Description

The ARIDOL MANNITOL CAP KIT, developed by Arna Pharma Pty Ltd, serves as a specialized diagnostic tool designed to assess bronchial hyperresponsiveness. This kit plays a crucial role in supporting the diagnosis of asthma and exercise-induced asthma, intended for use in both adults and children aged six years and older.

Intended Use

• Professional Administration: The test is not a standalone diagnostic tool and should be administered by trained healthcare professionals under medical supervision.
• Complementary Assessment: It complements a physician's overall assessment rather than serving as a screening test for asthma.

Kit Components

The kit includes:

• Mannitol Capsules: 19 capsules in varying doses (0 mg, 5 mg, 10 mg, 20 mg, 40 mg) designed for oral inhalation.
• Inhaler Device: A single-use dry powder inhaler with distinctive red push buttons.
• Instruction Leaflet: Comprehensive guidance for proper administration.

Active Ingredient

The active ingredient, mannitol, is a sugar alcohol with the empirical formula C₆H₁₄O₆. It is presented as a white, crystalline powder that is freely soluble in water. The capsules are made from gelatin and are packaged in consecutively numbered foil blister packs.

Administration Protocol

The test involves stepwise inhalation of increasing doses of mannitol, with each dose followed by measuring the forced expiratory volume in one second (FEV₁). A positive response is indicated by a significant fall in FEV₁, prompting the administration of a bronchodilator and monitoring for recovery.

Indications and Contraindications

• Indications: Suitable for identifying bronchial hyperresponsiveness in patients without clinically apparent asthma.
• Contraindications: Not recommended for individuals with hypersensitivity to mannitol or gelatin, or those with conditions like unstable angina or recent heart attack.

Precautions

• Emergency Preparedness: Healthcare providers should be equipped to manage potential bronchospasm.
• Medication Management: Specific medications may need to be withheld before testing.

Common Adverse Reactions

Reported reactions include headache, throat irritation, nausea, cough, and dizziness. These should be carefully monitored during the test.

Storage Instructions

Store the kit below 25°C, away from sunlight, and do not freeze. The inhaler is intended for single use and should be discarded after each test.

Additional Requirements

Conducting the test requires additional equipment such as a spirometer, mouthpiece, nose clip, and emergency medical tools. Proper adherence to the protocol ensures accurate results and patient safety.