Aridol

Critical Information

Safety Information

Essential safety guidelines for healthcare professionals

Important Safety Information

INDICATION: Aridol® (mannitol inhalation powder) is indicated for the assessment of bronchial hyperresponsiveness in individuals who do not have clinically apparent asthma.

CONTRAINDICATIONS

Severe airway obstruction (FEV₁ <50% predicted or <1.0 L)
Recent MI or stroke (within 3 months)
Uncontrolled hypertension
Known aortic or cerebral aneurysm

WARNINGS & PRECAUTIONS

May cause severe bronchospasm
Emergency equipment must be available
Continuous monitoring required
Qualified personnel must be present

View Full Prescribing Information

Adverse Reactions

Most Common Adverse Reactions (incidence ≥5%):

32%

Headache

21%

Throat Irritation

10%

Nausea

Cough

Chest Discomfort

Usage Guidelines

Comprehensive administration protocols and best practices

Administration Protocol

Patient Preparation

Medication Withholding

Withhold bronchodilators per protocol guidelines (SABA: 4hrs, LABA: 24hrs)

Baseline Spirometry

Perform baseline FEV₁ measurement (must be ≥70% predicted)

Patient Education

Explain procedure, potential side effects, and emergency protocols

Equipment Check

Verify emergency equipment and bronchodilator availability

Test Administration

Dose Administration

Administer capsules in ascending doses (0mg to 160mg)

Spirometry Measurement

Measure FEV₁ 60 seconds after each dose administration

Test Termination

Stop test when FEV₁ falls ≥15% from baseline or max dose reached

Post-Test Care

Administer bronchodilator and monitor until FEV₁ returns to baseline

Standard Dosing Schedule

Step	Dose (mg)	Cumulative (mg)	Action
0	0	0	Empty capsule (baseline)
1	5	5	Measure FEV₁ after 60 seconds
2	10	15	Measure FEV₁ after 60 seconds
3	20	35	Measure FEV₁ after 60 seconds
4	40	75	Measure FEV₁ after 60 seconds
5	80	155	Measure FEV₁ after 60 seconds
6	160	315	Measure FEV₁ after 60 seconds
7	160	475	Measure FEV₁ after 60 seconds
8	160	635	Final dose (if needed)

Important: Test is positive if FEV₁ falls ≥15% from baseline. Discontinue test immediately when positive response achieved. Maximum cumulative dose is 635mg.

Regulatory Disclaimers

Important regulatory information and compliance statements

FDA Approval

Aridol® (mannitol inhalation powder) is approved by the U.S. Food and Drug Administration (FDA) for the assessment of bronchial hyperresponsiveness. This product is manufactured in FDA-registered facilities under strict quality control standards and Good Manufacturing Practices (GMP).

NDA Approval | Manufactured under cGMP standards

For Healthcare Professionals Only

This website and its contents are intended exclusively for healthcare professionals. The information provided is not intended for use by patients or the general public. Aridol is a prescription medical device that must be administered only by qualified healthcare professionals with appropriate training in bronchial provocation testing. Patients should consult their healthcare provider for medical advice.

Full Prescribing Information

This website provides selected important information only. Healthcare professionals must refer to the complete Prescribing Information and Medication Guide before prescribing or administering Aridol. The full prescribing information includes comprehensive details on indications, dosing, contraindications, warnings, precautions, adverse reactions, and drug interactions.

Download Full Prescribing Information (PDF)

Adverse Event Reporting

Healthcare professionals and patients are encouraged to report adverse events or side effects. Reports can be submitted to Aridol Pharmaceuticals or the FDA MedWatch program.

Company Reporting

1-800-XXX-XXXX

safety@aridol.com

FDA MedWatch

1-800-FDA-1088

www.fda.gov/medwatch

Legal Disclaimer

The information provided on this website is for informational purposes only and is not intended to substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a qualified healthcare provider with any questions regarding a medical condition or treatment. Aridol Pharmaceuticals makes no representations or warranties about the accuracy, reliability, completeness, or timeliness of the information provided. Use of this website does not create a physician-patient relationship. Individual results may vary. This information is not intended to recommend any product for off-label use.

Off-Label Use Notice

Aridol is approved for specific indications as outlined in the FDA-approved labeling. Any use of Aridol for indications not specifically approved by the FDA constitutes off-label use. Healthcare professionals should use their clinical judgment when considering off-label use and should be aware that off-label uses are not supported by the same level of evidence as FDA-approved indications. Patients should be informed when products are being prescribed for off-label uses.