Application Nr Approved Date Route Status External Links
ANDA062298 1994-10-14 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Ery-Tab And Other Antibacterial Drugs, Ery-Tab Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. When Culture And Susceptibility Information Are Available, They Should Be Considered In Selecting Or Modifying Antibacterial Therapy. In The Absence Of Such Data, Local Epidemiology And Susceptibility Patterns May Contribute To The Empiric Selection Of Therapy. ® ® Ery-Tab Tablets Are Indicated In The Treatment Of Infections Caused By Susceptible Strains Of The Designated Microorganisms In The Diseases Listed Below: ® Upper Respiratory Tract Infections Of Mild To Moderate Degree Caused By ; ; (when Used Concomitantly With Adequate Doses Of Sulfonamides, Since Many Strains Of Are Not Susceptible To The Erythromycin Concentrations Ordinarily Achieved). (see Appropriate Sulfonamide Labeling For Prescribing Information.) Streptococcus Pyogenes Streptococcus Pneumoniae Haemophilus Influenzae H. Influenzae Lower Respiratory Tract Infections Of Mild To Moderate Severity Caused By Or . Streptococcus Pyogenes Streptococcus Pneumoniae Listeriosis Caused By . Listeria Monocytogenes Respiratory Tract Infections Due To . Mycoplasma Pneumoniae Skin And Skin Structure Infections Of Mild To Moderate Severity Caused By Or (resistant Staphylococci May Emerge During Treatment). Streptococcus Pyogenes Staphylococcus Aureus Pertussis (whooping Cough) Caused By . Erythromycin Is Effective In Eliminating The Organism From The Nasopharynx Of Infected Individuals, Rendering Them Noninfectious. Some Clinical Studies Suggest That Erythromycin May Be Helpful In The Prophylaxis Of Pertussis In Exposed Susceptible Individuals. Bordetella Pertussis Diphtheria: Infections Due To , As An Adjunct To Antitoxin, To Prevent Establishment Of Carriers And To Eradicate The Organism In Carriers. Corynebacterium Diphtheriae Erythrasma: In The Treatment Of Infections Due To . Corynebacterium Minutissimum Intestinal Amebiasis Caused By (oral Erythromycins Only). Extraenteric Amebiasis Requires Treatment With Other Agents. Entamoeba Histolytica Acute Pelvic Inflammatory Disease Caused By : Erythrocin Lactobionate-I.v. (erythromycin Lactobionate For Injection, Usp) Followed By Erythromycin Base Orally, As An Alternative Drug In Treatment Of Acute Pelvic Inflammatory Disease Caused By In Female Patients With A History Of Sensitivity To Penicillin. Patients Should Have A Serologic Test For Syphilis Before Receiving Erythromycin As Treatment Of Gonorrhea And A Follow-Up Serologic Test For Syphilis After 3 Months. Neisseria Gonorrhoeae ® N. Gonorrhoeae Erythromycins Are Indicated For Treatment Of The Following Infections Caused By : Conjunctivitis Of The Newborn, Pneumonia Of Infancy, And Urogenital Infections During Pregnancy. When Tetracyclines Are Contraindicated Or Not Tolerated, Erythromycin Is Indicated For The Treatment Of Uncomplicated Urethral, Endocervical, Or Rectal Infections In Adults Due To . Chlamydia Trachomatis Chlamydia Trachomatis When Tetracyclines Are Contraindicated Or Not Tolerated, Erythromycin Is Indicated For The Treatment Of Nongonococcal Urethritis Caused By . Ureaplasma Urealyticum Primary Syphilis Caused By . Erythromycin (oral Forms Only) Is An Alternative Choice Of Treatment For Primary Syphilis In Patients Allergic To The Penicillins. In Treatment Of Primary Syphilis, Spinal Fluid Should Be Examined Before Treatment And As Part Of The Follow-Up After Therapy. Treponema Pallidum Legionnaires' Disease Caused By . Although No Controlled Clinical Efficacy Studies Have Been Conducted, And Limited Preliminary Clinical Data Suggest That Erythromycin May Be Effective In Treating Legionnaires' Disease. Legionella Pneumophila In Vitro Prophylaxis Prevention Of Initial Attacks Of Rheumatic Fever Penicillin Is Considered By The American Heart Association To Be The Drug Of Choice In The Prevention Of Initial Attacks Of Rheumatic Fever (treatment Of Streptococcus Pyogenes Infections Of The Upper Respiratory Tract E.g., Tonsillitis, Or Pharyngitis). Erythromycin Is Indicated For The Treatment Of Penicillin-Allergic Patients. The Therapeutic Dose Should Be Administered For Ten Days. 4 Prevention Of Recurrent Attacks Of Rheumatic Fever Penicillin Or Sulfonamides Are Considered By The American Heart Association To Be The Drugs Of Choice In The Prevention Of Recurrent Attacks Of Rheumatic Fever. In Patients Who Are Allergic To Penicillin And Sulfonamides, Oral Erythromycin Is Recommended By The American Heart Association In The Long-Term Prophylaxis Of Streptococcal Pharyngitis (for The Prevention Of Recurrent Attacks Of Rheumatic Fever). 4

All Formulated Excipients (13 Total)

Name Structure Kind Function Status
1. Ammonia AMMONIA Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
4. Diacetylated Monoglycerides DIACETYLATED MONOGLYCERIDES Unresolved
5. Hypromelloses HYPROMELLOSES Unresolved
6. Hypromellose Phthalate HYPROMELLOSE PHTHALATE Unresolved
7. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
9. Povidones POVIDONES Unresolved
10. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
11. Sodium Citrate, Unspecified Form SODIUM CITRATE, UNSPECIFIED FORM Molecular
12. Sorbitan Monooleate SORBITAN MONOOLEATE Molecular EMUL-Emulsifier REG-Food additives for which a petition has been filed and a regulation issued.
13. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Erythromycin ERYTHROMYCIN ZINC85534336

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