ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 8940 8943 8947 Rx only

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

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:

Product: 63629-7001 NDC: 63629-7001-1 30 CAPSULE in a BOTTLE NDC: 63629-7001-2 50 CAPSULE in a BOTTLE Product: 63629-6349 NDC: 63629-6349-1 30 TABLET in a BOTTLE NDC: 63629-6349-2 35 TABLET in a BOTTLE NDC: 63629-6349-3 50 TABLET in a BOTTLE Product: 63629-6376 NDC: 63629-6376-1 60 TABLET in a BOTTLE NDC: 63629-6376-2 30 TABLET in a BOTTLE NDC: 63629-6376-3 50 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACYCLOVIR- ACYCLOVIR CAPSULE
ACYCLOVIR- ACYCLOVIR TABLET
BRYANT RANCH PREPACK
----------
ACYCLOVIR CAPSULES USP
ACYCLOVIR TABLETS USP
8940
8943
8947
RX ONLY
DESCRIPTION
Acyclovir, USP is a synthetic nucleoside analogue active against
herpes viruses. Each
capsule, for oral administration, contains 200 mg of acyclovir, USP.
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 Aluminum Lake, FD&C
blue No. 2
Aluminum Lake, FD&C red No. 40 Aluminum Lake and D&C yellow No. 10
Aluminum
Lake. Each tablet, for oral administration, contains 400 mg or 800 mg
of acyclovir, USP.
In addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
povidone,
pregelatinized corn starch and sodium starch glycolate. The 400 mg
tablets also contain
FD&C blue No. 2 Aluminum Lake.
Acyclovir, USP 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, USP are 2.27
and 9.25.
The chemical name of acyclovir, USP 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 ce