Loading…
Valacyclovir Hydrochloride is a brand name for Valacyclovir (also known as Valaciclovir). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Valacyclovir tablets are a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 ) Cold Sores (Herpes Labialis) Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode) Suppression in immunocompetent or HIV-1–infected patients Reduction…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Valacyclovir tablets may be given without regard to meals. 3) ] . 2 ) Cold Sores (aged greater than or equal to 12 years) 2 grams every 12 hours for 1 day Chickenpox (aged 2 to less than 18 years) 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from the 500 mg valacyclovir tablets.
1 Adult Dosing Recommendations Cold Sores (Herpes Labialis) The recommended dosage of valacyclovir tablets for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart. , tingling, itching, or burning). Genital Herpes Initial Episode The recommended dosage of valacyclovir tablets for treatment of initial genital herpes is 1 gram twice daily for 10 days.
Therapy was most effective when administered within 48 hours of the onset of signs and symptoms. Recurrent Episodes The recommended dosage of valacyclovir tablets for treatment of recurrent genital herpes is 500 mg twice daily for 3 days.
Initiate treatment at the first sign or symptom of an episode. Suppressive Therapy The recommended dosage of valacyclovir tablets for chronic suppressive therapy of recurrent genital herpes is 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. In HIV-1–infected patients with a CD4+ cell count greater than or equal to 100 cells/mm 3 , the recommended dosage of valacyclovir tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.
Reduction of Transmission The recommended dosage of valacyclovir tablets for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg once daily for the source partner. Herpes Zoster The recommended dosage of valacyclovir tablets for treatment of herpes zoster is 1 gram 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 rash. 2 Pediatric Dosing Recommendations Cold Sores (Herpes Labialis) The recommended dosage of valacyclovir tablets for the treatment of cold sores in pediatric patients aged greater than or equal to 12 years is 2 grams twice daily for 1 day taken 12 hours apart.
1) ]. 2) ] . 3) ] . 4) ] . The most common adverse reactions reported in at least 1 indication by greater than 10% of adult subjects treated with valacyclovir tablets and observed more frequently with valacyclovir tablets compared with placebo are headache, nausea, and abdominal pain.
The only adverse reaction reported in greater than 10% of pediatric subjects aged less than 18 years was headache. The most common adverse reactions reported in at least one indication by greater than 10% of adult subjects treated with valacyclovir tablets and more commonly than in subjects treated with placebo are headache, nausea, and abdominal pain.
1 ) The only adverse reaction occurring in greater than 10% of pediatric subjects aged less than 18 years was headache. gov/medwatch. 1 Clinical Trials Experience in Adult Subjects Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Cold Sores (Herpes Labialis) In clinical trials for the treatment of cold sores, the adverse reactions reported by subjects receiving valacyclovir tablets 2 grams twice daily (n = 609) or placebo (n = 609) for 1 day, respectively, included headache (14%, 10%) and dizziness (2%, 1%).
8% for placebo. Other laboratory abnormalities (hemoglobin, white blood cells, alkaline phosphatase, and serum creatinine) occurred with similar frequencies in the 2 groups. Genital Herpes Initial Episode In a clinical trial for the treatment of initial episodes of genital herpes, the adverse reactions reported by greater than or equal to 5% of subjects receiving valacyclovir tablets 1 gram twice daily for 10 days (n = 318) or oral acyclovir 200 mg 5 times daily for 10 days (n = 318), respectively, included headache (13%, 10%) and nausea (6%, 6%).
5 WARNINGS AND PRECAUTIONS Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS): Has occurred in patients with advanced HIV-1 disease and in allogenic bone marrow transplant and renal transplant patients receiving 8 grams per day of valacyclovir tablets in clinical trials.
Discontinue treatment if clinical symptoms and laboratory findings consistent with TTP/HUS occur. 1 ) Acute renal failure: May occur in elderly patients (with or without reduced renal function), patients with underlying renal disease who receive higher-than-recommended doses of valacyclovir tablets for their level of renal function, patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients.
Use with caution in elderly patients and reduce dosage in patients with renal impairment. , agitation, hallucinations, confusion, and encephalopathy): May occur in both adult and pediatric patients (with or without reduced renal function) and in patients with underlying renal disease who receive higher-than-recommended doses of valacyclovir tablets for their level of renal function.
Elderly patients are more likely to have central nervous system adverse reactions. Use with caution in elderly patients and reduce dosage in patients with renal impairment. 3 ) Severe cutaneous adverse reactions (SCARs): Including acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis (TEN), and Stevens-Johnson syndrome (SJS) have been reported during the postmarketing experience with valacyclovir.
Discontinue valacyclovir tablets immediately if a painful rash with mucosal involvement or a progressive severe rash develops, and closely monitor clinical status. 1 Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS) TTP/HUS, in some cases resulting in death, has occurred in patients with advanced HIV-1 disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of valacyclovir tablets at doses of 8 grams per day.
3) ] . , anaphylaxis), acyclovir, or any component of the formulation. ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in United States of America? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
, tingling, itching, or burning). Chickenpox The recommended dosage of valacyclovir for treatment of chickenpox in immunocompetent pediatric patients aged 2 to less than 18 years is 20 mg/kg administered 3 times daily for 5 days. The total dose should not exceed 1 gram 3 times daily.
4) ]. 3 Extemporaneous Preparation of Oral Suspension Ingredients and Preparation per USP-NF Valacyclovir 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.
Instructions for Preparing Suspension at Time of Dispensing Prepare SSV according to the USP-NF. Using a pestle and mortar, grind the required number of valacyclovir 500-mg tablets until a fine powder is produced (5 valacyclovir tablets for 25-mg/mL suspension; 10 valacyclovir tablets for 50-mg/mL suspension).
Gradually add approximately 5-mL aliquots of SSV to the mortar and triturate the powder until a paste has been produced. Ensure that the powder has been adequately wetted. Continue to add approximately 5-mL aliquots of SSV to the mortar, mixing thoroughly between additions, until a concentrated suspension is produced, to a minimum total quantity of 20 mL SSV and a maximum total quantity of 40 mL SSV for both the 25-mg/mL and 50- mg/mL suspensions.
Transfer the mixture to a suitable 100-mL measuring flask. Transfer the cherry flavor* to the mortar and dissolve in approximately 5 mL of SSV. Once dissolved, add to the measuring flask. Rinse the mortar at least 3 times with approximately 5-mL aliquots of SSV, transferring the rinsing to the measuring flask between additions.
Make the suspension to volume (100 mL) with SSV and shake thoroughly to mix. Transfer the suspension to an amber glass medicine bottle with a child-resistant closure. The prepared suspension should be labeled with the following information “Shake well before using.
Store suspension between 2°C to 8°C (36°F to 46°F) in a refrigerator. ” *The amount of cherry flavor added is as instructed by the suppliers of the cherry flavor. 3) ] . 73 m 2 . Table 1. Valacyclovir Tablets Dosage Recommendations for Adults with Renal Impairment Indications Normal Dosage Regimen (Creatinine Clearance ≥ 50 mL/min) Creatinine Clearance (mL/min) 30-49 10-29 < 10 Cold sores (Herpes Labialis) Do not exceed 1 day of treatment.
Two 2-gram doses taken 12 hours apart Two 1-gram doses taken 12 hours apart Two 500-mg doses taken 12 hours apart 500-mg single dose Genital herpes: Initial episode 1 gram every 12 hours no reduction 1 gram every 24 hours 500 mg every 24 hours Genital herpes: Recurrent episode 500 mg every 12 hours no reduction 500 mg every 24 hours 500 mg every 24 hours Genital herpes: Suppressive therapy Immunocompetent patients 1 gram every 24 hours no reduction 500 mg every 24 hours 500 mg every 24 hours Alternate dose for immunocompetent patients with less than or equal to 9 recurrences/year 500 mg every 24 hours no reduction 500 mg every 48 hours 500 mg every 48 hours HIV-1–infected patients 500 mg every 12 hours no reduction 500 mg every 24 hours 500 mg every 24 hours Herpes zoster 1 gram every 8 hours 1 gram every 12 hours 1 gram every 24 hours 500 mg every 24 hours Hemodialysis Patients requiring hemodialysis should receive the recommended dose of valacyclovir tablets after hemodialysis.
During hemodialysis, the half-life of acyclovir after administration of valacyclovir tablets is approximately 4 hours. About one-third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session. Peritoneal Dialysis There is no information specific to administration of valacyclovir tablets 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 end-stage renal disease (ESRD) not receiving hemodialysis.
Therefore, supplemental doses of valacyclovir tablets should not be required following CAPD or CAVHD.
For the incidence of laboratory abnormalities see Table 2. Recurrent Episodes In 3 clinical trials for the episodic treatment of recurrent genital herpes, the adverse reactions reported by greater than or equal to 5% of subjects receiving valacyclovir tablets 500 mg twice daily for 3 days (n = 402), valacyclovir tablets 500 mg twice daily for 5 days (n = 1,136), or placebo (n = 259), respectively, included headache (16%, 11%, 14%) and nausea (5%, 4%, 5%).
For the incidence of laboratory abnormalities see Table 2.
Suppressive Therapy:
Suppression of Recurrent Genital Herpes in Immunocompetent Adults In a clinical trial for the suppression of recurrent genital herpes infections, the adverse reactions reported by subjects receiving valacyclovir tablets 1 gram once daily (n = 269), valacyclovir tablets 500 mg once daily (n = 266), or placebo (n = 134), respectively, included headache (35%, 38%, 34%), nausea (11%, 11%, 8%), abdominal pain (11%, 9%, 6%), dysmenorrhea (8%, 5%, 4%), depression (7%, 5%, 5%), arthralgia (6%, 5%, 4%), vomiting (3%, 3%, 2%), and dizziness (4%, 2%, 1%).
For the incidence of laboratory abnormalities see Table 2. Suppression of Recurrent Genital Herpes in HIV-1 - Infected Subjects In HIV-1-infected subjects, frequently reported adverse reactions for valacyclovir tablets (500 mg twice daily; n = 194, median days on therapy = 172) and placebo (n = 99, median days on therapy = 59), respectively, included headache (13%, 8%), fatigue (8%, 5%), and rash (8%, 1%).
Post-randomization laboratory abnormalities that were reported more frequently in valacyclovir subjects versus placebo included elevated alkaline phosphatase (4%, 2%), elevated ALT (14%, 10%), elevated AST (16%, 11%), decreased neutrophil counts (18%, 10%), and decreased platelet counts (3%, 0%), respectively.
Reduction of Transmission In a clinical trial for the reduction of transmission of genital herpes, the adverse reactions reported by subjects receiving valacyclovir tablets 500 mg once daily (n = 743) or placebo once daily (n = 741), respectively, included headache (29%, 26%), nasopharyngitis (16%, 15%), and upper respiratory tract infection (9%, 10%).
Herpes Zoster In 2 clinical trials for the treatment of herpes zoster, the adverse reactions reported by subjects receiving valacyclovir tablets 1 gram 3 times daily for 7 to 14 days (n = 967) or placebo (n = 195), respectively, included nausea (15%, 8%), headache (14%, 12%), vomiting (6%, 3%), dizziness (3%, 2%), and abdominal pain (3%, 2%).
For the incidence of laboratory abnormalities see Table 2. Table 2. Incidence (%) of Laboratory Abnormalities in Herpes Zoster and Genital Herpes Trial Populations LLN = Lower limit of normal. ULN = Upper limit of normal. 0% Data were not collected prospectively.
2 Clinical Trials Experience in Pediatric Subjects The safety profile of valacyclovir tablets 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. Pediatric Subjects Aged 12 to Less than 18 Years (Cold Sores) In clinical trials for the treatment of cold sores, the adverse reactions reported by adolescent subjects receiving valacyclovir tablets 2 grams twice daily for 1 day, or valacyclovir tablets 2 grams twice daily for 1 day followed by 1 gram twice daily for 1 day (n = 65, across both dosing groups), or placebo (n = 30), respectively, included headache (17%, 3%) and nausea (8%, 0%).
Pediatric Subjects Aged 1 Month to Less than 12 Years Adverse events reported in more than 1 subject across the 3 pharmacokinetic and safety trials in children aged 1 month to less than 12 years were diarrhea (5%), pyrexia (4%), dehydration (2%), herpes simplex (2%), and rhinorrhea (2%).
No clinically meaningful changes in laboratory values were observed. 3 Postmarketing Experience In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of valacyclovir tablets.
Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to valacyclovir tablets.
General Facial edema, hypertension, tachycardia. Allergic Acute hypersensitivity reactions including anaphylaxis, angioedema, dyspnea, pruritus, rash, and urticaria [see Contraindications (4) ] . 6) ]. Eye Visual abnormalities. Gastrointestinal Diarrhea.
Hepatobiliary Tract and Pancreas Liver enzyme abnormalities, hepatitis. 6) ] . 1) ] . 4) ] .
Treatment with valacyclovir tablets should be stopped immediately if clinical signs, symptoms, and laboratory abnormalities consistent with TTP/HUS occur. 2 Acute Renal Failure Cases of acute renal failure have been reported in: Elderly patients with or without reduced renal function.
5) ]. Patients with underlying renal disease who received higher-than-recommended doses of valacyclovir tablets for their level of renal function. 6) ]. Patients receiving other nephrotoxic drugs. Caution should be exercised when administering valacyclovir tablets to patients receiving potentially nephrotoxic drugs.
Patients without adequate hydration. 5 mg/mL) is exceeded in the intratubular fluid. Adequate hydration should be maintained for all patients. 3) ] . 3 Central Nervous System Effects 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 tablets for their level of renal function.
Elderly patients are more likely to have central nervous system adverse reactions. 6) ]. 3) ] . Discontinue valacyclovir tablets immediately if a painful rash with mucosal involvement or a progressive severe rash develops. Closely monitor clinical status and initiate appropriate therapy.
3) ] .