Details for: JAMP ITRACONAZOLE ORAL SOLUTION
Company: JAMP PHARMA CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02484315 | JAMP ITRACONAZOLE ORAL SOLUTION | 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
Jamp Itraconazole Oral Solution 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 Jamp Itraconazole Oral Solution. 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
Jamp Itraconazole Oral Solution goes into your bloodstream and travels to the area of the infection.
When it should not be used
- if you have congestive heart failure, Jamp Itraconazole Oral Solution could make it worse. If your doctor decides that you need Jamp Itraconazole Oral Solution , 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 Jamp Itraconazole Oral Solution (see What the nonmedicinal ingredients are)
What the medicinal ingredient is
The medicinal ingredient in Jamp Itraconazole 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
Jamp Itraconazole Oral Solution contains: hydroxypropyl-β- cyclodextrin, sorbitol, propylene glycol, hydrochloric acid, cherry flavour, caramel flavour, sodium saccharin, sodium hydroxide and water.
What dosage form it comes in
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)
Jamp Itraconazole Oral Solution treatment is not for
everyone. Your doctor will decide if Jamp
Itraconazole Oral Solution is the right treatment for
you. Some patients should not take Jamp Itraconazole
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 Jamp Itraconazole Oral Solution may have to be adjusted;
- If you have a kidney disorder, your dose of Jamp Itraconazole Oral Solution may have to be adjusted.
BEFORE you use Jamp Itraconazole 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 Jamp Itraconazole Oral Solution.
Since scientific information on the use of Jamp Itraconazole Oral Solution in children is limited, it is not recommended for use in children.
Pregnancy
Do not take Jamp Itraconazole Oral Solution if you are pregnant (unless your doctor knows you are pregnant and decides you need Jamp Itraconazole Oral Solution) or planning to become pregnant within 2 months after you have finished your treatment. 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 discontinue nursing if you are taking Jamp Itraconazole Oral Solution. Jamp Itraconazole Oral Solution 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 Jamp Itraconazole Oral
Solution.
Never take Jamp Itraconazole 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
- eliglustat to treat Gaucher disease type 1 (GD1)
- colchicine, used to treat gout
- fesoterodine or solifenacin when used to control irritated urinary bladder
Medications that can decrease the action of Jamp Itraconazole 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.
Wait at least 2 weeks after stopping these medications before taking Jamp Itraconazole Oral Solution.
Medications not recommended unless your doctor feels it is necessary:
- 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.
Medications that may require a dose change (for either Jamp Itraconazole Oral Solution or the other medication):
- ciprofloxacin, clarithromycin, erythromycin, antibiotics
- bosentan, digoxin, nadolol and certain calciumchannel 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
- galantamine; to treat Alzheimer’s disease.
Proper use of this medication
You should always take Jamp Itraconazole Oral
Solution without food. You should 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 Jamp Itraconazole capsules without
talking to your doctor.
Usual dose:
Your doctor 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 prescribed by your doctor.
Use the dosing cup provided in your Jamp
Itraconazole Oral Solution package to accurately
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 mL10 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 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 Jamp Itraconazole 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 Jamp
Itraconazole Oral Solution 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
the pancreas, fever, excessive sweating may also occur.
Report any side effects to your doctor or pharmacist.
| Symptom / effect | 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 immediately |
|---|---|---|---|
| Uncommon | |||
| 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 | ✔ | ||
| Unusually tired | ✔ | ||
| Loss of appetite | ✔ | ||
| Nausea | ✔ | ||
| Abdominal pain | ✔ | ||
| Vomiting | ✔ | ||
| Yellow colour to skin or eyes | ✔ | ||
| Dark-coloured urine | ✔ | ||
| Pale stools | ✔ | ||
| Tingling | ✔ | ||
| Numbness | ✔ | ||
| Reduced sense of touch | ✔ | ||
| Weakness in the limbs | ✔ | ||
| Pain | ✔ | ||
| Pins and needles | ✔ | ||
| Prickling or burning | ✔ | ||
| Skin rash | ✔ | ||
| Itching | ✔ | ||
| Itching | ✔ | ||
| Difficulty breathing or shortness of breath and/or | ✔ | ||
| Swelling of the face | ✔ | ||
| Widespread rash with peeling skin and blisters in the mouth, eyes and genitals or | ✔ | ||
| Rash with small pustules or blisters | ✔ | ||
| 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 | ✔ | ||
a Cases of temporary or permanent hearing loss have been reported in patients taking Jamp Itraconazole Oral Solution .
This not a complete list of side effects. For any unexpected effects while taking Jamp Itraconazole Oral Solution, contact your doctor or pharmacist.How to store
Keep all medications, including Jamp Itraconazole Oral Solution, out of the reach and sight of children.
StoreJampItraconazoleOral Solutionat room
temperature(15C - 25 C). This medication can be
kept for only a limited time.
Discard any remaining unused Jamp Itraconazole Oral
Solution one month after opening the bottle.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health- canada.html); The manufacturer’s website jamppharma .ca, or by calling 1-866-399-9091.
1310 rue Nobel,
Boucherville, Québec, J4B 5H3
Last revised: September 3, 2019