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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 oral solution is indicated: For the treatment of oral and/or oesophageal candidosis in HIV-positive or other immunocompromised patients. As prophylaxis of deep fungal infections anticipated to be susceptible to itraconazole, when standard therapy is considered inappropriate, in patients with…
Verbatim from this product's MHRA label. Tap a section to expand.
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). For the treatment of oral and/or oesophageal candidosis, the liquid should be swished around the oral cavity (approx.
20 seconds) and swallowed. There should be no rinsing after swallowing. Treatment of oral and/or oesophageal candidosis: 200mg (20ml) per day in two intakes, or alternatively in one intake, for 1 week. If there is no response after 1 week, treatment should be continued for another week.
Treatment of fluconazole resistant oral and/or oesophageal candidosis: 100 to 200mg (10-20ml) twice daily for 2 weeks. If there is no response after 2 weeks, treatment should be continued for another 2 weeks. The 400mg (40ml) daily dose should not be used for longer than 14 days if there are no signs of improvement.
5ml/kg) per day administered in two intakes. In clinical trials, prophylaxis treatment was started immediately prior to the cytostatic treatment and generally one week before transplant procedure. Almost all proven deep fungal infections occurred in patients reaching neutrophil counts below 100 cells/μl.
e. > 1000 cells/μl). Pharmacokinetic parameters from clinical studies in neutropenic patients demonstrate considerable intersubject variation. Blood level monitoring should be considered particularly in the presence of gastrointestinal damage, diarrhoea and during prolonged courses of Itraconazole oral solution.
Use in patients with gastro-intestinal motility impairment When treating patients with severe fungal infections or when administering it as fungal prophylaxis to those with abnormal gastro-intestinal motility, patients should be carefully monitored and where appropriate drug therapeutic monitoring should be considered, where available.
Paediatric population The safety and efficacy of Itraconazole oral solution in children has not been established. 2 but no recommendation on a posology can be made. 4). Prophylaxis of fungal infections: there are no efficacy data available in neutropenic children.
8). Use in elderly Since 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.
Summary of the safety profile The most frequently reported adverse drug reactions (ADRs) with Itraconazole oral solution treatment identified from clinical trials and/or from spontaneous reporting were dizziness, headache, dysgeusia, dyspnoea, cough, abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, rash, and pyrexia.
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 (Special warnings and precautions for use) for additional information on other serious effects. Tabulated list of adverse reactions The ADRs in the table below were derived from double-blind and open-label clinical trials with Itraconazole oral solution involving 889 patients for the treatment of oropharyngeal and esophageal candidiasis, 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 Capsules and Itraconazole IV, excluding the ADR term “Injection site inflammation”, which is specific to the injection route of administration.
Infections and infestations:
Sinusitis, Upper respiratory tract infection, Rhinitis Blood and lymphatic system disorders: Granulocytopenia Immune system disorders: Anaphylactoid reaction Metabolism and nutrition disorders: Hyperglycaemia, Hyperkalaemia, Hypomagnesaemia Psychiatric disorders: Confusional state Nervous system disorders: Somnolence, Tremor Cardiac disorders: Left ventricular failure, Tachycardia Vascular disorders: Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders: Pulmonary oedema, Dysphonia Gastrointestinal disorders: Gastrointestinal disorder, Flatulence Hepatobiliary disorders: Hepatitis, Jaundice, Hepatic function abnormal Skin and subcutaneous tissue disorders: Rash erythematous, Hyperhidrosis Renal and urinary disorders: Renal impairment, Pollakiuria, Urinary incontinence Reproductive system and breast disorders: Erectile dysfunction General disorders and administration site conditions: Generalised oedema, Face oedema, Chest pain, Pain, Fatigue, Chills Investigations: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood lactate dehydrogenase increased, Blood urea increased, Gamma- glutamyltransferase increased, Hepatic enzyme increased, Urine analysis abnormal Paediatric Population The safety of Itraconazole oral solution was evaluated in 250 paediatric patients aged 6 months to 14 years who participated in five open-label clinical trials.
Use in patients with gastro-intestinal motility impairment When treating patients with severe fungal infections or when administering it as fungal prophylaxis to those with abnormal gastro-intestinal motility, patients should be carefully monitored and where appropriate drug therapeutic monitoring should be considered, where available.
Cross-hypersensitivity There is no information regarding cross hypersensitivity between itraconazole and other azole antifungal agents. Caution should be used in prescribing Itraconazole oral solution to patients with hypersensitivity to other azoles.
Cardiac effects In a healthy volunteer study with Itraconazole IV, a transient asymptomatic decrease of the left ventricular ejection fraction was observed. 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 400mg (40ml) 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. This individual benefit/risk assessment should take into consideration factors such as the severity of the indication, the dose and duration of treatment, and individual risk factors for congestive heart failure.
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.
• Itraconazole oral solution is contraindicated in patients with a known hypersensitivity to itraconazole or to any of the excipients. 4). 6). 5). g. dihydroergotamine, ergometrine, ergotamine, methylergometrine) Anti-bacterials for Systemic Use; Anti-mycobacterials; Antimycotics for Systemic Use Isavuconazole Anthelmintics; Antiprotozoals Halofantrine Antihistamines for Systemic Use Astemizole Mizolastine Terfenadine Antineoplastic Agents Irinotecan Venetoclax (in patients With chronic lymphocytic leukaemia during initiation and dose titration phase of venetoclax) Antithrombotic Agents Dabigatran Ticagrelor Antivirals for Systemic Use Ombitasvir/Paritaprevir/Ritonavir (with or without Dasabuvir) Cardiovascular System (Agents Acting on the Renin- Angiotensin System; Antihypertensives; Beta Blocking Agents; Calcium Channel Blockers; Cardiac Therapy; Diuretics) Aliskiren Eplerenone Quinidine Bepridil Finerenone Ranolazine Disopyramide Ivabradine Sildenafil (pulmonary hypertension) Dofetilide Lercanidipine Dronedarone Nisoldipine Gastrointestinal Drugs, including Antidiarrheals, Intestinal Anti- inflammatory/Anti-infective Agents; Antiemetics and Antinauseants; Drugs for Constipation; Drugs for Functional Gastrointestinal Disorders Cisapride Domperidone Naloxegol Immunosuppresants Voclosporin Lipid Modifying Agents Lovastatin Lomitapide Simvastatin Psychoanaleptics; Psycholeptics (eg, antipsychotics, anxiolytics, and hypnotics) Lurasidone Pimozide Sertindole Midazolam (oral) Quetiapine Triazolam Urologicals Avanafil Darifenacin Solifenacin (in patients with severe renal impairment or moderate to severe hepatic impairment) Dapoxetine Fesoterodine (in patients with moderate or severe renal or hepatic impairment).
Vardenafil (in patients older than 75 years). Miscellaneous Drugs and Other Substances Colchicine (in patients with renal or hepatic impairment) Eliglustat (in patients that are CYP2D6 poor metabolisers (PM), CYP2D6 intermediate metabolisers (IMs) or extensive metabolisers (EMs) that are taking a strong or moderate CYP2D6 inhibitor).
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4). Use in patients with hepatic impairment Limited data are available on the use of oral itraconazole in patients with hepatic impairment. 2). Use in patients with renal impairment Limited data are available on the use of oral itraconazole in patients with renal impairment.
2). Caution should be exercised when this drug is administered in this patient population and adjusting the dose or switching to an alternative antifungal medication may be considered based on an evaluation of clinical effectiveness.
These patients received at least one dose of Itraconazole oral solution for prophylaxis of fungal infections or for treatment of oral thrush or systemic fungal infections and provided safety data. 2%). The nature of ADRs in paediatric patients is similar to that observed in adult subjects, but the incidence is higher in the paediatric patients.
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.
Liver function monitoring should be considered in patients receiving Itraconazole treatment. 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.
Paediatric population Clinical data on the use of Itraconazole oral solution in paediatric patients are limited. The use of Itraconazole oral solution in paediatric patients is not recommended unless it is determined that the potential benefit outweighs the potential risks.
Use in elderly Since clinical data on the use of Itraconazole oral solution in elderly patients is limited, it is advised to use Itraconazole oral solution in these patients only if the potential benefit outweighs the potential risks.
4). 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 in 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 metabolised 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.
2). Renal impairment Limited data are available on the use of oral itraconazole in patients with renal impairment. 2). Caution should be exercised when this drug is administered in this patient population and adjusting the dose or switching to an alternative antifungal medication may be considered based on an evaluation of clinical effectiveness.
Prophylaxis in neutropenic patients In clinical trials diarrhoea was the most frequent adverse event. This disturbance of the gastrointestinal tract may result in impaired absorption and may alter the microbiological flora potentially favouring fungal colonisation.
Consideration should be given to discontinuing Itraconazole oral solution in these circumstances. Treatment of severely neutropenic patients Itraconazole oral solution as treatment for oral and/or oesophageal candidosis was not investigated in severely neutropenic patients.
2), Itraconazole oral solution is not recommended for initiation of treatment in patients at immediate risk of systemic candidosis. Hearing […]