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Posatif

Posatif

posaconazole

Manufacturer:

AET Laboratories

Distributor:

Medicell Pharma
Concise Prescribing Info
Contents
Posaconazole
Indications/Uses
Refractory invasive fungal infections (IFI) in patients ≥13 yr & those intolerant w/ IFI; fusariosis, zygomycosis, cryptococcosis, coccidioidomycosis, chromoblastomycosis & mycetoma in patients w/ disease refractory to other therapy or those who are intolerant of other therapy. Prophylaxis of invasive Aspergillus & Candida infections including both yeasts & molds in patients ≥13 yr who are at high risk of developing these infections (eg, those w/ prolonged neutropenia or hematopoietic stem cell transplant recipients).
Dosage/Direction for Use
Refractory IFI or IFI intolerant to 1st line therapy Loading dose: 300 mg bd on 1st day then 300 mg once daily thereafter. Invasive fungal infection prophylaxis Loading dose: 300 mg bd on 1st day then 300 mg once daily thereafter. Patient w/ acute myelogenous leukemia or myelodysplastic syndromes Start prophylaxis w/ posaconazole several days before anticipated onset of neutropenia & continue for 7 days after neutrophil count rises >500 cells per mm3.
Administration
May be taken with or without food: Swallow whole; do not divide/crush/chew.
Contraindications
Hypersensitivity. Increased plasma conc can lead to QT prolongation & rare occurrences of Torsade de Pointes when co-administered w/ CYP3A4 substrates (eg, terfenadine, astemizole, cisapride, pimozide, quinidine). Coadministration w/ HMG-CoA reductase inhibitors can lead to rhabdomyolysis. May increase plasma conc of ergot alkaloids which may lead to ergotism.
Special Precautions
Hypersensitivity to other azoles. Patient w/ potentially proarrhythmic conditions. Not to be administered w/ known QTc interval prolonging drugs & those metabolized through CYP3A4. Monitor & correct K, Mg or Ca levels as necessary before & during therapy. Possible neurotoxicity & other serious adverse reactions including seizures, peripheral neuropathy, SIADH & paralytic ileus when administered concomitantly w/ vincristine. May increase venetoclax toxicity including risk of tumor lysis syndrome & neutropenia. Patients w/ severe GI dysfunction. Closely monitor patients who have severe diarrhoea or vomiting for breakthrough fungal infections. Plasma conc following posaconazole tab administration are generally higher than obtained w/ posaconazole oral susp. Evaluate LFTs at the start & during therapy. Consider discontinuation if clinical signs & symptoms consistent w/ liver disease develop. Severe hepatic impairment. Advise women of childbearing potential to use effective contraceptive measures during treatment & for at least 2 wk after completion. Pregnancy & lactation. Childn <13 yr.
Adverse Reactions
Anemia, febrile neutropenia, thrombocytopenia; abdominal pain, constipation, diarrhea, nausea, vomiting; asthenia, catheter site erythema, chills, mucosal inflammation, peripheral edema, pyrexia; hypokalemia, hypomagnesemia; headache; cough, epistaxis; rash; HTN.
Drug Interactions
Decreased Cmax & AUC by rifabutin, efavirenz, phenytoin; repeat dose administration of fosamprenavir. May increase plasma conc of terfenadine, astemizole, cisapride, pimozole & quinidine, leading to potentially serious or life-threatening adverse events (eg, QT prolongation & rarely Torsade de Pointes). May increase plasma conc of ergot alkaloids which may lead to ergotism. May increase plasma conc of vinca alkaloids which may lead to neurotoxicity & other serious adverse reactions. Carefully monitor cyclosporine blood levels during coadministration & upon discontinuation of posaconazole treatment; adjust dose of cyclosporine as necessary. Increased Cmax & AUC of tacrolimus, sirolimus, rifabutin. Increased exposure of IV midazolam. Increase plasma levels of HIV PIs. Increased Cmax & AUC of simvastatin; increased HMG-CoA reductase inhibitor plasma conc can be associated w/ rhabdomyolysis. Frequently monitor for adverse effects & toxicity related to Ca channel blockers during coadministration w/ posaconazole. May increase plasma conc of digoxin. Increased venetoclax Cmax & AUC0-INF which may increase venetoclax toxicities. Possible decreased glucose conc when glipizide was co-administered w/ posaconazole; monitor glucose conc diabetic patients.
MIMS Class
Antifungals
ATC Classification
J02AC04 - posaconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Posatif gastro-resistant tab 100 mg
Packing/Price
2 × 12's
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