SITAVIG Delayed-release tablet Ref.[28039] Active ingredients: Aciclovir

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

SITAVIG (acyclovir) buccal tablet is applied topically to the gum and releases acyclovir as the buccal tablet gradually dissolves [see Clinical Pharmacology (12.3)].

Acyclovir is a synthetic purine nucleoside analogue active against herpes viruses. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has a molecular formula of C8H11N5O3 and a molecular weight of 225. The structural formula is shown in Figure 1.

Figure 1. Structural Formula of Acyclovir:

Acyclovir drug substance is a white or almost white crystalline powder.

SITAVIG contains 50 mg of acyclovir, USP and the following inactive ingredients: hypromellose, USP; milk protein concentrate; sodium lauryl sulfate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; povidone, USP; colloidal silicon dioxide, NF.

Dosage Forms and Strengths

SITAVIG is a buccal tablet containing 50 mg of acyclovir. SITAVIG tablets are round, off-white tablets, with a rounded side and a flat side. The tablets are marked with an “AL21” on the flat side.

How Supplied

SITAVIG buccal tablets are supplied as off-white tablets containing 50 mg of acyclovir. SITAVIG tablets have a rounded side and a flat side and are imprinted with AL21 on one side. SITAVIG tablets are packaged in blisters of two tablets (NDC 71403-049-02).

Drugs

Drug Countries
SITAVIG France, United States

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