Patient Medication Information: uses, side effects, how to take - Fluconazole Injection (Teva Canada)
ABOUT THIS MEDICATION
What the medication is used for:
TEVA-FLUCONAZOLE and FLUCONAZOLE INJECTION (fluconazole) is one of a group of medicines called antifungals.
TEVA-FLUCONAZOLE and FLUCONAZOLE INJECTION are prescribed by your doctor and are 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:
TEVA-FLUCONAZOLE and FLUCONAZOLE INJECTION 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-FLUCONAZOLE or FLUCONAZOLE INJECTION if you have ever had an allergic reaction to:
- any of the ingredients of TEVA-FLUCONAZOLE and FLUCONAZOLE INJECTION (see What the important 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-FLUCONAZOLE or FLUCONAZOLE INJECTION 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:
fluconazole
What the important non-medicinal ingredients are:
TEVA-FLUCONAZOLE tablets contain the following non-medicinal ingredients: dibasic calcium phosphate anhydrous, croscarmellose sodium, microcrystalline cellulose, FD & C Red #40 Aluminum Lakes (alumina hydrate base), povidone, colloidal silicon dioxide, and magnesium stearate.
FLUCONAZOLE INJECTION contains the following non-medicinal ingredients: sodium chloride (isotonicity) and Water for Injection.
What dosage forms it comes in:
TEVA-FLUCONAZOLE tablets:
- 50 mg: Bottles of 100.
- 100 mg: Bottles of 50.
FLUCONAZOLE INJECTION sterile aqueous solution for infusion:
- (2 mg / mL): 100 mL vial
- (2 mg / mL): 100 mL and 200 mL Cryovac bags
WARNINGS AND PRECAUTIONS
BEFORE you use TEVA-FLUCONAZOLE and FLUCONAZOLE INJECTION (fluconazole) 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 breast-feeding or planning to breast-feed. Fluconazole 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.
Use in Pregnancy
- TEVA-FLUCONAZOLE or FLUCONAZOLE INJECTION may cause harm to your unborn baby.
- If you are pregnant or planning to become pregnant, talk to your doctor.
- TEVA-FLUCONAZOLE or FLUCONAZOLE INJECTION should not be used in pregnancy except in severe or life-threatening infection.
- Your doctor will decide if TEVA-FLUCONAZOLE or FLUCONAZOLE INJECTION should be used in your
- situation.
If you are a woman of child-bearing potential then:
- Avoid becoming pregnant during treatment
- Use effective contraception during treatment and for 1 week after treatment
- Tell your doctor if you become pregnant during treatment.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with TEVA-FLUCONAZOLE and FLUCONAZOLE INJECTION (fluconazole) 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 as midazolam, 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
USUAL DOSE:
Take Fluconazole only as directed by your doctor.
OVERDOSE:
| In case of drug overdose, contact your healthcare professional, 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.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, TEVA-FLUCONAZOLE and FLUCONAZOLE INJECTION (fluconazole) may cause some side effects.
The most common side effects are:
- Headache,
- Skin rash,
- Abdominal pain,
- Diarrhea,
- Nausea and vomiting.
| 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) | ✓ | ||
| 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-FLUCONAZOLE and FLUCONAZOLE INJECTION, contact your doctor or pharmacist immediately.
HOW TO STORE IT
TEVA-FLUCONAZOLE tablet: Store bottles between 15°C- 30°C.
Keep out of sight and reach of children.
FLUCONAZOLE INJECTION: Store vials between 15°C- 30°C. Store bags between 5°C - 25°C. Do not freeze.
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
If you want more information about TEVA-FLUCONAZOLE:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://www.hc-sc.gc.ca/); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.