Overview
Benzonatate is an oral antitussive drug used in the relief and suppression of cough in patients older than ten years of age. Currently, benzonatate is the only non-narcotic antitussive available as a prescription drug. It works to reduce the activity of cough reflex by desensitizing the tissues of the lungs and pleura involved in the cough reflex. Benzonatate was approved by the FDA in 1958 under the market name Tessalon Perles. Because its chemical structure resembles that of the anesthetic agents in the para-amino-benzoic acid class (such as procaine and tetracaine), benzonatate exhibits anesthetic or numbing action. Although it not prone to drug misuse or abuse, benzonatate is associated with a risk for severe toxicity and overdose, especially in children.
Indication
用于急性支气管炎、支气管哮喘、肺炎、肺癌索引起的刺激性干咳、阵咳等,也可用于支气管镜、喉镜或支气管造影前预防咳嗽。
Associated Conditions
- Cough
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2018/10/29 | Phase 3 | UNKNOWN | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||
2014/08/04 | Phase 1 | Completed | |||
2012/09/24 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Ascend Laboratories LLC | 67877-574 | ORAL | 150 mg in 1 1 | 3/22/2017 | |
Bryant Ranch Prepack | 72162-1561 | ORAL | 100 mg in 1 1 | 8/29/2023 | |
Amneal Pharmaceuticals LLC | 65162-537 | ORAL | 200 mg in 1 1 | 12/18/2023 | |
A-S Medication Solutions | 50090-6294 | ORAL | 200 mg in 1 1 | 12/21/2018 | |
Proficient Rx LP | 63187-016 | ORAL | 100 mg in 1 1 | 11/1/2019 | |
Preferred Pharmaceuticals Inc. | 68788-8329 | ORAL | 200 mg in 1 1 | 3/1/2024 | |
Northwind Pharmaceuticals, LLC | 51655-769 | ORAL | 100 mg in 1 1 | 10/30/2015 | |
American Health Packaging | 68084-214 | ORAL | 100 mg in 1 1 | 8/31/2022 | |
XLCare Pharmaceuticals, Inc. | 72865-117 | ORAL | 100 mg in 1 1 | 1/21/2022 | |
RedPharm Drug Inc. | 67296-0567 | ORAL | 100 mg in 1 1 | 7/6/2011 |
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 |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
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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