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MYLAN-VALACYCLOVIR is a brand name for Valacyclovir (also known as Valaciclovir), supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Mylan-Valacyclovir (Valacyclovir Tablets) is indicated: • For the treatment of herpes zoster (shingles) in adult patients. • For the treatment of genital herpes in immunocompetent adult patients and for the suppression of recurrent genital herpes in HIV infected adult patients. • To reduce the risk of transmission of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • The dosage of Mylan-Valacyclovir should be reduced in patients with impaired renal function (see Table 1). • Therapy should be initiated as soon as possible after a diagnosis of herpes zoster, or at the first sign or symptoms of an outbreak of oral or genital herpes.
• The recommended dose and duration of use is dependent on the indication. 1 Adverse Drug Reaction Overview). 1 INDICATIONS, Pediatrics). Mylan-Valacyclovir tablets may be given without regard to meals.
MYLAN-VALACYCLOVIR (Valacyclovir Tablets) Page 5 of 34 Herpes Zoster (shingles):
The recommended dosage of Mylan-Valacyclovir tablets for the treatment of herpes zoster is 1000 mg orally three times daily for 7 days. Treatment with Mylan-Valacyclovir should be initiated within 72 hours of the onset of rash.
Initial Episode of Genital Herpes:
The recommended dosage of Mylan-Valacyclovir tablets for the treatment of an initial episode of genital herpes is 1000 mg orally twice daily for 10 days. There are no data on the effectiveness of treatment with Valacyclovir Tablets 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:
The recommended dosage of Mylan-Valacyclovir tablets for the treatment of recurrent episodes of genital herpes is 500 mg orally twice daily for 3 days. Therapy should be initiated at the earliest sign or symptom of recurrence. Mylan-Valacyclovir can prevent lesion development when taken at the first signs and symptoms of a genital herpes recurrence.
Suppression of Genital Herpes:
In patients with HIV infection with CD4 cell count > 100 cells/mm3, the recommended dosage of Mylan-Valacyclovir tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg orally twice daily. The safety and efficacy of therapy with Valacyclovir Tablets beyond 6 months in patients with HIV infection have not been established.
Reduction of Transmission of Genital Herpes:
1 Adverse Reaction Overview The following serious adverse reactions are discussed in greater detail in 7 WARNINGS AND PRECAUTIONS: • Thrombotic Thrombocytopenic Purpura / Hemolytic Uremic Syndrome • Acute Renal Failure • Central Nervous System Effects The most frequent adverse reactions associated with the use of Valacyclovir Tablets are headache and nausea.
Neurological side effects have also been reported in rare instances. Geriatric patients and patients with a history of renal impairment are at increased risk of developing these effects. 5 Post-Market Adverse Reactions). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real- world use.
Herpes Zoster:
Adverse drug reactions were not significantly different in recipients of Valacyclovir Tablets compared to placebo or acyclovir in the two double-blind, randomized clinical trials of treatment of herpes zoster (shingles) in immunocompetent patients.
The most frequent adverse drug reactions reported in recipients of Valacyclovir Tablets are listed in Table 3. Table 3 Incidence (%) of Drug-Related Adverse Reactions Occurring in ≥ 1% of Patients Receiving Valacyclovir Tablets in Two Clinical Trials of Treatment of Herpes Zoster Adverse Drug Reaction Herpes Zoster 18-50 Years > 50 Years Valacyclovir Tablets (n=202) (%) Placebo (n=195) (%) Valacyclovir Tablets (n=765) (%) Acyclovir (n=376) (%) Nausea 8 6 12 14 Headache 11 8 8 7 Diarrhea 4 4 4 4 Vomiting 2 2 4 3 MYLAN-VALACYCLOVIR (Valacyclovir Tablets) Page 12 of 34 Asthenia 1 3 3 2 Constipation < 1 < 1 3 3 Abdominal pain < 1 1 2 1 Anorexia < 1 2 2 2 Dizziness 1 1 2 2 Dry Mouth < 1 0 2 1 Dyspepsia 0 < 1 2 1 Flatulence 0 0 1 1 Pruritus 1 0 < 1 0 Genital Herpes: In two double-blind, randomized trials of treatment of recurrent genital herpes in immunocompetent patients, adverse drug reactions were not significantly different in recipients of Valacyclovir Tablets compared to placebo.
, Renal). 2 CONTRAINDICATIONS Mylan-Valacyclovir is contraindicated in patients with a known hypersensitivity or intolerance to valacyclovir, acyclovir, or any component of the formulation. For a complete listing of ingredients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
1 Dosing Considerations • The dosage of Mylan-Valacyclovir should be reduced in patients with impaired renal function (see Table 1). • Therapy should be initiated as soon as possible after a diagnosis of herpes zoster, or at the first sign or symptoms of an outbreak of oral or genital herpes.
• The recommended dose and duration of use is dependent on the indication. 1 Adverse Drug Reaction Overview). 1 INDICATIONS, Pediatrics). Mylan-Valacyclovir tablets may be given without regard to meals.
MYLAN-VALACYCLOVIR (Valacyclovir Tablets) Page 5 of 34 Herpes Zoster (shingles):
The recommended dosage of Mylan-Valacyclovir tablets for the treatment of herpes zoster is 1000 mg orally three times daily for 7 days. Treatment with Mylan-Valacyclovir should be initiated within 72 hours of the onset of rash.
Initial Episode of Genital Herpes:
The recommended dosage of Mylan-Valacyclovir tablets for the treatment of an initial episode of genital herpes is 1000 mg orally twice daily for 10 days. There are no data on the effectiveness of treatment with Valacyclovir Tablets 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:
The recommended dosage of Mylan-Valacyclovir tablets for the treatment of recurrent episodes of genital herpes is 500 mg orally twice daily for 3 days. Therapy should be initiated at the earliest sign or symptom of recurrence. Mylan-Valacyclovir can prevent lesion development when taken at the first signs and symptoms of a genital herpes recurrence.
Mylan-Valacyclovir is contraindicated in patients with a known hypersensitivity or intolerance to valacyclovir, acyclovir, or any component of the formulation. For a complete listing of ingredients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The recommended dosage of Mylan-Valacyclovir tablets for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg orally once daily for the source partner. The efficacy of reducing transmission beyond 8 months in couples discordant for HSV-2 infection has not been established.
1 Adverse Drug Reaction Overview).
Cold Sores (Herpes Labialis):
The recommended dosage of Mylan-Valacyclovir for the treatment of cold sores (herpes labialis) is 2000 mg orally twice daily for 1 day (24-hour period). The second dose should be taken approximately 12 hours after the first dose, but not less than 6 hours after the first dose.
, tingling, itching, or burning). , papule, vesicle or ulcer).
Patients with Acute or Chronic Renal Insufficiency:
Caution is advised when administering valacyclovir to patients with impaired renal function. Adequate hydration should be maintained. Pharmacokinetic and safety evaluations following administration of oral valacyclovir hydrochloride have been performed in patients with renal impairment and volunteers with end-stage renal disease (ESRD) managed by hemodialysis.
73m2): MYLAN-VALACYCLOVIR (Valacyclovir Tablets) Page 6 of 34 Table 1 Dosage Adjustments for Adults Renal Insufficiency Creatinine Clearance (mL/min) ≥ 50 30 to < 50 10 to < 30 < 10 Herpes Zoster 1000 mg every 8 hours† 1000 mg every 12 hours 1000 mg every 24 hours 500 mg every 24 hours Recurrent Episodes of Genital Herpes 500 mg every 12 hours† 500 mg every 12 hours† 500 mg every 24 hours 500 mg every 24 hours Suppression of Genital Herpes HIV-infected patients 500 mg every 12 hours† 500 mg every 12 hours† 500 mg every 24 hours 500 mg every 24 hours Initial Episode of Genital Herpes 1000 mg every 12 hours† 1000 mg every 12 hours† 1000 mg every 24 hours 500 mg every 24 hours Cold Sores (Herpes Labialis) § Two 2000 mg doses taken 12 hours apart† Two 1000 mg doses taken 12 hours apart Two 500 mg doses taken 12 hours apart 500 mg single dose †Standard dose - adjustment not necessary §Do not exceed one day of treatment Intermittent Hemodialysis: During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride is approximately 4 hours.
About 1/3 of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session. These patients should receive the daily dose of Mylan-Valacyclovir recommended (Table 1), the dose administered after hemodialysis on the days it is performed.
Peritoneal Dialysis:
There is no information specific to administration of Valacyclovir Tablets. The effect of continuous 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 Mylan-Valacyclovir should not be required following CAPD or CAVHD.
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The most frequent adverse reactions are listed in Table 4. Table 4 Incidence (%) of Drug-Related Adverse Reactions Occurring in ≥ 1% of Patients Receiving Valacyclovir Tablets in two Clinical Trials of Treatment of Recurrent Genital Herpes Adverse Drug Reaction Valacyclovir Tablets (n=1235) (%) Placebo (n=439) (%) Headache 11 9 Nausea 5 6 Diarrhea 4 4 Dizziness 2 2 Abdominal pain 2 1 Asthenia 1 3 In one multicenter, double-blind, randomized study of immunocompetent patients for the treatment of an initial episode of genital herpes, the frequency of adverse events, regardless of attributability to study medication, was similar in both treatment groups: Valacyclovir Tablets 1000 mg twice daily (n=318) compared to acyclovir 200 mg five times a day (n=318).
The most frequent adverse events were headache (13% with Valacyclovir Tablets versus 10% with ZOVIRAX® (acyclovir)) and nausea (6% with both treatments). All other adverse events were reported by 3% or less of patients. In a 6-month study of suppression of recurrent genital herpes in HIV-infected patients, adverse drug reactions were similar in nature and incidence in the groups receiving Valacyclovir Tablets 500 mg twice daily and placebo when duration of exposure was considered.
Adverse reactions reported with an incidence ≥ 1% during the double-blind phase are detailed in Table 5. d. (n=194) (%) Placebo (n=99) (%) Headache 5 3 Diarrhea 3 2 MYLAN-VALACYCLOVIR (Valacyclovir Tablets) Page 13 of 34 Nausea 2 5 Constipation 1 0 Dizziness 1 0 Adverse reactions reported by patients receiving Valacyclovir Tablets 500 mg once daily (n=743) or placebo once daily (n=741) in a clinical study for the reduction of transmission of genital herpes are listed below in Table 6.
Table 6 Incidence (%) of Drug-Related Adverse Reactions Occurring in ≥ 1% of Patients Receiving Valacyclovir Tablets in a Clinical Trial for the Reduction of Transmission of Genital Herpes Adverse Drug Reaction Valacyclovir Tablets (n=743) (%) Placebo (n=741) (%) Headache 6 4 Diarrhea 2 1 Nausea 2 2 Dyspepsia 1 1 Of the 1484 patients enrolled in the reduction of transmission study, 1018 entered the open-label phase of the study (≤ 12 months), 499 from the placebo group and 519 from the Valacyclovir Tablets group.
The nature and incidence of events in the open-label phase were similar to those observed during the double-blind phase of the study (Table 7). Table 7 Incidence (%) of Drug-Related Adverse Reactions Occurring in ≥ 1% of Patients Receiving Valacyclovir Tablets in the Double-Blind, Open-Label, and Combined Double-Blind + Open-Label Phases of a Clinical Trial for the Reduction of Transmission of Genital Herpes Double-Blind Phase (≤ 8 months) Open-Label Phase (≤ 12 months) Combined Double- Blind + Open-Label Phases (≤ 20 months) Adverse Drug Reaction Valacyclovir Tablets (n=5191) (%) Placebo (n=4992) (%) Valacyclovir Tablets (n=10183) (%) Valacyclovir Tablets (n=5194) (%) Headache 5 4 2 6 Diarrhea 2 2 < 1 2 Nausea 1 3 < 1 1 Dyspepsia 1 < 1 < 1 2 Abdominal pain, upper 1 0 < 1 1 1 Number of patients from the Valacyclovir Tablets group of the double-blind phase who entered the open-label phase of the study.
2 Number of patients from the placebo group of the double-blind phase who entered the open-label phase of the study. 3 Total number of patients […]
Suppression of Genital Herpes:
In patients with HIV infection with CD4 cell count > 100 cells/mm3, the recommended dosage of Mylan-Valacyclovir tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg orally twice daily. The safety and efficacy of therapy with Valacyclovir Tablets beyond 6 months in patients with HIV infection have not been established.
Reduction of Transmission of Genital Herpes:
The recommended dosage of Mylan-Valacyclovir tablets for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg orally once daily for the source partner. The efficacy of reducing transmission beyond 8 months in couples discordant for HSV-2 infection has not been established.
1 Adverse Drug Reaction Overview).
Cold Sores (Herpes Labialis):
The recommended dosage of Mylan-Valacyclovir for the treatment of cold sores (herpes labialis) is 2000 mg orally twice daily for 1 day (24-hour period). The second dose should be taken approximately 12 hours after the first dose, but not less than 6 hours after the first dose.
, tingling, itching, or burning). , papule, vesicle or ulcer).
Patients with Acute or Chronic Renal Insufficiency:
Caution is advised when administering valacyclovir to patients with impaired renal function. Adequate hydration should be maintained. Pharmacokinetic and safety evaluations following administration of oral valacyclovir hydrochloride have been performed in patients with renal impairment and volunteers with end-stage renal disease (ESRD) managed by hemodialysis.
73m2): MYLAN-VALACYCLOVIR (Valacyclovir Tablets) Page 6 of 34 Table 1 Dosage Adjustments for Adults Renal Insufficiency Creatinine Clearance (mL/min) ≥ 50 30 to < 50 10 to < 30 < 10 Herpes Zoster 1000 mg every 8 hours† 1000 mg every 12 hours 1000 mg every 24 hours 500 mg every 24 hours Recurrent Episodes of Genital Herpes 500 mg every 12 hours† 500 mg every 12 hours† 500 mg every 24 hours 500 mg every 24 hours Suppression of Genital Herpes HIV-infected patients 500 mg every 12 hours† 500 mg every 12 hours† 500 mg every 24 hours 500 mg every 24 hours Initial Episode of Genital Herpes 1000 mg every 12 hours† 1000 mg every 12 hours† 1000 mg every 24 hours 500 mg every 24 hours Cold Sores (Herpes Labialis) § Two 2000 mg doses taken 12 hours apart† Two 1000 mg doses taken 12 hours apart Two 500 mg doses taken 12 hours apart 500 mg single dose †Standard dose - adjustment not necessary §Do not exceed one day of treatment Intermittent Hemodialysis: During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride is approximately 4 hours.
About 1/3 of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session. These patients should receive the daily dose of Mylan-Valacyclovir recommended (Table 1), the dose administered after hemodialysis on the days it is performed.
Peritoneal Dialysis:
There is no information specific to administration of Valacyclovir Tablets. The effect of continuous ambulatory peritoneal dialysis (CAPD) and continuous arteriovenous hemofiltration/dialysis (CAVHD) on acyclovir pharmacokinetics has been studied.
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