FUNGIZONE

Non-equivalence of amphotericin products Different amphotericin products (sodium deoxycholate, liposomal, lipid complex) are not equivalent in terms of pharmacodynamics, pharmacokinetics and dosing and so the products should not be used interchangeably without accounting for these differences.

Both the trade name, common name and dose should be verified pre-administration. 5 mg/kg be exceeded. 9). Posology Fungizone should be administered by intravenous infusion over a period of 2-6 hours. Reduction of the infusion rate may reduce the incidence of side-effects.

0 mg/kg of body weight depending on individual response and tolerance. 0 mg/kg the daily dose should be maintained at the highest level which is not accompanied by unacceptable toxicity. 5 mg/kg. Since amphotericin B is excreted slowly, therapy may be given on alternate days in patients on the higher dosage schedule.

Several months of therapy are usually necessary; a shorter period of therapy may produce an inadequate response and lead to relapse. When commencing all new courses of treatment, it is advisable to administer a test dose immediately preceding the first dose.

e. 10 mL) should be infused over 20-30 minutes and the patient carefully observed for at least a further 30 minutes. It should be noted that patient responses to the test dose may not be predictive of subsequent severe side effects. 3 mg/kg amphotericin B intravenously over a period of 2 to 6 hours.

e. 5 to 10 mg) is recommended. 5 to 1 mg/kg. e. 25 mg/kg of body weight and increased gradually. The recommended concentration for intravenous infusion is 10 mg/100 mL. Paediatric population Safety and effectiveness in paediatric patients have not been established through adequate and well-controlled studies.

Systemic fungal infections have been treated in paediatric patients with reports of side effects similar to those seen in adults. Older people No specific dosage recommendations or precautions. g. candiduria): Continuous irrigation with 50 mg Fungizone in 1 litre sterile water each day until urinary cultures are negative.

5- 200 mcg/mL) has also been reported. The urine should be alkalinised (with potassium citrate) and antifungal ointment applied to the perineal area. g. pulmonary aspergillosis): 8-40 mg amphotericin B (nebulised in sterile water or 5% Glucose) has been given daily in divided doses.

The table below lists all adverse events. The list is presented by system organ class and frequency, which is defined 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), and not known (cannot be estimated from the available data).

4. 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.

Prolonged therapy with amphotericin B is usually necessary. Unpleasant reactions are quite common when the drug is given parenterally at therapeutic dosage levels. Some of these reactions are potentially dangerous. Hence amphotericin B should be used parenterally only in hospitalised patients, or those under close clinical observation.

Accidental overdose Care must be taken when administering Fungizone to prevent overdose, which can result in potentially fatal cardiac or cardiorespiratory arrest. 9). Rapid intravenous infusion, over less than one hour, particularly in patients with renal insufficiency, has been associated with hyperkalaemia and arrhythmias and should therefore be avoided.

2). Infusion related reactions While some patients may tolerate full intravenous doses of amphotericin B without difficulty, most will exhibit some intolerance particularly during the initiation of therapy. In patients experiencing adverse reactions these may be made less severe by giving aspirin, other antipyretics, antihistamines or anti- emetics.

Pethidine (25 to 50 mg IV) has been used in some patients to decrease the duration or intensity of shaking chills and fever following amphotericin B therapy. g. 25 mg hydrocortisone. This may be administered just prior to or during amphotericin B infusion.

The dosage and duration of such corticosteroid therapy should be kept to a minimum. Administration of the drug on alternate days may decrease anorexia and phlebitis. Adding a small amount of heparin (1000 units per infusion) to the infusion, rotation of the injection site, the use of a paediatric scalp-vein needle and alternate day therapy may lessen the incidence of thrombophlebitis and coagulation problems.

Extravasation may cause chemical irritation. Corticosteroids should not be administered concomitantly unless they are necessary to control drug reactions. Renal toxicity Renal function test abnormalities are commonly observed and usually improve upon interruption of therapy; however, some permanent impairment often occurs, especially in those patients receiving large cumulative amounts (over 5 g) of amphotericin B.

1.