Noxafil Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Posaconazole

Indications/Uses

Invasive aspergillosis in patients w/ disease refractory to amphotericin B, itraconazole or intolerant to these drugs. Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis & mycetoma in patients w/ disease refractory to other therapy or intolerant to other therapy. Prophylaxis of invasive fungal infections (IFI) in patients receiving remission-induction chemotherapy for AML or myelodysplastic syndrome (MDS); haematopoietic stem cell transplant (HSCT) recipients undergoing high-dose immunosuppressive therapy for graft versus host disease. Oral susp: Oropharyngeal candidiasis in immunocompromised adults.

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Dosage/Direction for Use

MR tab Refractory IFI/intolerant patient w/ IFI & prophylaxis of IFI Loading dose: 300 mg bd on 1st day then 300 mg once daily thereafter. Duration of therapy: AML/MDS Start prophylaxis several days before anticipated onset of neutropenia & continue for 7 days after neutrophil count rises >500 cells/mm³. Oral susp Refractory IFI/intolerant patient w/ IFI 400 mg bd, administer as 200 mg qds in patient w/ limited oral intake. Oropharyngeal candidiasis in HIV-infected patient Loading dose: 200 mg once daily on 1st day then 100 mg once daily for 13 days. Oropharyngeal candidiasis refractory to itraconazole or fluconazole in HIV-infected patient 400 mg bd. Prophylaxis of IFI 200 mg tds.

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Overdosage

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Administration

MR tab: May be taken with or without food: Swallow whole, do not divide/crush/chew. Oral susp: Should be taken with food: Take w/ a full meal or w/ a nutritional supplement in patients who cannot eat a full meal.

Contraindications

Hypersensitivity. Co-administration w/ ergot alkaloids, HMG-CoA reductase inhibitors, terfenadine, astemizole, cisapride, pimozide, quinidine.

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Special Precautions

Hypersensitivity to other azoles. Pro-arrhythmic conditions eg, congenital or acquired QTc prolongation, cardiomyopathy, sinus bradycardia, existing symptomatic arrhythmias. Monitor & correct electrolyte disturbances prior to & during therapy. Not to be administered w/ CYP3A4 substrates & drugs prolonging QTc interval. Concomitant use w/ vincristine, venetoclax & adrenal steroid hormones. Severe hepatic & renal impairment. Women of childbearing potential must use effective contraceptive during & for at least 2 wk after therapy. Not to be used during pregnancy & lactation. Not recommended in childn & adolescents <18 yr. MR tab: Not for oropharyngeal candidiasis.

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Use In Pregnancy & Lactation

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Adverse Reactions

Neutropenia; anorexia, electrolyte imbalance; paresthesia, dizziness, somnolence, headache; vomiting, nausea, abdominal pain, diarrhoea, dyspepsia, dry mouth, flatulence; elevated LFTs; rash; pyrexia, asthenia, fatigue.

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Drug Interactions

Decreased C_max & AUC by rifabutin, phenytoin, cimetidine, efavirenz, fosamprenavir. Increased plasma conc of terfenadine, astemizole, cisapride, pimozide, quinidine, vinca alkaloids (eg, vincristine & vinblastine), digoxin, HIV PIs. Ergotism w/ ergot alkaloids eg, ergotamine, dihydroergotamine. Elevated cyclosporine levels. Increased C_max & AUC of tacrolimus, sirolimus, rifabutin, midazolam, simvastatin, HIV PIs (eg, atazanavir). Decreased glucose conc w/ sulfonylureas. Increased venetoclax toxicities. Monitor for adverse effects & toxicity related to Ca-channel blockers.

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Storage

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Description

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Action

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MIMS Class

Antifungals

ATC Classification

J02AC04 - posaconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.

Regulatory Classification

Presentation/Packing

Form

Noxafil MR tab 100 mg

Packing/Price

24's;96's

Form

Noxafil oral susp 40 mg/mL

Packing/Price

(cherry flavour) 105 mL x 1's

Noxafil

posaconazole

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma