Posaconazole SP

Treatment should be initiated by a physician experienced in the management of fungal infections or in the supportive care in the high risk patients for which posaconazole is indicated as prophylaxis. Recommended dosage is shown in Table 1.

Medicinal product no longer authorised3 Table 1. Recommended dose according to indication Indication Dose and duration of therapy Refractory Invasive Fungal Infections (IFI)/Intolerant patients with IFI 400 mg (10 ml) twice a day. In patients who cannot tolerate a meal or a nutritional supplement, Posaconazole SP should be administered at a dose of 200 mg (5 ml) four times a day.

Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression, and clinical response. 5 ml) once a day for 13 days. Each dose of Posaconazole SP should be administered with a meal, or with a nutritional supplement in patients who cannot tolerate food to enhance the oral absorption and to ensure adequate exposure.

Prophylaxis of Invasive Fungal Infections 200 mg (5 ml) three times a day. Each dose of Posaconazole SP should be administered with a meal, or with a nutritional supplement in patients who cannot tolerate food to enhance the oral absorption and to ensure adequate exposure.

The duration of therapy is based on recovery from neutropenia or immunosuppression. For patients with acute myelogenous leukemia or myelodysplastic syndromes, prophylaxis with Posaconazole SP should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3.

There are limited pharmacokinetic data in patients with severe gastrointestinal dysfunction (such as severe diarrhoea). Patients who have severe diarrhoea or vomiting should be monitored closely for breakthrough fungal infections. The oral suspension must be shaken well before use.

2).

Use in hepatic impairment:

There are limited pharmacokinetic data in patients with hepatic impairment; therefore, no recommendation for dose adjustment can be made. 2).

Use in children:

Safety and efficacy in children and adolescents below the age of 18 years have not been established. 2).

The safety of posaconazole has been assessed in > 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience. The most frequently reported serious related adverse events included nausea, vomiting, diarrhoea, pyrexia, and increased bilirubin.

Table 2. 4. 4).

Hypersensitivity:

There is no information regarding cross-sensitivity between posaconazole and other azole antifungal agents. Caution should be used when prescribing Posaconazole SP to patients with hypersensitivity to other azoles. g. mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) have been reported during treatment with posaconazole.

Elevated liver function tests were generally reversible on discontinuation of therapy and in some instances these tests normalised without interruption of therapy. Rarely, more severe hepatic reactions with fatal outcomes have been reported.

Posaconazole should be used with caution in patients with severe hepatic impairment. In these patients, the prolonged elimination half-life may lead to increased exposure.

Monitoring of hepatic function:

Patients who develop abnormal liver function tests during Posaconazole SP therapy must be routinely monitored for the development of more severe hepatic injury. Patient management should include laboratory evaluation of hepatic function (particularly liver function tests and bilirubin).

Discontinuation of Posaconazole SP should be considered if clinical signs and symptoms are consistent with development of liver disease.

QTc prolongation:

Some azoles have been associated with prolongation of the QTc interval. 5). 3). Electrolyte disturbances, especially those involving potassium, magnesium or calcium levels, should be monitored and corrected as necessary before and during posaconazole therapy.

5). 5). 5). 75 g of glucose per 5 ml of suspension. Patients with glucose-galactose malabsorption should not take this medicine.

Hypersensitivity to the active substance or to any of the excipients. 5). 5). 5). Medicinal product no longer authorised4