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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/12/02 | Not Applicable | UNKNOWN | |||
2018/04/23 | Phase 3 | Completed | |||
2017/04/10 | Phase 4 | Recruiting | Dr. Diane Lougheed | ||
2015/12/15 | Not Applicable | Completed | |||
2015/10/14 | Phase 4 | UNKNOWN | Zhujiang Hospital | ||
2014/10/15 | Phase 1 | Completed | |||
2014/03/31 | Phase 3 | Completed | |||
2014/03/27 | Phase 3 | Completed | |||
2013/08/09 | Not Applicable | Completed | |||
2013/07/24 | Phase 4 | Completed |
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. |
Help Us Improve
Your feedback helps us provide better drug information and insights.