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Valtrex is an antiviral for treating herpes labialis in adults and adolescents aged 12 years and older. Previously, license in treating genital herpes and herpes zoster. The first oral treatment approved for this treatment.

Recommended Dosage is 2 g twice a day (about 12 hours apart) for 1 day, starting at the earliest sign of prodromal symptoms, such as tingling, burning, or itching and it belongs to Pregnancy category B. Special Considerations: Patients should have the medication at home between outbreaks, so they can start treatment rapidly No efficacy data are available on effectiveness when started after onset of clinical signs, such as vesicles, papules, or ulcers. Even at the 2-g dose that was indicated in clinical trials, adverse effects were similar to those seen with placebo, according to Dr. Stephen Tyring, instructor of internal medicine, dermatology microbiology and immunology at the University of Texas, Galveston.

Comment: Approval was according to on the two placebo-controlled studies of 1,856 otherwise healthy adults and adolescents aged 12 and over with recurrent herpes labialis (at least four outbreaks in the previous year). Those who are taking Valtrex when they began to experience the typical prodrome had significant reductions in duration of outbreaks; many were able to abort the outbreak, said Dr. Tying, the principal investigator. Most patients had started treatment within 2 hours of symptoms.

Episodes lasted a mean of 5.2 days in the Valtrex group and 7.6 days with placebo; outbreaks were aborted in 45% of those on Valtrex vs. 37% of those on placebo and the mean duration to lesion healing was almost 5 days with Valtrex and about 6 days with placebo, according to Dr. Tying.

The ability of Valtrex to inhibit outbreaks is unique among approved cold sore therapies, he said. Previously approved prescription agents--topical penciclovir and topical Zovirax (acyclovir)--"only treat the tip of the iceberg" and do not prevent outbreaks. A high oral dose is "the logical way to attack a disease that has its source deep in the nerve," he said.