Patient Medication Information: uses, side effects, how to take - Fluconazole Omega
ABOUT THIS MEDICATION
What the medication is used for:
Fluconazole is used to treat infections caused by fungi/yeasts. It may also be used to stop you from getting a fungal infection. The most common cause of fungal infections is a yeast called Candida.
You may be given Fluconazole Omega by your doctor to treat fungal infections such as:
- Internal (systemic) infections caused by Candida, e.g. infections of the urinary tract or other body organs.
- Internal (systemic) infections caused by Cryptococcus, e.g. cryptococcal meningitis, and infections of other sites such as the lungs.
You may also be given Fluconazole Omega to:
- stop you from getting a fungal infection (if your immune system is not working properly).
- stop an infection caused by Cryptococcus from coming back (e.g. in AIDS patients).
What it does:
Fluconazole belongs to a group of medications known as antifungals. It is capable of inhibiting the growth of fungi in the body and is used to treat a variety of fungal infections. It can also be used to prevent fungal infections in patients with a lowered immune system.
When it should not be used:
Do not use fluconazole if you are allergic to it or any of the non-medicinal ingredients, or to other azole antifungal drugs (e.g., ketoconazole, itraconazole). Fluconazole should also not be used if you are currently taking the medication cisapride, and should be used only under the direction of a doctor when used with astemizole and terfenadine. Do not use fluconazole if you have a heart condition known as torsade de pointes or electrolyte abnormalities, without first discussing with your physician. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use.
What the medicinal ingredient is:
The medicinal ingredient contained in this solution is fluconazole.
What the important nonmedicinal ingredients are:
This solution also contains sodium chloride and water.
For a full listing of non-medicinal ingredients, see Part I of the Product Monograph.
What dosage forms it comes in:
Fluconazole Omega is available in two different vial sizes; 200 mg fluconazole in 100 mL solution and 400 mg fluconazole in 200 mL solution.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of these highly unlikely but very serious side effects, seek immediate medical attention: severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, unusual tiredness.
- A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing.
- This drug may rarely cause a serious (possibly fatal) skin condition. Patients who develop rashes during treatment with fluconazole should seek immediate medical attention, and the drug should be discontinued if lesions progress.
Before Fluconazole Omega use or administration, talk to your doctor or pharmacist (or hospital personnel) if:
you are pregnant or trying to become pregnant;
- you are breast feeding or planning to breast feed;
- you have liver or kidney problems;
- you have ever had an allergic reaction to any of the ingredients in Fluconazole Omega or to other medicines that you may have taken to treat a fungal infections. This may have been itching, reddening of the skin, or difficulty breathing;
- you are taking astemizole (an antihistamine), terfenadine (an antihistamine) or cisapride (used for digestive problems related to disturbed gastrointestinal motility).
INTERACTIONS WITH THIS MEDICATION
Talk to you doctor if you are taking any of the following medications:
Astemizole, Benzodiazepimes, Cimetidine, Cisapride, Coumarin-type anticoagulants, Cyclosporine or Tacrolimus, Hydrochlorothiazide, Oral contraceptives, Oral hypoglycemics, such as Tolbutamide, Glipizide, Glyburide , Phenytoin, Rifabutin or Rifampin, Terfenadine, Theophylline, Zidovudine, also known as AZT.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use. IMPORTANT: PLEASE READ
PROPER USE OF THIS MEDICATION
Usual dose:
The usual dose is as directed by the doctor, pharmacist or hospital personnel depending on your condition. This will be administered by continuous intravenous infusion of about 200 mg/hr.
Overdose:
If overdose is suspected, contact hospital personnel, your local poison control center, or the emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: hallucinations, mental/mood changes.
Directions for Use
Fluconazole Omega is intended only for intravenous infusion using sterile equipment. Do not remove flip-off capsule until ready to use. Suspend container from eyelit support. Attach administration set. Refer to complete instructions for the set.
| SIDE EFFECTS, HOW OFTEN THEY HAPPEN, AND | ||
| WHAT TO DO ABOUT THEM |
If you notice any change in the way you feel after or during receiving the medicine, you should tell your doctor or pharmacist immediately. The infusion should be stopped and your doctor will take the appropriate measures.
The most common side effects are:
Headache, skin rash, stomach pain, diarrhea, nausea, vomiting.
Less common side effects are:
Itching, muscle pain, seizures, dizziness, tremors, dry mouth, increased sweating, insomnia, drowsiness, flatulence, anorexia, constipation, heartburn, digestive problems, liver problems (nausea, vomiting, stomach pain, yellowing eyes or skin, dark urine), taste perversion, anemia, fatigue, general discomfort, fever, weakness.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing.
This is not a complete list of side effects. For any unexpected effects while taking Fluconazole Omega, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15 - 30°C. Do not freeze. Protect from light during storage.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
Toll free telephone: 866-234-2345
Toll free fax: 866-678-6789
By e-mail: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Product Directorate
Tunney’s Pasture, AL O701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Omega Laboratories, Ltd., at:
Montreal: (514) 335-0310 or 1-800-363-0584
Ontario: (905) 629-8980 or 1-800-268-1326
Vancouver: (604) 271-6228 or 1-877-271-6228
By mail: Omega Laboratories, Ltd.
11 177 Hamon
Montreal, QC H3M 3E4