Erythromycin suspension COMPOSITION:
Each 5 ml (teaspoonful) of reconstituted suspension contains:
Erythromycin ethylsuccinate 235 mg eq. to erythromycin activity 200 mg.
Erythromycin suspension PROPERTIES :
Erythromycin Pharco (erythromycin ethylsuccinate) is a broad spectrum macrolide antibiotic for oral administration. Erythromycin is one of the safest antibiotics withhigh activity against a wide range of Gram-positive and Gram-negative bacteria. Erythromycin is also active against Chlamydiae, Rikettsiae, Actinomyces, Spirochaetes and Mycoplasmas which are resistant to any other antibiotics. Clinical experience with Erythromycin Pharco has demonstrated its high therapeutic efficacy in various infections caused by susceptible organisms, including penicillinase-producing bacteria. Erythromycin Pharco oral suspension is a well tolerated form of erythromycin. Erythromycin Pharco is palatable and safe with clinical superiority that is devoid of the widespread bacterial resistance commonly encountered with other antibiotics.
Erythromycin suspension PHARMACOKINETICS :
Erythromycin ethylsuccinate is readily absorbed from the small intestine after oral administration under fasting and nonfasting conditions. Peak plasma concentrations are achieved within 1 – 2 hours and the antibiotic diffuses into most body tissues and fluids. The drug is concentrated in the liver and excreted largely in the active form in the bile. Less than 5% of the administered dose is excreted in the active form in the urine. There is practically no risk of accumulation in the body in renal failure. Erythromycin is largely bound to plasma proteins and its plasma half-life is about 1.6 hours.
Erythromycin suspension ANTIMICROBIAL SPECTRUM :
Gram-positive bacteria:
Aerobes: Streptococcus pyogenes, S. pneumoniae, S. faecalis, Staphlococcus aureus, and Listeria monocytogenes:
Anaerobes :Propionibacterium acnes and Clostridium species.
Gram-negative bacteria :
Aerobes:Neisseria gonorrhoeae, N. meningitidis, Moraxella catarrhalis, Campylobacter jejuni, Haemophilus influenzae, Bordetella pertussis and Legionella pneumophila.
Anaerobes:Some Bacteroides and Fusobacterium species.
Erythromycin suspension Miscellaneous microorganisms :
Rickettsia prowazekii, R. mooseri, R. rickettsii, Coxiella burnetii, Chlamydia trachomatis, C. pneumoniae, C. psittaci, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, T. pertenue, Actinomyces species and some protozoa (Entamoeba histolytica).
Erythromycin suspension INDICATIONS :
Erythromycin Pharco Oral Suspensionis indicated for treatment of infections caused by susceptible organisms:
–Upper and lower respiratory tract infections: bronchitis with chronic purulent infections, whooping cough, pneumonia, atypical pneumonia, bronchiectasis, lung abscess, cystic fibrosis, acute respiratory infections with chronic lung diseases (e.g. bronchitis with chronic obstructive pulmonary disease such as emphysema ), empyema and mixed respiratory tract infections. Erythromycin Pharcocombined with sulfonamides gives almost complete cure in
H. influenzae-induced infections.
–Ear, nose and throat ( E.N.T. ) infections:otitis media, sinusitis and ulcerative pharyngitis.
–Eye infections:trachoma, inclusion conjunctivitis and other ophthalmic infections.
–Venereal diseases:gonorrhea and syphilis.
–Genital infections:cervicitis, epididymo-orchitis, chronic prostatitis, leptospirosis and pelvic inflammatory disease.
–Gastrointestinal tract infections:cholecystitis, cholangitis, enteritis, traveller’s diarrhea and intestinal amoebiasis (as an adjunct therapy).
–Dermatologic (skin and soft tissue) and bone infections:acne, cellulitis, abscesses, frunculosis, pyoderma, yaws, infected traumatic and post-operative wounds.
–Orodental infections:ulcerative gingivitis, periodontal abscess and following dental manipulations.
–As an adjunct to diphtheria antitoxinto prevent development of diphtheria carrier state and eradicate the causative bacteria in carriers.
–Other infections:relapsing fever, typhus, rocky mountain spotted fever, Q fever, psittacosis, anthrax and listeriosis.
–For prophylaxis against bacterial endocarditisfollowing dental or respiratory tract procedures in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease and are hypersensitive to penicillin.
Erythromycin suspension CONTRAINDICATIONS :
Hypersensitivity to erythromycin and in patients who have previously developed hepatic dysfunction while receiving it.
Erythromycin suspension PRECAUTIONS :
Erythromycin pharco should be used with care in patients with existing liver disease.
As with other antibiotics, prolonged therapy may result in overgrowth of non- susceptible microorganisms.
Erythromycin suspension PREGNANCY AND LACTATION :
No teratogenic or harmful fetal effects have been reported in animal studies. However, Erythromycin pharco should be used cautiously during pregnancy and lactation and only if clearly indicated.
Erythromycin suspension ADVERSE EFFECTS :
Rarely, gastrointestinal disturbances, such as abdominal cramps, nausea, vomiting and diarrhea might occur and are dose-related. Skin rashes, urticaria or other mild allergic reactions may rarely occur.
Erythromycin suspension DRUG INTERACTIONS :
Erythromycin pharco administration in patients concurrently treated with theophylline, digoxin, ergotamine, dihydroergotamine, triazolam, astemizole, carbamazepine, cyclosporin, hexobarbital or phenytoin may elevate their serum levels and potentiate their effects. Erythromycin pharco,administration also potentiates the effects of oral anticoagulants.
Erythromycin suspension DOSAGE AND ADMINISTRATION :
Preparation of the suspension:Shake the bottle to loosen the powder. Then add water gradually with shaking until the reconstituted suspension is at the marking level (60 ml) on the bottle. The resultant suspension will provide 200 mg erythromycin activity per teaspoonful (5 ml). Once reconstituted, the suspension is stable for 7 days at ( 15 – 30° C) or 14 days in the refrigerator (4° C).
Children:The dose depends upon the age and severity of infection. The recommended dose is 30 – 50 mg I kg I day in equally divided doses every 6, 8 or 12 hours (Table).
Body weight Total daily dosage
5 -10 kg 400mg
10-25kg 800 mg
over 25 kg 1200 mg
In streptococcal infection:Treatment with Erythromycin pharco should be continued for at least 10 days.
Prophylaxis against bacterial endocarditis:20 mg I kg orally, 1.5 – 2 hours before the procedure and then 10 mg/kg every 6 hours for two days.
Erythromycin suspension OVERDOSAGE :
Erythromvcin pharco is safe in the recommended dosag In case of overdosage, administration of the drug should be discontinued immediately with proper elimination of unabsorbed drug. Peritoneal dialysis and hemodialysis are not effective for removal of erythromycin from the body.
Packing:
A bottle containing powder for 60 ml oral suspension.
Storage:
Before reconstitution store at ( 15 – 30° C ) away from moisture.
Keep out of the reach of children.
Produced by :
PHARCO PHARMAaUTlCALS
ALEXANDRIA.