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Aridol

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Aridol

INDICATIONS

Mannitol, the active ingredient in ARIDOL (mannitol inhalation powder) , is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma.

Limitations of Use

ARIDOL (mannitol inhalation powder) is not a stand alone test or a screening test for asthma. Bronchial challenge testing with ARIDOL (mannitol inhalation powder) should be used only as part of a physician's

DOSAGE AND ADMINISTRATION

Basic Dosing Information

ARIDOL is a 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. The inhaler should be discarded after use.

Do not swallow ARIDOL (mannitol inhalation powder) capsules.

The airway response to bronchial challenge testing with ARIDOL (mannitol inhalation powder) is measured using forced expiratory volume in one second (FEV1).

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

An overview of the testing procedure can be found below. See the ARIDOL (mannitol inhalation powder) bronchial challenge test instructions for complete instructions on the dosing and spirometry procedures.

  1. A nose clip may be used if preferred. If so, apply nose clip to the subject and direct the subject to breathe through the mouth
  2. 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)
  3. The patient should exhale completely, before inhaling from device in a controlled rapid deep inspiration
  4. 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
  5. At the end of 60 seconds, measure the FEV1 in duplicate (the measurement after inhaling the 0 mg capsule is the baseline FEV1)
  6. 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 (mannitol inhalation powder)

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

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 (mannitol inhalation powder) or significant respiratory symptoms should receive a standard dose of a short acting inhaled beta-agonist and monitored until fully recovered to within baseline.

HOW SUPPLIED

Dosage Forms And Strengths

ARIDOL (mannitol inhalation powder) is 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
  • 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

Storage And Handling

ARIDOL (mannitol inhalation powder) is 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
  • 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

NDC-44178-XXX-XX

ARIDOL (mannitol inhalation powder) should be stored below 77°F (25°C) with excursions permitted between 59-86°F (15-30°C). [See USP Controlled Room Temperature]. Do not freeze. Do not refrigerate.

The ARIDOL (mannitol inhalation powder) 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. Be sure to read the accompanying ARIDOL (mannitol inhalation powder) bronchial challenge test kit instructions completely before test initiation. If you have any questions, contact the manufacturer support at 1-888-659-6396.

Manufactured by: Pharmaxis Ltd, Unit 2, 10 Rodborough Rd, Frenchs Forest NSW 2086, AUSTRALIA. Manufactured for: Pharmaxis, Inc. One East Uwchlan Avenue, Suite 405, Exton, PA 19341. 1-888-659-6396. www.aridol (mannitol inhalation powder) .info

Last reviewed on RxList: 10/29/2010
This monograph has been modified to include the generic and brand name in many instances.

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