Provocholine Inhalation Solution 48 mg/3mL

Methacholine Chloride Inhalation Solution · SOLUTION · Methapharm Inc.

No Recall History

Plain English

Provocholine (methacholine chloride) is a prescription inhalation solution used to diagnose airway hyperresponsiveness in patients suspected of having asthma or other respiratory conditions. During a bronchial challenge test, it is inhaled in gradually increasing concentrations to measure how sensitive a patient's airways are to this substance.

Key Facts

Brand Name: Provocholine Inhalation Solution
Generic Name: Methacholine Chloride Inhalation Solution
NDC Code (Product): 64281-116
Manufacturer: Methapharm Inc.
Strength: 48 mg/3mL
Dosage Form: SOLUTION
Route: RESPIRATORY (INHALATION)
Marketing Status
Application #: NDA019193
Marketing Start: 04/14/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

vomiting1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Provocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma. Provocholine, a cholinergic agonist used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma (1)

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The methacholine challenge test should be conducted in a pulmonary function laboratory or clinic, by adequately trained personnel, for safety and accuracy (2.1) Determine baseline FEV1 values to assess whether a patient is able to undergo the methacholine challenge test (2.1) Recommended dosage(s) of Provocholine in the Methacholine Challenge Test is administration of increasing concentrations of Provocholine solution via nebulization (2.2) Administer using either the 5-Breath Dosimeter Dosing Method or the 2-Minute Tidal Breathing Dosing Method with the doubling or quadrupling stepwise protocols (2.4, 2.5) See the Full Prescribing Information for the required reconstitution and dilution procedures prior to use (2.3) See the Full Prescribing Information for the calculation and interpretation of the results (2.6) 2.1 Methacholine Challenge Test Overview Provocholine should be administered in a methacholine challenge test in a pulmonary function laboratory or clinic, by adequately trained personnel, for safety and accuracy, and should be performed only under the responsibility of a healthcare practitioner trained in and thoroughly familiar with all aspects…

Contraindications

4 CONTRAINDICATIONS Provocholine is contraindicated in the following: Hypersensitivity to methacholine or other parasympathomimetic agents. Reactions have included rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Baseline FEV 1 < 60% predicted (adults or pediatric patients) or <1.5 L (adults) Known hypersensitivity to methacholine chloride or other parasympathomimetic agents (4) Baseline FEV 1 <60% predicted (adults or children) or <1.5 L (adults) (4)

Drug Interactions

7 DRUG INTERACTIONS Beta-Adrenergic Blockers The use of beta-adrenergic blockers may impair reversal of Provocholine-caused bronchoconstriction. Beta-Agonists, Anticholinergics, and Theophylline Beta-agonists, anticholinergics, and theophylline inhibit the response of airways to Provocholine; therefore, hold these drugs before Provocholine use for the following duration: • Short-acting β-agonists (e.g., albuterol): 6 hours • Long-acting β-agonists (e.g., salmeterol): 36 hours • Short-acting anti-cholinergics (e.g., ipratropium): 12 hours • Long-acting anti-cholinergics (e.g., tiotropium): ≥168 hours • Oral theophylline: 12-48 hours Oral or Inhaled Corticosteroids, and Inhaled Cromoglycate Regular use of oral or inhaled corticosteroids and inhaled cromoglycate may acutely decrease bronchial responsiveness to Provocholine. However, these drugs may be continued with Provocholine use. Beta-Adrenergic Blockers : May impair reversal of Provocholine-caused bronchoconstriction (7) Beta-Agonists, Anticholinergics, and Theophylline : Inhibit response to Provocholine; therefore, hold these drugs prior to Provocholine use (7) Oral or Inhaled Corticosteroids, and Inhaled Cromyoglycate : May dec…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions associated with the use of Provocholine were identified in clinical studies or post marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Bronchospasm (includes symptoms such as chest tightness, cough or wheezing). Adverse reactions less commonly associated with Provocholine include headache, throat irritation, light-headedness and itching. Adverse reactions associated with Provocholine include headache, throat irritation, light-headedness and itching (6) To report SUSPECTED ADVERSE REACTIONS, contact Methapharm at 1-866-701-4636 or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch

Frequently Asked Questions

What is Provocholine Inhalation Solution used for?

Is Provocholine Inhalation Solution a controlled substance?

Provocholine Inhalation Solution is not classified as a controlled substance by the DEA.

What is the generic name for Provocholine Inhalation Solution?

The generic name for Provocholine Inhalation Solution is Methacholine Chloride Inhalation Solution. There are no other listed brand versions of Methacholine Chloride Inhalation Solution.

What is the NDC code for Provocholine Inhalation Solution 48 mg/3mL?

The NDC (National Drug Code) for Provocholine Inhalation Solution 48 mg/3mL is 64281-116, listed by Methapharm Inc..

Product NDC

64281-116

Package NDC

64281-116-12