Voraiz

Voraiz

voriconazole

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Voriconazole
Indications/Uses
Invasive aspergillosis. Candidemia in non-neutropenic patients & serious invasive Candida infections (including C. krusei). Esophageal candidiasis. Serious fungal infections caused by Scedosporium spp. & Fusarium spp. Other serious fungal infections in patients intolerant of, or refractory to, other therapy. Prevention of breakthrough of fungal infections in febrile high-risk patients (allogeneic bone marrow transplants, relapsed leukemia patients). Prophylaxis in patients who are at high risk of developing invasive fungal infections eg, haematopoietic stem cell transplant (HSCT) recipients.
Dosage/Direction for Use
Adult & childn ≥12 yr Invasive aspergillosis Loading dose: ≥40 kg 400 mg every 12 hr for 1 day, <40 kg 200 mg every 12 hr for 1 hr. Maintenance dose: ≥40 kg 200 mg every 12 hr, <40 kg 100 mg every 12 hr. Continue treatment for at least 6-12 wk or throughout period of immunosuppression. Candidemia in non-neutropenic patients & serious invasive Candida infections Loading dose: ≥40 kg 400 mg every 12 hr for 1 day, <40 kg 200 mg every 12 hr for 1 day. Maintenance dose: ≥40 kg 200 mg every 12 hr, <40 kg 100 mg every 12 hr. Continue treatment at least 14 days following resolution of symptoms or following last positive culture, whichever is longer. Serious fungal infections caused by Scedosporium spp. & Fusarium spp. Loading dose: ≥40 kg 400 mg every 12 hr for 1 day, <40 kg 200 mg every 12 hr for 1 day. Maintenance dose: ≥40 kg 200 mg every 12 hr, <40 kg 100 mg every 12 hr. Total duration of therapy should be based on severity of the patients' underlying disease, recovery from immunosuppression, response to the drug. Other serious fungal infections in patients intolerant of, or refractory to, other therapy; prevention of breakthrough of fungal infections in febrile high-risk patients (allogeneic bone marrow transplants, relapsed leukemia patients); prophylaxis in patients who are at high risk of developing invasive fungal infections eg, haematopoietic stem cell transplant (HSCT) recipients Loading dose: ≥40 kg 400 mg every 12 hr for 1 day, <40 kg 200 mg every 12 hr for 1 day. Maintenance dose: ≥40 kg 200 mg every 12 hr, <40 kg 100 mg every 12 hr. Esophageal candidiasis ≥40 kg 200 mg every 12 hr for at least 14 days & for at least 7 days after symptoms resolve, <40 kg 100 mg every 12 hr for at least 14 days & for at least 7 days after symptoms resolve. Dosage adjustment: Patients weighing ≥40 kg Maintenance dose may be increased from 200 mg every 12 hr to 300 mg every 12 hr, depending on condition. Patients unable to tolerate 300 mg every 12 hr Reduce maintenance dose by 50 mg steps to a min 200 mg every 12 hr. Patients weighing <40 kg Maintenance dose may be increased from 100 mg every 12 hr to 150 mg every 12 hr. Patients unable to tolerate 150 mg every 12 hr Reduce maintenance dose by 50 mg steps to min 100 mg every 12 hr. Childn 2 to <12 yr Maintenance dose: 9 mg/kg every 12 hr. Max: 350 mg every 12 hr.
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 1 hr after meals.
Contraindications
Hypersensitivity. Concomitant use w/ carbamazepine, CYP3A4 substrates (eg, terfenadine, astemizole, cisapride, pimozide, quinidine), efavirenz (≥400 mg/day), ergot alkaloids (eg, ergotamine, dihydroergotamine), long acting barbiturates (eg, phenobarb, mephobarbital), rifabutin, rifampin, sirolimus, St John's Wort; high dose ritonavir (800 mg/day) & low dose ritonavir (200 mg/day).
Special Precautions
Hypersensitivity to other azoles. Monitor for the development of more severe hepatic injury using appropriate laboratory evaluations (particularly liver function tests & bilirubin); discontinue if consistent signs & symptoms of liver disease develop. Monitor visual function (visual acuity & field & color perception) if duration of therapy exceeds 28 days. Patients w/ potentially proarrhythmic conditions. Correct electrolyte imbalances (ie, K, Mg, Ca) prior to initiation of therapy. Discontinue if exfoliative cutaneous reaction occurs & if skin lesion consistent w/ squamous cell carcinoma or melanoma; skeletal pain & radiologic findings compatible w/ fluorosis or periostitis develops. Avoid intense or prolonged exposure to direct sunlight. Severely ill patients w/ other factors predisposing to impaired renal function (eg, underlying conditions, concomitant nephrotoxic drugs). Avoid potentially hazardous task eg, driving or operating machinery. Pregnancy & lactation.
Adverse Reactions
Tachycardia, peripheral oedema; chills, hallucinations, headache; skin rash; hypokalemia; nausea, vomiting, diarrhea, abdominal pain; cholestatic jaundice, increased serum alkaline phosphatase, serum ALT & serum AST, abnormalities in liver function test results; visual disturbances, photophobia; increased serum creatinine, acute renal failure; fever.
Drug Interactions
May increase levels/effects of ado-trastuzumab emtansine, alfuzosin, aprepitant, astemizole, asunaprevir, avanafil, axitinib, barnidipine, bionanserin, bosutinib, bromocriptine, budesonide (systemic), ceritinib, cisapride, cobimetinib, conivaptan, crizotinib, dabrafenib, dapoxetin, domperidone, dronedarone, eletriptan, eplerenone, ergoloid mesylate, ergonovine, ergotamine, everolimus, flibanserin, halofantrine, ibrutinib, irinotecan product, isavuconazonium sulfate, ivabradine, lapatinib, lercanidipine, lomitapide, lovastatin, lurasidone, macitentan, methylergonovine, naloxegol, nilotinib, nimodipine, nisoldipine, olaparib, albociclib, pimozide, quinidine, ranolazine, red yeast rice, regorafenib, rifamycin derivatives, salmeterol, silodosin, simeprevir, simvastatin, sirolimus, sonidegib, suvorexant, tamsulosin, terfenadine, ticagrelor, tolvaptan, toremifene, ulipristal, vemurafenib, vincristine (liposomal), vorapaxar, trabectedin. May increase levels/effects by atazanavir, fluconazole. May decrease levels/effects of atazanavir, ticagrelor. May decrease levels/effects by atazanavir, barbiturates, carbamazepine, lopinavir, lumacaftor, rifamycin derivatives, ritonavir, St. John's wort.
MIMS Class
ATC Classification
J02AC03 - voriconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Voraiz tab 200 mg
Packing/Price
3 × 10's
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