Patient Medication Information: uses, side effects, how to take - Apo-Ketoconazole
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.
PART III: CONSUMER INFORMATION
Pr APO-KETOCONAZOLE
(Ketoconazole Tablets USP)
This leaflet is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about APO-KETOCONAZOLE. Contact your doctor or pharmacist if you have any questions about the drug.
ABOUT THIS MEDICATION
What the medication is used for:
APO-KETOCONAZOLE is one of a group of medicines called antifungals.
APO-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:
APO-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 APO-KETOCONAZOLE if you have ever had an allergic reaction to:
any of the ingredients of APO-
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 APO-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) * not marketed in Canada
- Do not take APO-KETOCONAZOLE if you are a woman of child-bearing potential unless effective forms of contraception are used.
What the medicinal ingredient is:
ketoconazole
What the nonmedicinal ingredients are:
colloidal silicon dioxide, croscarmellose sodium, dextrates and magnesium stearate.
What dosage forms it comes in:
Tablets, 200 mg
WARNINGS AND PRECAUTIONS
BEFORE you use APO-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.
APO-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.
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
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with APO-
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)
Usual Dose:
Take APO-KETOCONAZOLE, 200mg once a day with a meal as determined by the doctor. Overdose:
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.
Like all medicines, APO-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 APO-KETOCONAZOLE immediately and contact your doctor.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | |||
| HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom / effect | Talk with your physician or pharmacist | Stop taking drug and call your physician or pharmacist | |
| Only if severe | In all cases | ||
PROPER USE OF THIS MEDICATION
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
Address Locator: 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service at: 1-800-667-4708
This leaflet can also be found at:
http://www.apotex.ca/products.
Apotex Inc.
Toronto, Ontario
M9L 1T9.
This is not a complete list of side effects. For any unexpected effects while taking APO-KETOCONAZOLE, contact your doctor or pharmacist.
Last revised: November 2, 2021
HOW TO STORE IT
Store at room temperature (15°C -30°C) in well closed containers.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | |||
| HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom / effect | Talk with your physician or pharmacist | Stop taking drug and call your physician 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, lightcolored 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) | √ | ||
Allergic Reaction with symptom such as swelling of the face, throat, mouth, extremities, difficulty in breathing, rash or itching | √ | ||