MedPath

Erythromycin

Generic Name
Erythromycin
Brand Names
Aktipak, Apo-Erythro-S, Benzamycin, E.E.S., Ery, Ery-tab, Erygel, Eryped, Erythro, Erythrocin, Erythrocin Stearate
Drug Type
Small Molecule
Chemical Formula
C37H67NO13
CAS Number
114-07-8
Unique Ingredient Identifier
63937KV33D

Overview

Erythromycin is a bacteriostatic antibiotic drug produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics which consists of Azithromycin, Clarithromycin, Spiramycin and others. It was originally discovered in 1952. Erythromycin is widely used for treating a variety of infections, including those caused by gram-positive and gram-negative bacteria. It is available for administration in various forms, including intravenous, topical, and eye drop preparations.

Background

Erythromycin is a bacteriostatic antibiotic drug produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics which consists of Azithromycin, Clarithromycin, Spiramycin and others. It was originally discovered in 1952. Erythromycin is widely used for treating a variety of infections, including those caused by gram-positive and gram-negative bacteria. It is available for administration in various forms, including intravenous, topical, and eye drop preparations.

Indication

Erythromycin is indicated in the treatment of infections caused by susceptible strains of various bacteria. The indications for erythromycin have been summarized by body system below: Respiratory infections Mild to moderate upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with appropriate doses of sulfonamides) can be treated with erythromycin. Mild to moderate lower-respiratory tract infections due to susceptible strains of Streptococcus pneumoniae or Streptococcus pyogenes may also be treated. Erythromycin treats listeriosis caused by Listeria monocytogenes may also be treated with erythromycin. Erythromycin is indicated to treat pertussis (whooping cough) caused by Bordetella pertussis. It is effective in eliminating the causative organism from the nasopharynx of infected individuals, rendering them noninfectious. Clinical studies suggest that erythromycin may aid in the prevention of pertussis infection for individuals who have been exposed to the bacteria. Respiratory tract infections due to Mycoplasma pneumoniae may also be treated with erythromycin. Despite the fact that no controlled clinical efficacy studies have been conducted to this date, in vitro and certain preliminary clinical study results indicate that erythromycin may be an effective treatment in Legionnaires’ Disease. Finally, erythromycin is indicated to treat diphtheria and other infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent carrier status and to eradicate the organism in existing carriers. In addition to the prevention of diphtheria, erythromycin can be used to prevent rheumatic fever in penicillin intolerant patients. Skin infections Mild to moderate skin or skin structure infections caused by Streptococcus pyogenes or Staphylococcus aureus may be treated with erythromycin, however, resistant staphylococcal organisms may emerge. Erythromycin can also be used to treat erythrasma, an infectious condition caused by Corynebacterium minutissimum. Gastrointestinal infections Intestinal amebiasis caused by Entamoeba histolytica can be treated with oral erythromycin. Extraenteric amebiasis warrants treatment with other antimicrobial drugs. Genital infections/STIs Erythromycin can be used as an alternative drug in treating acute pelvic inflammatory disease caused by N. gonorrheae in female patients who have demonstrated hypersensitivity or intolerance to penicillin. Syphilis, caused by Treponema pallidum, can be treated with erythromycin. It serves as an alternative treatment for primary syphilis in patients who have demonstrated penicillin hypersensitivity. Erythromycin can also be used in the primary stage of primary syphilis. Another approved indication of erythromycin is to treat chlamydial infections that cause conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections occurring in pregnancy. It is indicated as an alternative option to tetracyclines for the treatment of uncomplicated rectal, urethral and endocervical infections in adults caused by Chlamydia trachomatis. Erythromycin can be used in nongonococcal urethritis can be used when tetracyclines cannot be administered. Finally, erythromycin is indicated to treat nongonococcal urethritis due to Ureaplasma urealyticum.

Associated Conditions

  • Acne
  • Acne Vulgaris
  • Acute Otitis Media caused by Haemophilus Influenzae
  • Acute pelvic inflammatory disease caused by Neisseria Gonorrheae Infection
  • Bacterial Infections
  • Chancroid
  • Chlamydia Trachomatis
  • Chlamydial ophthalmia neonatorum
  • Community Acquired Pneumonia (CAP)
  • Diphtheria
  • Erythrasma
  • Gastroparesis
  • Granuloma Inguinale
  • Intestinal amebiasis caused by entamoeba histolytica
  • Legionella Pneumophila Infections
  • Listeria infection
  • Lower Respiratory Tract Infection (LRTI)
  • Lymphogranuloma Venereum
  • Nongonococcal urethritis
  • Ophthalmia neonatorum (gonococcal)
  • Pertussis
  • Postoperative Infections
  • Primary Syphilis
  • Respiratory Tract Infections (RTI)
  • Skin and skin structure infections
  • Staphylococcal Skin Infections
  • Syphilis
  • Upper Respiratory Tract Infection
  • Ureaplasma urethritis
  • Whooping Cough
  • Inflammatory papular lesions
  • Mild Acne vulgaris
  • Moderate Acne vulgaris
  • Predominant skin comedones, papules and pustules
  • Prophylaxis of Rheumatic fever
  • Pustular lesions
  • Skin and subcutaneous tissue bacterial infections caused by streptococcus pyogenes
  • Superficial ocular infections

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/29
Phase 1
Recruiting
2025/04/09
Phase 1
Recruiting
2024/08/27
N/A
Not yet recruiting
2024/06/17
Not Applicable
Not yet recruiting
2024/05/02
Phase 1
Completed
2024/05/02
Phase 4
Recruiting
2024/02/23
Phase 3
Recruiting
2023/08/16
Phase 1
Completed
2023/04/04
Phase 1
Completed
2021/01/19
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Wilshire Pharmaceuticals
52536-130
ORAL
400 mg in 5 mL
9/24/2020
REMEDYREPACK INC.
70518-0392
OPHTHALMIC
5 mg in 1 g
1/5/2024
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
24338-100
ORAL
400 mg in 1 1
12/16/2023
Rebel Distributors Corp
21695-389
ORAL
500 mg in 1 1
6/6/2006
Cadila Pharmaceuticals Limited
71209-100
ORAL
250 mg in 1 1
12/22/2023
Zydus Pharmaceuticals USA Inc.
70710-1756
ORAL
500 mg in 1 1
10/6/2023
Wilshire Pharmaceuticals
52536-180
ORAL
250 mg in 1 1
7/18/2019
Amneal Pharmaceuticals NY LLC
69238-1473
ORAL
500 mg in 1 1
12/29/2023
Zydus Pharmaceuticals USA Inc.
70710-1048
ORAL
500 mg in 1 1
3/20/2024
Torrent Pharmaceuticals Limited
13668-588
ORAL
500 mg in 1 1
9/21/2021

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
ERYSOL FOR ORAL SUSPENSION 200 mg/5 ml
SIN00126P
GRANULE, FOR SUSPENSION
200 mg/5 ml
3/18/1988
EROGRAN FOR ORAL SUSPENSION 200 mg/5 ml
SIN08042P
GRANULE, FOR SUSPENSION
200 mg/5 ml
2/23/1995
ERYSON TABLETS 250 mg
SIN00578P
ENTERIC COATED TABLET
250 mg
4/29/1988
ERMYCIN 250 TABLET 250 mg
SIN07545P
TABLET, FILM COATED
250 mg
11/1/1993
ERYSON LOTION 2%
SIN10446P
LOTION
2% w/v
11/20/1998
ERYCYN-250 TABLET 250 mg
SIN11952P
TABLET, FILM COATED
250 mg
5/25/2002
RETORIN POWDER FOR SUSPENSION 200 mg/5 ml
SIN11245P
POWDER, FOR SUSPENSION
200 mg/5 ml
12/16/1999
ERYSON GRANULES 200 mg/5 ml
SIN01860P
GRANULE, FOR SUSPENSION
200mg/5ml
6/17/1988

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Erythromycin Ethylsuccinate Chewable Tablets
国药准字H33021391
化学药品
片剂
4/26/2020
Erythromycin Stearate Granules
国药准字H13021493
化学药品
颗粒剂
3/18/2020
Erythromycin Ethylsuccinate Dispersible Tablets
国药准字H19990149
化学药品
片剂(分散片)
5/29/2020
Erythromycin Ethylsuccinate Dispersible Tablets
国药准字H20020256
化学药品
片剂(分散片)
5/29/2020
Erythromycin Enteric-Pellets Capsules
国药准字H19991413
化学药品
胶囊剂
7/8/2020
Erythromycin Stearate Tablets
国药准字H23021790
化学药品
片剂(糖衣)
5/18/2020
Erythromycin Stearate Tablets
国药准字H21021902
化学药品
片剂
7/13/2020
Erythromycin Stearate Tablets
国药准字H21022265
化学药品
片剂
7/13/2020
Erythromycin Stearate Tablets
国药准字H51022633
化学药品
片剂(糖衣片,薄膜衣片)
3/3/2021
Erythromycin Stearate Tablets
国药准字H37020548
化学药品
片剂
2/15/2020

PPB Drug Approvals

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