Prescription Valtrex

Generic Name: Valacyclovir

Brand Name: Valtrex

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Valtrex (Valacyclovyr) Medical Uses:
Valtrex (Valacyclovyr Hydrochloride) is an antiviral agent. is indicated for the treatment of herpes zoster (shingles); initial and recurrent episodes of genital herpes; suppression of recurrent genital herpes; cold sores. Valtrex may help prevent genital herpes from being passed on to a partner who does not have genital herpes if it is used with 'safer sex' practices.

Valtrex is not a cure for herpes virus infections.

Contraindications

Hypersensitivity to valacyclovir, acyclovir, or any component of the formulation.

Dosage

• Valtrex tablets may be given without regard to meals.
• Patients should be advised to maintain adequate hydration.
• In patients with reduced renal function, reduction in dosage is recommended.

Herpes zoster: 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.

Initial genital herpes: 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 of genital herpes: 500 mg twice daily for 3 days. 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 of recurrent genital herpes: 1 gram once daily in patients with normal immune function. 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.

Reduction of transmission of genital herpes: 500 mg once daily for the source partner (in patients with a history of 9 or fewer recurrences per year). Patients should be counseled to use safer sex practices in combination with suppressive therapy with Valtrex. The efficacy of reducing transmission beyond 8 months in discordant couples has not been established.

Cold sores (herpes labialis): 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).

Warnings & Precautions

• Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) has occurred.
• Dosage reduction is recommended when administering valacyclovir to patients with renal impairment.
• Pediatric Use: Safety and effectiveness of Valtrex in pre-pubertal pediatric patients have not been established.
• Geriatric Use:

Side Effects:

• Cardiovascular: hypertension, tachycardia (postmarketing).
• CNS Symptoms: headache (38%); depression (7%); dizziness (4%); aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, dysarthria, encephalopathy, mania, psychosis (including audio and visual hallucinations), seizures, tremors (postmarketing).
• Eye: visual abnormalities.
• Gastrointestinal: nausea (15%); abdominal pain (11%); vomiting (6%); diarrhea (postmarketing).
• Genitourinary: dysmenorrhea (8%); elevated creatinine, renal failure (postmarketing).
• Hematologic-Lymphatic: thrombocytopenia, aplastic anemia, leukocytoclastic vasculitis, TTP/HUS (postmarketing).
• Skin: erythema multiforme, rashes including photosensitivity, alopecia. (postmarketing).
• Lab Tests: increased AST (4%); decreased hemoglobin, increased serum creatinine, leukopenia (1%); abnormal liver enzymes, elevated creatinine (postmarketing).

Pregnancy & Lactation

Pregnancy Risk Factor: B.
Valacyclovir was not teratogenic in rats or rabbits at 10 and 7 times human plasma levels, respectively, during the period of major organogenesis.

There are no adequate and well-controlled studies of Valtrex or acyclovir in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999. There were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximates that found in the general population. Valtrex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation. Valacyclovir enters breast milk.

Drug Interactions:

• Probenecid: Decreased renal clearance of acyclovir; no dosage adjustment needed in patients with normal renal function. [2]
• Cimetidine: Decreased renal clearance of acyclovir; no dosage adjustment needed in patients with normal renal function. [2]

References:

• 1. U.S. Food and Drug Administration. Zovirax (Valacyclovir) U.S. Prescribing Information. Available at (PDF format): Prescribing Information
• 2. De Bony F, Tod M, Bidault R, On NT, Posner J, Rolan P. Multiple interactions of cimetidine and probenecid with valaciclovir and its metabolite acyclovir. Antimicrob Agents Chemother. 2002 Feb;46(2):458-63. PubMedCentral