Acyclovir (Acyclovir)

Trade Name : Acyclovir

Burel Pharmaceuticals, 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 Burel Pharmaceuticals, 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

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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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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 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 in a polyethylene glycol (PEG) base.
  • Acyclovir is a white to off-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.
  • The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula:
  • No data
  • 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. In 1 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.u00a0 Acyclovir excreted in the urine ranged fromu00a0u00a0<0.02% to 9.4% of the daily dose.u00a0 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 mainly 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 USP 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:n
  • DOSAGE AND ADMINISTRATION
  • Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Acyclovir Ointment 5%.
  • 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 Ointment 5% 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.
  • Acyclovir was not teratogenic in the mouse, rabbit, or rat at exposures greatly in excess of human exposure. There are no adequate and well-controlled studies of systemic acyclovir in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999.
  • There were 749 pregnancies followed in women exposed to acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximates that found in the general population. However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. Systemic acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • It is not known whether topically applied acyclovir is excreted in breast milk. Systemic exposure following administration is minimal. After administration of Acyclovir Ointment 5%, acyclovir concentrations have been documented in breast milk in 2 women and ranged from 0.6 to 4.1 times the corresponding plasma levels. These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg per day. Nursing mothers who have active herpetic lesions near or on the breast should avoid nursing.
  • Clinical studies of Acyclovir Ointment 5% 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 ).
  • Safety and effectiveness in pediatric patients have not been established.
  • 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: Based on clinical practice experience in patients treated with Acyclovir Ointment 5% in the US, spontaneously reported adverse events are uncommon. Data are insufficient to support an estimate of their incidence or to establish causation. These events may also occur as part of the underlying disease process. Voluntary reports of adverse events that have been received since market introduction include: n : Edema and/or pain at the application site. n : Pruritus, rash. n n n n n n
  • 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
  • Each gram of Acyclovir Ointment USP 5% contains 50 mg of acyclovir in a polyethylene glycol base. It is supplied as follows:15 g (NDC 35573-403-15) and30 g (NDC 35573-403-31) tubes.
  • Store at 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F) in a dry place.
  • Distributed by:n n Richland, MS 39218n
  • Iss: 10/2018n 8-0630BUR1
  • No data

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