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:

Physicians Total Care, 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 of acyclovir, USP. The 200 mg capsule is a hard-shell gelatin capsule with a lavender opaque cap and a lavender opaque body axially printed with MYLAN over 2200 in black ink on both the cap and body. The capsule is filled with white to off-white powder. They are available as follows: Acyclovir Tablets, USP are available containing 400 mg or 800 mg of acyclovir, USP. The 400 mg tablets are white round, unscored tablets debossed with M over 253 on one side of the tablet and blank on the other side. They are available as follows: The 800 mg tablets are white oval, unscored tablets debossed with MYLAN on one side of the tablet and 302 on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured in India by: Mylan Laboratories Limited Hyderabad—500 034, India Code No. MH/DRUGS/25/NKD/89 Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV  26505 U.S.A. REVISED FEBRUARY 2012 MX:ACYCT:R4 75004819 Distributed and Repackaged by: Physicians Total Care, Inc. Tulsa, Oklahoma        74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACYCLOVIR - ACYCLOVIR CAPSULE
ACYCLOVIR - ACYCLOVIR TABLET
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Acyclovir is a synthetic nucleoside analogue active against herpes
viruses. Acyclovir capsules and
tablets are formulations for oral administration.
Each 200 mg capsule contains 200 mg of acyclovir, USP and the inactive
ingredients colloidal silicon
dioxide, magnesium stearate, pregelatinized starch and sodium lauryl
sulfate. In addition, each of the
empty gelatin capsules contains gelatin and titanium dioxide and the
following colorant agents: FD&C
Blue No. 1 and FD&C Red No. 3. The imprinting ink contains the
following: black iron oxide, D&C
Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue
No. 2 Aluminum Lake,
FD&C Red No. 40 Aluminum Lake, pharmaceutical glaze and propylene
glycol.
Each 800 mg tablet contains 800 mg of acyclovir, USP and the inactive
ingredients croscarmellose
sodium, magnesium stearate, microcrystalline cellulose, povidone, and
sodium lauryl sulfate.
Each 400 mg tablet contains 400 mg of acyclovir, USP and the inactive
ingredients croscarmellose
sodium, magnesium stearate, microcrystalline cellulose, povidone, and
sodium lauryl sulfate.
Acyclovir, USP is a white to off-white, crystalline powder with a
molecular formula C H N O and a
molecular weight of 225. 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:
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