ACYCLOVIR tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

ACYCLOVIR (UNII: X4HES1O11F) (ACYCLOVIR - UNII:X4HES1O11F)

Disponible desde:

Northwind Pharmaceuticals, LLC

Designación común internacional (DCI):

ACYCLOVIR

Composición:

ACYCLOVIR 400 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Herpes Zoster Infections: Acyclovir tablets, USP are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets, USP are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets, USP are indicated for the treatment of chickenpox (varicella). Acyclovir tablets are contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

Resumen del producto:

Acyclovir tablets USP, 400 mg containing 400 mg of acyclovir USP are pink, shield shaped, flat tablets debossed with 'J' on one side and '49' in triangle on the other. They are supplied as follows: Bottles of 14 tablets NDC 51655-300-84 Bottles of 15 tablets NDC 51655-300-54 Bottles of 25 tablets NDC 51655-300-23 Bottles of 30 tablets NDC 51655-300-52 Bottles of 35 tablets NDC 51655-300-35 Bottles of 60 tablets NDC 51655-300-50 Bottles of 90 tablets NDC 51655-300-26 Store between 15º and 25ºC. Protect from light and moisture. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By:HETERO TM Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabub nagar-509 301, India. Revised: 02/2020

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ACYCLOVIR- ACYCLOVIR TABLET
NORTHWIND PHARMACEUTICALS, LLC
----------
ACYCLOVIR TABLETS, USP
RX ONLY
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against
herpesviruses. Acyclovir
tablets, USP is a formulation for oral administration.
Each Acyclovir Tablet contains 400 mg or 800 mg of acyclovir. In
addition, each tablet
contains the inactive ingredients colloidal silicon dioxide, magnesium
stearate,
microcrystalline cellulose, povidone and sodium starch glycolate. The
400 mg and 800
mg tablet also contains ferric oxide and FD&C blue lake # 2 Indigo
carmine AL,
respectively.
Acyclovir USP is a white to off white crystalline powder, slightly
hygroscopic with the
molecular formula C
H
N
O
and a molecular weight of 225.20. The maximum
solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are
2.27 and 9.25.
The chemical name of acyclovir is 6H-Purin-6-one,
2-amino-1,9-dihydro-9-[(2-
hydroxyethoxy)methyl]-. It has the following structural formula:
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 3 ways: 1) competitive inhibition
of viral DNA
8
11
5
3
polymerase, 2) incorporation into and termination of the growing viral
DNA chain, and 3)
inactivation of the viral DNA polymerase. The greater antiviral
activity of acyclovir against
HSV compared with VZV is due to its more efficient phosphorylation by
the viral TK.
ANTIVIRAL ACTIVITIES: The quantitative r