Provocholine Generic Name & Formulations
Legal Class
Rx
General Description
Methacholine chloride 100mg; per vial; pwd for soln, for oral inh after reconstitution and dilution.
Pharmacological Class
Cholinergic.
How Supplied
Vials—6
Manufacturer
Generic Availability
NO
Provocholine Indications
Indications
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.
Provocholine Dosage and Administration
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
Contraindications
Hypersensitivity to other parasympathomimetic agents. Baseline FEV1 <60% (adults or children) or <1.5L (adults).
Provocholine Boxed Warnings
Boxed Warning
Severe bronchoconstriction.
Provocholine Warnings/Precautions
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 Pharmacokinetics
See Literature
Provocholine Interactions
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.
Provocholine Adverse Reactions
Adverse Reactions
Headache, throat irritation, light-headedness, itching; bronchospasm.
Provocholine Clinical Trials
See Literature
Provocholine Note
Not Applicable
Provocholine Patient Counseling
See Literature