PCE SUMMARY
PCE®
(erythromycin particles in tablets)
Dispertab® Tablets
PCE (erythromycin particles in tablets) is an antibacterial product containing specially coated erythromycin base particles for oral administration. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PCE and other antibacterial drugs, PCE 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.
PCE 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
Streptococcus pyogenes; Streptococcus pneumoniae; 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 pyogenes
or
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
Streptococcus pyogenes
or
Staphylococcus aureus
(resistant staphylococci may emerge during treatment).
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 prophylaxis of pertussis in exposed susceptible individuals.
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.
Intestinal amebiasis caused by
Entamoeba histolytica
(oral erythromycins only). Extraenteric amebiasis requires treatment with other agents.
Acute pelvic inflammatory disease caused by
Neisseria gonorrhoeae: 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
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 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 nongonococcal urethritis caused by
Ureaplasma urealyticum.
Primary syphilis caused by
Treponema pallidum. 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.
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.
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).3 Erythromycin is indicated for the treatment of penicillin-allergic patients. 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).3
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