ACYCLOVIR- acyclovir capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

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, USP. Each opaque blue cap and body size #1 hard gelatin capsule is imprinted with black ink N over 940 and 200 on opposing cap and body portion of the capsule. They are supplied as follows: NDC 0093-8940-01 Bottles of 100 NDC 0093-8940-05 Bottles of 500 Acyclovir Tablets USP are available containing 400 mg acyclovir, USP. 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 0093-8943-01 Bottles of 100 NDC 0093-8943-05 Bottles of 500 Acyclovir Tablets USP are available containing 800 mg acyclovir, USP. 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 0093-8947-01 Bottles of 100 NDC 0093-8947-05 Bottles of 500 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Czech Republic By: TEVA Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. J 9/2014

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACYCLOVIR- ACYCLOVIR CAPSULE
REMEDYREPACK INC.
----------
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
cellular enzymes. _In vitro_, ac