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ITRACONAZOLE is a brand name for Itraconazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Itraconazole is indicated for the treatment of histoplasmosis. Itraconazole is indicated in the following systemic fungal conditions when first-line systemic anti-fungal therapy is inappropriate or has proved ineffective. (This may be due to underlying pathology, insensitivity of the pathogen or drug toxicity).…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Itraconazole is given on the first two days in a loading dose twice daily, followed by once daily dosing. 6). From day 3 on: one 1-hour infusion of 200 mg (60 ml of the admixed solution) Itraconazole each day. Safety for periods longer than 14 days has not been established.
Paediatric population Clinical data on the use of itraconazole IV in paediatric patients are limited. 4). Elderly Since clinical data of the use of itraconazole in elderly patients are limited, it is advised to use itraconazole in these patients only if the potential benefit outweighs the potential risks.
4). Renal impairment Limited data are available on the use of intravenous itraconazole in patients with renal impairment. Hydroxypropyl-β-cyclodextrin, a required component of itraconazole intravenous formulation, is eliminated through glomerular filtration.
3). In patients with mild and moderate renal impairment, itraconazole IV should be used with caution. 4. 2). Hepatic impairment Limited data are available on the use of itraconazole in patients with hepatic impairment. 2). Method of administration Intravenous use.
2 μm in- line filter. 6). 6.
Summary of the safety profile The most frequently reported adverse drug reactions (ADRs) with itraconazole intravenous treatment identified from clinical trials and/or from spontaneous reporting were cough, diarrhoea, vomiting, nausea, rash, and oedema (including generalised oedema and face oedema).
The most serious ADRs were serious allergic reactions, cardiac failure/congestive heart failure/pulmonary oedema, pancreatitis, serious hepatotoxicity (including some cases of fatal acute liver failure), and serious skin reactions.
Refer to subsection ‘Tabulated list of adverse reactions’ for the frequencies and for other observed ADRs. 4 for additional information on other serious effects. Tabulated list of adverse reactions The ADRs in the table below were derived from one randomized, active controlled, open-label clinical trial with itraconazole intravenous involving 192 patients for empirical therapy of febrile neutropenia, and from spontaneous reporting.
The table below presents ADRs by System Organ Class. Within each System Organ Class, the ADRs are presented by incidence, using the following convention: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data).
4. Description of selected adverse reactions The following is a list of additional ADRs associated with itraconazole that have been reported in clinical trials of itraconazole oral solution and itraconazole capsules.
Infections and infestations:
Sinusitis, Upper respiratory tract infection, Rhinitis Blood and lymphatic system disorders: Leukopenia Metabolism and nutrition disorders: Hypokalaemia Nervous system disorders: Peripheral neuropathy*, Paraesthesia Ear and labyrinth disorders: Tinnitus Gastrointestinal disorders: Flatulence Hepatobiliary disorders: Hepatic failure*, Hepatic function abnormal Musculoskeletal and connective tissue disorders: Arthralgia Renal and urinary disorders: Pollakiuria Reproductive system and breast disorders: Erectile dysfunction, Menstrual disorder Paediatric population The safety of itraconazole IV was evaluated in 36 paediatric patients aged 6 months to 17 years who participated in 3 open-label clinical trials.
Cross hypersensitivity There is no information regarding cross hypersensitivity between itraconazole and other azole antifungal agents. Caution should be used in prescribing itraconazole to patients with hypersensitivity to other azoles Cardiac effects In a healthy volunteer study with itraconazole, a transient asymptomatic decrease of the left ventricular ejection fraction was observed; this resolved before the next infusion.
A similar investigation was not performed in the target patient population. Itraconazole has been shown to have a negative inotropic effect and itraconazole has been associated with reports of congestive heart failure. Heart failure was more frequently reported among spontaneous reports of 400 mg total daily dose than among those of lower total daily doses, suggesting that the risk of heart failure might increase with the total daily dose of itraconazole.
Itraconazole should not be used in patients with congestive heart failure or with a history of congestive heart failure unless the benefit clearly outweighs the risk. Physicians should carefully review the risks and benefits of itraconazole therapy for patients with known risk factors for congestive heart failure.
These risk factors include cardiac disease, such as ischaemic and valvular disease; significant pulmonary disease, such as chronic obstructive pulmonary disease; and renal failure and other oedematous disorders. Such patients should be informed of the signs and symptoms of congestive heart failure, should be treated with caution, and should be monitored for signs and symptoms of congestive heart failure during treatment.
If such signs or symptoms do occur during treatment, itraconazole should be discontinued. 5). Hepatic effects Very rare cases of serious hepatotoxicity, including some cases of fatal acute liver failure, have occurred with the use of itraconazole.
Some of these cases involved patients with no pre-existing liver disease. Some of these cases have been observed within the first month of treatment, including some within the first week. Liver function monitoring should be considered in patients receiving itraconazole treatment.
1. Itraconazole cannot be used when administration of Sodium Chloride injection is contraindicated. The excipient hydroxypropyl-β-cyclodextrin is eliminated through glomerular filtration. 2). 5). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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These patients received at least one dose of itraconazole IV for prevention or treatment of fungal infections and provided safety data. 1 %). The nature of ADRs in paediatric patients is similar to that observed in adult subjects, but in general, the incidence is higher in the adult subjects.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Patients should be instructed to promptly report to their physician signs and symptoms suggestive of hepatitis such as anorexia, nausea, vomiting, fatigue, abdominal pain or dark urine. In these patients treatment should be stopped immediately and liver function testing should be conducted.
Most cases of serious hepatotoxicity involved patients who had pre-existing liver disease, were treated for systemic indications, had significant other medical conditions and/or were taking other hepatotoxic drugs. Elderly Since clinical data of the use of itraconazole in elderly patients are limited, it is advised to use itraconazole in these patients only if the potential benefit outweighs the potential risks.
4). Hepatic impairment Studies have not been conducted with intravenous itraconazole in patients with hepatic impairment. Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Caution should be exercised when the drug is administered to this patient population.
It is recommended that patients with impaired hepatic function be carefully monitored when taking itraconazole. It is recommended that the prolonged elimination half-life of itraconazole observed in the single oral dose clinical trial with itraconazole capsules in cirrhotic patients be considered when deciding to initiate therapy with other medications metabolized by CYP3A4.
In patients with elevated or abnormal liver enzymes or active liver disease, or who have experienced liver toxicity with other drugs, treatment with itraconazole is strongly discouraged unless there is a serious or life threatening situation where the expected benefit exceeds the risk.
). Renal impairment Hydroxypropyl-β-cyclodextrin, when administered intravenously, is eliminated through glomerular filtration. 2). Itraconazole IV should be used with caution in patients with a lesser degree of renal failure. 4). Hearing Loss Transient or permanent hearing loss has been reported in patients receiving treatment with itraconazole.
5). The hearing loss usually resolves when treatment is stopped, but can persist in some patients. Neuropathy If neuropathy occurs that may be attributable to itraconazole, the treatment should be discontinued. Cross-resistance In systemic candidosis, if fluconazole-resistant strains of Candida species are suspected, it cannot be assumed that these are sensitive to itraconazole, hence their sensitivity should be tested before the start of itraconazole therapy.
Interaction potential Co-administration of specific drugs with itraconazole may result in changes in efficacy or safety of itraconazole and/or the co-administered drug. For example, the use of itraconazole with CYP3A4 inducing agents may lead to […]