ACYCLOVIR capsule ACYCLOVIR tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

ACYCLOVIR

Composition:

ACYCLOVIR 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Acyclovir capsules USP are available containing 200 mg acyclovir. Each opaque blue cap and body size #1 hard gelatin capsule is imprinted with black ink N 940 and 200 on opposing cap and body portion of the capsule. They are supplied as follows: NDC 33261-419-30 Bottles of 30 Acyclovir tablets USP are available containing 400 mg acyclovir. Each blue colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N 943 on one side and 400 on the other side. They are supplied as follows: NDC 33261-491-21 Bottles of 21 NDC 33261-491-25 Bottles of 25 NDC 33261-491-28 Bottles of 28 NDC 33261-491-30 Bottles of 30 NDC 33261-491-60 Bottles of 60 NDC 33261-491-90 Bottles of 90 Acyclovir tablets USP are available containing 800 mg acyclovir. Each white to off-white colored, biconvex, capsule shaped, compressed unscored tablet is debossed with N 947 on one side and 800 on the other side. They are supplied as follows: NDC 33261-227-16 Bottles of 30 NDC 33261-227-30 Bottles of 30 NDC 33261-227-35 Bottles of 30 NDC 33261-227-40 Bottles 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: NOVOPHARM LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Repackaged By: Aidarex Pharmaceuticals, LLC. Corona, CA 92880 Rev. F 9/2008

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACYCLOVIR- ACYCLOVIR CAPSULE
ACYCLOVIR- ACYCLOVIR TABLET
AIDAREX PHARMACEUTICALS LLC
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ACYCLOVIR
CAPSULES USP
ACYCLOVIR
TABLETS USP
8940
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
8
11
5
3
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. T