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Posaconazole oral suspension
NOXAFIL®
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FDA Approval: |
18 September 2006 |
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Indication: |
Prevention of invasive Aspergillus and Candida infections in
immunosuppressed patients |
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Pharmacology: |
Triazole antifungal agent |
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Usual Dose: |
≥ 13 years: 200mg 3 times a day
with a meal or nutritional supplement |
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Contraindications: |
Hypersensitivity to any ingredient Concomitant ergot alkaloids,
terfenadine, astemizole, cisapride, pimozide, halofantrine,
quinidine |
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Warnings: |
Caution recommended in patients with history of allergy to other
azoles Mild to severe hepatotoxicity has been reported (including
fatalities)
LFTs should be monitored at baseline and during treatment
May increase levels of cyclosporine, tacrolimus, and sirolimus;
blood concentrations should be monitored
May prolong QT interval; caution recommended in patients with
proarrhythmic conditions or who are taking other QT prolonging drugs
Should be avoided during lactation unless potential benefit
outweighs risk
Safety and effectiveness not established in pediatric patients |
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Pregnancy Category: |
C |
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Side Effects: |
Frequency >10%:
Fever, headache, rigors, fatigue, edema, anorexia, dizziness,
weakness, infections
Hypertension, hypotension, tachycardia
Anemia, neutropenia, thrombocytopenia, petechiae, vaginal
hemorrhage,
Diarrhea, nausea, vomiting, abdominal pain, constipation,
mucositis, dyspepsia,
Hypokalemia, hypomagnesemia, hyperglycemia, hypocalcemia,
bilirubinemia
Musculoskeletal pain, arthralgia
Insomnia, anxiety
Cough, dyspnea, epistaxis
Rash, pruritus |
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Drug Interactions: |
Astemizole Calcium channel blockers that are CYP450 3A4 substrates
Cimetidine
Cisapride
Cyclosporine
Ergot alkaloids
Halofantrine
HMG-CoA reductase inhibitors
Midazolam
Phenytoin
Pimozide
Quinidine
Rifabutin
Sirolimus
Tacrolimus
Terfenadine
Vinca alkaloids |
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