Frequently Asked Questions

Beta-Adrenergic Blockers

Do beta-adrenergic blockers need to be withheld prior to the administration of Provocholine?

Precaution should be taken when the methacholine challenge is performed in patients receiving any beta-adrenergic blocking agents, as it is possible that bronchoconstriction may not reverse as readily. The required withholding period for the beta-adrenergic blocker would vary based on the half-life.

BSE-TSE Content

Is Provocholine BSE-TSE free?

Yes. No animal products are used in the synthesis, manufacturing or packaging of Provocholine.

Diluent Options

What diluents are approved to reconstitute Provocholine?

There are two approved diluents for use. 0.9% sodium chloride injection or 0.9% sodium chloride injection containing 0.4% phenol (pH 7.0)

Expiration

How long before Provocholine powder expires?

Provocholine powder stored at 59° to 86°F (15° to 30°C) is stable for three years from the date of manufacture. Each vial has an expiration date printed on the label in the format of Year/Month with the Provocholine expiring the last day of the month.

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FDA Approval

Is Provocholine FDA approved?

Provocholine is the only FDA approved methacholine chloride for human use.

Glass Vials

Once reconstituted do Provocholine solutions need to be stored in glass vials or can plastic vials/syringes be used instead?

All dilutions should be made in USP type 1 borosilicate glass vials. Our stability data is based exclusively on this type of vial.

Gluten Content

Does Provocholine contain gluten?

Provocholine as manufactured is produced from materials that do not contain gluten.

Latex Content

Does Provocholine, the vial or the stopper contain latex?

No natural rubber latex or synthetic derivatives of natural rubber latex were used as materials in the manufacture of the above-mentioned medicinal product, container, glass tubing, or rubber stopper. However, we cannot guarantee that the product has not come into contact with latex during the manufacturing process.

Pediatric Use

Is it safe to perform the methacholine challenge test on pediatric patients?

The safety and efficacy of Provocholine has not been established in children below the age of 5.

Pregnancy

Is it safe to administer methacholine chloride to pregnant patients?

Animal reproduction studies have not been conducted with methacholine chloride. It is not known whether methacholine chloride can cause fetal harm when administered to a pregnant patient or affect reproductive capacity. Methacholine chloride should be given to a pregnant woman only if clearly needed.

Product Insert

Where do I find the product insert for Provocholine?

Here is a PDF version of the Provocholine product insert for the United States. For a copy of the insert for other countries please use the form on the contact page.

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Safety Data Sheet (SDS)

Do you have a safety data sheet for methacholine chloride?

We do have a safety data sheet available. Please select the Download icon below to access it.

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How Provocholine is Supplied

What form is Provocholine sold in?

In the United States Provocholine is available in cartons of 6 vials, each vial containing 100mg of powder. Those vials would then need to be reconstituted to reach the desired concentrations for the methacholine challenge test. For other countries please use the form on the contact us tab to learn about your options.

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