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Acyclovir (Acyclovir)

Trade Name : Acyclovir

West-Ward Pharmaceuticals Corp

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 500 mg/1

ACYCLOVIR SODIUM 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 West-Ward Pharmaceuticals Corp. It is available in strength of 500 mg/1 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
  • Rx Only
  • FOR INTRAVENOUS INFUSION ONLY
  • Acyclovir is a synthetic nucleoside analog active against herpes viruses. Acyclovir for Injection, USP is a sterile lyophilized powder for intravenous administration only. Each 500 mg vial contains 500 mg of acyclovir and 49 mg of sodium, and each 1,000 mg vial contains 1,000 mg acyclovir and 98 mg of sodium. Reconstitution of the 500 mg or 1,000 mg vials with 10 mL or 20 mL, respectively, of Sterile Water for Injection, USP results in a solution containing 50 mg/mL of acyclovir. The pH of the reconstituted solution is approximately 11. Further dilution in any appropriate intravenous solution must be performed before infusion (seeu00a0u00a0and ).
  • Acyclovir sodium is a white, crystalline powder with the molecular formula CHNNaO and a molecular weight of 247.19. The maximum solubility in water at 25u00b0C exceeds 100 mg/mL. At physiologic pH, acyclovir sodium exists as the un-ionized form with a molecular weight of 225 and a maximum solubility in water at 37u00b0C of 2.5 mg/mL. The pkas of acyclovir are 2.27 and 9.25.
  • The chemical name of acyclovir sodium is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6-purin-6-one monosodium salt; it has the following structural formula:
  • No data
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  • Acyclovir for Injection is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.
  • Acyclovir for Injection is intended for intravenous infusion only, and should not be administered topically, intramuscularly, orally, subcutaneously, or in the eye. Intravenous infusions must be given over a period of at least 1 hour to reduce the risk of renal tubular damage (seeu00a0 and ).
  • Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (seeu00a0u00a0and ). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.
  • No data
  • The adverse reactions listed below have been observed in controlled and uncontrolled clinical trials in approximately 700 patients who received acyclovir at approximately 5 mg/kg (250 mg/m) three times daily, and approximately 300 patients who received approximately 10 mg/kg (500 mg/m) three times daily.
  • The most frequent adverse reactions reported during administration of u00a0acyclovir were inflammation or phlebitis at the injection site in approximately 9% of the patients, and transient elevations of serum creatinine or BUN in 5% to 10% (the higher incidence occurred usually following rapid [less than 10 minutes] intravenous infusion). Nausea and/or vomiting occurred in approximately 7% of the patients (the majority occurring in nonhospitalized patients who received 10 mg/kg). Itching, rash, or hives occurred in approximately 2% of patients. Elevation of transaminases occurred in 1% to 2% of patients.
  • The following hematologic abnormalities occurred at a frequency of less than 1%: anemia, neutropenia, thrombocytopenia, thrombocytosis, leukocytosis, and neutrophilia. In addition, anorexia and hematuria were observed.
  • In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of Acyclovir for Injection in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to acyclovir, or a combination of these factors.
  • General:
  • Digestive:
  • Cardiovascular:
  • Hematologic and Lymphatic:
  • Musculoskeletal:
  • Skin:
  • Overdoses involving ingestions of up to 20 g have been reported. Adverse events that have been reported in association with overdosage include agitation, coma, seizures, and lethargy. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. Overdosage has been reported following bolus injections or inappropriately high doses, and in patients whose fluid and electrolyte balance were not properly monitored. This has resulted in elevated BUN and serum creatinine, and subsequent renal failure. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored (see ).
  • CAUTIONu2014RAPID OR BOLUS INTRAVENOUS INJECTION MUST BE AVOIDED (seeu00a0 and ).
  • INTRAMUSCULAR OR SUBCUTANEOUS INJECTION MUST BE AVOIDED (see ).
  • Therapy should be initiated as early as possible following onset of signs and symptoms of herpes infections.
  • A maximum dose equivalent to 20 mg/kg every 8 hours should not be exceeded for any patient.
  • Acyclovir for Injection, USP is available as sterile vials, each containing:
  • Store at 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F).
  • Manufactured by
  • :n
  • Distributed by: n
  • Revised: November 2015PIN428-WES/1
  • NDC 0143-9657-01n n FOR INJECTION, USPn n FOR INTRAVENOUS INFUSION ONLYRx ONLYSingle Dose VialPreparation of Solution: Inject 10 mL SterileWater for Injection into vial. Shake vial until clearsolution is achieved and use within 12 hours.n n Dilute to 7 mg/mL or lower prior to infusion.See package insert for usual dosage,reconstitution and dilution instructions.Store between 15u00ba and 25u00baC (59u00ba to 77u00baF).
  • NDC 0143-9657-10n n n n FOR INJECTION, USPn n 10 Single Dose Vials, 500 mg in each vialEach vial contains: Acyclovir sodium equivalentto 500 mg of acyclovir. The sodium content is49 mg per vial.Preparation of Solution: Inject 10 mL Sterile Water forInjection into vial. Shake vial until clear solution isachieved and use within 12 hours.n n Dilute to 7 mg/mL or lower prior to infusion.See package insert for usual dosage,reconstitution and dilution instructions.Store between 15u00ba and 25u00baC (59u00ba to 77u00baF).
  • NDC 0143-9658-01n n FOR INJECTION, USPn n FOR INTRAVENOUS INFUSION ONLYRx ONLYSingle Dose VialPreparation of Solution: Inject 20 mL SterileWater for Injection into vial. Shake vial until clearsolution is achieved and use within 12 hours.n n Dilute to 7 mg/mL or lower prior to infusion.See package insert for usual dosage,reconstitution and dilution instructions.Store between 15u00ba and 25u00baC (59u00ba to 77u00baF).
  • NDC 0143-9658-10n n n FOR INJECTION, USPn n n n 10 Single Dose Vials, 1 g in each vialEach vial contains: Acyclovir sodium equivalentto 1u00a0g of acyclovir. The sodium content is 98 mg per vial.Preparation of Solution: Inject 20 mL Sterile Water forInjection into vial. Shake vial until clear solution isachieved and use within 12 hours.n n Dilute to 7 mg/mL or lower prior to infusion.See package insert for usual dosage,reconstitution and dilution instructions.Store between 15u00ba and 25u00baC (59u00ba to 77u00baF).
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