acyclovir (acyclovir)

US NDC LINE: 68382-992

Trade Name: acyclovir

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Zydus Pharmaceuticals (USA) Inc.

Presentation: OINTMENT

Strength: 50 mg/g

Storage and handling

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]

  • No data
  • Acyclovir Ointment USP, 5% 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]-6-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. 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 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 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.
  • No data
  • 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.
  • Based on clinical practice experience in patients treated with Acyclovir Ointment 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:
  • General
  • Edema and/or pain at the application site.
  • Skin
  • Pruritus, rash.
  • 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 to prevent autoinoculation of other body sites and transmission of infection to other persons. u00a0n
  • Each gram of Acyclovir Ointment USP, 5% contains 50 mg acyclovir in a polyethylene glycol base.
  • Acyclovir Ointment USP, 5% is supplied in 15 gram and 30 gram tubes.
  • NDC 68382-992-01 in tube of 15 gm
  • NDC 68382-992-04 in tube of 30 gm
  • Store at 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F) in a dry place.
  • Keep this and all medications out of the reach of children.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Manufactured by:
  • Cadila Healthcare Ltd.
  • Ahmedabad, India
  • Distributed by:
  • Zydus Pharmaceuticals (USA) Inc.
  • Pennington, NJ 08534
  • Rev.: 04/18
  • Acyclovir Ointment USP, 5%
  • NDC 68382-992-01 in tube of 15 gm
  • Rx Only
  • Zydus
  • Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

GNH India is WHO GDP and ISO 9001 2015 Global Pharmaceutical Distributor/ Wholesaler/ Supplier/ Exporter/ Importer of acyclovir (acyclovir) which is also known as acyclovir and manufactured by Zydus Pharmaceuticals (USA) Inc.. It is available in strength of 50 mg/g per ml.

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.

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