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Basic Drug Info
Drug Name:ERYC
Manufacturer:Warner Chilcott (US), Inc.
Other Info:



Clinical Trials:


Indications and Usage

Erythromycin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below:Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H.

influenzae are not susceptible to the erythromycin concentrations ordinarily achieved).

(See appropriate sulfonamide labeling for prescribing information).Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes.Listeriosis caused by Listeria monocytogenes.Pertussis (whooping cough) caused by Bordetella pertussis.

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 pro-phylaxis of pertussis in exposed susceptible individuals.

Respiratory tract infections due to Mycoplasma pneumoniae.Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment).Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers.Erythrasma: In the treatment of infections due to Corynebacterium minutissimum.Syphilis caused by Treponema pallidum: Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients.

In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy.Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only).

Extraenteric amebiasis requires treatment with other agents.Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythromycin lactobionate for injection, USP followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N.

gonorrhoeae 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.Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: 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.When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongono-coccal urethritis caused by Ureaplasma urealyticum.Legionnaires’ Disease caused by Legionella pneumophila.

Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires’ Disease.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.3 The therapeutic dose should be administered for ten days.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).3To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERYC and other antibacterial drugs, ERYC 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.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Upper Respiratory Infections --

Lower respiratory tract infection --

Listeriosis -- Infections with bacteria of the genus LISTERIA.

Pertussis -- A respiratory infection caused by BORDETELLA PERTUSSIS and characterized by paroxysmal coughing ending in a prolonged crowing intake of breath.

Whooping cough due to unspecified organism --

respiratory infection -- Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases.

Mycoplasma pneumonia -- Interstitial pneumonia caused by extensive infection of the lungs (LUNG) and BRONCHI, particularly the lower lobes of the lungs, by MYCOPLASMA PNEUMONIAE in humans. In SHEEP, it is caused by MYCOPLASMA OVIPNEUMONIAE. In CATTLE, it may be caused by MYCOPLASMA DISPAR.

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

ERYTHRASMA -- A chronic bacterial infection of major folds of the skin, caused by Corynebacterium minutissimum.

Syphilis -- A contagious venereal disease caused by the spirochete TREPONEMA PALLIDUM.

Syphilitic chancre -- The primary sore of syphilis, a painless indurated, eroded papule, occurring at the site of entry of the infection.

Amebic colitis -- DYSENTERY caused by intestinal PROTOZOA infection, chiefly with ENTAMOEBA HISTOLYTICA. This condition may be associated with amebic infection of the LIVER and other distant sites.

Amebiasis -- Infection with any of various amebae. It is an asymptomatic carrier state in most individuals, but diseases ranging from chronic, mild diarrhea to fulminant dysentery may occur.

PELVIC INFLAMMATORY DISEASE ACUTE --

Gonorrhea -- Acute infectious disease characterized by primary invasion of the urogenital tract. The etiologic agent, NEISSERIA GONORRHOEAE, was isolated by Neisser in 1879.

Inclusion conjunctivitis -- An infection of the eyes characterized by the presence in conjunctival epithelial cells of inclusion bodies indistinguishable from those of trachoma. It is acquired by infants during birth and by adults from swimming pools. The etiological agent is CHLAMYDIA TRACHOMATIS whose natural habitat appears to be the genito-urinary tract. Inclusion conjunctivitis is a less severe disease than trachoma and usually clears up spontaneously.

Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

Nonspecific urethritis --

Urethritis -- Inflammation involving the URETHRA. Similar to CYSTITIS, clinical symptoms range from vague discomfort to painful urination (DYSURIA), urethral discharge, or both.

Legionnaires' Disease -- An acute, sometimes fatal, pneumonia-like bacterial infection characterized by high fever, malaise, muscle aches, respiratory disorders and headache. It is named for an outbreak at the 1976 Philadelphia convention of the American Legion.

Rheumatic Fever -- A febrile disease occurring as a delayed sequela of infections with group A hemolytic streptococci and characterized by multiple focal inflammatory lesions of the connective tissue structures, especially of the heart, blood vessels, and joints (polyarthritis), and by the presence of Aschoff bodies in the myocardium and skin. (Dorland, 27th ed)

Tonsillitis -- Inflammation of the tonsils, especially the PALATINE TONSILS but the ADENOIDS (pharyngeal tonsils) and lingual tonsils may also be involved. Tonsillitis usually is caused by bacterial infection. Tonsillitis may be acute, chronic, or recurrent.

Streptococcal sore throat --

Contraindications

Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic.Erythromycin is contraindicated in patients taking terfenadine or astemizole.

(SeePRECAUTIONS, Drug interactions).
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

There have been reports of prolonged QT syndrome in geriatric patients receiving oral erythromycin products.There have been reports of hepatic dysfunction, with or without jaundice, occurring in patients receiving oral erythromycin products.There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis.

Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin.

Therefore, patients receiving concomitant lovastatin and erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels.

(See package insert for lovastatin.)Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ERYC®Capsules, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.

difficile.C.

difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of C.

difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.

difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.

difficile, and surgical evaluation should be instituted as clinically indicated.

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