Loading…
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). A graduated measuring cup is provided to measure out the correct dose. 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: 200 mg (20 ml) 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.
0019 CCRF24141 Treatment of fluconazole resistant oral and/or oesophageal candidosis: 100 to 200 mg (10-20 ml) twice daily for 2 weeks. If there is no response after 2 weeks, treatment should be continued for another 2 weeks. The 400mg daily dose should not be used for longer than 14 days if there are no signs of improvement.
Prophylaxis of fungal infections: 5 mg/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.
Use in children Since clinical data on the use of itraconazole oral solution in paediatric patients is limited, its use in children is not recommended unless the potential benefit outweighs the potential risks. 4) Prophylaxis of fungal infections: there are no efficacy data available in neutropenic children.
Limited safety experience is available with a dose of 5 mg/kg per day administered in two intakes. 8) 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.
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 involving 889 patients for the treatment of oropharyngeal and oesophageal candidiasis, and from spontaneous reporting.
The table below presents adverse drug reactions 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 events 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.
). 6). 5). g. , 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).
4 Special warnings and precautions for use 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 has been associated with reports of congestive heart failure.
Heart failure was more frequently reported among spontaneous reports of 400mg total daily dose than among those of lower total daily doses, suggesting that the risk of heart failure 0019 CCRF24141 might increase with the total daily dose of itraconazole.
Itraconazole oral solution 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 the treatment, and individual risk factors for congestive heart failure.
1. Itraconazole oral solution 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 (see section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Itraconazole in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
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). Use 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 this drug is administered in this patient population. 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.
6.
These patients received at least one dose of itraconazole 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.
IE: HPRA Pharmacovigilance, […]
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 oral solution 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. 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 […]