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ODAN 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.
Verbatim from this product's HC label. Tap a section to expand.
). 4. 1. Dosing Considerations When ODAN 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.
ODAN ITRACONAZOLE oral solution is a different preparation than itraconazole capsules and should not be used interchangeably. 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).
Concomitant administration of ODAN ITRACONAZOLE with certain medications may require a dose adjustment for either ODAN ITRACONAZOLE or for the other medication (see 9. Drug Interactions).
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 ODAN ITRACONAZOLE oral solution in elderly patients are limited. It is advised to use ODAN 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 Odan-Itraconazole (itraconazole oral solution) Page 7 of 56 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.
The exposure of itraconazole may be lower in some patients with renal insufficiency. 3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). 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.
, Hepatic/Biliary/Pancreatic and
, Table 1;
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Itraconazole in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
4. Administration The solution should be swished in the oral cavity and swallowed. There should be no rinsing after swallowing. 5. Missed Dose If a patient misses a dose by a few hours, the patient should be advised to take their dose as soon as they remember.
If it is close to the next dose the patient should be advised to NOT take the missed dose. The patient should wait and restart ODAN ITRACONAZOLE at their next scheduled dose. 5. Overdose There is no experience of overdosage with ODAN 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 ODAN ITRACONAZOLE, standard supportive treatment should be applied as necessary. Odan-Itraconazole (itraconazole oral solution) Page 8 of 56 It has been reported that itraconazole cannot be removed by hemodialysis.
No specific antidote is available. Discontinue therapy immediately. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669).
6. Dosage Forms, Strengths, Composition, and Packaging Table 2 – Dosage Forms, Strengths, and Composition Description ODAN ITRACONAZOLE oral solution is available as a 10 mg itraconazole per mL solution, with 150 mL in each amber glass bottle.
A graduated dosing cup is supplied with the ODAN ITRACONAZOLE oral solution. The dosing cup is provided in the ODAN ITRACONAZOLE package to accurately measure the amount of solution needed. ODAN ITRACONAZOLE oral solution should be poured into the end of the cup containing markings which indicate dosing amounts (5 mL to 30 mL, in increments of 5 mL).
7. Warnings and Precautions See 3. SERIOUS WARNINGS AND PRECAUTIONS BOX. General ODAN ITRACONAZOLE oral solution and itraconazole capsules should not be used interchangeably. ODAN ITRACONAZOLE oral solution is indicated only for the treatment of oropharyngeal and/or esophageal candidiasis.
The efficacy of ODAN ITRACONAZOLE oral solution for other indications is unknown. 3 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).
Route of Administration Dosage Form/ Strength/Composition Non-Medicinal Ingredients […]