aridol
Aridol (Mannitol) is an osmotic diuretic used to treat Anuria, Brain Edema, Ocular Hypertension, Oliguria.
Mannitol · by Pharmaxis Europe
Every strength approved under this FDA application (2)
- Aridol (this page)Mannitol 10MG · Mannitol 20MG · Mannitol 40MG
- Aridol Kit
Key facts
- Active ingredient
- Mannitol
- Drug class
- Osmotic Diuretic
- Form
- Kit
- Strength
- Mannitol 10MG · Mannitol 20MG · Mannitol 40MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- anuria, brain edema, ocular hypertension
- Manufacturer
- Pharmaxis Europe
- FDA application
- NDA022368
- FDA boxed warning
- Yes — see the boxed warning
What is Aridol?
From the FDA label:D-mannitol (referred to throughout as mannitol), the active ingredient in ARIDOL is a hexahydric alcohol, that is a sugar alcohol, with the following chemical name (2R,3R,4R,5R)-hexane-1,2,3,4,5,6-hexol and chemical structure: Mannitol is a white or almost white crystalline powder of free-flowing granules with an empirical formula of C 6 H 14 O 6 and molecular weight of 182.2. Mannitol is freely soluble in water, and very slightly soluble in alcohol. Mannitol shows polymorphism. The ARIDOL Bronchial Challenge Test Kit contains one single patient use dry powder inhaler and 3 consecutively numbered foil blister packs containing a total of 19 capsules of mannitol for oral inhalation. All except the 0 mg printed hard gelatin capsules contain dry powder mannitol for oral inhalation. The accompanying dry powder inhaler is a plastic device used for inhaling the capsules. All doses are to be administered using the same device supplied with each kit without washing or sterilizing the device at anytime during the test. To use the delivery system, a mannitol capsule is placed in the well of the inhaler, and the capsule is pierced by pressing and releasing the buttons ONCE on the side of the device. The mannitol dry powder is dispersed into the air stream when the patient inhales deeply through the mouthpiece. There are no inactive ingredients in the mannitol capsules supplied with the…
How to use
For Oral Inhalation Use Only One ARIDOL test kit contains dry powder mannitol capsules in graduated doses and a single patient use inhaler necessary to perform one bronchial challenge test. ( 2 ) The mannitol capsules supplied in the ARIDOL kit are to be used with the single patient use inhaler device ( 2 ). Discard the inhaler after use. Capsule contents are to be inhaled in increasing dosage until either a positive response (15% reduction in FEV 1 from baseline or a 10% incremental reduction in FEV 1 between consecutive doses) is achieved or all capsules are inhaled (maximum total dose 635mg) ( 2 ) Starting and maximum dose is the same for children (≥6 years old) and adults ( 2 ) 2.1 Bronchial Challenge Test Kit Overview ARIDOL is a bronchial challenge test kit containing the required capsules of dry powder mannitol for oral inhalation in graduated doses with the supplied single patient use inhaler necessary to perform one bronchial challenge test. Do not swallow ARIDOL capsules. The airway response to bronchial challenge testing with ARIDOL is measured using forced expiratory volume in one second (FEV 1 ). Prior to bronchial challenge testing with ARIDOL, standard spirometry should be performed and the reproducibility of the resting FEV 1 established. 2.2 Administration Instructions An overview of the testing procedure can be found below. The ARIDOL bronchial challenge test…
Side effects
The following clinically significant adverse reaction is described elsewhere in the labeling: • Severe Bronchospasm [ see Warnings and Precautions ( 5.1 )]. Most common adverse reactions (rate ≥1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea, chest discomfort, wheezing, retching and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Methapharm, Inc. at 1-866-701-4636 or email at [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety population for the ARIDOL bronchial challenge test consisted of 1,082 subjects (577 females and 505 males) including patients with asthma, symptoms suggestive of asthma, and healthy individuals from 6 to 83 years of age who participated in the two clinical trials (Studies 1 and 2). The racial distribution of subjects was 84% Caucasian, 5% Asian, 4% Black, and 7% Other. Pediatric and adolescents patients comprised 23% of the total study population with 118 pediatric patients aged 6-11 years and 128 adolescents aged 12-17 years. Adverse reactions were reported at the…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm. Bronchial challenge testing with ARIDOL is for diagnostic purposes only. Bronchial challenge testing with ARIDOL should only be conducted by trained professionals under the supervision of a physician familiar with all aspects of the bronchial challenge test and the management of acute bronchospasm. Medications (such as short-acting inhaled beta-agonist) and equipment to treat severe bronchospasm must be present in the testing area. If severe bronchospasm occurs it should be treated immediately by administration of a short-acting inhaled beta-agonist. Because of the potential for severe bronchoconstriction, the bronchial challenge testing with ARIDOL should not be performed in any patient with clinically apparent asthma or very low baseline pulmonary function tests (e.g., FEV 1 <1-1.5 liters or <70% of the predicted values) [ see Warnings and Precautions ( 5.1 ) ]. WARNING: RISK OF SEVERE BRONCHOSPASM See full prescribing information for complete boxed warning. Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm. Bronchial challenge testing with ARIDOL is for diagnostic purposes only. Only trained professionals under the supervision of a physician who are familiar with the management of acute bronchospasm should perform bronchial challenge testing with ARIDOL. Medications (such as short-acting inhaled beta-agonist) and equipment to treat severe bronchospasm must be present in the testing area. Because of the potential for severe bronchoconstriction, bronchial challenge testing with ARIDOL should not be performed in any patient with clinically apparent asthma or very low baseline pulmonary function tests (e.g., FEV 1 <1-1.5 liters or <70% of the predicted values) ( 5.1 )
Warnings
Important safety information
& PRECAUTIONS Severe bronchospasm: ARIDOL may cause severe bronchospasm in susceptible patients. Administer by trained professionals under the supervision of a physician. Medications and equipment to treat severe bronchospasm must be present in the testing area. ( 5.1 ) Subjects with co-morbid conditions: Use with caution in patients with conditions that may increase sensitivity to the bronchoconstricting or other potential effects of ARIDOL such as: severe cough, ventilatory impairment, unstable angina, or active upper or lower respiratory tract infection that may worsen with use of a bronchial irritant. ( 5.2 ) 5.1 Severe Bronchospasm Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm in susceptible patients. The test should only be conducted by trained professionals under the supervision of a physician familiar with all aspects of the bronchial challenge test and the management of acute bronchospasm. Patients should not be left unattended during the bronchial challenge test. Medications and equipment to treat severe bronchospasm must be present in the testing area. If a patient has a ≥10% reduction in FEV 1 (from pre-challenge FEV 1 ) on administration of the 0 mg capsule, the ARIDOL Bronchial Challenge Test should be discontinued and the patient should be given a dose of a short-acting inhaled beta-agonist and monitored accordingly. Patients with either a positive response to bronchial challenge testing with ARIDOL or significant respiratory symptoms should receive a short-acting inhaled beta-agonist. Patients should be monitored until fully recovered to within baseline. 5.2 Subjects with Co-morbid Conditions Bronchial challenge testing with ARIDOL should be performed with caution in patients with conditions that may increase sensitivity to the bronchoconstricting or other potential effects of ARIDOL such as severe cough, ventilatory impairment, spirometry-induced bronchoconstriction, hemoptysis of unknown origin, pneumothorax, recent abdominal or thoracic surgery, recent intraocular surgery, unstable angina, or active upper or lower respiratory tract infection.
Who should not take Aridol
ARIDOL is contraindicated in: Patients with known hypersensitivity to mannitol or to the gelatin used to make the capsules Patients with conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers. Some examples include: aortic or cerebral aneurysm, uncontrolled hypertension, recent myocardial infarction or cerebral vascular accident [ see Warnings and Precautions ( 5.2 )]. Known hypersensitivity to mannitol or to the gelatin used to make the capsules ( 4 ) Conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers ( 4 )
Overdose — what happens if you take too much
Susceptible persons may experience excessive bronchospasm from an overdosage. If such bronchospasm occurs, immediately administer a short-acting inhaled beta-agonist and other medical treatments such as oxygen, as necessary.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No formal drug-drug interaction studies were conducted with mannitol, the active ingredient in ARIDOL.
Drug class
How this class works, per Mannitol - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Aridol ranks — best-rated osmotic diuretic for:
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Aridol treat?
- Aridol (Mannitol) may be used to treat anuria, brain edema, ocular hypertension, oliguria, ascites, cardiac edema, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Aridol work?
- Aridol is a osmotic diuretic. Osmotic diuretics like mannitol are sugar-like molecules that the kidney filters but cannot reabsorb, so they stay in the urine and pull water along with them like a magnet. This boosts urine output and can also draw excess fluid out of swollen tissues, such as a swollen brain.
- Is there a coupon or discount for Aridol?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Aridol. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Aridol?
- Aridol is marketed by Pharmaxis Europe. You can see Pharmaxis Europe's full profile, rating, and other products on pharmaranks.
- Is Aridol a brand-name or generic drug?
- Aridol is a brand-name product with the active ingredient Mannitol.
- Is Aridol available over the counter?
- No. Aridol is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Aridol come in?
- Aridol is currently marketed as kit, per the FDA's National Drug Code Directory.
- What class of drug is Aridol?
- Aridol is classified as osmotic diuretic, per the FDA's Established Pharmacologic Class.
- Is Aridol FDA-registered?
- Aridol is on record with the U.S. FDA under application number NDA022368. You can verify this on its official FDA label.
- Is Aridol safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Aridol. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Aridol?
- Aridol's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reaction is described elsewhere in the labeling: • Severe Bronchospasm [ see Warnings and Precautions ( 5.1 )]. Most common adverse reactions (rate ≥1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
aridol kit
Mannitol
bronchitol
Mannitol
mannitol 10% in plastic container
Mannitol
mannitol 15% in plastic container
Mannitol
mannitol 20% in plastic container
Mannitol
mannitol 5% in plastic container
Mannitol
Compare Aridol head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
aridol
New