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. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Eryc blend white | 25396 | Medicine | A | 10/10/1991 | |
MAYNE PHARMA ERYTHROMYCIN erythromycin 250mg capsule bottle | 195842 | Medicine | A | 7/10/2012 | |
ERYTHROMYCIN HHH erythromycin (as lactobionate) 1 g powder for injection vial | 290145 | Medicine | A | 5/24/2018 | |
E-MYCIN 400mg tablet | 71310 | Medicine | A | 10/7/1999 | |
Erythrocin IV 1g powder for injection vial | 131444 | Medicine | A | 12/4/2006 | |
E-MYCIN 400 erythromycin 400mg/5mL powder for oral liquid | 48287 | Medicine | A | 4/22/1994 | |
ERYC erythromycin 250mg capsule bottle | 63154 | Medicine | A | 4/15/1998 | |
Eryc capsules 250mg (white/white) | 25379 | Medicine | A | 10/10/1991 | |
ERYTHROMYCIN PANPHARMA erythromycin (as lactobionate) 1 g powder for Injection vial | 295583 | Panpharma Australia Pty Ltd | Medicine | A | 10/18/2018 |
Eryc (erythromycin) 250mg capsule bottle | 214090 | Medicine | A | 9/2/2013 |