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Voriconazole (Systemic)


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Voriconazole (Systemic)

US Brand Names

• VFEND

Description

Voriconazole ((vohr-ih-KON-uh-zohl)) is used to treat different kinds of serious fungal infections. It may also be used to treat patients with serious fungal infections who cannot tolerate other types of treatment or do not respond to other types of treatment.

This medicine is available only with your doctor's prescription, in the following dosage forms:

    Oral

    • Oral suspension (U.S.)

    • Tablets (U.S.)

    Parenteral

    • Injection (U.S.)

Special Considerations

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 voriconazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to voriconazole or other azole antifungal (e.g., fluconazole [Diflucan], itraconazole [Sporanox], ketoconazole [Nizoral]). Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy

Voriconazole has been shown to cause fetal harm. Women should use effective contraception during treatment with voriconazole. However, this medicine may be needed in serious diseases or other situations that threaten the mother's life. Before taking this medicine, be sure your doctor knows if you are pregnant or plan to become pregnant.

Breast-feeding

It is not known whether voriconazole passes into breast milk. Voriconazole should not be used by nursing mothers unless the benefit outweighs the risk.

Children

Studies on this medicine have been done only in patients 12 and older, and there is no specific information comparing the use of voriconazole in children with use in other age groups.

Older adults

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Voriconazole is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines

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 voriconazole, it is especially important that your doctor and pharmacist know if you are taking any of the following:

    • Alprazolam (e.g., Xanax) or

    • Midazolam (e.g., Versed) or

    • Triazolam (e.g., Halcion)- Voriconazole may increase the amount of these medicines in your body. Taking these medicines at the same time as voriconazole is not recommended.

    • Amprenavir (e.g., Agenerase) or

    • Nelfinavir (e.g., Viracept) or

    • Saquinavir (e.g., Invirase)-Taking these medicines together with voriconazole can increase blood levels of either these medicines or of voriconazole.

    • Astemizole (e.g., Hismanal) or

    • Cisapride or

    • Pimozide (e.g., Orap) or

    • Quinidine or

    • Terfenadine-Voriconazole may cause these drugs to remain in your body longer, which can lead to heart problems. Taking these medicines at the same time as voriconazole is not recommended.

    • Barbiturates, long acting or

    • Carbamazepine (e.g., Tegretol)-These medicines may decrease the amount of voriconazole in your body. Taking these medicines at the same time as voriconazole is not recommended.

    • Calcium channel blockers (medicine for high blood pressure) such as:

    • Felodipine (e.g., Plendil)-Using these medicines together with voriconazole can increase blood levels of these medicines. Your doctor may want to change the dose of your medicine.

    • Cyclosporine or

    • Tacrolimus (e.g., Prograf)-Using these medicines together with voriconazole can increase blood levels of these medicines.

    • Efavirenz (e.g., Sustiva)-Taking this medicine with voriconazole is not recommended.

    • Ergot alkaloids (e.g., Belladonna, Phenobarbital, Ergotomine tartrate)-Voriconazole may increase the blood levels of these medicines. Taking these medicines at the same time as voriconazole is not recommended.

    • HMG CoA reductase inhibitors ("statins"), such as:

    • Lovastatin (e.g., Mevacor)-Using these medicines with voriconazole may increase blood levels of the "statin" and increase your chance of side effects. Your doctor may change the amount of "statin" that you take.

    • Rifabutin-Using this medicine with voriconazole may increase blood levels of rifabutin and decrease blood levels of voriconazole. Taking this medicine at the same time as voriconazole is not recommended.

    • Rifampin-Using this medicine with voriconazole may decrease blood levels of voriconazole. Taking this medicine at the same time as voriconazole is not recommended.

    • Ritonavir (e.g., Norvir)-Using this medicine with voriconazole may decrease blood levels of voriconazole. Taking this medicine at the same time as voriconazole is not recommended.

    • Sirolimus (e.g., Rapamune)-Using this medicine with voriconazole may increase blood levels of sirolimus. Taking this medicine at the same time as voriconazole is not recommended.

    • Warfarin (e.g., Coumadin)-Taking this medicine with voriconazole may increase your bleeding time. The dose of warfarin may need to be adjusted.

Other medical problems

The presence of other medical problems may affect the use of voriconazole. Make sure you tell your doctor if you have any other medical problems, especially:

    • Hypersensitivity to voriconazole, other azole antifungal agents, or any of the ingredients in voriconazole.

Administration

Dosing

The dose of voriconazole will be different for different patients. The dose that is used may depend on a number of things, including how many doses you have already received and how well you tolerate the dose. The injection form of voriconazole may be given by a doctor or nurse in the hospital or clinic. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of voriconazole. If your dose is different, do not change it unless your doctor tells you to do so. Your doctor may need to change your dose if blood levels of voriconazole are too high or too low.

For the oral suspension, shake well before measuring the dose. Use the oral dispenser supplied with your medicine to measure the dose.

The number of tablets that you take, amount of oral suspension, or the strength of solution you get 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 taking voriconazole.

    • For oral dosage forms (oral suspension or tablets):

      o For serious fungal infections:

        Adults-Your dose will be determined based on your weight and other medicines you are taking. Check with your doctor for more dosage information. Oral suspension or tablets should be taken 1 hour before or after a meal.

        Children-Safety and effectiveness have not been established in children less than 12 years of age. For children over 12 years of age, use and dose will be determined by your doctor.

    • For injection dosage form:

      o For serious fungal infections:

        Adults-Your dose will be determined based on your weight and other medicines you are taking. The dose should be infused over 1 to 2 hours. Check with your doctor for more dosage information.

        Children-Safety and effectiveness have not been established in children less than 12 years of age. For children over 12 years of age, use and dose will be determined by your doctor.

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

To store this medicine:

    • Keep out of the reach of children.

    • Keep the medicine from freezing. Do not refrigerate.

    • Throw away any unused oral suspension after the date listed on the label.

    • Do not keep outdated medicine or medicine longer than needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions

It is very important that your doctor check you at regular visits to see if the medicine is working properly and decide if you should continue to take it.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. Your doctor will discuss with you any changes in your medicine. Ask your doctor if you have any questions.

This medicine may cause some people to have changes in vision, such as blurred vision and seeing bright spots or wavy lines. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you have vision changes .

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

Rash.

Less common

Abdominal or stomach pain; bloating or swelling of face, arms, hands, lower legs, or feet; blurred vision; chills; clay-colored stools; confusion; convulsions; dark urine; decreased urine; dizziness; dry mouth; faintness or light-headedness when getting up from a lying or sitting position; fever; headache; increased thirst; irregular or pounding heartbeat; itching; loss of appetite; mood or mental changes; muscle pain or cramps; muscle spasms or twitching; nausea; nervousness; numbness or tingling in hands, feet, or lips; pounding in the ears; rapid weight gain; rash with flat lesions or small raised lesions on the skin; shortness of breath; slow or fast heartbeat; suddenly sweating; trembling; unpleasant breath odor; unusual tiredness or weakness; vomiting of blood; vasodilation (flushing); yellow eyes or skin.

Rare

Abnormal kidney function; black, bloody, or tarry stools; bleeding gums; blood in eye; blood in urine or stools; chest pain; eye pain; painful or difficult urination; pale skin; pinpoint red spots on skin; redness in whites of eyes; sores, ulcers, or white spots on lips or in mouth; sore throat; sudden kidney failure; swollen glands; trouble breathing with activity; unusual bleeding or bruising.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

More Common

Changes in vision; seeing things that are not there.

Less common

Diarrhea; difficulty seeing at night; disturbance in vision; dry mouth; feeling unusually cold; increased sensitivity of eyes to sunlight; shivering; vomiting.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

June 23, 2004

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