ACYCLOVIR- acyclovir sodium injection, solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

ACYCLOVIR SODIUM (UNII: 927L42J563) (ACYCLOVIR - UNII:X4HES1O11F)

MAH:

Fresenius Kabi USA, LLC

INN:

ACYCLOVIR SODIUM

composition:

ACYCLOVIR 50 mg in 1 mL

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Acyclovir Sodium Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients. Acyclovir Sodium Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immuno-competent patients. Acyclovir Sodium Injection is indicated for the treatment of herpes simplex encephalitis. Acyclovir Sodium Injection is indicated for the treatment of neonates and infants with herpes simplex infections. Acyclovir Sodium Injection is indicated for the treatment of varicella-zoster (shingles) infections in immunocompromised patients. Acyclovir Sodium Injection is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

leaflet_short:

Acyclovir Sodium Injection is available as: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion. This container closure is not made with natural rubber latex. 45769J Revised: April 2020

authorization_status:

Abbreviated New Drug Application

SPC

ACYCLOVIR - ACYCLOVIR SODIUM INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
ACYCLOVIR SODIUM INJECTION
FOR INTRAVENOUS INFUSION ONLY
Rx only
DESCRIPTION
Acyclovir Sodium Injection is a synthetic nucleoside analog, active
against herpes viruses. It is a
sterile, aqueous solution for intravenous infusion, containing 50 mg
acyclovir per mL in Water for
Injection, USP. The concentration is equivalent to 54.9 mg of
acyclovir sodium per mL in Water for
Injection, USP. The sodium content is approximately 5.1 mg/mL. The pH
range of the solution is 10.85
to 11.50. Further dilution of Acyclovir Sodium Injection in an
appropriate intravenous solution must be
performed before infusion (see DOSAGE AND ADMINISTRATION,
ADMINISTRATION).
The chemical name of acyclovir sodium is 9-[(2-Hydroxyethoxy)methyl]
guanine, and has the following
structural formula:
Acyclovir sodium is a white, crystalline powder with the molecular
formula C H N NaO and a
molecular weight of 247.19. The maximum solubility in water at 25°C
exceeds 100 mg/mL. At
physiologic pH, acyclovir sodium exists as the unionized form with a
molecular weight of 225 and a
maximum solubility in water at 37°C of 2.5 mg/mL. The pka's of
acyclovir are 2.27 and 9.25.
VIROLOGY
MECHANISM OF ANTIVIRAL ACTION
Acyclovir is a synthetic purine nucleoside analogue with _in vitro_
and _in vivo_ inhibitory activity against
herpes simplex virus types 1 (HSV-1), 2 (HSV-2) and varicella-zoster
virus (VZV).
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. _In vitro_, acyclovir
triphosphate stops replication of herpes viral DNA. This is
accomplished in three ways: 1) competitive
inhibition of viral DNA polymerase, 2) incorporation into and
termination of the growing vi