PHL-Fluconazole: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Tablets:

• 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.

Capsules:

Your doctor has prescribed phl-FLUCONAZOLE for a vaginal yeast (fungal) infection.

phl-FLUCONAZOLE is used for the treatment of vaginal yeast infection and is taken orally. phl-FLUCONAZOLE is convenient because one capsule taken by mouth provides a full course of 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 phl-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:

Tablets:

Croscarmellose Sodium, Dibasic Calcium Phosphate Anhydrous, FD&C Red No. 3 and No. 40 Lake Dye, Magnesium Stearate, Microcrystalline Cellulose and Povidone.

Capsules:

Colloidal silicon dioxide, gelatin, lactose monohydrate, magnesium stearate, pregelatinized starch and titanium dioxide.

What dosage forms it comes in:

Tablets: 100 mg

Capsules: 150 mg

WARNINGS AND PRECAUTIONS

Tell your doctor before using phl-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. Capsules:

• Clearing a yeast infection does take time. Although phl FLUCONAZOLE is taken only once, phl-FLUCONAZOLE remains active in your body for several days.

Most patients can expect to see symptom relief of a vaginal yeast infection (i.e. itching) within 24 hours. As phl-FLUCONAZOLE works to cure the infection, symptoms will lesson and eventually disappear. If your symptoms have not improved within 3 or 5 days, contact your doctor.

While taking phl-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

Tablets and Capsules

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 phl-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

Tablets:

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.

Capsules:

Single dose therapy: phl-FLUCONAZOLE should be taken by mouth, once only, with or without meals at any time of the day or night. It should be taken immediately to ensure the earliest possible relief from vaginal yeast infection and it's symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Tablets

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).

Capsules

In clinical studies of phl-FLUCONAZOLE, the most common side effects were headache, nausea, abdominal pain, and diarrhea. Most reported side effects were mild to moderate in nature.

Very infrequently, some patients develop skin eruptions or allergy symptoms such as hives after they take this drug. Rarely, severe allergic reactions have occurred

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 phl-FLUCONAZOLE, contact your doctor or pharmacist.

HOW TO STORE IT

Store phl-FLUCONAZOLE between 15ºC and 30ºC.

Keep out of reach of children.

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 email: cadrmp@hc-sc.gc.ca

By regular mail:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Health Canada

Address Locator: 0701C

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 obtained by contacting Pharmel Inc.:

By telephone: 1-888-550-6060.

By post: Pharmel Inc.

6111 avenue Royalmount, #100

Montreal, QC H4P 2T4