ACYCLOVIR- acyclovir tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Clinical Solutions Wholesale

INN (Tarptautinis Pavadinimas):

ACYCLOVIR

Sudėtis:

ACYCLOVIR 400 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

Acyclovir tablets USP are available containing 400 mg acyclovir. Each blue colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N943 on one side and 400 on the other side. They are supplied as follows: NDC 58118-8943-08 Blister cards of 30 Acyclovir tablets USP are available containing 800 mg acyclovir. Each white to off-white colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N947 on one side and 800 on the other side. They are supplied as follows: NDC 58118-8947-08 Blister cards of 30 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Manufactured In Canada By: TEVA CANADA LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA North Wales, PA 19454 Rev. H 8/2012 Repackaged by: CLINICAL SOLUTIONS WHOLESALE Franklin, TN 37067

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ACYCLOVIR- ACYCLOVIR TABLET
CLINICAL SOLUTIONS WHOLESALE
----------
ACYCLOVIR
TABLETS USP
8943
8947
RX ONLY
DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against
herpesviruses. Each capsule, for oral
administration, contains 200 mg of acyclovir. In addition, each
capsule contains the following inactive
ingredients: corn starch, lactose monohydrate, magnesium stearate and
sodium lauryl sulfate. The
capsule shell consists of gelatin, FD&C blue No. 1, D&C red No. 28,
D&C red No. 33 and titanium
dioxide. Printed with edible black ink that contains FD&C blue No. 1,
FD&C blue No. 2, FD&C red No.
40 and D&C yellow No. 10. Each tablet, for oral administration,
contains 400 mg or 800 mg of
acyclovir. In addition, each tablet contains the following inactive
ingredients: colloidal silicon dioxide,
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
povidone, pregelatinized starch
and sodium starch glycolate. The 400 mg tablets also contain FD&C blue
No. 2.
Acyclovir is a white to off-white, crystalline powder. 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
2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 _H-_purin-6-one;
it has the following structural formula:
C
H
N
O
M.W. 225
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 vira