Miscellaneous diagnostic tests:

Indications for: PROVOCHOLINE

To be used in a methacholine challenge test for the diagnosis of bronchial airway hyperreactivity in patients aged ≥5yrs who do not have clinically apparent asthma.

Adults and Children:

<5yrs: not established. Prior to initiation, must perform baseline spirometry to confirm baseline FEV1 ≥60% of the predicted value (in adults and children) and ≥1.5L (in adults). ≥5yrs: Administer using either the 5-Breath Dosimeter Dosing Method or the 2-Minute Tidal Breathing Dosing Method with the doubling or quadrupling stepwise protocols; see full labeling.

PROVOCHOLINE Contraindications:

Hypersensitivity to other parasympathomimetic agents. Baseline FEV1 <60% (adults or children) or <1.5L (adults).

Boxed Warning:

Severe bronchoconstriction.

PROVOCHOLINE Warnings/Precautions:

Should be administered in a pulmonary function lab or clinic by adequately trained personnel. Have emergency equipment and medication readily available. Risk of severe bronchoconstriction. Clinically apparent asthma or wheezing: not recommended. Reverse immediately with a rapid-acting inhaled β-agonist if severe bronchoconstriction occurs. Risk of bronchoconstriction in healthcare providers administering Provocholine; do not inhale the powder or handle the product if you have asthma or hay fever; apply a lower resistance filter to dosing apparatus to prevent powder release in the room air. Uncontrolled hypertension, aortic aneurysm, history of MI or stroke diseases: not recommended. Epilepsy, vagotonia, peptic ulcer, thyroid disease, urinary tract obstruction or other conditions that could be affected by a cholinergic agent: consider benefits/risks. Elderly. Pregnancy: not recommended. Nursing mothers.

PROVOCHOLINE Classification:

Cholinergic.

PROVOCHOLINE Interactions:

Concomitant β-adrenergic blockers may impair reversal of Provocholine-caused bronchoconstriction. β-agonists, anticholinergics, and theophylline inhibit the response to Provocholine; hold these drugs for a certain duration prior to Provocholine use; see full labeling. May decrease bronchial responsiveness to Provocholine with oral or inhaled corticosteroids, and inhaled cromoglycate.

Adverse Reactions:

Headache, throat irritation, light-headedness, itching; bronchospasm.

Generic Drug Availability:

NO

How Supplied:

Vials—6