"The US Food and Drug Administration (FDA) has approved 5-aminolevulinic acid (ALA; Ameluz, Biofrontera) gel in combination with the activating BF-RhodoLED photodynamic therapy (PDT) lamp for treatment of patients with actinic keratosis ("...
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The overall safety of SITAVIG was assessed in 378 adult subjects having at least 4 herpes labialis episodes the previous year.
One randomized, double-blind, placebo controlled trial was conducted in patients with recurrent herpes labialis (cold sores). In this trial, 378 HSV infected subjects used SITAVIG as a single dose, and 397 subjects used placebo.
Selected treatment emergent adverse events without regard to causality and reported in at least 1% of patients can be seen in Table 1.
Table 1 : Selected Treatment Emergent Adverse Events
reported in at least 1% of patients
N = 378
N = 397
|Nervous System Disorders|
|Gastrointestinal system Disorders|
|Administration Site Conditions|
|Application Site Pain||1%||1%|
|Application Site Irritation||1%||0|
|Skin and Subcutaneous Disorders|
The treatment emergent adverse events considered related to treatment that occurred in greater than or equal to 1% of patients included headache (1% SITAVIG vs. 2% placebo) and application site pain (1% both arms). There was no discontinuation of SITAVIG due to adverse drug reactions. Most treatment related adverse events were mild or moderate in severity. One report of headache from both treatment arms was classified as severe.
Read the Sitavig (acyclovir buccal tablets) Side Effects Center for a complete guide to possible side effects
No interaction studies have been performed with SITAVIG. Acyclovir is primarily eliminated unchanged in the urine via active tubular secretion. Drugs administered concomitantly that compete with tubular secretion may increase acyclovir plasma concentrations. However, due to the low dose and minimal systemic absorption of SITAVIG, systemic drug interactions are unlikely.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/29/2013
Additional Sitavig Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.