Patient Medication Information: uses, side effects, how to take - Teva-Ketoconazole
ABOUT THIS MEDICATION
What the medication is used for:
TEVA-KETOCONAZOLE is one of a group of medicines called antifungals.
TEVA-KETOCONAZOLE is prescribed by your doctor and is used to treat serious and life-threatening infections in the body caused by fungi including yeasts. The most common cause of fungal infection is a yeast called Candida.
What it does:
TEVA-KETOCONAZOLE selectively interferes with the normal sterol production in fungi and helps to stop fungal growth.
When it should not be used:
Do not take TEVA-KETOCONAZOLE if you have ever had an allergic reaction to:
any of the ingredients of TEVA-
KETOCONAZOLE (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 TEVA-KETOCONAZOLE if you are taking any of the following drugs:
Cisapride* (used as a gastrointestinal
motility agent),
Terfenadine* or astemizole* (antihistamines
for allergies),
- Benzodiazepines such as midazolam, triazolam, or similar medicines (used to help you sleep or for anxiety)
HMG-CoA reductase inhibitors (eg. lovastatin, for
lowering cholesterol)
Do not take TEVA-KETOCONAZOLE if you are a woman of child-bearing potential unless effective
forms of contraception are used.
* not marketed in Canada
What the medicinal ingredient is:
ketoconazole
What the nonmedicinal ingredients are:
pregelatinized starch, sodium starch glycolate, lactose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.
What dosage forms it comes in:
T
a
blets; 200mg
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Oral ketoconazole is associated with liver (hepatic) toxicity, including cases of death. Your doctor will tell you of the risk and monitor your situation.
BEFORE you use TEVA-KETOCONAZOLE 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.
TEVA-KETOCONAZOLE 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
Use in Children
Your doctor will decide whether this medication is suitable for your child.
Your doctor may test your liver function, before and during treatment.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with TEVA-
KETOCONAZOLE include:
- Alfentanil, fentanyl or methadone (used to treat pain)
Antiarrhythmics (e.g. digoxin, quinidine,
disopyramide)
- Antipsychotics ( e.g. pimozide)
- Amitriptyline, nortriptyline (used to treat migraine)
- Amphotericin B and Voriconazole (used to treat fungal infections)
- Calcium channel blockers or losartan (for lowering blood pressure)
- Carbamazepine or phenytoin (used to control epilepsy)
- Celecoxib (used to treat some types of arthritis)
- Cimetidine (for heartburn and peptic ulcers)
- Coumarin-Type Anticoagulants (used to thin the blood to prevent blood clots)
- Cyclophosphamide, prednisone or vinca alkaloids (for treating some forms of leukaemia)
- Cyclosporine, sirolimus or tacrolimus (to prevent transplant rejection)
Ergot alkaloids ( e,g. ergotamine,
methylergometaine)
Glucocorticoids ( e.g. dexamethasone,
fluticasone).
- Halofantrine (to treat malaria)
- 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
- 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)
- 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
Usual Adult dose:
Take TEVA-KETOCONAZOLE, 200mg or 400mg once a day with a meal as determined by the doctor.
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.
Missed Dose:
| 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. | |||
| S | IDE EFFECTS AND WHAT TO DO ABOUT THEM | ||
Like all medicines, TEVA-KETOCONAZOLE may cause some side effects.
The most common side effects are:
- Headache,
- Skin rash,
- Abdominal pain,
- Diarrhea,
- Nausea and vomiting
If you develop symptoms of liver problems, such as nausea, vomiting, abdominal pain, dark urine, pale stools or yellowing of the skin or eyes, stop taking TEVA-KETOCONAZOLE immediately and contact your doctor.
| 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 | |
| Only if severe | In all cases | ||
Exfoliative skin disorders: Severe 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 | √ | ||
Hepatic necrosis (death of liver cells which may cause abdominal pain and dark urine, fever, light-colored stool, and jaundice (a yellow appearance to the skin and white portion of the eyes) | √ | ||
Heart conditions: Unstable or irregular heartbeat (e.g. QT prolongation, torsade de pointes) | √ | ||
| 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 | |
Allergic Reaction with symptom such as swelling of the face, throat, mouth, extremities, difficulty in breathing, rash or itching | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking TEVA- KETOCONAZOLE, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15 and 30°C. Unit dose strip should be stored between 15 and 25°C and protected from high humidity.
Keep this and all medications out of the reach and sight of children.
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 Health Canada
Postal Locator 0701E Ottawa, Ontario K1A 0K9
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 found by contacting the sponsor, Teva Canada Limited at:
1-800-268-4127 ext. 1255005 (English
1-877-777-9117 (French)
or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
Canada M1B 2K9 www.tevacanada.com