POSATIF POSACONAZOLE GASTRO-RESISTANT TABLETS 100MG

6. INDICATIONS AND USAGE
Posaconazole delayed release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections, including both yeasts and molds, in patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or hematopoietic stem cell transplant (HSCT) recipients.
Posaconazole delayed release tablets are indicated for use in the treatment of the following fungal infections in patients 13 years of age or older:

• Refractory Invasive Fungal infections (IFI) /Intolerant Patients with IFI: Fusariosis, zygomycosis, cryptococcosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients with disease refractory to other therapy, or patients who are intolerant of other therapy. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

9. CONTRAINDICATIONS
Posaconazole is contraindicated in patients with known hypersensitivity to posaconazole or any component of the product.
Although not studied in vitro or in vivo, coadministration of the CYP3A4 substrates terfenadine, astemizole, cisapride, pimozide, or quinidine with posaconazole are contraindicated since increased plasma concentrations of these drugs can lead to QT prolongation and rare occurrences of torsade de pointes.
Coadministration with the HMG-CoA reductase inhibitors that are primarily metabolized through CYP3A4 is contraindicated since increased plasma concentration of these drugs can lead to rhabdomyolysis.
Although not studied in vitro or in vivo, posaconazole may increase the plasma concentrations of ergot alkaloids which may lead to ergotism. Coadministration of posaconazole and ergot alkaloids is contraindicated.

7. DOSAGE AND ADMINISTRATION
Important Administration Instructions
Non-Interchangeability between Posaconazole Delayed Release Tablets and Posaconazole Oral Suspension
The prescriber should follow the specific dosing instructions for each formulation. The tablet and oral suspension are not to be used interchangeably due to the differences in the dosing of each formulation.

Posatif Posaconazole gastro-resistant tablets

• Tablets should not be administered together with alcohol.
• Swallow tablets whole. Do not divide, crush, or chew.
• Tablets may be taken without regard to food intake.

Use in renal impairment: No dose adjustment is required for renal dysfunction and posaconazole is not significantly renally eliminated, an effect of severe renal insufficiency on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended.
Use in hepatic impairment: There are limited pharmacokinetic data in patients with hepatic insufficiency; therefore, no recommendation for dose adjustment can be made. In the small number of subjects studied who had hepatic insufficiency, there was an increase in half-life with a decrease in hepatic function.
Use in children: Safety and efficacy in children below the age of 13 years have not been established.