Patient Medication Information: uses, side effects, how to take - Jamp Itraconazole Oral Solution
Serious Warnings and Precautions
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What is JAMP Itraconazole Oral Solution used for?
JAMP Itraconazole Oral Solution is a prescription medicine used to treat fungal infections of the mouth and throat in:
- adult HIV-positive patients
- patients with a weakened immune system.
How does JAMP Itraconazole Oral Solution work?
JAMP Itraconazole Oral Solution goes into your bloodstream and travels to the area of the infection.
What are the ingredients in JAMP Itraconazole Oral Solution?
Medicinal ingredient: itraconazole.
Non-medicinal ingredients: caramel flavour, cherry flavour, hydrochloric acid,
hydroxypropyl-β- cyclodextrin, propylene glycol, purified water, sodium hydroxide, sodium saccharin, and sorbitol.
JAMP Itraconazole Oral Solution comes in the following dosage forms:
- Oral Solution 10 mg / mL
- You will receive JAMP Itraconazole Oral Solution in a glass bottle. This bottle will contain 150 mL of solution (10 mg itraconazole per millilitre solution), along with a measuring cup.
- One full measuring cup contains 10 mL of solution, equal to 100 mg of itraconazole.
Do not use JAMP Itraconazole Oral Solution if:
you have congestive heart failure, JAMP Itraconazole Oral Solution could make it worse.
- If your healthcare professional decides that you need JAMP Itraconazole Oral Solution, be sure to get immediate medical help if you experience signs of heart failure (see What are possible side effects from using JAMP Itraconazole Oral Solution?)
- you are taking certain medicines (see The following may interact with JAMP Itraconazole Oral Solution section).
- you have had an allergic reaction to itraconazole, any of the other ingredients in JAMP Itraconazole Oral Solution or the container it is provided in (see What are the ingredients in JAMP Itraconazole Oral Solution?).
JAMP Itraconazole Oral Solution is not for everyone. Your healthcare professional will decide if JAMP Itraconazole Oral Solution is the right medicine for you. Some patients should not take JAMP Itraconazole Oral Solution because they may have certain health problems or may be taking certain medicines that could lead to serious or life- threatening health problems.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JAMP Itraconazole Oral Solution. Talk about any health conditions or problems you may have, including if you:
have high or abnormal liver enzymes, liver disease or have experienced liver toxicity with other drugs.
- If you have liver problems, your dose of JAMP Itraconazole Oral Solution may have to be adjusted.
- have or have had heart disease, including congestive heart failure.
have a kidney problem.
- If you have a kidney disorder, your dose of JAMP Itraconazole Oral Solution may have to be adjusted.
- have a lung problem, including cystic fibrosis.
Other warnings you should know about:
Driving and Using Machines:
JAMP Itraconazole Oral Solution can sometimes cause dizziness, blurred / double vision, or hearing loss. If you have these symptoms, do not drive, or use machines.
Children and Adolescents (under 18 years of age):
JAMP Itraconazole Oral Solution is not recommended for use in children as scientific information on the use of itraconazole in children is limited.
Pregnancy
Do not take JAMP Itraconazole Oral Solution if you are pregnant or are planning to become pregnant If you are taking JAMP Itraconazole Oral Solution, do not plan to become pregnant within 2 months of finishing your treatment.
If you are pregnant and your healthcare professional decides you need urgent treatment with JAMP Itraconazole Oral Solution, they will discuss with you, the possible risks of taking this medicine during pregnancy.
Serious birth defects have been seen in animals and women treated with itraconazole during pregnancy. It is not known whether itraconazole caused these defects. A reliable form of barrier contraception must always be used even if you or your partner are using other methods of contraception such as the pill or other hormonal therapy (e.g., implants, injections). JAMP Itraconazole Oral Solution may remain in your blood for a time after therapy is stopped. Therefore, you should continue use of a reliable form of contraception for 2 months after stopping treatment with JAMP Itraconazole Oral Solution.
Breast-feeding
Do not take JAMP Itraconazole Oral Solution if you are breast-feeding or stop breast-feeding if you are taking JAMP Itraconazole Oral Solution.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
Serious Drug Interactions The following list of medicines must NOT be taken during your JAMP Itraconazole Oral Solution treatment: DO NOT take JAMP Itraconazole Oral Solution if you are taking any of the following medicines:
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If you have kidney or liver problems, DO NOT take JAMP Itraconazole Oral Solution while taking any of the following medicines:
Medicines that must NEVER be taken while you are on JAMP Itraconazole Oral Solution, if you have chronic lymphocytic leukemia/small lymphocytic lymphoma and you want to newly start this medicine or are making dose adjustments:
Wait at least 2 weeks after stopping JAMP Itraconazole Oral Solution before taking any of these medicines. |
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Some medicines must not be taken at the same time, and if certain medicines are taken at the same time, changes need to be made (to the dose, for example).
The following may interact with JAMP Itraconazole Oral Solution:
Medicines that can decrease the action of JAMP Itraconazole Oral Solution and are NOT recommended unless your healthcare professional 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
Always tell your healthcare professional if you are using any of these medicines so that the appropriate precautions can be taken.
Wait at least 2 weeks after stopping these medicines before taking JAMP Itraconazole Oral Solution.
Medicines NOT recommended unless your healthcare professional feels it is necessary:
- axitinib, bosutinib, cabazitaxel, cabozantinib, ceritinib, cobimetinib, crizotinib, dabrafenib, dasatinib, docetaxel, entrectinib, glasdegib, ibrutinib, lapatinib, nilotinib, olaparib, pazopanib, regorafenib, sunitinib, talazoparib, 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
- conivaptan, tolvaptan, to treat low blood sodium
- edoxaban 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
- tamsulosin to treat male urinary incontinence
- vardenafil to treat erectile dysfunction
- Saccharomyces boulardii to treat diarrhea
- Lumacaftor / ivacaftor to treat Cystic Fibrosis.
Wait at least 2 weeks after stopping these medicines before taking JAMP Itraconazole Oral Solution.
Medicines NOT recommended while you are on JAMP Itraconazole Oral Solution when you are on a stable dose of this medicine:
- venetoclax
Wait at least 2 weeks after stopping JAMP Itraconazole Oral Solution before starting this medicine unless your healthcare professional feels it is necessary.
Medicines that may require a dose change (for either JAMP Itraconazole Oral Solution or the other medicine):
- 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, glecaprevir / pibrentasvir; elbasvir / grazoprevir used in the treatment of Hepatitis C Virus
bortezomib, brentuximab vedotin, busulfan, erlotinib, gefitinib, idelalisib, imatinib,
- 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, netupitant; 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 Parkinson’s 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
- galantamine; to treat Alzheimer’s disease.
How to take JAMP Itraconazole Oral Solution:
You should always take JAMP Itraconazole Oral Solution on an empty stomach. Do NOT eat or drink for one hour after taking JAMP Itraconazole Oral Solution.
Do not use JAMP Itraconazole Oral Solution for a condition for which it was not prescribed. Do not give JAMP Itraconazole Oral Solution to other people, even if they have the same symptoms you have. It may harm them.
Do NOT switch to itraconazole capsules without talking to your healthcare professional
Usual dose:
Your healthcare professional will decide the right dose for you.
Depending on your infection, you will take JAMP Itraconazole Oral Solution once or twice a day for as long as instructed by your healthcare professional
Use the dosing cup provided to measure the amount of solution needed.
- JAMP Itraconazole Oral Solution should be poured into the end of the cup containing markings which indicate dosing amounts (2.5 mL, 5 mL, 10 mL, 15 mL and 20 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 about 20 seconds before swallowing it and avoid rinsing your mouth after taking it.
Overdose:
| If you think you, or a person you are caring for, have taken too much JAMP Itraconazole Oral Solution, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed dose:
If you miss a dose of JAMP Itraconazole Oral Solution, ask your healthcare professional what you should do. Do not take a double dose to make up for a missed dose.
What are possible side effects from using JAMP Itraconazole Oral Solution?
These are not all the possible side effects you may have when taking JAMP Itraconazole Oral Solution. If you experience any side effects not listed here, tell your healthcare professional
- high triglyceride test results (fats in your blood)
- high liver test results
- nausea
- upset stomach
- vomiting
- abdominal pain
- constipation
- excess gas in the stomach
- diarrhea
- 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
- chest pain
- generalized swelling
- unpleasant taste
- hair loss
- inflammation of the pancreas
- fever
- excessive sweating
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||
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| Only if severe | In all cases | ||||
| UNCOMMON | |||||
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 night. | √ | ||||
| Liver Problems: Unusually tired, loss of appetite, 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 | √ | ||||
| Blurry or double vision | √ | ||||
| Tinnitus (Ringing in ears) | √ | ||||
Photosensitivity (oversensitivity to sunlight) | √ | ||||
| Urinary Incontinence (loss of ability to control urine or urinate much more than usual) | √ | ||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
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| Only if severe | In all cases | |||
| Hearing loss symptomsa | √ | |||
a Cases of temporary or permanent hearing loss have been reported in patients taking JAMP Itraconazole Oral Solution.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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. |
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Storage:
Store JAMP Itraconazole Oral Solution at room temperature (15-25°C). This medicine can be kept for only a limited time. Discard any remaining unused JAMP Itraconazole Oral Solution one month after opening the bottle.
Keep out of reach and sight of children.
If you want more information about JAMP Itraconazole Oral Solution:
- 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: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by contacting the manufacturer at: 1-866-399-9091
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada