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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/24 | Not Applicable | Not yet recruiting | Yongquan Shi | ||
2025/07/16 | Not Applicable | Recruiting | Yongquan Shi | ||
2025/05/18 | Not Applicable | Recruiting | Zhongshan Hospital (Xiamen), Fudan University | ||
2025/01/06 | Not Applicable | Completed | Minia University | ||
2024/07/19 | Phase 4 | ENROLLING_BY_INVITATION | |||
2024/01/26 | Early Phase 1 | Recruiting | |||
2023/12/13 | Phase 4 | Completed | Yongquan Shi | ||
2023/05/25 | Phase 4 | Recruiting | Shanghai Jiao Tong University School of Medicine | ||
2023/05/25 | Phase 4 | Recruiting | Shanghai Jiao Tong University School of Medicine | ||
2023/04/07 | Phase 4 | Recruiting | Shandong University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ingenus Pharmaceuticals, LLC | 50742-283 | ORAL | 125 mg in 1 1 | 7/4/2023 | |
| Bryant Ranch Prepack | 71335-2141 | ORAL | 500 mg in 1 1 | 5/25/2023 | |
| H2-Pharma, LLC | 61269-380 | ORAL | 125 mg in 1 1 | 10/19/2023 | |
| Physicians Total Care, Inc. | 54868-0025 | ORAL | 500 mg in 1 1 | 4/11/2011 | |
| Par Pharmaceutical, Inc. | 49884-151 | ORAL | 125 mg in 1 1 | 3/15/2023 | |
| Physicians Total Care, Inc. | 54868-0024 | ORAL | 250 mg in 1 1 | 4/11/2011 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-766 | ORAL | 250 mg in 1 1 | 3/31/2020 | |
| Preferred Pharmaceuticals Inc. | 68788-8853 | ORAL | 500 mg in 1 1 | 3/24/2025 | |
| Pharmaka Generics Inc. | 82644-870 | ORAL | 500 mg in 1 1 | 1/17/2024 | |
| Amneal Pharmaceuticals NY LLC | 69238-1523 | ORAL | 500 mg in 1 1 | 12/30/2023 |
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 |
|---|---|---|---|---|---|
| BEATACYCLINE CAPSULE 250 mg | SIN02053P | CAPSULE | 250 mg | 6/24/1988 | |
| TETRACYCLINE MC CAPSULE 250 mg | SIN00969P | CAPSULE | 250 mg | 5/10/1988 | |
| BIOTINE OINTMENT 3% w/w | SIN08514P | OINTMENT | 3% w/w | 1/5/1996 |
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 |
|---|---|---|---|---|---|
| TETRACLIN CAP 250MG ORANGE/YELLOW | N/A | N/A | N/A | 8/8/1983 | |
| NEO-CYCLIN CAP 250MG | N/A | N/A | N/A | 4/27/1979 |
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 |
|---|---|---|---|---|---|
| NOVO-TETRA SUS 125MG/5ML | novopharm limited | 00151416 | Liquid - Oral | 125 MG / 5 ML | 12/31/1967 |
| APO TETRA TABS 250MG | 00603252 | Tablet - Oral | 250 MG | 12/31/1984 | |
| TETRACYCLINE CAP 250MG | PRO DOC LIMITEE | 00156744 | Capsule - Oral | 250 MG | 12/31/1962 |
| MEDICYCLINE CAP 250MG | medic laboratory ltée | 00134406 | Capsule - Oral | 250 MG / CAP | 12/31/1962 |
| ACTISITE | procter & gamble inc | 02231649 | Miscellaneous - Dental | 12.7 MG / PIECE | N/A |
| TETRACYCLINE CAP 250MG | 00448729 | Capsule - Oral | 250 MG / CAP | 12/31/1981 | |
| TETRACYCLINE | aa pharma inc | 00580929 | Capsule - Oral | 250 MG | 12/31/1983 |
| ACHROMYCIN V CAP 250MG | lederle cyanamid canada inc. | 00014605 | Capsule - Oral | 250 MG / CAP | 12/31/1957 |
| NU-TETRA CAPSULES 250MG | nu-pharm inc | 00717606 | Capsule - Oral | 250 MG | 12/31/1990 |
| NOVO-TETRA 250MG | novopharm limited | 00021059 | Capsule - Oral | 250 MG / CAP | 12/31/1967 |
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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