Fluconazole

WHY is this medicine prescribed?

Fluconazole is used to treat fungal infections, including yeast infections of the vagina, mouth, throat, esophagus (tube leading from the mouth to the stomach), abdomen (area between the chest and waist), lungs, blood, and other organs. Fluconazole is also used to treat meningitis (infection of the membranes covering the brain and spine) caused by fungus. Fluconazole is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before a bone marrow transplant (replacement of unhealthy spongy tissue inside the bones with healthy tissue). Fluconazole is in a class of antifungals called triazoles. It works by slowing the growth of fungi that cause infection.

Are there OTHER USES for this medicine?

Fluconazole is also sometimes used to treat serious fungal infections that begin in the lungs and can spread through the body and fungal infections of the eye, skin and nails. Fluconazole is also sometimes used to prevent fungal infections in people who are likely to become infected because they have human immunodeficiency virus (HIV) or cancer or have had a transplant operation (surgery to remove an organ and replace it with a donor or artificial organ). Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Fluconazole comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken once a day, with or without food. You may need to take only one dose of fluconazole, or you may need to take fluconazole for several weeks or longer. The length of your treatment depends on your condition and on how well you respond to fluconazole. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fluconazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may tell you to take a double dose of fluconazole on the first day of your treatment. Follow these directions carefully.

Shake the liquid well before each use to mix the medication evenly.

You should begin to feel better during the first few days of treatment with fluconazole. If your symptoms do not improve or get worse, call your doctor.

Continue to take fluconazole until your doctor tells you that you should stop, even if you feel better. Do not stop taking fluconazole without talking to your doctor. If you stop taking fluconazole too soon, your infection may come back after a short time.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking fluconazole,

• tell your doctor and pharmacist if you are allergic to fluconazole, other antifungal medications such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), or voriconazole (Vfend), any other medications, or any of the ingredients in fluconazole tablets or suspension. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you are taking astemizole (Hismanal) (not available in the US), cisapride (Propulsid) (not available in the US), erythromycin (E.E.S., E-Mycin, Erythrocin); pimozide (Orap), quinidine (Quinidex), or terfenadine (Seldane) (not available in the US). Your doctor will probably tell you not to take fluconazole if you are taking any of these medications.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking, or plan to take. Also you should tell your doctor you have taken fluconazole before starting to take any new medications within 7 days of receiving fluconazole. Be sure to mention any of the following: amitriptyline; amphotericin B (Abelcet, AmBisome); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); calcium channel blockers such as amlodipine (Norvasc, in Caduet, in Lotrel, others), felodipine , isradipine , and nifedipine (Adalat, Afeditab, Procardia); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol); celecoxib (Celebrex, in Consensi); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet), fluvastatin (Lescol), and simvastatin (Zocor, in Vytorin); cyclophosphamide; cyclosporine (Gengraf, Neoral, Sandimmune); diuretics ('water pills') such as hydrochlorothiazide ( Microzide, in Diovan HCT, in Tribenzor, others ); fentanyl (Actiq, Duragesic, Fentora, Sublimaze, Subsys, others); isoniazid (Laniazid, in Rifamate,in Rifater); losartan (Cozaar, in Hyzaar); methadone (Methadose); midazolam (Seizalam); nevirapine (Viramune); nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Anaprox, Naprelan, in Treximet, in Vimovo); oral contraceptives (birth control pills); oral medication for diabetes such as glipizide (Glucotrol), glyburide (Diabeta, Glynase), and tolbutamide; nortriptyline (Pamelor); phenytoin (Dilantin, Phenytek); prednisone (Rayos); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); saquinavir (Invirase); sirolimus (Rapamune); tacrolimus (Astagraf, Prograf); theophylline (Elixophyllin, Theo-24, Theochron); tofacitinib (Xeljanz); triazolam (Halcion); valproic acid (Depakene, Depakote); vinblastine; vincristine (Marqibo); vitamin A; voriconazole (Vfend); and zidovudine (Retrovir, in Combivir, in Trizivir). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with fluconazole, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have or have ever had cancer; acquired immunodeficiency syndrome (AIDS); an irregular heartbeat; a low level of calcium, sodium, magnesium, or potassium in your blood; rare, inherited conditions where the body is not able to tolerate lactose or sucrose;or heart, kidney, or liver disease.

• tell your doctor if you are pregnant, especially if you are in the first 3 months of your pregnancy, plan to become pregnant, or are breastfeeding. Your doctor may tell you to use birth control to prevent pregnancy during your treatment and for 1 week after your final dose. If you become pregnant while taking fluconazole, call your doctor. Fluconazole may harm the fetus.

• you should know that fluconazole may make you dizzy or cause seizures. Do not drive a car or operate machinery until you know how this medication affects you.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Fluconazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dizziness
• diarrhea
• stomach pain
• heartburn
• change in ability to taste food

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency treatment:

• nausea
• vomiting
• extreme tiredness
• unusual bruising or bleeding
• lack of energy
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• flu-like symptoms
• dark urine
• pale stools
• seizures
• rash
• blistering or peeling skin
• hives
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• difficulty breathing or swallowing

Fluconazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of any unused liquid medication after 14 days.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• hallucinations (seeing things or hearing voices that do not exist)
• extreme fear that others are trying to harm you

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to fluconazole.

Do not let anyone else use your medication. Ask your pharmacist if you have questions about refilling your prescription. If you still have symptoms of infection after you finish taking the fluconazole, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.