ACYCLOVIR capsule ACYCLOVIR tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Chartwell RX, LLC

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

Acyclovir Capsules, USP 200 mg are available for oral administration as white opaque body, powder blue opaque cap with black ‘Y211’. They are supplied as follows: Bottle of 50 (NDC 62135-039-50) Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Protect from light and moisture. Acyclovir Tablets, USP 800 mg are available for oral administration as white capsule-shaped tablets, engraved Y213 on one side and plain on other side. They are supplied as follows: Bottle of 50 (NDC 62135-019-50) Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Protect from light and moisture. Manufactured by: Yiling Pharmaceutical Ltd No.36 Zhujiang Road, Shijiazhuang, 050035, China Manufactured For: Chartwell RX, LLC. Congers, NY 10920 Revised: 06/2022 L70960

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

ACYCLOVIR- ACYCLOVIR CAPSULE
ACYCLOVIR- ACYCLOVIR TABLET
CHARTWELL RX, LLC
----------
ACYCLOVIR CAPSULES, USP
200 MG
ACYCLOVIR TABLETS, USP
800 MG
DESCRIPTION
Acyclovir, USP is a synthetic nucleoside analogue active against
herpesviruses. Acyclovir
Capsules, USP and Acyclovir Tablets, USP are formulations for oral
administration.
Each capsule contains 200 mg of acyclovir, USP and the inactive
ingredients corn
starch, lactose monohydrate, magnesium stearate, and sodium lauryl
sulfate. The
capsule shell consists of gelatin, FD&C Blue No. 1, FD&C Red No. 3,
FD&C Yellow No. 6
and titanium dioxide. Printed with edible black ink.
Each 800 mg tablet of acyclovir contains 800 mg of acyclovir, USP and
the inactive
ingredients magnesium stearate, microcrystalline cellulose PH101,
povidone K30, and
sodium starch glycolate (Type A) (Starch from Non GMO potatoes).
Acyclovir, USP is a white, crystalline powder with the molecular
formula C
H
N
O
and a molecular weight of 225. The maximum solubility in water at
37°C is 2.5mg/mL.
The pka’s of acyclovir are 2.27 and 9.25.
The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-
hydroxyethoxy)methyl]-6H-purin-6-one; 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
8
11
5
3
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
polymerase, 2) incorporation into and termination of the growing viral
DNA