ACYCLOVIR- acyclovir tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCarePharmaceuticals, Inc.

INN (International Name):

ACYCLOVIR

Composition:

ACYCLOVIR 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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 15 NDC 68071-3155-1 Bottles of 21 NDC 68071-3155-2 Bottles of 25 NDC 68071-3155-5 Bottles of 30 NDC 68071-3155-3 Bottles of 35 NDC 68071-3155-7 Bottles of 60 NDC 68071-3155-6 Bottles of 40 NDC 68071-3155-4 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, 2022708 Jadcherla, Mahaboob Nagar-509 301, India. Barcode Revised: June 2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACYCLOVIR- ACYCLOVIR TABLET
NUCAREPHARMACEUTICALS, INC.
----------
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 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 relationship