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JAMP ITRACONAZOLE is a brand name for Itraconazole, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: JAMP Itraconazole Oral Solution (itraconazole) 10 mg/mL is indicated for: • the treatment of oral and/or esophageal candidiasis in adult HIV-positive or other immunocompromised patients. Itraconazole oral solution as treatment for oral and/or esophageal candidiasis was not investigated in neutropenic patients. Due to…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations When JAMP Itraconazole Oral Solution may be indicated, the type of organism responsible for the infection should be isolated and identified; however, therapy may be initiated prior to obtaining these results, when clinically warranted.
JAMP Itraconazole Oral Solution (Itraconazole Oral Solution) Page 7 of 63 For optimal absorption, itraconazole oral solution should be taken without food (patients are advised to refrain from eating for at least 1 hour after intake).
2 Recommended Dose and Dosage Adjustment Oral Candidiasis: The recommended dosage of itraconazole oral solution for oral candidiasis is 200 mg (20 mL of oral solution) daily in a single dose or divided doses; treatment should continue for 1-2 weeks to decrease the likelihood of relapse.
Esophageal Candidiasis:
The recommended dosage for esophageal candidiasis is 100 mg (10 mL of oral solution) daily for a minimum treatment of three weeks. Treatment should continue for two weeks following resolution of symptoms. Doses of up to 200 mg (20 mL of oral solution) per day may be used based on medical assessment of the patient's response to therapy.
Special Populations Pediatrics (<18 years of age):
Health Canada has not authorized an indication for pediatric use. 1 Special Populations).
Geriatrics (>65 years of age):
Clinical data on the use of itraconazole oral solution in elderly patients are limited. It is advised to use Itraconazole oral solution in these patients only if it is determined that the potential benefit outweighs the potential risks.
In general, it is recommended that the dose selection for an elderly patient should be taken into consideration, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Patients with Hepatic Impairment Limited data are available on the use of oral itraconazole in patients with hepatic impairment. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). Patients with Renal Impairment Limited data are available on the use of oral itraconazole in patients with renal impairment.
). 1 Dosing Considerations When JAMP Itraconazole Oral Solution may be indicated, the type of organism responsible for the infection should be isolated and identified; however, therapy may be initiated prior to obtaining these results, when clinically warranted.
JAMP Itraconazole Oral Solution (Itraconazole Oral Solution) Page 7 of 63 For optimal absorption, itraconazole oral solution should be taken without food (patients are advised to refrain from eating for at least 1 hour after intake).
2 Recommended Dose and Dosage Adjustment Oral Candidiasis: The recommended dosage of itraconazole oral solution for oral candidiasis is 200 mg (20 mL of oral solution) daily in a single dose or divided doses; treatment should continue for 1-2 weeks to decrease the likelihood of relapse.
Esophageal Candidiasis:
The recommended dosage for esophageal candidiasis is 100 mg (10 mL of oral solution) daily for a minimum treatment of three weeks. Treatment should continue for two weeks following resolution of symptoms. Doses of up to 200 mg (20 mL of oral solution) per day may be used based on medical assessment of the patient's response to therapy.
Special Populations Pediatrics (<18 years of age):
Health Canada has not authorized an indication for pediatric use. 1 Special Populations).
Geriatrics (>65 years of age):
Clinical data on the use of itraconazole oral solution in elderly patients are limited. It is advised to use Itraconazole oral solution in these patients only if it is determined that the potential benefit outweighs the potential risks.
In general, it is recommended that the dose selection for an elderly patient should be taken into consideration, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
5 Post-Market Adverse Reactions). • Coadministration with JAMP Itraconazole Oral Solution, a potent cytochrome P450 3A4 isoenzyme system (CYP3A4) inhibitor, causes elevated plasma concentrations of drugs metabolized by this pathway which may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious situation may occur.
4 Drug-Drug Interactions, Table 4).
JAMP Itraconazole Oral Solution (Itraconazole Oral Solution) Page 5 of 63 Table 1:
Drugs that are contraindicated with JAMP Itraconazole Oral Solution Drug Class Drugs within Class that are Contraindicated with JAMP Itraconazole Oral Solution Analgesics methadone Antiarrhythmics disopyramide, dronedarone, quinidine Anticoagulants and Antiplatelet Drugs ticagrelor, apixaban, rivaroxaban Antifungals isavuconazole Antimigraine Drugs ergot alkaloids, such as dihydroergotamine, ergometrine (ergonovine), ergotamine, eletriptan Antineoplastics irinotecan, venetoclax (for chronic lymphocytic leukemia/small lymphocytic lymphoma patients during initiation/titration/ramp- up phase).
Antipsychotics, Anxiolytics and Hypnotics lurasidone, pimozide, triazolam Antivirals asunaprevir (boosted) Calcium Channel Blockers felodipine Cardiovascular Drugs ivabradine, ranolazine Diuretics eplerenone Gastrointestinal Drugs domperidone, naloxegol Lipid Regulating Drugs lomitapide, lovastatin, simvastatin Urologic Drugs fesoterodine, in subjects with moderate to severe renal impairment, or moderate to severe hepatic impairment solifenacin, in subjects with severe renal impairment or moderate to severe hepatic impairment.
Miscellaneous Drugs and Other Substances colchicine, in subjects with renal or hepatic impairment, eliglustat. • JAMP Itraconazole Oral Solution is contraindicated in patients with a known hypersensitivity to itraconazole or its excipients.
02/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ................................................................................................................................................
1 Pediatrics ........................................................................................................ 2 Geriatrics ........................................................................................................
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The exposure of itraconazole may be lower in some patients with renal insufficiency. 3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). 4 Administration The solution should be swished in the oral cavity and swallowed.
There should be no rinsing after swallowing.
Patients with Hepatic Impairment Limited data are available on the use of oral itraconazole in patients with hepatic impairment. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). Patients with Renal Impairment Limited data are available on the use of oral itraconazole in patients with renal impairment.
The exposure of itraconazole may be lower in some patients with renal insufficiency. 3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). 4 Administration The solution should be swished in the oral cavity and swallowed.
There should be no rinsing after swallowing. 5 OVERDOSAGE JAMP Itraconazole Oral Solution (Itraconazole Oral Solution) Page 8 of 63 There is no experience of overdosage with itraconazole oral solution; however, based on animal toxicity data, symptoms of a gastrointestinal or central nervous system nature may be expected to occur.
Although no data are available for itraconazole, standard supportive treatment should be applied as necessary. It has been reported that itraconazole cannot be removed by hemodialysis. No specific antidote is available. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2: Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Oral Solution 10 mg/mL caramel flavour, cherry flavour, hydrochloric acid, hydroxypropyl-ß- cyclodextrin, propylene glycol, purified water, sodium hydroxide, sodium saccharin, and sorbitol.
JAMP Itraconazole Oral Solution is available as a 10 mg itraconazole per mL solution, with 150 mL in each amber glass bottle. A dosing cup is supplied with the JAMP Itraconazole Oral Solution. The dosing cup is provided in the JAMP Itraconazole Oral Solution package to accurately measure the amount of solution needed.
5 mL, 5 mL, 10 mL, 15 mL and 20 mL). There are arrows on the sides of the dosing cup showing which end to pour the solution into. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX General JAMP Itraconazole Oral Solution and Itraconazole capsules should not be used interchangeably.
JAMP Itraconazole Oral Solution is indicated only for the treatment of oropharyngeal and/or esophageal candidiasis. The efficacy of itraconazole oral solution for other indications is unknown. 3 JAMP Itraconazole Oral Solution (Itraconazole Oral Solution) Page 9 of 63 Pharmacokinetics).
In patients receiving continuous treatment of more than one month and in patients developing symptoms such as anorexia, nausea, vomiting, fatigue, abdominal pain or dark urine, it is advisable to monitor liver function. If tests are abnormal, treatment should be terminated.
In systemic candidosis, if fluconazole-resistant strains of Candida species are suspected, it cannot be assumed that these are sensitive to itraconazole, hence it is recommended to have their sensitivity tested before the start of itraconazole therapy (see 15 MICROBIOLOGY, Resistance and Cross-Resistance).
Carcinogenesis and Mutagenesis JAMP Itraconazole Oral Solution contains the excipient hydroxypropyl-β-cyclodextrin, which produced adenocarcinomas in the large intestine and exocrine pancreas in a rat carcinogenicity study, but not in a similar mouse carcinogenicity study.
The clinical relevance of these findings is unknown. See 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity for discussion on […]
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • There is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents. Caution should be used in prescribing JAMP Itraconazole Oral Solution to patients with hypersensitivity to other azoles.
JAMP Itraconazole Oral Solution (Itraconazole Oral Solution) Page 6 of 63 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Congestive Heart Failure: JAMP Itraconazole Oral Solution (itraconazole) should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF except for the treatment of life- threatening or other serious infections.
If signs or symptoms of congestive heart failure occur during administration of JAMP Itraconazole Oral Solution, discontinue administration. 5 Post-Market Adverse Reactions). • Drug Interactions: Coadministration of a number of CYP3A4 substrates with itraconazole oral solution is contraindicated.
Coadministration with itraconazole, a potent cytochrome P450 3A4 isoenzyme system (CYP3A4) inhibitor, causes increased plasma concentrations of drugs metabolized by this pathway which may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious situation may occur.
For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes, a potentially fatal arrhythmia. 4 Drug-Drug Interactions, Table 4).
• Liver Toxicity: Itraconazole oral solution has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre- existing liver disease nor a serious underlying medical condition and some of these cases developed within the first week of treatment.
It is advisable to monitor liver function. If clinical signs or symptoms develop that are consistent with liver disease, such as anorexia, nausea, vomiting, jaundice, fatigue, abdominal pain, dark urine, or pale stools, treatment should be discontinued, and liver function testing performed.
Continued use of JAMP Itraconazole Oral Solution or reinstitution of treatment with JAMP Itraconazole Oral Solution is strongly discouraged unless there is a serious or life-threatening situation where the expected benefit exceeds the risk (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic and