Source: FDA, National Drug Code (US) Revision Year: 2020
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). |
| Drug | Countries | |
|---|---|---|
| SITAVIG | France, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
