Valtrex Valacyclovir Hydrochloride: Side Effects, Uses, Dosage, Interactions, Warnings

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 rash. Of the total number of subjects in clinical trials of VALTREX, 906 were 65 and over, and 352 were 75 and over. In a clinical trial of herpes zoster, the duration of pain after healing (post-herpetic neuralgia) was longer in subjects 65 and older compared with younger adults. Elderly patients are more likely to have reduced renal function and require dose reduction.

Bromocryptine has been shown to reduce serum TSH in patients with selective pituitary resistance to thyroid hormone (11). The pharmacokinetics of acyclovir after a single dose of VALTREX (1 gram) were unchanged by coadministration of a single dose of antacids (Al3+ or Mg++). The absolute bioavailability of acyclovir after administration of VALTREX is 54.5% ± 9.1% as determined following a 1-gram oral dose of VALTREX and a 350-mg intravenous acyclovir dose to 12 healthy volunteers. Acyclovir bioavailability from the administration of VALTREX is not altered by administration with food (30 minutes after an 873 Kcal breakfast, which included 51 grams of fat). 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.

Clinical Trials Experience In Pediatric Subjects

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Drug Interactions for Valtrex

• Do not share this medicine with another person, even if they have the same symptoms you have.
• Renal clearance of acyclovir following the administration of a single 1-gram dose of VALTREX to 12 healthy subjects was approximately 255 ± 86 mL/min which represents 42% of total acyclovir apparent plasma clearance.
• Therefore, when VALTREX is coadministered with these drugs in patients with normal renal function, no dosage adjustment is recommended.
• 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.

Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster. Dosage recommendations for adult patients with reduced renal function are provided in Table 1 see Use In Specific Populations, CLINICAL PHARMACOLOGY. Data are not available for the use of VALTREX in pediatric patients with a creatinine clearance less than 50 mL/min/1.73 m².

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Using multivitamin with minerals together with levothyroxine may decrease the effects of levothyroxine.
• Genital herpes is frequently transmitted in the absence of symptoms through asymptomatic viral shedding.
• VALTREX tablets 500 mg, cherry flavor, and Suspension Structured Vehicle USP-NF (SSV).

The safety profile of VALTREX has been studied in 177 pediatric subjects aged 1 month to less than 18 years. Sixty-five of these pediatric subjects, aged 12 to less than 18 years, received oral tablets for 1 to 2 days for treatment of cold sores. The remaining 112 pediatric subjects, aged 1 month to less than 12 years, participated in 3 pharmacokinetic and safety trials and received valacyclovir oral suspension. Fifty-one of these 112 pediatric subjects received oral suspension for 3 to 6 days. The frequency, intensity, and nature of clinical adverse reactions and laboratory abnormalities were similar to those seen in adults. Many drugs and medications can affect thyroid function, but only a small subset (glucocorticoids, dopamine agonists, somatostatin analogs and rexinoids) suppress TSH at the level of the hypothalamus or pituitary.

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Do not take VALTREX if you are allergic to valacyclovir, acyclovir, or any of the ingredients in VALTREX. See the end of this leaflet for a complete list of ingredients in VALTREX. In the mouse lymphoma assay, valacyclovir was not mutagenic in the absence of metabolic activation.

Acyclovir Cmax and AUC following a single dose of VALTREX (1 gram) increased by 22% and 49%, respectively, after probenecid (1 gram). Acyclovir Cmax and AUC following a single dose of VALTREX (1 gram) increased by 8% and 32%, respectively, after a single dose of cimetidine (800 mg). Reduction in dosage is recommended in patients with renal impairment see DOSAGE AND ADMINISTRATION, Use In Specific Populations. Available studies have methodological limitations including insufficient sample size to support conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored see DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS. VALTREX tablets (blue, film-coated, capsule-shaped tablets printed with “VALTREX 500 mg”) containing 556.2 mg of valacyclovir hydrochloride equivalent to 500 mg valacyclovir.

• There is no accumulation of acyclovir after the administration of valacyclovir at the recommended dosage regimens in adults with normal renal function.
• Studies using dopamine infusions in critically ill adults and neonates with the nonthyroidal illness (NTI) syndrome suggest that dopamine and NTI have and additive effect of HPT axis suppression.
• As this newer class of drugs may be used in more patients (advanced cancer, metabolic disorders, dermatologic disorders), clinicians need to be aware of this unique and treatable side-effect.
• Lysine systemic is used for aphthous ulcer, herbal supplementation, herpes simplex (hsv), herpes …

Patients should be advised to initiate treatment at the earliest sign or symptom of chickenpox. VALTREX tablets 500 mg, cherry flavor, and Suspension Structured Vehicle USP-NF (SSV). Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) should be prepared in lots of 100 mL. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Valtrex only for the indication prescribed. Lysine systemic is used for aphthous ulcer, herbal supplementation, herpes simplex (hsv), herpes … Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

Acyclovir pharmacokinetic parameter estimates following administration of VALTREX to healthy adult volunteers are presented in Table 3. The pharmacokinetic profile and safety of valacyclovir oral suspension in children aged less than 12 years were studied in 3 open-label trials. 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.

The source partner had a history of 9 or fewer genital herpes episodes per year. Both partners were counseled on safer sex practices and were advised to use condoms throughout the trial period. Source partners were randomized to treatment with either VALTREX 500 mg once daily or placebo once daily for 8 months. The primary efficacy endpoint was symptomatic acquisition of HSV-2 in susceptible partners. Overall HSV-2 acquisition was defined as symptomatic HSV-2 acquisition and/or HSV-2 seroconversion in susceptible partners. Acyclovir pharmacokinetic parameter estimates following a 20-mg/kg dose are provided in Table 4.