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SANDOZ 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: Sandoz Valacyclovir, valacyclovir tablets (as valacyclovir hydrochloride monohydrate), is indicated: • For the treatment of herpes zoster (shingles) in adult patients. • For the treatment or suppression of genital herpes in immunocompetent adult patients and for the suppression of recurrent genital herpes in HIV…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • The dosage of Sandoz Valacyclovir (valacyclovir hydrochloride monohydrate) 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 Reaction Overview). 1 Indications, Pediatrics). Sandoz Valacyclovir (valacyclovir hydrochloride) Page 5 of 39 Sandoz Valacyclovir tablets may be given without regard to meals.
Herpes Zoster (shingles):
The recommended dosage of Sandoz Valacyclovir tablets for the treatment of herpes zoster is 1000 mg orally three times daily for 7 days. Treatment with Sandoz Valacyclovir should be initiated within 72 hours of the onset of rash.
Initial Episode of Genital Herpes:
The recommended dosage of Sandoz Valacyclovir 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 hydrochloride 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 Sandoz Valacyclovir 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. Sandoz Valacyclovir can prevent lesion development when taken at the first signs and symptoms of a genital herpes recurrence.
Suppression of Genital Herpes:
The recommended dosage of Sandoz Valacyclovir for chronic suppressive therapy of recurrent genital herpes is 1000 mg orally once daily in patients with normal immune function. The safety and efficacy of valacyclovir hydrochloride 1000 mg once daily beyond 1 year have not been established.
In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg orally once daily. 1 Adverse Reaction Overview). In patients with HIV infection with CD4 cell count > 100 cells/mm3, the recommended dosage of Sandoz Valacyclovir tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg orally twice daily.
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 hydrochloride 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 Drug Reactions). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug 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 hydrochloride 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 hydrochloride are listed in Table 3. Table 3 Incidence (%) of Drug-Related Adverse Reactions Occurring in ≥ 1 % of Patients Receiving Valacyclovir hydrochloride in Two Clinical Trials of Treatment of Herpes Zoster Adverse Drug Reaction Herpes Zoster 18-50 Years > 50 Years Valacyclovir (n=202) (%) Placebo (n=195) (%) Valacyclovir (n=765) (%) Acyclovir (n=376) (%) Nausea 8 6 12 14 Headache 11 8 8 7 Sandoz Valacyclovir (valacyclovir hydrochloride) Page 12 of 39 Adverse Drug Reaction Herpes Zoster 18-50 Years > 50 Years Valacyclovir (n=202) (%) Placebo (n=195) (%) Valacyclovir (n=765) (%) Acyclovir (n=376) (%) Diarrhea 4 4 4 4 Vomiting 2 2 4 3 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 hydrochloride compared to placebo.
04/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..................................................................................................................................
2 TABLE OF CONTENTS ..................................................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................................................................
4 1 INDICATIONS ........................................................................................................................................................ 1 PEDIATRICS ..........................................................................................................................................................
2 GERIATRICS ......................................................................................................................................................... 4 2 CONTRAINDICATIONS ..........................................................................................................................................
4 4 DOSAGE AND ADMINISTRATION ......................................................................................................................... 1 DOSING CONSIDERATIONS ......................................................................................................................................
2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT ..................................................................................................... 5 MISSED DOSE ......................................................................................................................................................
Sandoz 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, STRENGHTS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Valacyclovir in Canada.
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The safety and efficacy of therapy with valacyclovir hydrochloride beyond 6 months in patients with HIV infection have not been established.
Reduction of Transmission of Genital Herpes:
The recommended dosage of Sandoz 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 Reaction Overview).
Cold Sores (Herpes Labialis):
The recommended dosage of Sandoz 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 hydrochloride 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) Sandoz Valacyclovir (valacyclovir hydrochloride) Page 6 of 39 managed by hemodialysis.
73m2): Table 1 Dosage Adjustments for Adult Renal Impairment 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 Immunocompetent patients 1000 mg every 24 hours† 1000 mg every 24 hours† 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† 500 mg every 24 hours† 500 mg every 48 hours 500 mg every 48 hours 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: […]
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 hydrochloride in two Clinical Trials of Treatment of Recurrent Genital Herpes Adverse Drug Reaction Valacyclovir (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 two recurrent genital herpes suppression studies of immunocompetent patients, adverse drug reactions were not significantly different in recipients of valacyclovir hydrochloride 1000 mg once daily or valacyclovir hydrochloride 500 mg once daily, compared to placebo or acyclovir 400 mg twice daily.
The most frequent adverse reactions are reported in Table 5. d. d. d. d. (n=288) (%) Placebo (n=94) (%) Headache 13 13 12 11 7 6 Nausea 8 8 6 5 6 9 Abdominal pain 4 2 3 3 2 2 Diarrhea 4 3 5 7 2 0 Dyspepsia 3 < 1 3 2 < 1 0 Dizziness 2 2 1 1 < 1 1 Pain 2 2 < 1 < 1 < 1 1 Acne 1 < 1 < 1 0 < 1 0 Arthralgia 1 0 0 0 0 0 Constipation 1 < 1 1 0 < 1 0 Flu syndrome 1 < 1 < 1 < 1 0 0 Vomiting 1 < 1 1 0 < 1 2 Depression < 1 1 < 1 1 < 1 0 Insomnia < 1 2 < 1 < 1 0 0 Migraine < 1 < 1 < 1 1 1 1 Paresthesia < 1 1 < 1 < 1 0 0 Rash < 1 2 1 1 1 0 Asthenia 0 2 1 < 1 0 1 Dry mouth 0 3 < 1 < 1 < 1 1 Eczema 0 1 < 1 0 < 1 1 Pruritis 0 1 1 0 < 1 0 Vasodilatation 0 < 1 0 0 1 0 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 hydrochloride 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 hydrochloride versus 10% with 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 hydrochloride 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 6. d. (n=194) (%) Placebo (n=99) (%) Headache 5 3 Diarrhea 3 2 Nausea 2 5 Constipation 1 0 Dizziness 1 0 Adverse reactions reported by patients receiving valacyclovir hydrochloride 500 mg once daily (n=743) or placebo once daily (n=741) in a clinical study for the reduction of transmission of genital […]
6 5 OVERDOSAGE ....................................................................................................................................................... 7 6 DOSAGE FORMS, STRENGHTS, COMPOSITION AND PACKAGING ......................................................................
7 7 WARNINGS AND PRECAUTIONS .......................................................................................................................... 1 SPECIAL POPULATIONS ...........................................................................................................................................
1 Pregnant Women ................................................................................................................................... 2 Breast-feeding ......................................................................................................................................
3 Pediatrics .............................................................................................................................................. 4 Geriatrics ..............................................................................................................................................
10 8 ADVERSE REACTIONS ......................................................................................................................................... 1 ADVERSE REACTION OVERVIEW .............................................................................................................................
2 CLINICAL TRIAL ADVERSE REACTIONS ...................................................................................................................... 4 ABNORMAL LABORATORY FINDINGS: HEMATOLOGIC, CLINICAL CHEMISTRY AND OTHER QUANTITATIVE DATA......................
5 POST-MARKET ADVERSE DRUG REACTIONS ............................................................................................................. 15 9 DRUG INTERACTIONS.........................................................................................................................................
4 DRUG-DRUG INTERACTIONS ................................................................................................................................. 5 DRUG-FOOD INTERACTIONS ..................................................................................................................................
6 DRUG-HERB INTERACTIONS .................................................................................................................................. 7 DRUG-LABORATORY TEST INTERACTIONS.................................................................................................................
17 10 CLINICAL PHARMACOLOGY ............................................................................................................................... 1 MECHANISM OF ACTION .................................................................................................................................
3 PHARMACOKINETICS ....................................................................................................................................... 18 11 STORAGE AND STABILITY...................................................................................................................................
20 Sandoz Valacyclovir (valacyclovir hydrochloride) Page 3 of 39 12 SPECIAL HANDLING INSTRUCTIONS .................................................................................................................. 20 PART II: SCIENTIFIC INFORMATION.............................................................................................................................
21 13 PHARMACEUTICAL INFORMATION ................................................................................................................... 21 14 CLINICAL TRIALS […]