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JAMP 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: JAMP Voriconazole (voriconazole) is 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 MICROBIOLOGY). 1.1 Pediatrics Pediatrics…
Verbatim from this product's HC label. Tap a section to expand.
and 10 CLINICAL PHARMACOLOGY). 2 CONTRAINDICATIONS • JAMP Voriconazole is contraindicated in patients with known hypersensitivity to voriconazole or its excipients. For a complete listing see
, 4 DOSAGE AND ADMINISTRATION, 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 Product Monograph JAMP Voriconazole (Voriconazole Tablets) Page 14 of 67 A and B) receiving voriconazole (see above under Hepatic/Biliary/Pancreatic, 8 ADVERSE REACTIONS, 4 DOSAGE AND ADMINISTRATION, 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 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).
, Skin 02/2024 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis 02/2024 7 WARNINGS AND PRECAUTIONS, Tyrosine kinase inhibitors (CYP3A4 substrates) 02/2024 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph 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 ................................................. 4 Administration ............................................................................................... 5 Missed Dose ...................................................................................................
10 5 OVERDOSAGE ....................................................................................................... 10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING........................... 11 7 WARNINGS AND PRECAUTIONS ............................................................................
02/2024 4. DOSAGE AND ADMINISTRATION 12/2024 7 WARNINGS AND PRECAUTIONS, Skin 02/2024 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis 02/2024 7 WARNINGS AND PRECAUTIONS, Tyrosine kinase inhibitors (CYP3A4 substrates) 02/2024 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph 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
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.
Product Monograph JAMP Voriconazole (Voriconazole Tablets) Page 15 of 67 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.
These events occurred primarily in severely ill patients who had underlying conditions and/or concomitant medications which may have caused or contributed to these events (see 8 ADVERSE REACTIONS – 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. 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. Skin There have been cases of severe cutaneous adverse reactions, such as Stevens-Johnson Syndrome (uncommon), toxic epidermal necrolysis (rare), drug reaction with eosinophilia and systemic symptoms and erythema multiforme (rare) which can be life-threatening or fatal (see 8 ADVERSE REACTIONS).
Stevens-Johnson Syndrome and toxic epidermal Product Monograph JAMP Voriconazole (Voriconazole Tablets) Page 16 of 67 necrolysis should be considered as a differential diagnosis if patients develop prodromal flu- like symptoms (fever, malaise, rhinitis, chest pain.
vomiting, sore throat, cough, diarrhea, headache, myalgia and arthralgia). If a patient develops an exfoliative cutaneous reaction voriconazole should be discontinued. Photosensitivity reactions have been observed. An increased risk of skin toxicity with concomitant use of methotrexate, a drug associated with ultraviolet (UV) reactivation has been observed.
There is a potential for this risk to be observed with other drugs associated with UV reactivation. It is recommended that patients, including children, avoid exposure to direct sunlight during voriconazole treatment and use […]
1 Special Populations ........................................................................................ 1 Pregnant Women ........................................................................................ 2 Breast-feeding .............................................................................................
3 Pediatrics .................................................................................................... 4 Geriatrics ..................................................................................................... 17 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 .....................................................................
25 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....................................................................... 47 PART II: SCIENTIFIC INFORMATION...................................................................................
48 13 PHARMACEUTICAL INFORMATION........................................................................ 48 14 CLINICAL TRIALS .................................................................................................... 1 Clinical Trials by Indication .............................................................................
2 Comparative Bioavailability Studies ............................................................... 52 15 MICROBIOLOGY .................................................................................................... 53 16 NON-CLINICAL TOXICOLOGY .................................................................................
56 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................ 59 […]