Patient Medication Information: uses, side effects, how to take - Fluconazole (Sorres Pharma, 50 mg, 100 mg)
ABOUT THIS MEDICATION
What the medication is used for:
- For the treatment of oropharyngeal and esophageal candidiasis (fungal infections of the mouth and throat caused by Candida species). Fluconazole is also effective for the treatment of serious systemic candidal infections (serious internal fungal infections caused by Candida species), including urinary tract infection, peritonitis and pneumonia.
- Cryptococcal meningitis.
- Prevention of the recurrence of cryptococcal meningitis in patients with acquired immunodeficiency syndrome (AIDS).
- Decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
What it does:
Fluconazole interferes with normal fungal growth to cause an accumulation of certain components (sterols) to cause cell death or to stop cell growth.
When it should not be used:
You should not take FLUCONAZOLE if you ever had an allergic reaction to it or to other antifungal drugs of the same family or to the nonmedicicnal ingredients (See What the Nonmedicinal Ingredients are). If you are in doubt, talk to your doctor or pharmacist.
What the medicinal ingredient is:
Fluconazole
What the nonmedicinal ingredients are:
Croscarmellose Sodium, Dibasic Calcium Phosphate Anhydrous, FD&C Red No. 3 and No. 40 Lake Dye, Magnesium Stearate, Microcrystalline Cellulose and Povidone.
What dosage forms it comes in:
Tablets: 50 & 100 mg
WARNINGS AND PRECAUTIONS
Tell your doctor before using FLUCONAZOLE if:
- you have liver disease
- you have heart disease, irregular heartbeat.
you are pregnant or planning to become pregnant. There have been reports of abnormalities in infants whose mothers have taken fluconazole. Fluconazole is normally not recommended in pregnancy and your doctor will discuss with you whether this medication is appropriate. If you could become pregnant while taking fluconazole, it is recommended that you use a reliable contraceptive method.
- you are breastfeeding. Fluconazole is secreted in human breast milk, so it is recommended that you do not nurse while taking fluconazole.
- you are using any other medications (See Interactions with this medication).
Other warnings:
The safety of fluconazole in children has been established although its efficacy has not been established in infants less than 6 months of age.
While taking FLUCONAZOLE, tell your doctor if:
- you develop liver problems with symptoms such as yellowing of the skin and eyes (jaundice), persistent nausea, vomiting, or abdominal pain, etc.
- you develop rashes during treatment.
INTERACTIONS WITH THIS MEDICATION
Significant drug interactions have been observed with the following agents/classes and you should talk to your doctor to confirm whether you should be taking the following: benzodiazepines (short acting), cimetidine, coumarin-type anti-coagulants, cyclosporine, drugs prolonging the QTc interval (astemiazole*, cisapride*, terfenadine*), hydrochlorothiazide, oral contraceptives, oral hypoglycemics (tolbutamide, glipizide, glyburide),
phenytoin, rifabutin, rifampin, tacrolimus, theophylline, zidovudine, simethicone (Maalox).
If you take drugs containing antihistaminic preparations such as terfenadine* (SELDANE®) or astemizole* (HISMANAL®), or if you take cisapride* (PREPULSID®), consult your doctor before taking FLUCONAZOLE.
Also inform your doctor if you take oral medicine for diabetes, epilepsy or if you take blood-thinning medication.
* no longer marketed in Canada.
PROPER USE OF THIS MEDICATION
Your doctor will advise taking twice the usual dose the first day, followed by the usual dose after this, not to exceed a maximum single dose of 400 mg in adults or 12 mg/kg in children, on the first date of treatment. Your doctor will determine the dose and duration of treatment.
Oropharyngeal candidiasis:
Adults: 100 mg once daily for at least 2 weeks.
Children: 3 mg/kg once daily for at least 2 weeks.
Systemic Candidiasis:
Adults: 100-200 mg once daily for a minimum of 3 weeks and for at least 2 weeks after symptoms have resolved.
Children: 6 mg/kg to 12 mg/kg per day have been used.
Cryptoccocal meningitis:
Adults: 200 mg to 400 mg once daily, usually for at least 10 weeks.
Children: 6 mg/kg to 12 mg/kg once daily for at least 10 weeks after certain tests are done.
Prevention of Recurrence of Cryptococcal Meningitis in Patients with AIDS:
Adults: 200 mg once daily.
Children: 6 mg/kg once daily.
Overdose:
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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The two most serious adverse clinical events noted during clinical trials with fluconazole were exfoliative skin disorders (severe skin reactions such as dermatitis) and hepatic necrosis liver tissue death).
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| If effect persists or becom es bothers ome | In all cases | |||
Liver- failure, swollen, inflamed with symptoms such as yellowing of the skin and eyes, persistent abdominal pain, nausea, vomiting | / | |||
| Severe skin disorders such as Steven’s Johnson syndrome, toxic epidermal necrolysis, skin eruptions, peeling skin, itching, hives, rashes, etc. | / | |||
| Persistent muscle pain, fatigue, lethargy, fever, lack of energy (anemia) | / | |||
| Low potassium in the blood (hypokalemia) and symptoms such as muscle weakness, disturbed hearth rhythm, irregular heartbeat and prolonged QT interval, | / | |||
In clinical studies, the most common and self-limiting side effects included headache, nausea, abdominal pain, vomiting and diarrhea.
Other side effects that were infrequent included: constipation, dizziness, dry mouth, gas, difficulty in sleeping, loss of appetite, sleepiness, increased swelling, upset stomach and taste perversion.
This is not a complete list of side effects. If you have any unexpected effects while taking
FLUCONAZOLE, contact your doctor or pharmacist.
HOW TO STORE IT
Store FLUCONAZOLE between 15 – 30oC.
Keep out of reach of children.
REPORTING 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:
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 side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Sorres Pharma Inc. at, 1-888-550-6060.
Sorres Pharma Inc.
Montreal Quebec
H4P 2T4