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Tetracycline

Generic Name
Tetracycline
Brand Names
Pylera, Sumycin
Drug Type
Small Molecule
Chemical Formula
C22H24N2O8
CAS Number
60-54-8
Unique Ingredient Identifier
F8VB5M810T

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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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
Aspen Veterinary Resources
46066-256
ORAL
324 g in 2.27 kg
8/20/2025
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

EMA Drug Approvals

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

HSA Drug Approvals

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

NMPA Drug Approvals

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

PPB Drug Approvals

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

TGA Drug Approvals

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

Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
TETRACYCLINE 1% OPHTHALMIC OINTMENT
steri-med pharma inc.
00792594
Ointment - Ophthalmic
10 MG / G
12/31/1988
TETRACYN CAP 250MG
00024422
Capsule - Oral
250 MG / CAP
12/31/1952
NOVO-TETRA 250MG
novopharm limited
00021806
Tablet - Oral
250 MG
12/31/1967
ACHROMYCIN ONT OPH 1%
lederle cyanamid canada inc.
00015083
Ointment - Ophthalmic
1 %
12/31/1955
PYLERA
laboratoires juvise pharmaceuticals
02246962
Capsule - Oral
125 MG
N/A
JAA TETRA TAB 250MG
jaapharm canada inc.
00889393
Tablet - Oral
250 MG
12/31/1993

CIMA AEMPS Drug Approvals

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

Philippines FDA Drug Approvals

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

Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

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

UK EMC Drug Information

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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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