The efficacy and safety of valAcyclovir (Acyclovir) hydrochloride tablets have not been established in:

Labeling describing use of valAcyclovir (Acyclovir) hydrochloride in pediatric patients with chickenpox (ages of 2 to ≤ 18 years) is approved for GlaxoSmithKline’s Valtrex Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of that pediatric use is not approved for this valAcyclovir (Acyclovir) hydrochloride tablet product.

Labeling describing use of valAcyclovir (Acyclovir) hydrochloride in pediatric patients for whom a solid dosage form is not appropriate is approved for GlaxoSmithKline’s Valtrex Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of that information is not approved for this valAcyclovir (Acyclovir) hydrochloride tablet product.

Tablets:

ValAcyclovir (Acyclovir) hydrochloride tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valAcyclovir (Acyclovir) , Acyclovir (Acyclovir) or any component of the formulation .

Cases of acute renal failure have been reported in:

In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored .

Central nervous system adverse reactions, including agitation, hallucinations, confusion, delirium, seizures and encephalopathy, have been reported in both adult and pediatric patients with or without reduced renal function and in patients with underlying renal disease who received higher than recommended doses of valAcyclovir (Acyclovir) for their level of renal function. Elderly patients are more likely to have central nervous system adverse reactions. ValAcyclovir (Acyclovir) should be discontinued if central nervous system adverse reactions occur .

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

The most common adverse reactions reported in at least one indication by > 10% of adult patients treated with valAcyclovir (Acyclovir) and observed more frequently with valAcyclovir (Acyclovir) compared to placebo are headache, nausea and abdominal pain. The only adverse reaction reported in > 10% of pediatric patients

No clinically significant drug-drug or drug-food interactions with valAcyclovir (Acyclovir) are known

ValAcyclovir (Acyclovir) is indicated for treatment of cold sores in pediatric patients ≥ 12 years of age

The use of valAcyclovir (Acyclovir) for treatment of cold sores is based on two double-blind, placebo-controlled clinical trials in healthy adults and adolescents (≥ 12 years of age) with a history of recurrent cold sores .

The efficacy and safety of valAcyclovir (Acyclovir) have not been established in pediatric patients:

In infants 1 month to
Labeling describing pediatric use information in pediatric patients with chickenpox (ages 2 to ≤ 18 years) and additional pharmacokinetic studies in pediatric patients (ages 3 months to

Caution should be exercised to prevent inadvertent overdose . Precipitation of Acyclovir (Acyclovir) in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored .

ValAcyclovir (Acyclovir) hydrochloride is the hydrochloride salt of the -valyl ester of the antiviral drug Acyclovir (Acyclovir) .

ValAcyclovir (Acyclovir) hydrochloride tablets are for oral administration. Each tablet contains valAcyclovir (Acyclovir) hydrochloride equivalent to 500 mg or 1 gram valAcyclovir (Acyclovir) and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. The white film-coated tablets are printed with edible black ink which contains black iron oxide.

The chemical name of valAcyclovir (Acyclovir) hydrochloride is -valine, 2-[(2-amino-1,6-dihydro-6-oxo-9-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:

ValAcyclovir (Acyclovir) hydrochloride is a white to off-white powder with the molecular formula CHNO•HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pks for valAcyclovir (Acyclovir) hydrochloride are 1.90, 7.47 and 9.43.

The pharmacokinetics of valAcyclovir (Acyclovir) and Acyclovir (Acyclovir) after oral administration of valAcyclovir (Acyclovir) has been investigated in 14 volunteer studies involving 283 adults.

Labeling describing use of valAcyclovir (Acyclovir) in pediatric patients with chickenpox (ages one month to

Two double-blind, placebo-controlled clinical trials were conducted in 1,856 healthy adults and adolescents (≥ 12 years old) with a history of recurrent cold sores. Patients self-initiated therapy at the earliest symptoms and prior to any signs of a cold sore. The majority of patients initiated treatment within 2 hours of onset of symptoms. Patients were randomized to valAcyclovir (Acyclovir) 2 grams twice daily on Day 1 followed by placebo on Day 2, valAcyclovir (Acyclovir) 2 grams twice daily on Day 1 followed by 1 gram twice daily on Day 2, or placebo on Days 1 and 2.

The mean duration of cold sore episodes was about 1 day shorter in treated subjects as compared with placebo. The 2 day regimen did not offer additional benefit over the one day regimen.

No significant difference was observed between subjects receiving valAcyclovir (Acyclovir) or placebo in the prevention of progression of cold sore lesions beyond the papular stage.

Two randomized double-blind clinical trials in immunocompetent adults with localized herpes zoster were conducted. ValAcyclovir (Acyclovir) was compared with placebo in patients less than 50 years of age, and with oral Acyclovir (Acyclovir) in patients greater than 50 years of age. All patients were treated within 72 hours of appearance of zoster rash. In patients less than 50 years of age, the median time to cessation of new lesion formation was 2 days for those treated with valAcyclovir (Acyclovir) compared with 3 days for those treated with placebo. In patients greater than 50 years of age, the median time to cessation of new lesions was 3 days in patients treated with either valAcyclovir (Acyclovir) or oral Acyclovir (Acyclovir) . In patients less than 50 years of age, no difference was found with respect to the duration of pain after healing (post-herpetic neuralgia) between the recipients of valAcyclovir (Acyclovir) and placebo. In patients greater than 50 years of age, among the 83% who reported pain after healing (post-herpetic neuralgia), the median duration of pain after healing [95% confidence interval] in days was: 40 [31, 51], 43 [36, 55] and 59 [41, 77] for 7 day valAcyclovir (Acyclovir) , 14 day valAcyclovir (Acyclovir) and 7 day oral Acyclovir (Acyclovir) , respectively.

Labeling describing clinical studies of valAcyclovir (Acyclovir) hydrochloride in pediatric patients with chickenpox (ages 2 to ≤ 18 years) for the treatment of chickenpox is approved for GlaxoSmithKline’s Valtrex Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of those clinical studies is not approved for this valAcyclovir (Acyclovir) hydrochloride tablet product.

ValAcyclovir (Acyclovir) Hydrochloride Tablets are available containing valAcyclovir (Acyclovir) hydrochloride equivalent to 500 mg of valAcyclovir (Acyclovir) .

The 500 mg tablets are white, film-coated, oval shaped tablets imprinted with in black ink on one side of the tablet and blank on the other side. They are available as follows:

NDC 51079-093-03 - Unit dose blister packages of 30 (5 cards of 6 tablets each).

Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]

See .

Patients should be informed that valAcyclovir (Acyclovir) hydrochloride tablets are not a cure for genital herpes. Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes is frequently transmitted in the absence of symptoms through asymptomatic viral shedding. Therefore, patients should be counseled to use safer sex practices in combination with suppressive therapy with valAcyclovir (Acyclovir) hydrochloride tablets. Sex partners of infected persons should be advised that they might be infected even if they have no symptoms. Type-specific serologic testing of asymptomatic partners of persons with genital herpes can determine whether risk for HSV-2 acquisition exists.

ValAcyclovir (Acyclovir) hydrochloride tablets have not been shown to reduce transmission of sexually transmitted infections other than HSV-2.

If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode.

There are no data on the effectiveness of treatment initiated more than 72 hours after the onset of signs and symptoms of a first episode of genital herpes or more than 24 hours after the onset of signs and symptoms of a recurrent episode.

There are no data on the safety or effectiveness of chronic suppressive therapy of more than one year’s duration in otherwise healthy patients. There are no data on the safety or effectiveness of chronic suppressive therapy of more than 6 months’ duration in HIV-infected patients.

There are no data on treatment initiated more than 72 hours after onset of the zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.

Labeling describing use of valAcyclovir (Acyclovir) hydrochloride in pediatric patients with chickenpox (ages of 2 to ≤ 18 years) for the treatment of chickenpox is approved for GlaxoSmithKline’s Valtrex Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of that use is not approved for this valAcyclovir (Acyclovir) hydrochloride tablet product.