Aridol Bronchial Challenge Test Kit

ARIDOL BRONCHIAL CHALLENGE TEST KIT- mannitol
Methapharm, Inc.

WARNING: RISK OF SEVERE BRONCHOSPASM

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., FEV1 <1-1.5 liters or <70% of the predicted values) [see Warnings and Precautions (5.1) ].

1 INDICATIONS AND USAGE

ARIDOL is indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma.

Limitations of Use:
ARIDOL is not a standalone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be used only as part of a physician’s overall assessment of asthma.

2 DOSAGE AND ADMINISTRATION

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 (FEV1 ).

Prior to bronchial challenge testing with ARIDOL, standard spirometry should be performed and the reproducibility of the resting FEV1 established.

2.2 Administration Instructions

An overview of the testing procedure can be found below. The ARIDOL bronchial challenge test should only be used with the provided inhaler. All remaining unused (opened and unopened) blister packs and the inhaler should be properly discarded at the completion of the test. See the ARIDOL Bronchial Challenge Test Kit instructions for complete instructions on the dosing and spirometry procedures.

a. A nose clip may be used if preferred. If so, apply nose clip to the patient and direct the patient to breathe through the mouth

b. Insert 0 mg capsule into inhalation device. Puncture capsule by depressing buttons on side of device slowly, and ONCE ONLY (a second puncture may fragment the capsules)

c. The patient should exhale completely, before inhaling from device in a controlled deep inspiration

d. At the end of deep inspiration, start 60 second timer, subject should hold breath for 5 seconds and exhale through mouth before removal of nose clip

e. At the end of 60 seconds, measure the FEV1 in duplicate (the measurement after inhaling the 0 mg capsule is the baseline FEV1 )

f. Repeat steps a-e following the mannitol capsule dose steps from Table 1 below until the patient has a positive response or 635 mg of mannitol has been administered (negative test)

Table 1: Mannitol dose steps for bronchial challenge testing with ARIDOL

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

2.3 Bronchial Challenge Test Response and Patient Management

A positive response is achieved when the patient experiences a 15% reduction in FEV1 from (0 mg) baseline (or a 10% incremental reduction in FEV1 between consecutive doses). The test result is expressed as a PD15 .

Patients with either a positive response to bronchial challenge testing with ARIDOL or significant respiratory symptoms should receive a standard dose of a short-acting inhaled beta-agonist and monitored until fully recovered to within baseline.

3 DOSAGE FORMS AND STRENGTHS

Inhalation powder: 0 mg, 5 mg, 10 mg, 20 mg, and 40 mg of mannitol dry powder per capsule in a bronchial challenge test kit.

Each kit contains one, single patient use, dry powder inhaler device and 3 consecutively numbered foil blister packs containing a total of 19 capsules of mannitol for oral inhalation as described below:


Blister pack “1”:

  • Marked 1 — 1 x empty clear capsule printed with two white bands
  • Marked 2 — 1 x 5 mg white/clear capsule printed with 5 mg
  • Marked 3 — 1 x 10 mg yellow/clear capsule printed with 10 mg
  • Marked 4 — 1 x 20 mg pink/clear capsule printed with 20 mg

Blister pack “2”:

  • Marked 5 — 1 x 40 mg red/clear capsule printed with 40 mg
  • Marked 6 — 2 x 40 mg red/clear capsules printed with 40 mg
  • Marked 7 — 4 x 40 mg red/clear capsules printed with 40 mg

Blister pack “3”:

  • Marked 8 — 4 x 40 mg red/clear capsules printed with 40 mg
  • Marked 9 — 4 x 40 mg red/clear capsules printed with 40 mg

4 CONTRAINDICATIONS

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)].

5 WARNINGS & PRECAUTIONS

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 FEV1 (from pre-challenge FEV1 ) 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.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.