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Methacholine

Generic Name
Methacholine
Brand Names
Provocholine
Drug Type
Small Molecule
Chemical Formula
C8H18NO2
CAS Number
55-92-5
Unique Ingredient Identifier
03V657ZD3V

Overview

Asthma is a complex condition associated with phenomena such as airway hyperresponsiveness (AHR), in which the smooth muscle in the airways (ASM) excessively contracts in response to stimuli, reducing pulmonary function and causing symptoms such as difficulty breathing. Although the underlying pathology of AHR is complex, ASM contraction can be stimulated by cholinergic agonists that activate M muscarinic receptors that stimulate ASM contraction. Methacholine is a non-specific cholinergic agonist (parasympathomimetic) that acts through muscarinic receptors in the lungs to induce bronchoconstriction. In patients with AHR, a lower dose of methacholine is required to induce bronchoconstriction, which forms the basis for the methacholine challenge test to diagnose AHR. Methacholine was granted FDA approval on October 31, 1986, and is marketed under the trademark PROVOCHOLINE® by Methapharm Inc.

Indication

Methacholine is indicated in adult and pediatric patients aged five years and older without clinically apparent asthma for the diagnosis of bronchial airway hyperactivity via the methacholine challenge test.

Associated Conditions

  • Bronchial airway hyperreactivity

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Methapharm Inc.
64281-100
RESPIRATORY (INHALATION)
100 mg in 100 mg
7/14/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
METHACHOLINE CHLORIDE, USP
panda pharmaceuticals inc.
02468271
Powder For Solution - Inhalation
160 MG / VIAL
N/A
METHACHOLINE CHLORIDE, USP
panda pharmaceuticals inc.
02468298
Powder For Solution - Inhalation
320 MG / VIAL
N/A
METHACHOLINE OMEGA
omega laboratories limited
02263890
Powder For Solution - Inhalation
100 MG / VIAL
3/27/2006
METHACHOLINE CHLORIDE, USP
panda pharmaceuticals inc.
02468301
Powder For Solution - Inhalation
1280 MG / VIAL
N/A
STERILE PROVOCHOLINE SOLUTION 16
02283743
Solution - Inhalation
16 MG / ML
N/A
METHACHOLINE CHLORIDE, USP
panda pharmaceuticals inc.
02468263
Powder For Solution - Inhalation
100 MG / VIAL
N/A
PROVOCHOLINE
02246493
Powder For Solution - Inhalation
320 MG / VIAL
3/12/2003
PROVOCHOLINE
02243834
Powder For Solution - Inhalation
1280 MG / VIAL
9/24/2001
PROVOCHOLINE
02239656
Powder For Solution - Inhalation
100 MG / VIAL
4/1/1999
PROVOCHOLINE
02288826
Powder For Solution - Inhalation
1600 MG / VIAL
2/28/2008

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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