Valtrex

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Valtrex Information

Generic Name: Valacyclovir hydrochloride

Valtrex indications:

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).

Valtrex Ingredients and Composition

How Does Valtrex Work?

Clinical Pharmacology

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 hepatic metabolism.

How To Take Valtrex and Valtrex Dosage and Administration

Valxtrex Caplets may be given without regard to meals.

Herpes Zoster

The recommended Valtrex dosage for the treatment of herpes zoster is 1 gram orally 3 times daily for 7 days. Valtrex 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).;

DOSAGE

Store Valtrex at 15° to 25°C (59° to 77°F).

If you suspect a Valtrex Overdose

Caution should be exercised to prevent inadvertent Valtrex overdose. Precipitation of 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.

Valtrex Side Effects

Valtrex Warnings

Valtrex Precautions and Contraindications

Dosage reduction is recommended when administering Valtrex to patients with renal impairment. 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. Treatment should not exceed 1 day (2 doses of 2 grams in 24 hours). Therapy beyond 1 day does not provide additional clinical benefit.

Precipitation of 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.

The safety and efficacy of Valtrex have not been established in immunocompromised patients.

Contraindications to Valtrex

Valtrex is contraindicated in patients with a known hypersensitivity or intolerance to valacyclovir, acyclovir, or any component of the formulation.

Taking Valtrex during Pregnancy or Breast-feeding

There is no experience with Valtrex. However, acyclovir concentrations have been documented in breast milk in 2 women following oral administration of Zovirax and ranged from 0.6 to 4.1 times corresponding plasma levels. These concentrations would potentially expose the nursing infant to a dose of acyclovir as high as 0.3 mg/kg/day. Valtrex should be administered to a nursing mother with caution and only when indicated.

How To Take Valtrex and Valtrex Dosage and Administration

Valxtrex Caplets may be given without regard to meals.

Herpes Zoster

The recommended Valtrex dosage for the treatment of herpes zoster is 1 gram orally 3 times daily for 7 days. Valtrex 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).;

DOSAGE

Store Valtrex at 15° to 25°C (59° to 77°F).

Additional Patient Information for Valtrex

Herpes Zoster

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

Genital Herpes

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 Valtrex therapy at the first sign or symptom of an episode.

There are no data on the effectiveness of Valtrex 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 Valtrex in chronic suppressive therapy of more than 1 year's duration.

Cold Sores (Herpes Labialis)

Valtrex treatment 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). 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).

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