PATIENT INFORMATION
(voriconazole)
tablets, for oral use
(voriconazole)
for oral suspension |
Read the Patient Information that comes with voriconazole before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your condition or treatment. |
What is voriconazole?
Voriconazole is a prescription medicine used to treat certain serious fungal infections in your blood and body. These infections are called "aspergillosis," "esophageal candidiasis," "Scedosporium," "Fusarium," and "candidemia".
It is not known if voriconazole is safe and effective in children younger than 2 years old.
|
Do not take Voriconazole if you: - •
- are allergic to voriconazole or any of the ingredients in voriconazole. See the end of this leaflet for a complete list of ingredients in voriconazole.
- •
- are taking any of the following medicines:
|
| - o
- pimozide
- o
- rifampin
- o
- efavirenz
- o
- ergotamine, dihydroergotamine (ergot alkaloids)
- o
- tolvaptan
- o
- venetoclax
| - o
- quinidine
- o
- carbamazepine
- o
- ritonavir
- o
- St. John's Wort (herbal supplement)
- o
- lurasidone
| - o
- sirolimus
- o
- long-acting barbiturates like phenobarbital
- o
- rifabutin
- o
- naloxegol
- o
- ivabradine
|
Ask your healthcare provider or pharmacist if you are not sure if you are taking any of the medicines listed above.
Do not start taking a new medicine without talking to your healthcare provider or pharmacist. |
Before you take voriconazole, tell your healthcare provider about all of your medical conditions, including if you: - •
- have or ever had heart disease, or an abnormal heart rate or rhythm. Your healthcare provider may order a test to check your heart (EKG) before starting voriconazole.
- •
- have low potassium levels, low magnesium levels, and low calcium levels. Your healthcare provider may do blood tests before starting and during treatment with voriconazole.
- •
- have liver or kidney problems. Your healthcare provider may do blood tests to make sure you can take voriconazole.
- •
- have trouble digesting dairy products, lactose (milk sugar), or regular table sugar. Voriconazole tablets contain lactose. Voriconazole oral suspension contains sucrose (table sugar).
- •
- are pregnant or plan to become pregnant. Voriconazole can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant. Women who can become pregnant should use effective birth control while taking voriconazole. Talk to your healthcare provider about birth control methods that may be right for you.
- •
- are breastfeeding or plan to breastfeed. It is not known if voriconazole passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take voriconazole.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Voriconazole may affect the way other medicines work, and other medicines may affect how voriconazole works.
Know what medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. |
How should I take voriconazole? - •
- Voriconazole may be prescribed to you as:
- o
- voriconazole tablets or
- o
- voriconazole oral suspension
- •
- Take voriconazole tablets or oral suspension exactly as your healthcare provider tells you to.
- •
- Take voriconazole tablets or oral suspension at least 1 hour before or at least 1 hour after meals.
- •
- Voriconazole oral suspension will be mixed for you by your pharmacist. Shake the bottle of voriconazole oral suspension for 10 seconds each time before you use it.
- •
- Only use the oral dispenser that comes with your voriconazole oral suspension to administer your medicine.
- •
- Do not mix voriconazole oral suspension with any other medicine, flavored liquid, or syrup.
- •
- If you take too much voriconazole, call your healthcare provider or go to the nearest hospital emergency room.
|
What should I avoid while taking voriconazole? - •
- You should not drive at night while taking voriconazole. Voriconazole can cause changes in your vision such as blurring or sensitivity to light.
- •
- Do not drive or operate machinery, or do other dangerous activities until you know how voriconazole affects you.
- •
- Avoid direct sunlight. Voriconazole can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your healthcare provider if you get sunburn.
|
What are the possible side effects of voriconazole?
Voriconazole may cause serious side effects including: - •
- liver problems. Symptoms of liver problems may include:
|
| - o
- itchy skin
- o
- flu-like symptoms
| - o
- yellowing of your eyes
- o
- nausea or vomiting
| - o
- feeling very tired
|
- •
- serious heart problems. Voriconazole may cause changes in your heart rate or rhythm, including your heart stopping (cardiac arrest).
- •
- allergic reactions. Symptoms of an allergic reaction may include:
|
| - o
- fever
- o
- chest tightness
- o
- nausea
- o
- flushing
| - o
- sweating
- o
- trouble breathing
- o
- itching
| - o
- feels like your heart is beating fast (tachycardia)
- o
- feel faint
- o
- skin rash
|
- •
- vision changes. Symptoms of vision changes may include:
- o
- blurred vision
- o
- changes in the way you see colors
- •
- serious skin reactions. Symptoms of serious skin reactions may include:
- o
- rash or hives
- o
- mouth sores
- o
- blistering or peeling of your skin
- o
- trouble swallowing or breathing
- •
- sensitivity to light or sun (photosensitivity). Voriconazole can cause serious photosensitivity. There is an increased chance of skin toxicity while taking Voriconazole. This can happen with or without taking other medicines like methotrexate. Photosensitivity reactions may also increase your risk of:
- o
- faster skin aging from the sun
- o
- skin cancer
Call your healthcare provider right away if you get a new skin rash or your skin rash gets worse. |
- •
- kidney problems. Voriconazole may cause new or worse problems with kidney function, including kidney failure. Your healthcare provider should check your kidney function while you are taking voriconazole. Your healthcare provider will decide if you can keep taking voriconazole.
|
- •
- adrenal gland problems
- o
- Voriconazole may cause reduced adrenal function (adrenal insufficiency).
- o
- Voriconazole may cause overactive adrenal function (Cushing's syndrome) when voriconazole is used at the same time with corticosteroids.
|
| Symptoms of adrenal insufficiency include: |
| - o
- feeling tired
- o
- nausea and vomiting
- o
- abdominal pain
| - o
- lack of energy
- o
- feeling dizzy or lightheaded
| - o
- weakness
- o
- weight loss
|
| Symptoms of Cushing's syndrome include: |
| - o
- weight gain
- o
- thinning skin
- o
- excessive hair growth
| - o
- fatty hump between the shoulders (buffalo hump) and a rounded face (moon face)
- o
- bruising easily
- o
- excessive sweating
| - o
- darkening of the skin on the stomach, thighs, breasts, and arms
- o
- high blood sugar
|
- •
- inflammation of the pancreas (pancreatitis). Symptoms of pancreatitis may include pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back. The pain may happen with or without vomiting.
- •
- bone problems. Voriconazole may cause weakening of bones and bone pain. Tell your healthcare provider if you have bone pain.
Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the symptoms listed above.
The most common side effects of voriconazole in adults include: |
| - o
- vision changes
- o
- nausea
- o
- hallucinations (seeing or hearing things that are not there)
| - o
- rash
- o
- headache
- o
- abnormal liver function tests
- o
- chills
| - o
- vomiting
- o
- fast heart beat (tachycardia)
- o
- fever
|
The most common side effects of voriconazole in children include: |
| - o
- fever
- o
- diarrhea
- o
- low platelet counts
- o
- abnormal liver function tests
- o
- low blood calcium levels
- o
- low blood phosphate levels
- o
- vision changes
- o
- rash
- o
- stomach pain
- o
- trouble breathing
- o
- dizziness
| - o
- high blood pressure
- o
- cough
- o
- low blood pressure
- o
- swelling in the arms and legs
- o
- high blood sugar levels
- o
- headache
- o
- fast heart beat (tachycardia)
- o
- nose bleeds
- o
- low blood potassium levels
- o
- low blood levels of albumin
- o
- kidney problems
| - o
- inflammation of mucous membranes
- o
- hallucinations (seeing or hearing things that are not there)
- o
- coughing up blood
- o
- constipation
- o
- low blood magnesium levels
- o
- fullness of the stomach area
- o
- vomiting
- o
- nausea
- o
- upper respiratory tract infection
|
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of voriconazole.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store voriconazole? - •
- Store voriconazole tablets and oral suspension at room temperature between 59°F to 86°F (15°C to 30°C). Do not refrigerate or freeze.
- •
- Voriconazole oral suspension should be thrown away (discarded) after 14 days.
- •
- Keep voriconazole tablets and oral suspension in a tightly closed container.
- •
- Safely throw away medicine that is out of date or no longer needed.
- •
- Keep voriconazole, as well as all other medicines, out of the reach of children.
|
General information about the safe and effective use of voriconazole.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use voriconazole for a condition for which it was not prescribed. Do not give voriconazole to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about voriconazole that is written for health professionals. |
What are the ingredients in voriconazole?
Active ingredient: voriconazole.
Inactive ingredients:
Voriconazole tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin.
Voriconazole oral suspension: anhydrous citric acid, colloidal silicon dioxide, natural orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum. 
For more information, go to www.greenstonellc.com or call 1-877-446-3679.
|