ARIDOL BRONCHIAL CHALLENGE TEST KIT- mannitol kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A)

Available from:

Methapharm, Inc.

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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)]. Risk Summary There are no available human data regarding inhaled mannitol to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, no eviden

Product summary:

How Supplied ARIDOL 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 dry powder mannitol for oral inhalation as described below: Blister pack "1" : Blister pack "2" : Blister pack "3" : NDC-67850-552-01 Storage Store below 77°F (25°C) with excursions permitted between 59°F-86°F (15°C-30°C). [See USP Controlled Room Temperature]. Do not freeze. Do not refrigerate.

Authorization status:

New Drug Application

Summary of Product characteristics

ARIDOL BRONCHIAL CHALLENGE TEST KIT- MANNITOL
METHAPHARM, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARIDOL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARIDOL.
ARIDOL (MANNITOL INHALATION POWDER) , FOR ORAL INHALATION USE
BRONCHIAL CHALLENGE TEST KIT
INITIAL U.S. APPROVAL: 1964
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 <1-1.5 LITERS OR
<70% OF THE
PREDICTED VALUES) (5.1)
INDICATIONS AND USAGE
ARIDOL is a sugar alcohol 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. (1)
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.
DOSAGE AND ADMINISTRATION
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