Voriconazole Oral suspension

What is this medicine?

VORICONAZOLE (vohr ih KON uh zohl) is an antifungal. It stops the growth of some fungus and yeast. This medicine is used to treat many kinds of fungal infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• history of irregular heartbeat

• kidney disease

• liver disease

• an unusual or allergic reaction to voriconazole, other antifungal medicines, foods, dyes or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Shake well before using. Use the oral dispenser that was supplied with this medicine to take your dose. Take this medicine on an empty stomach, at least one hour before or one hour after a meal. Do not take with food. Do not mix the dose with other drinks, flavorings, or medicines before taking. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think your are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• astemizole

• barbiturates like phenobarbital

• carbamazepine

• certain antibiotics like rifabutin, rifampin

• certain medicines for cholesterol like atorvastatin, lovastatin, simvastatin, lomitapide

• certain medicines for the irregular heart beat like dofetilide, dronedarone, quinidine

• cisapride

• efavirenz

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• ibrutinib

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• pimozide

• ranolazine

• ritonavir

• sirolimus

• St. John’s wort

• terfenadine

• thioridizine

• ziprasidone

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS

• birth control pills

• certain medicines for blood pressure like amlodipine, nifedipine

• certain medicines for cancer like vinblastine, vincristine

• certain medicines for diabetes like glipizide, glyburide, tolbutamide

• certain medicines for depression, anxiety, or psychotic disturbances like alprazolam, midazolam, triazolam

• certain medicines for pain like alfentanil, fentanyl, methadone, oxycodone

• certain medicines for stomach problems like omeprazole

• certain medicines that treat or prevent blood clots like warfarin

• medicines that lower your chance of fighting infection like cyclosporine, everolimus, tacrolimus

• NSAIDS, medicines for pain and inflammation, like diclofenac, ibuprofen

• other medicines for fungal infections

• phenytoin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checkups. If you are taking this medicine for a long time you may need blood work. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Some fungal infections need many weeks or months of treatment to cure.

You may have changes in vision, including blurring and/or light sensitivity. Do not drive at night while taking this medicine. If you notice a change in vision avoid potentially hazardous tasks, such as driving or operating machinery. Avoid strong, direct sunlight during this therapy.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or itching, hives, swelling of the lips, mouth, tongue, or throat

• breathing problems

• change in amount or color of urine

• changes in vision

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• fever, chills, or infection

• hallucinations

• pale colored stools

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizures, tremors

• stomach pain

• unusual bleeding or bruising

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• agitation, anxiety, or confusion

• diarrhea

• dry mouth

• headache

• loss of appetite

• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

After this medicine is mixed by your pharmacist, store it at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after 14 days.

Voriconazole Oral tablet

What is this medicine?

VORICONAZOLE (vohr ih KON uh zohl) is an antifungal. It stops the growth of some fungus and yeast. This medicine is used to treat many kinds of fungal infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• history of irregular heartbeat

• kidney disease

• liver disease

• an unusual or allergic reaction to voriconazole, other antifungal medicines, foods, dyes or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least one hour before or one hour after a meal. Do not take with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think your are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• astemizole

• barbiturates like phenobarbital

• carbamazepine

• certain antibiotics like rifabutin, rifampin

• certain medicines for cholesterol like atorvastatin, lovastatin, simvastatin, lomitapide

• certain medicines for irregular heart beat like dofetilide, dronedarone, quinidine

• cisapride

• efavirenz

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• ibrutinib

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• pimozide

• ranolazine

• ritonavir

• sirolimus

• St. John’s wort

• terfenadine

• thioridizine

• ziprasidone

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS

• birth control pills

• certain medicines for blood pressure like amlodipine, nifedipine

• certain medicines for cancer like vinblastine, vincristine

• certain medicines for depression, anxiety, or psychotic disturbances like alprazolam, midazolam, triazolam

• certain medicines for diabetes like glipizide, glyburide, tolbutamide

• certain medicines for pain like alfentanil, fentanyl, methadone, oxycodone

• certain medicines for stomach problems like omeprazole

• certain medicines that treat or prevent blood clots like warfarin

• medicines that lower your chance of fighting infection like cyclosporine, everolimus, tacrolimus

• NSAIDS, medicines for pain and inflammation, like diclofenac, ibuprofen

• other medicines for fungal infections

• phenytoin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checkups. If you are taking this medicine for a long time you may need blood work. Tell your doctor if your symptoms do not improve. Some fungal infections need many weeks or months of treatment to cure.

You may have changes in vision, including blurring and/or light sensitivity. Do not drive at night while taking this medicine. If you notice a change in vision avoid potentially hazardous tasks, such as driving or operating machinery. Avoid strong, direct sunlight during this therapy.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or itching, hives, swelling of the lips, mouth, tongue, or throat

• change in vision

• dark urine

• difficulty breathing

• dizzy, faint

• fast heart rate

• fever, chills, infection

• hallucinations

• less or more urine

• pale colored stools

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizure, tremor

• stomach pain

• unusual bruising or bleeding

• yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• agitation, anxiety, confusion

• diarrhea

• dry mouth

• headache

• loss of appetite

• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

Voriconazole Solution for injection

What is this medicine?

VORICONAZOLE (vohr ih KON uh zohl) is an antifungal medicine. It is used to treat certain kinds of fungal or yeast infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• history of irregular heartbeat

• kidney disease

• liver disease

• an unusual or allergic reaction to voriconazole, other antifungal medicines, foods, dyes or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is usually given by a health care professional in a hospital or clinic setting.

If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• astemizole

• barbiturates like phenobarbital

• carbamazepine

• certain antibiotics like rifabutin, rifampin

• certain medicines for cholesterol like atorvastatin, lovastatin, simvastatin, lomitapide

• certain medicines for irregular heart beat like dofetilide, dronedarone, quinidine

• cisapride

• efavirenz

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• ibrutinib

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• pimozide

• ranolazine

• ritonavir

• sirolimus

• St. John’s wort

• terfenadine

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS

• birth control pills

• certain medicines for blood pressure like amlodipine, nifedipine

• certain medicines for cancer like vinblastine, vincristine

• certain medicines for depression, anxiety, or psychotic disturbances like alprazolam, midazolam, triazolam

• certain medicines for diabetes like glipizide, glyburide, tolbutamide

• certain medicines for pain like alfentanil, fentanyl, methadone, oxycodone

• certain medicines for stomach problems like omeprazole

• certain medicines that treat or prevent blood clots like warfarin

• medicines that lower your chance of fighting infection like cyclosporine, everolimus, tacrolimus

• NSAIDS, medicines for pain and inflammation, like diclofenac, ibuprofen

• other medicines for fungal infections

• phenytoin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You will need blood work done while you are taking this medicine. Some fungal infections need many weeks or months of treatment to cure.

You may have changes in vision, including blurring and/or light sensitivity. Do not drive at night while taking this medicine. If you notice a change in vision avoid potentially hazardous tasks, such as driving or operating machinery. Avoid strong, direct sunlight during this therapy.

Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or itching, hives, swelling of the lips, mouth, tongue, or throat

• breathing problems

• change in amount or color of urine

• changes in vision

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• fever, chills, or infection

• hallucinations

• pale colored stools

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• seizures, tremors

• stomach pain

• unusual bleeding or bruising

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• agitation, anxiety, or confusion

• diarrhea

• dry mouth

• headache

• loss of appetite

• nausea, vomiting

• pain at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

If you are using this medicine at home, you will be instructed on how to store this medicine. Do not use if the solution is discolored or if it has any solids in it. Throw away any unused medicine after the expiration date on the label.