Patient Medication Information: uses, side effects, how to take - Fluconazole Injection (Sandoz Canada)
ABOUT THIS MEDICATION
What the medication is used for:
Fluconazole Injection SDZ and Fluconazole Injection are part of a group of medicines called antifungals.
Fluconazole Injection SDZ 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:
Fluconazole Injection SDZ and Fluconazole Injection selectively interfere with the normal sterol production in fungi and helps to stop fungal growth.
When it should not be used:
Do not take Fluconazole Injection SDZ or Fluconazole Injection if you have ever had an allergic reaction to:
- any of the ingredients of Fluconazole Injection SDZ or Fluconazole Injection (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 Fluconazole Injection SDZ or Fluconazole Injection if you are taking any of the following drugs:
- Erythromycin (an antibiotic for treating infections),
- Pimozide (for treating schizophrenia) and
- Quinidine (used for irregular heartbeats).
What the medicinal ingredient is:
Fluconazole
What the nonmedicinal ingredients are:
Fluconazole Injection SDZ contains the following non-medicinal ingredients: sodium chloride for isotonicity, hydrochloric acid to adjust pH and water for injection.
Fluconazole Injection contains the following non-medicinal ingredients: sodium chloride for isotonicity, hydrochloric acid and/or sodium hydroxide to adjust pH and water for injection.
What dosage forms it comes in:
Fluconazole Injection SDZ 2 mg/mL is available in 100 mL single use vials, boxes of 1.
Fluconazole Injection 2 mg/mL is available in 100 mL single use vials, boxes of 1.
WARNINGS AND PRECAUTIONS
BEFORE you use Fluconazole Injection SDZ or Fluconazole Injection 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
- Fluconazole Injection SDZ and Fluconazole Injection may cause permanent harm to your unborn baby and may cause a miscarriage of your pregnancy.
- If you are pregnant or planning to become pregnant, talk to your doctor.
- Fluconazole Injection SDZ and Fluconazole Injection should not be used in pregnancy except in severe or life-threatening infection.
Your doctor will decide if Fluconazole Injection SDZ 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 Fluconazole Injection SDZ or Fluconazole Injection include:
- Alfentanil, fentanyl or methadone (used to treat pain)
- Amiodarone (used for irregular hearbeats)
- 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 or Indanedione 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
- Olaparib (for treating some forms of cancer)
- 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)
- Tofacinitib (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)
§Indanedione Anticoagulants not commercially available in Canada
PROPER USE OF THIS MEDICATION
Overdose:
| If you think you have taken too much Fluconazole Injection SDZ or Fluconazole Injection, contact your health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, Fluconazole Injection SDZ and Fluconazole Injection may cause some side effects.
The most common side effects are:
- Headache,
- Skin rash,
- Abdominal pain,
- Diarrhea,
- Nausea and vomiting.
SERIOUS SIDE EFFECTS 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 Fluconazole Injection SDZ or Fluconazole Injection, contact your doctor or pharmacist.
HOW TO STORE IT
Store between 15°C and 30°C. Protect from light. Protect from freezing. Keep out of reach and sight of children.
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
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sandoz Canada Inc., at:
1-800-361-3062
or by written request at:
110 de Lauzon
Boucherville QC
J4B 1E6
Or by e-mail at :
medinfo@sandoz.com