VALTREX (valacyclovir hydrochloride)

The pharmacokinetics of valacyclovir and acyclovir after oral administration of VALTREX have been investigated in 14 volunteer trials involving 283 adults and in 3 trials involving 112 pediatric subjects aged 1 month to less than 12 years. Pharmacokinetics in Adults Absorption and Bioavailability: After oral administration, valacyclovir hydrochloride is rapidly absorbed from the gastrointestinal tract and nearly completely converted to acyclovir and L- valine by first-pass intestinal and/or hepa...

14.1 Cold Sores (Herpes Labialis) Two double‑blind, placebo‑controlled clinical trials were conducted in 1,856 healthy adults and adolescents (aged greater than or equal to 12 years) with a history of recurrent cold sores. Subjects self‑initiated therapy at the earliest symptoms and prior to any signs of a cold sore. The majority of subjects initiated treatment within 2 hours of onset of symptoms. Subjects were randomized to VALTREX 2 grams twice daily on Day 1 followed by placebo on Day 2, VALTREX 2 grams twice daily on Day 1 followed by 1 gram twice daily on Day 2, or placebo on Days 1 and 2...

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome [see Warnings and Precautions ( 5.1 )]. Acute Renal Failure [see Warnings and Precautions ( 5.2 )] . Central Nervous System Effects [see Warnings and Precautions ( 5.3 )] . Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.4 )] . The most common adverse reactions reported in at least 1 indication by greater tha...

VALTREX is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction [e.g., anaphylaxis, severe cutaneous adverse reactions (SCARs)] to valacyclovir, acyclovir, or any component of the formulation [see Warnings and Precautions ( 5.4 ), Adverse Reactions ( 6.3 )] . Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or any component of the...

Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS): Has occurred in patients with advanced HIV-1 disease and in allogenic bone marrow transplant and renal transplant patients receiving 8 grams per day of VALTREX in clinical trials. Discontinue treatment if clinical symptoms and laboratory findings consistent with TTP/HUS occur. ( 5.1 ) Acute renal failure: May occur in elderly patients (with or without reduced renal function), patients with underlying renal disease who recei...

7 DRUG INTERACTIONS No clinically significant drug-drug or drug-food interactions with VALTREX are known [see Clinical Pharmacology ( 12.3 )].