Voriconazole-Trima 200 mg

/ Trima

The dosage will be determined depending on the patient weight and the type of infection.
Tablets should only be given if the child is capable of swallowing tablets.
Patients less than 40 kg: 100 mg twice a day (every 12 hours).
Patients 40 kg and above: 200 mg twice a day (every 12 hours).
As there is no score line, do not split the tablet. There is no information
about crushing/chewing.

Treatment of: invasive aspergillosis, candidemia in non-neutropenic patients, fluconazole-resistant serious invasive Candida infections (including C. krusei), serious fungal infections caused by Scedosporium spp. and Fusarium spp.
Voriconazole should be administered primarily to immunocompromised patients with progressive, possibly life-threatening infections.
Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.

Known hypersensitivity to vinorelbine or any other constituent.
Not to take together with: Terfenadine, Estemizole, Cisapride, Pimozide, Quinidine, Rifabutin, Rifampicin, Carbamazepine, Phenobarbital, Mephobarbital, Ergot derivatives (like Ergotamine,  Dihydroergotamine), Sirolimus, Efavirenz, Ritonavir, St. John’s Wort plant.
People who are intolerant to galactose or unable to digest lactose or galactose, since the tablets contain lactose.
Children under 2 years of age.

If you are sensitive to any food or medicine, inform the doctor before taking the medicine.
Liver and kidney function should be monitored by the attending doctor by regularly performing blood tests during treatment with this medicine.
Before starting and throughout treatment, monitoring for electrolyte level disturbances such as hypokalemia, hypomagnesemia, hypocalcemia, should be performed.
Avoid any sun exposure while using the medicine. It is important to cover areas of the body that may be exposed to the sun and to use sunscreen with a high sun protection factor (SPF), as an increased sensitivity of the skin to the sun’s radiation may occur. This warning is also applicable to children.
During use of the medicine, tell the doctor immediately if you get a sunburn, develop a severe rash or blisters, pain in the bones. If you develop one of these skin effects, your doctor may refer you to a dermatologist. There is a small chance of developing skin cancer upon long-term use of Voriconazole-Trima.
See prescribing information for full details.

Serious side effects: Pancreatitis, jaundice and/or change in blood test results for liver function, rash.
Very common (≥1/10): Vision impairment (change in vision including blurred vision, color alterations, increased sensitivity to light, color blindness, eye disorder, halo, night blindness, swinging vision, seeing sparks, aura, reduced visual acuity, blinding brightness, narrowed field of vision, blotches/spots in the field of vision), fever, nausea, vomiting, diarrhea, headache, swelling in the extremities, abdominal pain, difficulty breathing, rash, increased liver enzymes.
Common (1≥10/100): Sinusitis, inflammation of the gums, chills, weakness; low level, including severe, of certain red and/or white blood cells (sometimes accompanied by fever), low level of platelets that help the blood to clot; low blood sugar level, low blood potassium level, low blood sodium level, anxiety, agitation, depression, confusion, sleep difficulties, hallucinations; seizures, tremor or involuntary muscle movement, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, dizziness; bleeding in the eye; heart rhythm problems including very fast/very slow heartbeat, fainting; low blood pressure, inflammation of the veins (which may be associated with the formation of a blood clot); acute breathing difficulties, chest pain, swelling of the face (mouth, lips, around the eyes), fluid retention in the lungs; constipation, indigestion, inflammation of the lips; jaundice, inflammation of the liver (hepatitis) and liver damage, redness of the skin; skin rashes which may lead to severe peeling and blistering of the skin; itchiness; hair loss; back pain; kidney failure, blood in the urine, changes in kidney function tests.
See prescribing information for full details.

Medicines that must not be taken concomitantly with Voriconazole-Trima:
Terfenadine, astemizole, cisapride, pimozide, quinidine, rifabutin, rifampicin, carbamazepine, long-acting barbiturates such as phenobarbital, mephobarbital, ergot derivatives (ergotamine, dihydroergotamine, for treating migraines), sirolimus, efavirenz at a dosage of 400 mg and above once a day, ritonavir at dosages given twice a day of 400 mg and above each time, Hypericum (St. John’s Wort).
Medicines whose administration in combination with Voriconazole-Trima should be avoided and a dosage adjustment is required if given together:
Phenytoin- if you are taking this medicine, the blood level of phenytoin should be monitored.
Ritonavir at a low dosage of 100 mg twice a day – its concomitant use with Voriconazole-Trima should be avoided if possible (at a high dosage of 400 mg or more, twice a day – do not take concomitantly with Voriconazole-Trima).
Medicines whose blood levels rise when taken in combination with Voriconazole-Trima and there may be a need for dosage adjustment:
fluconazole – since the combination elevates voriconazole levels in the blood.
ciclosporin, everolimus, tacrolimus – it is recommended to also monitor their blood levels upon completion of treatment with VoriconazoleTrima, anticoagulants such as coumarins (phenprocoumon, acenocoumarol), warfarin – it is recommended to monitor blood clotting times.
benzodiazepines (sedatives, e.g., midazolam, alprazolam and triazolam).
methadone, oxycodone, hydrocodone – it is recommended to monitor their blood levels.
non-steroidal anti-inflammatory drugs (e.g., ibuprofen and diclofenac).
omeprazole.
oral contraceptives.
short-acting opiates (e.g., alfentanil, fentanyl, sufentanil).
statins such as: atorvastatin, simvastatin, lovastatin.
sulphonylureas such as: tolbutamide, glipizide and glyburide – it is recommended to monitor blood sugar levels.
vinca derivatives such as vincristine, vinblastine (anti-cancer).
HIV protease inhibitors for treating AIDS (e.g., saquinavir, amprenavir, nelfinavir, indinavir).
medicines from the NNRTI family for treating AIDS (e.g., delavirdine, nevirapine).

Do not use this medicine if you are pregnant, unless you received an explicit instruction from the doctor. Women of childbearing age must use effective contraceptives when using the medicine and inform the doctor immediately if they become pregnant during the course of treatment with Voriconazole-Trima.
If you are pregnant or breastfeeding, planning to become pregnant or if you suspect you are pregnant, refer to a doctor before taking the medicine.

Before/after meal: Should be taken one hour before/after a meal.
Driving and use of machinery: Use of the medicine may cause blurred vision or sensitivity to light. If the patient suffer from these effects, he/she  should not drive or operate dangerous machinery or perform activities that require normal vision, until the effect passes. Children should be warned against riding bicycles or playing near the road, and the like.