Description
Voriconazole is used to treat serious fungal or yeast infections, such as aspergillosis (fungal infection in the lungs), candidemia (fungal infection in the blood), esophageal candidiasis (candida esophagitis), or other fungal infections (infections in the skin, stomach, kidney, bladder, or wounds). It may also be used to treat patients with serious fungal or yeast infections who cannot tolerate or do not respond to other types of treatment.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Suspension
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of voriconazole in children younger than 2 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of voriconazole in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Alprazolam
- Astemizole
- Atazanavir
- Bepridil
- Carbamazepine
- Cisapride
- Colchicine
- Conivaptan
- Dihydroergotamine
- Dronedarone
- Efavirenz
- Eletriptan
- Eplerenone
- Ergoloid Mesylates
- Ergonovine
- Ergotamine
- Finerenone
- Flibanserin
- Fluconazole
- Gepirone
- Isavuconazonium Sulfate
- Ivabradine
- Levoketoconazole
- Lisuride
- Lomitapide
- Lonafarnib
- Lovastatin
- Lurasidone
- Mavacamten
- Mephobarbital
- Mesoridazine
- Metergoline
- Methylergonovine
- Methysergide
- Naloxegol
- Nicergoline
- Nimodipine
- Nirmatrelvir
- Pacritinib
- Phenobarbital
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acalabrutinib
- Acenocoumarol
- Adagrasib
- Ado-Trastuzumab Emtansine
- Afatinib
- Alectinib
- Alfentanil
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Apalutamide
- Apixaban
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asciminib
- Asenapine
- Atogepant
- Atorvastatin
- Avacopan
- Avanafil
- Avapritinib
- Axitinib
- Azathioprine
- Azithromycin
- Baricitinib
- Bedaquiline
- Belzutifan
- Benzhydrocodone
- Bictegravir
- Boceprevir
- Bosutinib
- Brentuximab Vedotin
- Bretylium
- Brexpiprazole
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amlodipine
- Amprenavir
- Cerivastatin
- Clopidogrel
- Desogestrel
- Dienogest
- Drospirenone
- Esomeprazole
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etravirine
- Fosamprenavir
- Gestodene
- Glipizide
- Glyburide
- Levonorgestrel
- Meloxicam
- Mestranol
- Midazolam
- Nomegestrol
- Norethindrone
- Norgestimate
- Norgestrel
- Tolbutamide
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cancer treatment (eg, chemotherapy), recent or history of or
- Electrolyte imbalance (eg, low potassium, magnesium, calcium) or
- Heart disease, history of or
- Stem cell transplant—Use with caution. These conditions may increase your risk of having serious side effects.
- Galactose intolerance (rare hereditary problem) or
- Glucose-galactose malabsorption (rare hereditary problem) or
- Lapp lactase deficiency (rare hereditary problem) or
- Any condition that makes it hard for you to digest sugars or dairy products—Use with caution. The tablet form of this medicine contains lactose (milk sugar) and the oral liquid contains sucrose (table sugar), which can make these conditions worse.
- Heart rhythm problems (eg, arrhythmia, QT prolongation) or
- Kidney disease or
- Liver disease (including cirrhosis) or
- Pancreas problems—Use with caution. May make these conditions worse.
- Hypocalcemia (low calcium in the blood), uncorrected or
- Hypokalemia (low potassium in the blood), uncorrected or
- Hypomagnesemia (low magnesium in the blood)—Use with caution. These should be corrected first before starting treatment and during treatment with voriconazole.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
It is best to take this medicine at least 1 hour before or 1 hour after a meal.
Shake the oral liquid well before each use. Use the oral dispenser that comes with the package to measure the dose. Rinse the oral dispenser with water after each use.
Do not mix the oral liquid with any other medicine, liquid, or syrup.
Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (suspension or tablets):
- For fungal infections:
- Adults, children 12 to 14 years of age weighing 50 kilograms (kg) or more, and children 15 years of age and older—At first, a loading dose of voriconazole injection is given by your doctor on the first 24 hours of treatment. Then, your doctor may switch you to an oral maintenance dose of 200 milligrams (mg) or 5 milliliters (mL) taken every 12 hours. Your doctor may adjust your dose as needed.
- Adults weighing less than 40 kilograms (kg)—At first, a loading dose of voriconazole injection is given by your doctor on the first 24 hours of treatment. Then, your doctor may switch you to an oral maintenance dose of 100 or 150 milligrams (mg) or 2.5 to 3.75 mL taken every 12 hours. Your doctor may adjust your dose as needed.
- Children 12 to 14 years of age weighing less than 50 kilograms (kg) and children 2 to 11 years of age—Dose is based on body weight and must be determined by your doctor. At first, a loading dose of voriconazole injection is given by your doctor on the first 24 hours of treatment. Then, your doctor may switch you to an oral maintenance dose of 9 milligrams (mg) or 0.225 mL per kg of body weight taken every 12 hours. Your doctor may adjust your dose as needed. However, the dose is usually not more than 350 mg or 8.75 mL every 12 hours.
- Children younger than 2 years of age—Use is not recommended.
- For fungal infections:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not refrigerate or freeze the oral liquid. It should be kept at room temperature and used within 14 days.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests will be needed to check for unwanted effects.
If your or your child's symptoms do not improve, or if they become worse, check with your doctor. You may need to take this medicine for several months before your infection gets better.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
You or your child should not use astemizole (Hismanal®), barbiturates (eg, phenobarbital, Luminal®), carbamazepine (Tegretol®), efavirenz (Sustiva®), ergot medicines (eg, dihydroergotamine, ergotamine, Cafergot®, Ergomar®, Wigraine®), finerenone (Kerendia®), ivabradine (Corlanor®, Procoralan®), lemborexant (Dayvigo®), lurasidone (Latuda®), naloxegol (Movantik®), pimozide (Orap®), quinidine (Quinaglute®), rifabutin (Mycobutin®), rifampin (Rifadin®, Rimactane®), ritonavir (Norvir®), sirolimus (Rapamune®), St. John's wort, terfenadine (Seldane®), tolvaptan (Jynarque®, Samsca®), or venetoclax (Venclexta®). Using any of them together with this medicine may increase the chance of unwanted effects.
This medicine may cause vision problems. Do not drive (especially at night) or do anything else that could be dangerous until you know how this medicine affects you. Call your doctor if you or your child have any vision changes or if bright lights bother your eyes.
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Voriconazole tablets contain lactose (milk sugar) while the oral liquid contains sucrose (table sugar), which can make patients with conditions that make it hard for them to digest sugars or dairy products worse. Talk to your doctor if you or your child have concerns about this.
Contact your doctor right away if you or your child have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem, including QT prolongation.
Voriconazole may increase your or your child's risk of having kidney problems, including acute kidney failure. Check with your doctor right away if you have blood in the urine, decreased urine output, muscle twitching, nausea, rapid weight gain, seizures, decreased awareness or responsiveness, severe sleepiness, swelling of the face, ankles, or hands, or unusual tiredness or weakness.
This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you or your child have black, tarry stools, blistering, peeling, loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, painful or difficult urination, swollen glands. trouble breathing, unusual bleeding, bruising, tiredness, or weakness.
Pancreatitis (swelling of the pancreas) may occur while you or your child are using this medicine. Check with your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
This medicine may make your or your child's skin more sensitive to sunlight when used together with methotrexate (Reditrex®). Use sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
This medicine may cause adrenal gland problems. Check with your doctor right away if you or your child have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
This medicine may cause bone pain when used for a long period of time. Check with your doctor right away if you or your child have bone pain while using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Black, tarry stools
- blistering, peeling, loosening of the skin
- chest pain
- chills
- cough
- diarrhea
- difficulty seeing at night
- fever
- increased sensitivity of the eyes to sunlight
- itching, rash
- joint or muscle pain
- painful or difficult urination
- red irritated eyes
- red skin lesions, often with a purple center
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vision changes
Less common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chapped, red, or swollen lips
- chills
- clay-colored stools
- confusion
- dark urine
- decreased urine
- dizziness
- dry mouth
- faintness or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of warmth
- increased thirst
- irregular or pounding heartbeat
- loss of appetite
- muscle pain or cramps
- muscle spasms or twitching
- nausea
- nervousness
- numbness or tingling in the hands, feet, or lips
- pounding in the ears
- rapid weight gain
- rash with flat lesions or small raised lesions on the skin
- redness of the face, neck, arms, and occasionally, the upper chest
- scaling, redness, burning, pain, or other signs of inflammation of the lips
- seizures
- stomach pain
- slow or fast heartbeat
- sweating
- trembling
- unpleasant breath odor
- vomiting of blood
- yellow eyes or skin
Rare
- Agitation
- blistering, peeling, or loosening of the skin
- hostility or anger
- increased sensitivity of the skin to sunlight
- irritability
- redness or other discoloration of the skin
- seeing things that are not there
- severe sunburn
Incidence not known
- Backache
- blindness
- blue-yellow color blindness
- bone pain
- darkening of the skin
- decreased vision
- diarrhea
- facial hair growth in females
- fainting
- fractures
- full or round face, neck, or trunk
- increased urination
- irritability
- loss of sexual desire or ability
- menstrual irregularities
- mental depression
- muscle wasting
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Headache
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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