DrugBuyers.Com: Valtrex

VALTREX (valacyclovir hydrochloride) is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir (ZOVIRAX® Brand, GlaxoSmithKline).

VALTREX Caplets are for oral administration. Each caplet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients carnauba wax, colloidal silicon dioxide, crospovidone, FD&C Blue No. 2 Lake, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. The blue, film-coated caplets are printed with edible white ink.

The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo- 9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride.
Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C13H20N6O4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.

INDICATIONS
AND USAGE

Herpes Zoster: VALTREX is indicated for the treatment of herpes zoster (shingles).

Genital Herpes: VALTREX is indicated for the treatment or suppression of genital herpes.

Cold Sores (Herpes Labialis): VALTREX is indicated for the treatment of cold sores (herpes labialis).

DOSAGE AND ADMINISTRATION

VALTREX Caplets may be given without regard to meals.

Herpes Zoster: The recommended dosage of VALTREX for the treatment of herpes zoster is 1 gram orally 3 times daily for 7 days. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of zoster rash. No data are available on efficacy of treatment started greater than 72 hours after rash onset.

Genital Herpes

Initial Episodes: The recommended dosage of VALTREX for treatment of initial genital herpes is 1 gram twice daily for 10 days.

There are no data on the effectiveness of treatment with VALTREX when initiated more than 72 hours after the onset of signs and symptoms. Therapy was most effective when administered within 48 hours of the onset of signs and symptoms.

Recurrent Episodes: The recommended dosage of VALTREX for the treatment of recurrent genital herpes is 500 mg twice daily for 3 days.

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 with VALTREX when initiated more than 24 hours after the onset of signs or symptoms.

Suppressive Therapy: The recommended dosage of VALTREX for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily. In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg once daily. The safety and efficacy of therapy with VALTREX beyond 1 year have not been established.

Cold Sores (Herpes Labialis): The recommended dosage of VALTREX for the treatment of cold sores is 2 grams twice daily for 1 day taken about 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). There are no data on the effectiveness of treatment initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer).

Hemodialysis: During hemodialysis, the half-life of acyclovir after administration of VALTREX is approximately 4 hours. About one third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session. Patients requiring hemodialysis should receive the recommended dose of VALTREX after hemodialysis.

Peritoneal Dialysis: There is no information specific to administration of VALTREX in patients receiving peritoneal dialysis. The effect of chronic ambulatory peritoneal dialysis (CAPD) and continuous arteriovenous hemofiltration/dialysis (CAVHD) on acyclovir pharmacokinetics has been studied. The removal of acyclovir after CAPD and CAVHD is less pronounced than with hemodialysis, and the pharmacokinetic parameters closely resemble those observed in patients with ESRD not receiving hemodialysis. Therefore, supplemental doses of VALTREX should not be required following CAPD or CAVHD.

HOW SUPPLIED

VALTREX Caplets (blue, film-coated, capsule-shaped tablets) containing valacyclovir hydrochloride equivalent to 500 mg valacyclovir and printed with "VALTREX 500 mg" - Bottle of 42 (NDC 0173-0933-03) and unit dose pack of 100 (NDC 0173-0933-56).

VALTREX Caplets (blue, film-coated, capsule-shaped tablets) containing valacyclovir hydrochloride equivalent to 1 gram valacyclovir and printed with "VALTREX 1 gram" -

Bottle of 21 (NDC 0173-0565-02).

Store at 15° to 25°C (59° to 77°F).

PATIENT INFORMATION

Herpes Zoster: 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.

Genital Herpes: Patients should be informed that VALTREX is not a cure for genital herpes. There are no data evaluating whether VALTREX will prevent transmission of infection to others. 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 can also be transmitted in the absence of symptoms through asymptomatic viral shedding. 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 of 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 1 years duration.

Cold Sores (Herpes Labialis): Patients should be advised to initiate treatment at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). There are no data on the effectiveness of treatment initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer). Patients should be instructed that treatment for cold sores should not exceed 1 day (2 doses) and that their doses should be taken about 12 hours apart. Patients should be informed that VALTREX is not a cure for cold sores (herpes labialis).

Also refer to the WARNINGS and PRECAUTIONS sections.

WARNINGS

Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), in some cases resulting in death, has occurred in patients with advanced HIV disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of VALTREX at doses of 8 grams per day.

PRECAUTIONS

Dosage reduction is recommended when administering VALTREX to patients with renal impairment (see DOSAGE AND ADMINISTRATION). Acute renal failure and central nervous system symptoms have been reported in patients with underlying renal disease who have received inappropriately high doses of VALTREX for their level of renal function. Similar caution should be exercised when administering VALTREX to geriatric patients and patients receiving potentially nephrotoxic agents.

Given the dosage recommendations for treatment of cold sores, special attention should be paid when prescribing VALTREX for cold sores in patients who are elderly or who have impaired renal function (see DOSAGE AND ADMINISTRATION and Geriatric Use). Treatment should not exceed 1 day (2 doses of 2 grams in 24 hours). Therapy beyond 1 day does not provide additional clinical benefit.

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