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SANDOZ VORICONAZOLE is a brand name for Voriconazole, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sandoz Voriconazole and Voriconazole for Injection (voriconazole) are indicated for: • Invasive aspergillosis • Candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall and wounds (see 14 CLINICAL TRIALS and 15…
Verbatim from this product's HC label. Tap a section to expand.
12/2024 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis 06/2023 7 WARNINGS AND PRECAUTIONS, Skin 02/2024 7 WARNINGS AND PRECAUTIONS, Tyrosine kinase inhibitors (CYP3A4 substrates) 06/2023 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 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 7 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ...................................................... 3 Reconstitution .....................................................................................................
4 Administration ..................................................................................................... 5 Missed Dose ........................................................................................................
13 5 OVERDOSAGE............................................................................................................. 13
, 10 CLINICAL PHARMACOLOGY). Patients with Hepatic Impairment It is recommended that the standard loading dose regimens be used but that the maintenance dose be halved in patients with mild to moderate hepatic cirrhosis (Child-Pugh A and B) receiving voriconazole (see above under Hepatic/Biliary/Pancreatic, 4 DOSAGE AND ADMINISTRATION, 8 ADVERSE REACTIONS, 10 CLINICAL PHARMACOLOGY).
Safety and efficacy of reduced voriconazole dosing in this setting is not established. Due to the small number of subjects studied, close clinical monitoring is advised. Voriconazole has not been studied in patients with severe cirrhosis (Child-Pugh Class C).
Voriconazole has been associated with elevations in liver function tests and clinical signs of liver damage, such as jaundice, and should only be used in patients with severe hepatic insufficiency if the benefit outweighs the potential risk.
Patients with hepatic insufficiency must be carefully monitored for drug toxicity. , recent chemotherapy, hematopoietic stem cell transplantation [HSCT]), should be monitored for development of pancreatitis during voriconazole treatment.
Monitoring and Laboratory Tests Patient management should include periodic laboratory evaluation of renal function (particularly serum creatinine). Patients receiving voriconazole must be carefully monitored for hepatic toxicity. Clinical management should include laboratory evaluation of hepatic function (particularly liver Product Monograph Sandoz Voriconazole, Voriconazole for Injection (voriconazole) Page 18 of 71 Protected B / Protégé B function tests and bilirubin) at the initiation of treatment with voriconazole and at least weekly for the first month of treatment.
If treatment is continued, monitoring frequency can be reduced to monthly if there are no changes in the liver function tests. Electrolyte disturbances such as hypokalemia, hypomagnesemia and hypocalcemia should be monitored and corrected, if necessary, prior to initiation of and during voriconazole therapy (see 4 DOSAGE AND ADMINISTRATION).
, Carcinogenesis and Mutagenesis 06/2023 7 WARNINGS AND PRECAUTIONS, Skin 02/2024 7 WARNINGS AND PRECAUTIONS, Tyrosine kinase inhibitors (CYP3A4 substrates) 06/2023 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 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 7 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ...................................................... 3 Reconstitution .....................................................................................................
4 Administration ..................................................................................................... 5 Missed Dose ........................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Musculoskeletal Non-infectious periostitis with elevated fluoride and alkaline phosphatase levels has been reported in transplant patients. If a patient develops skeletal pain and radiologic findings compatible with fluorosis or periostitis, voriconazole should be discontinued.
Ophthalmologic Voriconazole may cause visual symptoms including photophobia altered/enhanced visual perception, blurred vision and/or color vision change. The majority of visual symptoms appeared to spontaneously resolve within 60 minutes.
The effect of voriconazole on visual function is not known if treatment continues beyond 28 days. If treatment continues beyond 28 days, visual function including visual acuity, visual field and color perception should be monitored.
There has been a small number of post-marketing reports of vision loss (including decreased visual acuity or visual fields) where a relationship to voriconazole could not be excluded. These events mostly occurred in medically complex patients, where underlying disease processes and the primary infections themselves confound interpretation (see below under 8 ADVERSE REACTIONS).
There have been post-marketing reports of prolonged visual adverse events, including optic neuritis and papilledema. 5 Post-Market Adverse Reactions). Renal Acute renal failure has been observed in severely ill patients undergoing treatment with voriconazole.
Patients being treated with voriconazole are likely to be treated concomitantly with nephrotoxic medications and have concurrent conditions that may result in decreased renal function. Patients with Renal Impairment In patients with moderate to severe renal dysfunction (creatinine clearance < 50 mL/min), accumulation of the intravenous vehicle, SBECD, occurs.
Oral voriconazole should be administered to these patients, unless an assessment of the benefit/risk to the patient justifies the use of intravenous voriconazole. Renal function (including serum creatinine levels and creatinine clearance) should be closely monitored in these patients, and if significant changes occur, consideration should be given to changing to oral voriconazole therapy (see 4 DOSAGE Product Monograph Sandoz Voriconazole, Voriconazole for Injection (voriconazole) Page 19 of 71 Protected B / Protégé B AND ADMINISTRATION, 10 CLINICAL PHARMACOLOGY).
1. Pregnant Women). • Fertility No effects on fertility were observed in the rat study performed with voriconazole at exposures similar to those obtained in humans at therapeutic doses. • Teratogenic Risk Voriconazole can cause fetal harm when administered to a pregnant woman.
In animals, voriconazole administration was associated with fetal malformation, embryotoxicity, increased gestational length, dystocia, and embryomortality (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicity). Sensitivity/Resistance Voriconazole does not have activity against Zygomycete spp in vitro (see 15 MICROBIOLOGY).
Cases of breakthrough zygomycosis, most fatal, have been reported in patients who had received voriconazole. Infusion Related Reactions During infusion of the intravenous formulation of voriconazole in healthy subjects, anaphylactoid-type reactions, including flushing, fever, sweating, tachycardia, chest tightness, dyspnea, faintness, nausea, pruritus and rash, have occurred uncommonly.
Symptoms appeared immediately upon initiating the infusion. Consideration should be given to stopping the infusion should these reactions occur. Other symptoms, […]
13 5 OVERDOSAGE............................................................................................................. 13 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 14 7 WARNINGS AND PRECAUTIONS .................................................................................
1 Special Populations.............................................................................................. 1 Pregnant Women ................................................................................................ 2 Breast-feeding .....................................................................................................
3 Pediatrics ............................................................................................................. 4 Geriatrics .............................................................................................................
21 8 ADVERSE REACTIONS ................................................................................................. 1 Adverse Reaction Overview ................................................................................. 2 Clinical Trial Adverse Reactions ...........................................................................
3 Less Common Clinical Trial Adverse Reactions .................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................
5 Post-Market Adverse Reactions .......................................................................... 29 9 DRUG INTERACTIONS ................................................................................................. 1 Serious Drug Interactions ....................................................................................
2 Drug Interactions Overview ................................................................................. 3 Drug-Behavioural Interactions............................................................................. 4 Drug-Drug Interactions ........................................................................................
5 Drug-Food Interactions........................................................................................ 6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions.......................................................................
40 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action........................................................................................... 2 Pharmacodynamics .............................................................................................
3 Pharmacokinetics ................................................................................................ 41 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 47 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................
48 PART II: SCIENTIFIC INFORMATION ........................................................................................ 49 13 PHARMACEUTICAL INFORMATION .............................................................................
49 14 CLINICAL TRIALS ......................................................................................................... 1 Clinical Trials by Indication ..................................................................................
2 Comparative Bioavailability […]