NOXAFIL ORAL SUSPENSION 40 mg/ml

Patheon Inc. (CANADA)🇸🇬 Health Sciences Authority

Approval Date: May 25, 2009
Approval ID: 83b1eb6883f97621
Company: Patheon Inc. (CANADA)
Type: Therapeutic

Approval Details

Approval Id: 83b1eb6883f97621
Drug Name: NOXAFIL ORAL SUSPENSION 40 mg/ml
Product Name: NOXAFIL ORAL SUSPENSION 40 mg/ml
Approval Number: SIN13654P
Approval Date: 2009-05-25
Registrant: MSD PHARMA (SINGAPORE) PTE. LTD.
Licence Holder: MSD PHARMA (SINGAPORE) PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: SUSPENSION
Dosage: DOSAGE AND ADMINISTRATION: Important Administration Instructions for NOXAFIL Delayed Release Tablet and Oral Suspension Non-Interchangeability between NOXAFIL Delayed Release Tablets and NOXAFIL 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. NOXAFIL Delayed Release Tablets NOXAFIL Delayed Release Tablets may be taken without regard to food intake. NOXAFIL Delayed Release Tablets should be swallowed whole, and not be divided, crushed, or chewed. <img src="/TGIF/Noxafil-Table3_040424.png" alt="Noxafil Dosage Table 3" /> NOXAFIL Oral Suspension NOXAFIL Oral Suspension should be administered with a meal, or with 240 ml of a nutritional supplement to enhance the oral absorption and to ensure adequate exposure. The oral suspension must be shaken well before use. <img src="/TGIF/Noxafil-Table4_040424.png" alt="Noxafil Dosage Table 4" /> Use in renal impairment: No dose adjustment is required for renal dysfunction and NOXAFIL is not significantly renally eliminated, an effect of severe renal insufficiency on the pharmacokinetics of NOXAFIL 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.
Route Of Administration: ORAL
Indication Info: INDICATIONS AND USAGE: NOXAFIL Delayed Release Tablets and Oral Suspension are indicated for 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. NOXAFIL Delayed Release Tablets and Oral Suspension are indicated for use in the treatment of the following fungal infections in patients 13 years of age or older: <ul> <li>Refractory Invasive Fungal infections/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.</li> </ul> NOXAFIL Oral Suspension is also indicated for use in the treatment of the following fungal infections in patients 13 years of age or older: <ul> <li>Oropharyngeal candidiasis in patients who have severe disease or who are immunocompromised, including in patients with disease that is refractory to itraconazole and fluconazole. 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.</li> </ul>
Contraindications: CONTRAINDICATIONS: NOXAFIL is contraindicated in patients with known hypersensitivity to NOXAFIL 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 NOXAFIL 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, NOXAFIL may increase the plasma concentrations of ergot alkaloids which may lead to ergotism. Coadministration of NOXAFIL and ergot alkaloids is contraindicated.
Atc Code: J02AC04
Atc Item Name: posaconazole
Pharma Manufacturer Name: MSD PHARMA (SINGAPORE) PTE. LTD.

Active Ingredients

Posaconazole

40mg/ml

POSACONAZOLE

40 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

May 25, 2009

Approval ID

83b1eb6883f97621

Type

Therapeutic

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