Details for: ARIDOL
Company: PHARMAXIS LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02489562 | ARIDOL | MANNITOL; MANNITOL; MANNITOL; MANNITOL | 5 MG / CAP; 10 MG / CAP; 20 MG / CAP; 40 MG / CAP | POWDER | INHALATION |
| 02489562 | ARIDOL | MANNITOL; MANNITOL; MANNITOL; MANNITOL | 5 MG / CAP; 10 MG / CAP; 20 MG / CAP; 40 MG / CAP | KIT | INHALATION |
Summary Reports
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
Aridol is a bronchial challenge test. It is used:
- in patients 6 years of age and older
- to check how your airways (bronchi) respond when you do not have typical asthma symptoms
Aridol is used as part of the doctor’s overall assessment for asthma.
What it does
Aridol contains mannitol. When you breath in Aridol, it:
- will make airways narrower in people who do have asthma. This may make it harder to breathe.
- will not make airways narrower in people who do not have asthma. They will still be able to breathe normally.
When it should not be used
Do not use Aridol if you or your child:
- are allergic to mannitol or to any ingredient in the formulation (see non-medicinal list above).
- now have or used to have a swollen or weakened blood vessel around the heart or brain (aneurysm).
- have high blood pressure which is not controlled by medicine.
- have had a heart attack.
- you have had a stroke in the last 6 months.
- you have recently had eye surgery.
What the medicinal ingredient is
Medicinal ingredients: Mannitol
What the non-medicinal ingredients are
Non-medical ingredients: gelatin, red iron oxide (20 mg and 40 mg capsule) , titanium dioxide, yellow iron oxide (10 mg capsule)
What dosage form it comes in
Aridol comes in a kit that contains:
- capsules containing a dry powder for oral inhalation: 0 mg, 5 mg, 10 mg, 20 mg and 40 mg
- an Aridol device (inhaler) that is only to be used with capsules provided in the kit
Warnings and precautions
Serious Warnings and Precautions
WARNING: RISK OF SEVERE BRONCHOSPASM: Mannitol, the active ingredient in Aridol, acts as bronchoconstrictor and may cause severe bronchospasm (a sudden narrowing of the airway).
Bronchial challenge testing with Aridol:
- is for diagnostic purposes only
- should only be given to you or your child by trained healthcare professionals under the supervision of a doctor who is familiar:
- with all aspects of the challenge test and
- with the management of severe bronchospasm. The healthcare professional performing the test must have medications and equipment to treat severe bronchospasms in the testing area.
You or your child should not take this test if you or your child has asthma or have very low baseline pulmonary function test results. Your healthcare professional will do a test to check your lung function before giving you or your child Aridol.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Aridol. Talk about any health conditions or problems you may have, including if you or your child:
- have a severe cough
- have kidney problems
- have reduced lung capacity. This will be measured by a spirometry test (where you blow forcefully into a tube) given to you by your healthcare professional before you start the bronchial challenge test
- have previously experienced difficulty in breathing, or have wheezed or coughed during a spirometry test
- are coughing up blood
- if you have air in the pleural space between the chest wall and the lungs, causing chest pain and shortness of breath (pneumothorax)
- recently had surgery on your stomach
- recently had chest surgery
- recently had surgery on your spine
- have chest pain (angina)
- had or have a respiratory tract infection
- are pregnant
- are breast-feeding
Other warnings you should know about:
Aridol and other medicines: Some medicines may affect how you respond to Aridol. You may need to stop taking them before the test. Tell your doctor about all the medicines you or your child are taking.Your doctor will tell you which ones to stop taking, and when to stop taking them.
Aridol with food and drink: Do not drink coffee, tea or cola, eat chocolate or any other foods containing caffeine 12 hours before the test.
Exercise: Vigorous exercise should be avoided 12 hours before the test.
Smoking: It is recommended that you do not smoke for at least 6 hours before the test.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with Aridol:
- drugs used to treat asthma such as:
- Inhaled non-steriodal anti-inflammatory drugs (such as cromolyn sodium and nedocromil sodium)
- Short-acting beta2 agonists (such as salbutamol and terbutaline)
- Inhaled corticosteroids (such as such as beclomethasone, budesonide, ciclesonide, fluticasone)
- Inhaled corticosteriods plus long-acting beta2 agonists (such as fluticasone and salmeterol)
- Long-acting beta2 agonists (such as formoterol and vilanterol)
- Xanthines (such as theophylline and oxtriphylline)
- Leukotriene-receptor antagonists (such as montelukast sodium and zafirlukast)
- Drugs used to treat allergies:
- Inhaled corticoseroids (such as mometasone)
- Antihistamines (such as cetirizine, desloratatdine, fexofenadine and loratadine)
- Drugs used to treat chronic obstructive pulmonary disease (COPD)
- Short-acting muscarinic antagonists (such as ipratropium bromide)
- Long-acting muscarinic antagonists(such as aclidinium, glycopyrronium,tiotropium and umeclidinium)
Proper use of this medication
Aridol is for oral inhalation only. DO NOT SWALLOW the capsules.
You or your child will be given Aridol using the inhaler provided in the kit by a doctor or another specially trained healthcare professional. They will:
- show you how to use the inhaler correctly.
- be with you throughout the test. You will not be left on your own.
Follow your healthcare professional’s instructions carefully. If you are unsure about any part of the test, or have questions about the medicine, please talk to the doctor or the trained healthcare professional performing the test.
During the test
- You or your child will be asked to sit comfortably on a chair
- Initially you or your child will be asked to do a spirometry test. This is a test where you blow forcefully into a tube. This test is done so your or your child’s healthcare professional can check lung function before starting the bronchial challenge test.
- A nose clip may then be put on your or your child’s nose so you will only be able to breathe in and out of your mouth.
- After breathing out fully, you or your child will be asked to deeply breathe in the Aridol medicine using the inhaler.
- You or your child will then hold your breath for five seconds before breathing out (away from the inhaler).
- The nose clip will be removed and you or your child will be asked to breathe normally.
- Next you or your child will be asked to blow forcefully into the tube again to measure the effect of Aridol on your lungs.
- Steps 3-7 may be repeated up to 9 times, with more and more Aridol depending on the effect Aridol has on your or your child's lungs, until the test is finished (see Table 1 for the doses that may be given to you or your child).
- 80 mg and 160 mg doses: you or your child will be given mulitple capsules to inhale for these doses. The healthcare professional will give you one capsule followed right away by the next one until the total dose has been inhaled.
- Inhaling a dry powder can make you or your child cough and/or have a dry throat. You or your child may be given water to sip inbetween each dose and/or after the test is done.
After the test:
- You may be given a medicine to help you breathe
Usual Dose (adults and children 6 years of age and older):
Table 1 shows the doses of Aridol you or your child may be given during the test.
| Dose # | Dose (mg) | Cumulative Dose (mg) | Capsules per dose |
|---|---|---|---|
| 1 | 0 | 0 | 1 |
| 2 | 5 | 5 | 1 |
| 3 | 10 | 15 | 1 |
| 4 | 20 | 35 | 1 |
| 5 | 40 | 75 | 1 |
| 6 | 80 | 155 | 2 X 40 mg |
| 7 | 160 | 315 | 4 X 40 mg |
| 8 | 160 | 475 | 4 X 40 mg |
| 9 | 160 | 635 | 4 X 40 mg |
Overdose
Tell the person performing the test right away if you think you have taken too much Aridol. It may feel like you cannot breathe, you may become wheezy or cough. You may be given oxygen and medication to help you breathe.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Aridol. If you experience any side effects not listed here, contact your healthcare professional.
- headache
- cough
- sore or irritated throat
- nausea (feeling sick)
- upper stomach pains
- vomiting
- retching
- dizziness
- runny nose
- sneezing
- discomfort when swallowing
- sweating
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| UNCOMMON | |||
| Asthma: difficulty breathing and coughing, chest tightness, wheezing or whistling sound when breathing | ✔ | ||
| Tighness in your chest | ✔ | ||
| Dyspnea: (shortness of breath) | ✔ | ||
| Wheezing | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Aridol should be stored below 25°C.
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:
- Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
- Call 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
If you want more information about Aridol:
- Talk to your doctor or pharmacist.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the distributors website or by calling 1-800-287-7686
This leaflet was prepared by Pharmaxis Ltd.
Last Revised June 12, 2019