Diflucan Consumer Medicine Information
|Condition:||Blastomycosis, Bone Marrow Transplantation, Candida Urinary Tract Infection, Candidemia, Cryptococcosis, Prophylaxis, Cryptococcal Meningitis, Immunosuppressed Host, Cryptococcal Meningitis, Immunocompetent Host, Coccidioidomycosis, Meningitis, Coccidioidomycosis, Chronic Mucocutaneous Candidiasis, Esophageal Candidiasis, Fungal Pneumonia, Fungal Peritonitis, Fungal Infection, Internal and Disseminated, Fungal Infection Prophylaxis, Histoplasmosis, Oral Thrush, Sporotrichosis, Vaginal Yeast Infection|
|Class:||Antifungals, Azole antifungals|
|Form:||Liquid solution, Intravenous (IV), Tablets, Powder|
|Ingredients:||fluconazole, sucrose, sodium citrate, citric acid, sodium benzoate, titanium dioxide, colloidal silicon dioxide, xanthan gum and natural orange flavour, sodium chloride solution 9 mg/mL|
Powder for Oral Suspension
(50 mg / 5 mL) (when reconstituted)
Sterile aqueous solution for infusion (2 mg / mL)
About This Medication
What the Medication is Used For
DIFLUCAN is one of a group of medicines called antifungals.
DIFLUCAN is prescribed by your doctor and is used to treat infections caused by fungi including yeasts and may also be used to stop you from getting a fungal infection. The most common cause of fungal infection is a yeast called Candida.
What it Does
DIFLUCAN selectively interferes with the normal sterol production in fungi and helps to stop fungal growth.
When it Should not Be Used
Do not take DIFLUCAN if you have ever had an allergic reaction to:
- any of the ingredients of DIFLUCAN (see What the nonmedicinal ingredients are)
- other medicines you have taken to treat a fungal infection.
The symptoms may include itching, reddening of the skin or difficulty in breathing.
Do not take DIFLUCAN if you are taking any of the following drugs:
- Cisapride* (used as a gastrointestinal motility agent),
- Terfenadine* or astemizole* (antihistamines for allergies),
- Erythromycin (an antibiotic for treating infections),
- Pimozide (for treating schizophrenia) and
- Quinidine (used for irregular heartbeats).
* not marketed in Canada
What the Medicinal Ingredient Is
What the Important Non-Medicinal Ingredients Are
DIFLUCAN Powder for Oral Suspension contains the following on-medicinal ingredients: sucrose, sodium citrate, citric acid, sodium benzoate, titanium dioxide, colloidal silicon dioxide, xanthan gum and natural orange flavour.
DIFLUCAN aqueous solution for infusion contains the following non-medicinal ingredient: sodium chloride solution 9 mg/mL
What Dosage Forms it Comes In
DIFLUCAN Tablets§ (50 mg and 100 mg)
DIFLUCAN Powder for Oral Suspension (50 mg / 5 mL) (when reconstituted)
DIFLUCAN Sterile aqueous solution for infusion (2 mg / mL)
§ Not commercially available in Canada
Warnings and Precautions
Tell your doctor if you become pregnant while taking Diflucan products.
BEFORE you use DIFLUCAN talk to your doctor or pharmacist if you:
- have liver or kidney problems
- are allergic to any other medicines including those used to treat yeast and other fungal infections
- have abnormal levels of potassium, calcium or magnesium in your blood
- are pregnant or are planning to become pregnant.
- are breast-feeding or planning to breast-feed. DIFLUCAN is excreted in human breast milk. Breast-feeding is not recommended.
- have heart disease such as heart conditions, blood disorders or any other medical conditions.
- are driving and using machines. It should be taken into account that occasionally dizziness or seizures may occur.
- are taking or have taken any other medicines, including medicines obtained without a prescription
- have hereditary fructose, glucose/galactosemalabsorption and sucrase-isomaltase deficiency as Diflucan powder for oral suspension contains sucrose.
- Have galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption because Diflucan capsules contain lactose.
- Use in Children
Your doctor will decide whether this medication is suitable for your child.
Interactions With This Medication
Drugs that may interact with DIFLUCAN include:
- Alfentanil, fentanyl or methadone (used to treat pain)
- Amitriptyline, nortriptyline (used to treat migraine and other conditions)
- Amphotericin B and Voriconazole (used to treat fungal infections)
- Benzodiazepines such asmidazolam, triazolam, or similar medicines (used to help you sleep or for anxiety)
- Calcium channel blockers or losartan (for lowering blood pressure)
- Carbamazepine or phenytoin (used to control epilepsy)
- Celecoxib (used to treat some types of arthritis and certain other types of pain)
- Cimetidine (for heartburn and peptic ulcers)
- Coumarin-Type Anticoagulants (used to thin the blood to prevent blood clots)
- Cyclophosphamide, or vinca alkaloids (for treating some forms of cancer)
- Cyclosporine, sirolimus or tacrolimus (to prevent transplant rejection)
- Halofantrine (to treat malaria)
- HMG-CoA reductase inhibitors (statins) (for lowering cholesterol)
- Medicines for treating infections (antibiotics) such as azithromycin, erythromycin, rifampin or rifabutin
- Non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid and ibuprofen) that are used to treat pain and fever
- Oral Contraceptives
- Prednisone (used to treat many types of inflammatory and allergic conditions)
- Saquinavir or zidovudine, also known as AZT (used in HIV-infected patients)
- Sulfonylureas and other Oral Hypoglycemics (medicines for diabetes)
- Theophylline (used to control asthma)
- Tofacitinib (used to treat rheumatoid arthritis)
- Vitamin A (as a trans-retinoid acid used to treat acne)
- Water tablets (diuretics), such as hydrochlorothiazide, (used to treat fluid retention and high blood pressure)
Proper Use of This Medication
Take DIFLUCAN only as directed by your doctor.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double dose.
Side Effects And What to Do About Them
Like all medicines, DIFLUCAN may cause some side effects.
The most common side effects are:
- Skin rash,
- Abdominal pain,
- Nausea and vomiting.
Serious Side Effects how Often They Happen and What to Do About Them
|Symptom / effect||Talk with your|
doctor or pharmacist
skin reactions, such
as a rash that causes
blistering, itching all
over the body,
reddening of the
skin or itchy red
spots, swelling of
eyelids, face or lips,
peeling or lost skin
(death of liver cells
which may cause
abdominal pain and
dark urine, fever,
and jaundice (a
to the skin and
white portion of the
torsade de pointes)
with symptom such
as swelling of the
face, throat, mouth,
breathing, rash or
This is not a complete list of side effects. For any unexpected effects while taking DIFLUCAN, contact your doctor or pharmacist immediately.
How to Store It
Store at room temperature (15°-30°C). Do not freeze. Keep out of reach and sight of children.
The reconstituted suspension is stable for 2 weeks at 5°C-30°C
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of the side effect, please contact your health care professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full Product Monograph, prepared for health professionals can be found at:http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001.