Overview
Tetracycline is a broad spectrum polyketide antibiotic produced by the Streptomyces genus of Actinobacteria. It exerts a bacteriostatic effect on bacteria by binding reversible to the bacterial 30S ribosomal subunit and blocking incoming aminoacyl tRNA from binding to the ribosome acceptor site. It also binds to some extent to the bacterial 50S ribosomal subunit and may alter the cytoplasmic membrane causing intracellular components to leak from bacterial cells. The FDA withdrew its approval for the use of all liquid oral drug products formulated for pediatric use containing tetracycline in a concentration greater than 25 mg/ml. Other formulations of tetracycline continue to be used.
Indication
Used to treat bacterial infections such as Rocky Mountain spotted fever, typhus fever, tick fevers, Q fever, rickettsialpox and Brill-Zinsser disease. May be used to treat infections caused by Chlamydiae spp., B. burgdorferi (Lyme disease), and upper respiratory infections caused by typical (S. pneumoniae, H. influenzae, and M. catarrhalis) and atypical organisms (C. pneumoniae, M. pneumoniae, L. pneumophila). May also be used to treat acne. Tetracycline may be an alternative drug for people who are allergic to penicillin.
Associated Conditions
- Acinetobacter Infections
- Actinomycosis
- Anthrax
- Bacterial Infections
- Bartonellosis
- Brucellosis
- Campylobacter Infection
- Chancroid
- Chlamydial Infections
- Cholera (Disorder)
- Clostridium Infections
- Conjunctivitis, Inclusion
- Cystitis
- Endometritis
- Entamoebic histolytica infection
- Escherichia infections
- Granuloma Inguinale
- Helicobacter Pylori Infection
- Infection
- Infection, Bacteroides
- Klebsiella Infections
- Listeria infection
- Lower respiratory tract infection bacterial
- Lymphogranuloma Venereum
- Necrotizing ulcerative gingivostomatitis
- Neisseria Gonorrhoeae Infection
- Nephritis
- Ornithosis
- Plague
- Prostatitis
- Psittacosis
- Q Fever
- Relapsing Fever
- Rickettsialpox
- Rocky Mountain Spotted Fever
- Rosacea
- Severe Acne
- Shigella Infection
- Skin Infections caused by Staphylococcus Aureus
- Skin and Subcutaneous Tissue Bacterial Infections
- Syphilis
- Trachoma
- Tularemia
- Typhus
- Upper respiratory tract infection bacterial
- Urinary Tract Infection
- Yaws
- Grade 1, grade 2, grade 3, grade 4 Urinary Tract Infection
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/06/24 | Phase 4 | Completed | Shandong University | ||
2022/02/22 | Phase 4 | UNKNOWN | Shanghai Zhongshan Hospital | ||
2022/02/02 | Phase 2 | ENROLLING_BY_INVITATION | |||
2021/09/30 | Phase 4 | Recruiting | Shanghai Zhongshan Hospital | ||
2021/09/20 | Phase 4 | Completed | Shandong University | ||
2021/08/24 | Phase 4 | UNKNOWN | Shanghai Zhongshan Hospital | ||
2021/05/25 | Phase 4 | UNKNOWN | Shandong University | ||
2021/03/23 | N/A | Completed | Shandong University | ||
2021/01/29 | Not Applicable | Completed | |||
2021/01/22 | N/A | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-767 | ORAL | 500 mg in 1 1 | 3/31/2020 | |
| Rebel Distributors Corp | 21695-640 | ORAL | 500 mg in 1 1 | 1/13/2010 | |
| Rebel Distributors Corp | 21695-302 | ORAL | 250 mg in 1 1 | 1/13/2010 | |
| Actavis Pharma, Inc. | 0591-2474 | ORAL | 250 mg in 1 1 | 11/30/2018 | |
| Breckenridge Pharmaceutical, Inc. | 51991-907 | ORAL | 500 mg in 1 1 | 2/8/2024 | |
| Strides Pharma Science Limited | 64380-891 | ORAL | 500 mg in 1 1 | 10/21/2022 | |
| Amneal Pharmaceuticals NY LLC | 69238-1522 | ORAL | 250 mg in 1 1 | 12/30/2023 | |
| Physicians Total Care, Inc. | 54868-6151 | ORAL | 125 mg in 1 1 | 3/14/2011 | |
| H2-Pharma, LLC | 61269-385 | ORAL | 125 mg in 1 1 | 5/31/2023 | |
| State of Florida DOH Central Pharmacy | 53808-0877 | ORAL | 500 mg in 1 1 | 9/30/2013 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tetracycline Ointment | 国药准字H42021323 | 化学药品 | 软膏剂 | 5/19/2020 | |
| Tetracycline Ointment | 国药准字H21021662 | 化学药品 | 软膏剂 | 7/29/2020 | |
| Tetracycline Ointment | 国药准字H34020312 | 化学药品 | 软膏剂 | 7/3/2020 | |
| Tetracycline Ointment | 国药准字H45020907 | 化学药品 | 软膏剂 | 9/1/2020 | |
| Tetracycline Ointment | 国药准字H41024249 | 化学药品 | 软膏剂 | 5/6/2020 | |
| Tetracycline Ointment | 国药准字H41020140 | 化学药品 | 软膏剂 | 3/5/2020 | |
| Tetracycline Ointment | 国药准字H42020315 | 化学药品 | 软膏剂 | 7/13/2020 | |
| Tetracycline Ointment | 国药准字H13022084 | 化学药品 | 软膏剂 | 9/20/2020 | |
| Tetracycline Ointment | 国药准字H31021415 | 化学药品 | 软膏剂 | 7/9/2024 | |
| Tetracycline Ointment | 国药准字H35020046 | 化学药品 | 乳膏剂 | 6/29/2021 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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