Provocholine (Page 4 of 4)

12.3 Pharmacokinetics

There are no metabolic and pharmacokinetic data available on methacholine chloride.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

16 HOW SUPPLIED/STORAGE AND HANDLING

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)].

17 PATIENT COUNSELING INFORMATION

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.

methapharm

Distributed by Methapharm, Inc. Coral Springs, FL 33065.
For more information visit www.provocholine.com, email sales@methapharm.com or call 1-833-887-7686.® Provocholine is a registered trademark of Methapharm Inc.

Revision: October 2020

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inner-label
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PROVOCHOLINE methacholine chloride powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64281-100
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHACHOLINE CHLORIDE (METHACHOLINE) METHACHOLINE 100 mg in 100 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64281-100-06 6 VIAL, GLASS in 1 BOX contains a VIAL, GLASS (64281-100-00)
1 NDC:64281-100-00 100 mg in 1 VIAL, GLASS This package is contained within the BOX (64281-100-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019193 03/27/2013
Labeler — Methapharm Inc. (253526222)
Registrant — Methapharm Inc. (253526222)

Revised: 10/2020 Methapharm Inc.

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