ACYCLOVIR SODIUM injection, solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

AuroMedics Pharma LLC

INN (Միջազգային անվանումը):

ACYCLOVIR SODIUM

Կազմը:

ACYCLOVIR 500 mg in 10 mL

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 neonatal herpes 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.

Ապրանքի ամփոփագիր:

Acyclovir Sodium Injection is a clear, colorless solution and is available as: Acyclovir Sodium Injection equivalent to acyclovir,                  NDC 55150-154-11     50 mg/mL in 10 mL glass vials, in a Carton of 10. Acyclovir Sodium Injection equivalent to acyclovir,                  NDC 55150-155-21     50 mg/mL in 20 mL glass vials, in a Carton of 10. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Discard unused portion. Vial stoppers are not made with natural rubber latex. Retain in Carton until time of use. Sterile, Nonpyrogenic Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad - 500038 India NOVAPLUS is a registered trademark of Vizient, Inc. Revised: September 2017

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

ACYCLOVIR SODIUM - ACYCLOVIR SODIUM INJECTION, SOLUTION
AUROMEDICS PHARMA LLC
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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 USP is a white to off-white, crystalline powder. Acyclovir
sodium is the sodium salt of
acyclovir, which is formed _in situ_, 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) competit