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(floo kon' na zole)
[Posted 11/17/2009] FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid. New data show that when clopidogrel and omeprazole are taken together, the effectiveness of clopidogrel is reduced. Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine if they are also taking omeprazole. Separating the dose of clopidogrel and omeprazole in time will not reduce this drug interaction.
Other drugs that are expected to have a similar effect and should be avoided in combination with clopidogrel include: cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine.
Recommendations for healthcare professionals are provided in the Information for Healthcare Professionals sheet. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Fluconazole comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken once a day. 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.
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.
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, prostate (a male reproductive organ), 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 drug for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking fluconazole,
tell your doctor and pharmacist if you are allergic to fluconazole, other antifungal medications such as itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend) or any other medications.
do not take cisapride (Propulsid) while taking fluconazole.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking, especially amiodarone (Cordarone); anticoagulants ('blood thinners') such as warfarin (Coumadin); astemizole (Hismanal) (not available in the United States); benzodiazepines such as midazolam (Versed);cyclosporine (Neoral, Sandimmune); disopyramide (Norpace); diuretics ('water pills') such as hydrochlorothiazide (HydroDIURIL, Microzide); dofetilide (Tikosyn); erythromycin (E.E.S, E-Mycin, Erythrocin); isoniazid (INH, Nydrazid); moxifloxacin (Avelox); oral contraceptives (birth control pills); oral medicine for diabetes such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glycron, others), and tolbutamide (Orinase); phenytoin (Dilantin); pimozide (Orap); procainamide (Procanbid, Pronestyl); quinidine (Quinidex); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); sotalol (Betapace); sparfloxacin (Zagam); tacrolimus (Prograf); terfenadine (Seldane) (not available in the US); theophylline (TheoDur); thioridazine (Mellaril); valproic acid (Depakene, Depakote); and zidovudine (Retrovir).
tell your doctor if you drink or have ever drunk large amounts of alcohol and if you have or have ever had cancer; acquired immunodeficiency syndrome (AIDS); an irregular heartbeat; or heart, kidney, or liver disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking fluconazole, call your doctor.
Unless your doctor tells you otherwise, continue your normal diet.
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.
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:
nausea
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
hives
itching
swelling of the face , throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
difficulty breathing or swallowing
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 [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
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). Throw away any medication that is outdated or no longer needed. Throw away any unused liquid medication after 14 days. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
hallucinations (seeing things or hearing voices that do not exist)
extreme fear that others are trying to harm you
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 take 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.
Diflucan®
