Description
Mannitol inhalation is used in patients 6 years of age and older to help diagnose asthma. It is used in a procedure called bronchial challenge test to help your doctor measure the effect of this medicine on your lungs and check if you have difficulty with breathing.
Mannitol inhalation is also used as an add-on maintenance treatment to improve lung function in patients with cystic fibrosis. Your doctor will perform the Bronchitol® Tolerance Test (BTT) before using Bronchitol®.
Aridol™ is to be given only by or under the immediate supervision of your doctor.
Bronchitol® is available only for patients who have passed the Bronchitol® Tolerance Test (BTT). Do not use this medicine if you failed to pass the BTT.
This product is available in the following dosage forms:
- Capsule
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Aridol™ in children 6 years of age and older. However, mannitol inhalation should not be given to children younger than 6 years of age.
Bronchitol® is not indicated for use in children. Safety and efficacy have not been established in children with cystic fibrosis.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of mannitol inhalation in the geriatric population. Safety and efficacy have not been established.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Arsenic Trioxide
- Droperidol
- Levomethadyl
- Sotalol
- Tobramycin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Licorice
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Angina (severe chest pain), unstable or
- Cough, severe or
- Hemoptysis (coughing up blood) or
- Infection (eg, upper and lower respiratory tract) or
- Lung disease or other breathing problems (eg, ventilatory impairment) or
- Pneumothorax (air or gas in the chest cavity) or
- Spirometry-induced bronchoconstriction (breathing problem during the spirometry test) or
- Surgery (eg, stomach, chest, or eyes), recent—Use with caution. May make these conditions worse.
- Aortic or cerebral aneurysm (heart or blood vessel problem) or
- Heart attack, recent or
- Hypertension (high blood pressure), uncontrolled or
- Stroke, recent—Should not be used in patients with these conditions. May cause bronchospasm.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Aridol™ is used with a special inhaler which will measure the effect of this medicine on your lungs. It is given by a doctor or other trained health professional who will be with you during the test. After you have completed the test, your doctor will know the result right away (positive or negative for asthma).
Aridol™ is a test kit containing one single patient use inhaler and 3 blister packs containing 19 capsules of mannitol for inhalation in marked doses to perform one bronchial challenge test.
Do not put the capsules in your mouth or swallow them.
To perform the test:
- Before doing the bronchial challenge test, your doctor may ask you to perform a breathing or lung test (eg, spirometry test).
- A nose clip will then be put on your nose so you will only able to breathe in and out of your mouth.
- Place 0 mg capsule into the inhaler. Press the side buttons of the inhaler once to puncture the capsule.
- To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the inhaler just in front of your mouth.
- Open your mouth and breathe in slowly and deeply (like yawning).
- Hold your breath for about 5 seconds, then breathe out slowly before removal of the nose clip.
- You will be asked to repeat the above steps up to 8 times (total of 9 increasing doses of Aridol™). This is to measure the effect of Aridol™ in your lungs.
- Once you have finished the test, you will be given a short-acting inhaler to help you breathe (for patients who have a positive result).
- Throw away the inhaler after using.
Bronchitol® should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Bronchitol® should only be used with the provided inhaler. To use the Bronchitol® inhaler:
- Clean and dry your hands properly. Remove the cap and twist open the inhaler by turning the mouthpiece to the right.
- Take one capsule out of the blister pack and put it in the chamber. Do not place the capsule into the mouthpiece of the inhaler.
- Hold the inhaler upright and turn the mouthpiece to the left until it locks in place.
- Push both piercing buttons at the same time. Release both piercing buttons at the same time. Keep the inhaler upright and never keep piercing buttons pressed.
- Breathe out fully. Do not breathe out into the inhaler. Close your lips around the mouthpiece and take a steady deep breath in through your mouth. Do not breathe through your nose. Remove inhaler from your mouth. Hold your breath for 5 seconds before breathing out. You should hear a rattling sound while breathing in.
- After inhaling contents of all 10 capsules, close the mouthpiece and place cap on the inhaler.
Your first dose of Bronchitol® is given by your doctor during the Bronchitol® Tolerance Test.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For inhalation dosage form (capsules):
- For cystic fibrosis
- Adults—400 milligrams (mg) (10 capsules of 40 mg) two times a day, taken once in the morning and once in the evening (at least 2 to 3 hours before bedtime). Use an inhaled short-acting bronchodilator, 5 to 15 minutes before every dose of this medicine.
- Children—Use is not recommended.
- For cystic fibrosis
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Discard and replace the Bronchitol® inhaler after 7 days of use. If the inhaler needs to be washed, allow it to air dry before next use.
Precautions
Your doctor will check you closely while doing the bronchial challenge test or Bronchitol® Tolerance Test. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.
This medicine may cause severe bronchospasm. Tell your doctor right away if you are having a cough or trouble breathing after receiving this medicine. Your doctor will give you a short-acting inhaler right away to treat your symptoms.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Cough
- coughing or spitting up blood
- sore throat
Less common
- Chest discomfort or tightness
- dry heaves
- fever
- runny nose
- trouble breathing
- vomiting
Incidence not known
- Gagging
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Headache
Less common
- Difficulty in moving
- dizziness
- muscle pain or stiffness
- nausea
- pain in the joints
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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