 0.78 mcg/mL in 1 patient with impaired renal function. Acyclovir excreted in the urine ranged from <0.02% to 9.4% of the daily dose. Therefore, systemic absorption of acyclovir after topical application is minimal.
  • In clinical trials of initial genital herpes infections, acyclovir ointment 5% has shown a decrease in healing time and, in some cases, a decrease in duration of viral shedding and duration of pain. In studies in immunocompromised patients primarily with herpes labialis, there was a decrease in duration of viral shedding and a slight decrease in duration of pain.
  • In studies of recurrent genital herpes and of herpes labialis in nonimmunocompromised patients, there was no evidence of clinical benefit; there was some decrease in duration of viral shedding.
  • 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.
  • Acyclovir ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.
  • Acyclovir ointment 5% is intended for cutaneous use only and should not be used in the eye.
  • General:
  • Drug Interactions:
  • Carcinogenesis, Mutagenesis, Impairment of Fertility:
  • Pregnancy: n- Arrayn- systemic
  • Nursing Mothers:n- topicaln- oral
  • Geriatric Use:
  • Pediatric Use:
  • In the controlled clinical trials, mild pain (including transient burning and stinging) was reported by about 30% of patients in both the active and placebo arms; treatment was discontinued in 2 of these patients. Local pruritus occurred in 4% of these patients. In all studies, there was no significant difference between the drug and placebo group in the rate or type of reported adverse reactions nor were there any differences in abnormal clinical laboratory findings.
  • Observed During Clinical Practice:
  • Arrayn- General:
  • Arrayn- Skin:
  • To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Overdosage by topical application of acyclovir ointment 5% is unlikely because of limited transcutaneous absorption (see ).
  • Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times per day for 7 days. The dose size per application will vary depending upon the total lesion area but should approximate a one-half inch ribbon of ointment per 4 square inches of surface area. A finger cot or rubber glove should be used when applying acyclovir ointment 5% to prevent autoinoculation of other body sites and transmission of infection to other persons. n
  • Acyclovir Ointment, USP 5% is supplied as a white color ointment.u00a0 Each gram of acyclovir ointment, USP 5% contains acyclovir, USP in a polyethylene glycol base.
  • It is supplied as follows:
  • 15 g tubes (NDCu00a0 16714-668-01)
  • 30 g tubes (NDCu00a0 16714-668-02)
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. Store in a dry place.
  • u00a0
  • Manufactured for:
  • Northstar Rx LLC
  • Memphis, TN 38141.
  • Manufactured by:
  • Amneal Pharmaceuticals LLC
  • Piscataway, NJu00a0 08854.
  • Iss. 05-2017-00
  • No data
  • No data
  • No data
  • No data

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