Voratex

Voratex

voriconazole

Manufacturer:

Pharmathen

Distributor:

SB Pharma
Concise Prescribing Info
Contents
Voriconazole
Indications/Uses
Treatment of fungal infections in adults & childn >2 yr: Invasive aspergillosis; candidaemia in non-neutropenic patients; serious invasive Candida sp infections when the fungus is resistant to fluconazole; serious fungal infections caused by Scedosporium sp or Fusarium sp. Intended for patients w/ worsening, possibly life-threatening, fungal infections. Prevention of fungal infections in high risk bone marrow transplant recipients.
Dosage/Direction for Use
Adult (including the elderly) weighing ≥40 kg Loading dose: 400 mg every 12 hr for the 1st 24 hr. Maintenance: 200 mg bd, weighing <40 kg Loading dose: 200 mg every 12 hr for the 1st 24 hr. Maintenance: 100 mg bd. Depending on the response, may increase daily dose to 300 mg bd. Adolescent 12-14 yr weighing ≥50 kg & adolescent >14 yr Loading dose: 400 mg every 12 hr for the 1st 24 hr. Maintenance: 200 mg bd. Childn 2 to <12 yr & adolescent 12-14 yr weighing <50 kg Loading dose: Start treatment w/ an infusion. Maintenance: 9 mg/kg bd. Max: 350 mg bd.
Administration
Should be taken on an empty stomach: Take at least 1 hr before, or 1 hr after a meal. Swallow whole w/ water.
Contraindications
Hypersensitivity. Concomitant use w/ terfenadine, astemizole, cisapride, pimozide, quinidine, ivabradine, rifampicin, efavirenz ≥400 mg once daily, carbamazepine, phenobarb, ergot alkaloids, sirolimus, ritonavir ≥400 mg bd, St. John's wort, naloxegol, tolvaptan, lurasidone, venetoclax.
Special Precautions
Patients w/ allergic reaction to other azoles; history or current liver disease; cardiomyopathy, irregular heartbeat, slow heart rate or long QTc syndrome; intolerance to some sugars. Avoid any sunlight & sun exposure while on therapy. Risk of skin cancer w/ long-term use of Voratex; adrenal insufficiency; Cushing's syndrome. Monitor liver & kidney function during treatment. Do not drive or operate any tools or machines in case of blurred vision or uncomfortable sensitivity to light. Effective contraception must be used in women of childbearing potential. Must not be taken during pregnancy. Should not be given to childn <2 yr.
Adverse Reactions
Visual impairment; fever; rash; nausea, vomiting, diarrhoea; headache; swelling of the extremities; stomach pains; breathing difficulties; elevated liver enzymes. Inflammation of the sinuses, inflammation of the gums, chills, weakness; low RBCs/WBC/platelets; low blood sugar, K, Na; anxiety, depression, confusion, agitation, inability to sleep, hallucinations; seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, dizziness; bleeding in the eye; heart rhythm problems; low BP, inflammation of a vein; acute breathing difficulty, chest pain, swelling of the face (mouth, lips & around eyes), fluid accumulation in the lungs; constipation, indigestion, inflammation of the lips; jaundice, inflammation of the liver & liver injury; skin rashes which may lead to severe blistering and peeling of the skin characterized by a flat, red area on the skin that is covered w/ small confluent bumps, redness of the skin; itchiness; hair loss; back pain; kidney failure, blood in the urine, changes in kidney function tests.
Drug Interactions
Avoid ritonavir & glasdegib if possible. Avoid or adjust dose if concomitantly taking rifabutin or phenytoin. Dose adjustment or monitoring may be required w/ warfarin & other anticoagulants (eg, phenprocoumon, acenocoumarol); ciclosporin; tacrolimus; sulfonylureas (eg, tolbutamide, glipizide, glyburide); statins (eg, atorvastatin, simvastatin); benzodiazepines (eg, midazolam, triazolam); omeprazole; OCs; vinca alkaloids (eg, vincristine, vinblastine); tyrosine kinase inhibitors (eg, axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib); tretinoin; indinavir & other HIV PIs; NNRTIs (eg, efavirenz, delavirdine, nevirapine); methadone; alfentanil, fentanyl & other short-acting opiates eg, sufentanil; oxycodone & other long-acting opiates eg, hydrocodone; NSAIDs (eg, ibuprofen, diclofenac); fluconazole; everolimus; letermovir; ivacaftor.
MIMS Class
Antifungals
ATC Classification
J02AC03 - voriconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Voratex tab 200 mg
Packing/Price
14's
Form
Voratex tab 50 mg
Packing/Price
14's
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