Details for: SPORANOX ORAL SOLUTION 10MG PER ML
Company: JANSSEN INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02231347 | SPORANOX ORAL SOLUTION 10MG/ML | ITRACONAZOLE | 10 MG / ML | SOLUTION | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
SPORANOX® is a prescription medication used to treat fungal
infections of the mouth and throat in adult HIV-positive patients
or other patients with a lowered immune system.
This Consumer Information discusses only the oral solution form
of SPORANOX®. You will receive the oral solution in a glass
bottle, containing 150 mL of solution (10 mg itraconazole per
millilitre solution), along with a measuring cup.
What it does
SPORANOX® goes into your bloodstream and travels to the area of the infection.
When it should not be used
- if you have congestive heart failure, SPORANOX® could make it worse. If your doctor decides that you need SPORANOX®, be sure to get immediate medical help if you experience signs of heart failure (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM)
- if you are taking certain medications (see INTERACTIONS WITH THIS MEDICATION)
- if you have had an allergic reaction to itraconazole or any of the other ingredients in SPORANOX® oral solution (see What the nonmedicinal ingredients are)
What the medicinal ingredient is
The medicinal ingredient in SPORANOX® oral solution is itraconazole. One full measuring cup contains 10 millilitres of solution, corresponding to 100 milligrams of itraconazole.
What the non-medicinal ingredients are
SPORANOX® oral solution contains: hydroxypropyl-β- cyclodextrin, sorbitol, propylene glycol, hydrochloric acid, cherry flavour 1 and 2, caramel flavour, sodium saccharin, sodium hydroxide and water.
What dosage form it comes in
Oral Solution 10 mg/mL
Warnings and precautions
Serious Warnings and Precautions
- Liver toxicity (see SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM)
- Heart problems (see SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM)
- Drug interactions (see INTERACTIONS WITH THIS MEDICATION)
SPORANOX® treatment is not for everyone. Your doctor will
decide if SPORANOX® is the right treatment for you. Some
patients should not take SPORANOX® oral solution because they
may have certain health problems or may be taking certain
medications that could lead to serious or life-threatening medical
problems.
Tell your doctor about any other medical conditions you have had,
especially heart, lung, liver or kidney conditions.
- If you have a liver problem, your dose of SPORANOX® oral solution may have to be adjusted;
- If you have a kidney disorder, your dose of SPORANOX® oral solution may have to be adjusted.
Also tell your doctor and pharmacist the name of all the
prescription and non-prescription medications you are taking,
including dietary supplements and herbal remedies.
BEFORE you use SPORANOX® oral solution, let your doctor or
pharmacist know if:
- you have elevated or abnormal liver enzymes or active liver disease, or have experienced liver toxicity with other drugs;
- you have or have had heart disease, including congestive heart failure;
- you have cystic fibrosis;
- you have ever had an allergic reaction to itraconazole or any of the other ingredients in SPORANOX® oral solution.
SPORANOX® oral solution can sometimes cause dizziness,
blurred/double vision or hearing loss. If you have these
symptoms, do not drive or use machines.
Since scientific information on the use of SPORANOX® oral
solution in children is limited, it is not recommended for use in
children.
Pregnancy
Do not take SPORANOX® oral solution if you are pregnant
(unless your doctor knows you are pregnant and decides you need
SPORANOX®) or planning to become pregnant within 2 months
after you have finished your treatment.
If you are able to become pregnant, you should use effective birth
control during SPORANOX® treatment and for
2 months after finishing treatment. Ask your doctor about
effective types of birth control.
Breast-feeding Do not take SPORANOX® oral solution if you are
breast-feeding or discontinue nursing if you are taking
SPORANOX®. SPORANOX® is found in human breast milk.
Interactions with this medication
Tell your doctor or pharmacist what medications you are currently
taking. In particular, some medications must not be taken at the
same time, and if certain medications are taken at the same time,
changes need to be made (to the dose, for example). A wide
variety of drugs may interact with SPORANOX® oral solution.
Never take SPORANOX® oral solution if you are taking any of the
following medications:
- boosted asunaprevir to treat Hepatitis C Virus
- eplerenone, felodipine, ivabradine, ranolazine used to treat angina (crushing chest pain) or high blood pressure
- ticagrelor used to slow down blood clotting
- eletriptan used to treat migraine headaches
- lomitapide, lovastatin, simvastatin which lower cholesterol
- triazolam, sleeping pills
- disopyramide, dronedarone, quinidine, used to treat irregular heart beat rhythms
- lurasidone, pimozide used for psychotic disorders
- methadone for severe pain or to manage addiction
- irinotecan, an anti-cancer drug
- dihydroergotamine or ergotamine (called ergot alkaloids) used in the treatment of migraine headaches
- ergometrine (ergonovine) (called ergot alkaloids) used to control bleeding and maintain uterine contraction after child birth
- domperidone used to treat nausea and vomiting
- naloxegol; to treat constipation caused by taking opioid painkillers
If you have kidney or liver impairment, never take SPORANOX® oral solution while taking any of the following medications:
- colchicine, used to treat gout
- fesoterodine or solifenacin when used to control irritated urinary bladder
Wait at least 2 weeks after stopping SPORANOX® oral solution
before taking any of these medications.
Medications that can decrease the action of SPORANOX® oral
solution and are not recommended unless your doctor feels it is
necessary:
- carbamazepine, phenobarbital, phenytoin used to treat epilepsy
- isoniazid, rifabutin, rifampicin used to treat tuberculosis
- efavirenz, nevirapine used to treat HIV/AIDS.
You should therefore always tell your doctor if you are using any
of these products so that the appropriate measures can be taken.
Wait at least 2 weeks after stopping these medications before
taking SPORANOX® oral solution.
Medications not recommended unless your doctor feels it is
necessary:
- axitinib, dabrafenib, dasatinib, ibrutinib, nilotinib, sunitinib, trabectedin; certain medications used in the treatment of cancer;
- axitinib, bosutinib, cabazitaxel, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, trabectedin, trastuzumab emtansine, vinca alkaloids used in the treatment of cancer
- riociguat, sildenafil, tadalafil, when used to treat pulmonary hypertension (increased blood pressure in the blood vessels in the lungs)
- everolimus, rapamycin (also known as sirolimus), usually given after an organ transplant
- rifabutin to treat tuberculosis
- conivaptan, tolvaptan; to treat low blood sodium
- apixaban, rivaroxaban to slow down blood clotting
- alfuzosin, silodosin to treat Benign Prostatic enlargement
- aliskiren to treat hypertension
- carbamazepine to treat epilepsy
- colchicine to treat gout
- darifenacin to treat urinary incontinence
- fentanyl a strong medication to treat pain
- vorapaxar used to treat heart attacks or strokes
- salmeterol to improve breathing
- simeprevir to treat Hepatitis C Virus
- tamsulosin to treat male urinary incontinence
- vardenafil to treat erectile dysfunction
- Saccharolmyces boulardii to treat diarrhea
- lumacaftor/ ivacaftor to treat Cystic Fibrosis.
Wait at least 2 weeks after stopping these medications before
taking SPORANOX® oral solution.
Medications that may require a dose change (for either
SPORANOX® oral solution or the other medication):
- ciprofloxacin, clarithromycin, erythromycin, antibiotics
- bosentan, digoxin, nadolol and certain calcium-channel blockers including verapamil; that act on the heart or blood vessels
- guanfacine to treat Attention Deficit Hyperactivity Disorder
- diltiazem to treat hypertension
- cilostazol, coumarins (e.g., warfarin), dabigatran; that slow down blood clotting
- budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone (medications given by mouth, injection or inhalation for conditions such as inflammations, asthma, and allergies)
- cyclosporine, tacrolimus, temsirolimus, which are usually given after an organ transplant
- cobicistat, boosted elvitegravir, tenofovir disoproxil fumarate (TDF), maraviroc, and protease inhibitors: indinavir, ritonavir, boosted darunavir, ritonavir-boosted fosamprenavir, saquinavir; used in the treatment of HIV/AIDS
- dienogest, ulipristal used as contraceptives
- daclatasvir, telaprevir used in the treatment of Hepatitis C Virus
- bortezomib, brentuximab vedotin, busulphan, erlotinib, gefitinib, idelalisib, imatinib, ixabepilone, nintedanib, ponatinib, ruxolitinib, vandetanib; used in the treatment of cancer
- alprazolam, brotizolam, buspirone, midazolam IV, perospirone, ramelteon for anxiety or to help you sleep (tranquillizer)
- alfentanil, buprenorphine, oxycodone, sufentanil; strong medications to treat pain
- repaglinide, saxagliptin to treat diabetes
- aripiprazole, haloperidol, quetiapine, risperidone to treat psychosis
- zopiclone to treat insomnia
- aprepitant to treat nausea and vomiting during cancer treatment
- loperamide to treat diarrhea
- fesoterodine, imidafenacin, oxybutynin, solifenacin, tolterodine; to control irritated urinary bladder
- dutasteride to treat Benign Prostatic enlargement
- sildenafil, tadalafil to treat erectile dysfunction
- praziquantel; to treat fluke and tapeworms
- bilastine, ebastine, rupatadine; for allergy
- reboxetine, venlafaxine; to treat depression and anxiety
- quinine to treat malaria
- atorvastatin to lower cholesterol
- meloxicam to treat joint inflammation and pain
- cinacalcet; to treat an over active parathyroid
- mozavaptan to treat low blood sodium
- alitretinoin (oral formulation), to treat eczema
- cabergoline to treat Parkinsons Disease
- cannabinoids; to treat nausea and vomiting, weight loss for patients with immune system problems and muscle spasms in patients with Multiple Sclerosis
- ivacaftor to treat Cystic Fibrosis
Always tell your doctor, nurse or pharmacist if you are taking any other medications, either prescription or over-the- counter, herbal medications or natural health products.
Proper use of this medication
You should always take SPORANOX® oral solution without food.
You should not eat or drink for one hour after taking
SPORANOX® oral solution.
Do not use SPORANOX® oral solution for a condition for which
it was not prescribed. Do not give SPORANOX® oral solution to
other people, even if they have the same symptoms you have. It
may harm them.
Do not switch to SPORANOX® capsules without talking to your
doctor.
Usual dose
Your doctor will decide the right dose for you. Depending on
your infection, you will take SPORANOX® oral solution once or
twice a day for as long as prescribed by your doctor.
Use the dosing cup provided in your SPORANOX® package to
accurately measure the amount of solution needed.
SPORANOX® oral solution should be poured into the end of the
cup containing markings which indicate dosing amounts (2.5 mL,
5 mL and 10 mL). There are arrows on the sides of the dosing
cup showing you which end to pour the solution into. You should
swish the solution around in your mouth for approximately 20
seconds before swallowing it, and avoid rinsing your mouth after
taking it.
Overdose
Missed Dose
If you forget to take, or miss doses of SPORANOX® oral solution, ask your doctor what you should do with the missed doses. Do not double dose.
Side effects and what to do about them
The most common side effects that cause people to stop treatment
either for a short time or completely include: skin rash, high
triglyceride test results (fats in your blood), high liver test results,
and digestive system problems (such as nausea, bloating, and
diarrhea).
Other side effects that may occur with SPORANOX® treatment
include upset stomach, vomiting, abdominal pain, constipation or
excess gas in stomach, cough, fluid in the lungs, altered voice,
inflammation of the sinuses, inflammation of the nose, upper
respiratory tract infection, headache, dizziness, menstrual
disorders, erectile dysfunction, confusion, tremor, sleepiness,
fatigue, chills, muscle weakness or pain, painful joints, pain, chest
pain, swelling, generalized swelling, unpleasant taste, hair loss,
inflammation of the pancreas, fever, excessive sweating may also
occur.
Report any side effects to your doctor or pharmacist.
| Symptom / effect The following side effects are all uncommon: |
Talk with your doctor or pharmacist immediately Only if severe | Talk with your doctor or pharmacist immediately In all cases | Stop taking drug and call your doctor or pharmacist Only if immediately |
|---|---|---|---|
| Heart Problems | |||
| Develop Shortness of breath | ✔ | ||
| Unusual swelling of feet, ankles or legs | ✔ | ||
| Sudden weight gain | ✔ | ||
| Unusually tired | ✔ | ||
| Cough up white or pink phlegm | ✔ | ||
| Unusual fast heartbeats | ✔ | ||
| Begin to wake up at nights | ✔ | ||
| Liver Problems | |||
| Unusually tired | ✔ | ||
| Loss of appetite | ✔ | ||
| Nausea | ✔ | ||
| Abdominal pain | ✔ | ||
| Vomiting | ✔ | ||
| Yellow colour to skin or eyes | ✔ | ||
| Dark-coloured urine | ✔ | ||
| Pale stools | ✔ | ||
| Nerve Problems | |||
| Tingling | ✔ | ||
| Numbness | ✔ | ||
| Reduced sense of touch | ✔ | ||
| Weakness in the limbs | ✔ | ||
| Pain | ✔ | ||
| Pins and needles | ✔ | ||
| Prickling or burning | ✔ | ||
| Hypersensitivity | |||
| Skin rash | ✔ | ||
| Itching | ✔ | ||
| Hives | ✔ | ||
| Difficulty breathing or shortness of breath and/or | ✔ | ||
| Swelling of the face | ✔ | ||
| Severe Skin Disorder | |||
| Widespread rash with peeling skin and blisters in the mouth, eyes and genitals or | ✔ | ||
| Rash with small pustules or blisters | ✔ | ||
| Other | |||
| Blurry or double vision | ✔ | ||
| Ringing in ears | ✔ | ||
| Oversensitivity to sunlight | ✔ | ||
| Loss of ability to control urine or urinate much more than usual | ✔ | ||
| Hearing loss symptomsa | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking SPORANOX® oral solution, contact your doctor or pharmacist.
How to store
Keep all medications, including SPORANOX® oral solution, out of the reach and sight of children.
Store SPORANOX® oral solution at room temperature (15ºC - 25ºC). This medication can be kept for only a limited time. Discard any remaining unused SPORANOX® oral solution three months after opening the bottle
Reporting 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 MedEffect® (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada)
- 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 1908C
Ottawa, ON 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.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada
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 questions, concerns or the full Product Monograph, go to
:www.janssen.com/canada
or contact the manufacturer, Janssen Inc., at:
1-800-567-3331 or 1-800-387-8781.
This leaflet was prepared by
Janssen Inc.
Toronto, Ontario M3C 1L9
Last revised: December 5, 2018