There are no metabolic and pharmacokinetic data available on methacholine chloride.
There have been no studies with methacholine chloride that would permit an evaluation of its carcinogenic or mutagenic potential or of its effect on fertility.
Provocholine (methacholine chloride) powder for solution is supplied in amber glass vials that contain 100 mg of methacholine chloride powder, white to off-white in color. Cartons have 6 vials (NDC 64281-100-06).
Store the supplied powder at 59o to 86o F (15o to 30o C). Refrigerate the reconstituted and diluted solutions at 36o to 46o F (2o to 8o C) for up to 2 weeks [see Dosage and Administration (2.5)].
Risk of Severe Bronchoconstriction
Inform the patient or caregiver that severe bronchoconstriction can result from Provocholine administration [see Warnings and Precautions (5.1)].
Cough, Chest Tightness, or Shortness of Breath
Inform the patient or caregiver that Provocholine may produce mild cough, chest tightness or shortness of breath.
Distributed by Methapharm, Inc. Coral Springs, FL 33065.
For more information visit www.provocholine.com, email email@example.com or call 1-833-887-7686.® Provocholine is a registered trademark of Methapharm Inc.
Revision: October 2020
|PROVOCHOLINE methacholine chloride powder, for solution|
|Labeler — Methapharm Inc. (253526222)|
|Registrant — Methapharm Inc. (253526222)|
Revised: 10/2020 Methapharm Inc.
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