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RiteMED Erythromycin

RiteMED Erythromycin

erythromycin

Manufacturer:

RiteMED

Distributor:

United Lab
Concise Prescribing Info
Contents
Erythromycin
Indications/Uses
URTI: Laryngitis, pharyngitis, sinusitis, tonsillitis, peritonsillar abscess, otitis media, otitis externa, mastoiditis, secondary infections in flu & common colds. Lower resp tract infections: Acute & chronic bronchitis, bronchiectasis, pneumonia, tracheitis, Legionnaire's disease. GI infections: Cholecystitis, staphylococcal enterocolitis, intestinal amebiasis (extraenteric amebiasis requires treatment w/ other agents). Genitourinary infections: Urethritis, gonorrhea, primary syphilis, lympogranuloma venereum, prostatitis. Skin & skin structure infections: Boils, carbuncles, paronychia, abscesses, pustular acne, impetigo, cellulitis, erysipelas, erythrasma. Other infections: Blepharitis, gingivitis, Vincent's angina, listeriosis, osteomyelitis, scarlet fever, diphtheria (as an adjunct to antitoxin, to prevent establishment of carriers & to eradicate the organism in carriers). Prophylaxis for pre- & post-op trauma, burns, rheumatic fever, pertussis.
Dosage/Direction for Use
Adult 250 mg every 6 hr or 500 mg every 12 hr. Severe infection May be increased up to 4 g daily. Bid dosing schedule is not recommended in dosage >1 g daily. Strep infection Administer for at least 10 days. Urogenital infection during pregnancy due to Chlamydia trachomatis 500 mg every 6 hr for 7 days or 250 mg every 6 hr for 14 days (for women who cannot tolerate the previous dose). Uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis (when tetracycline is contraindicated or not tolerated) 500 mg every 6 hr for 7 days. Nongonococcal urethritis caused by Ureaplasma urealyticum (when tetracycline is contraindicated or not tolerated) 500 mg every 6 hr for 7 days. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae 500 mg erythromycin lactobionate IV every 6 hr for 3 days, followed by oral erythromycin 250 mg every 6 hr or 500 mq every 12 hr for 7 days [10 days (IV + oral)]. Primary syphilis 30-40 g in divided doses over a period of 10-15 days. Intestinal amebiasis 250 mg every 6 hr or 500 mg every 12 hr, 10-14 days. Pertussis 40-50 mg/kg daily in divided doses for 5-14 days. Legionnaires' Disease 1-4 g daily in divided doses. Continuous prophylaxis of strep infections in person w/ history of rheumatic heart disease 250 mg every 12 hr. Prophylaxis against bacterial endocarditis in patient allergic to penicillin w/ congenital heart disease, or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper resp tract 1 g orally given 1.5-2 hr before the procedure, then 500 mg every 6 hr for 8 doses. Childn (who can swallow tab whole) 30-50 mg/kg daily in 3 or 4 divided doses. More severe infection Not to exceed 4 g daily. Prophylaxis against bacterial endocarditis in childn allergic to penicillin w/ congenital heart disease, or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of upper resp tract 20 mg/kg given 1.5-2 hr before the procedure, then 10 mg/kg every 6 hr for 8 doses.
Administration
Should be taken on an empty stomach: Take on empty stomach or immediately before meals.
Contraindications
Hypersensitivity. Severe hepatic impairment. Patients taking astemizole, terfenadine, cisapride, pimozide & ergotamine or dihydroergotamine.
Special Precautions
Concomitant use of CYP3A inhibitors like nitroimidazole-antifungals can increase the risk of cardiac arrhythmia. Avoid concurrent use of diltiazem or verapamil in patients at risk for heart irregularities or those w/ long QT manifestations. Clostridium difficile-associated diarrhea. Rhabdomyolysis w/ or w/o renal impairment in seriously ill patients receiving erythromycin concomitantly w/ lovastatin. Monitor carefully for creatine kinase & serum transaminase levels. Myasthenia gravis. Syphilis (infants born to women treated during pregnancy w/ oral erythromycin for early syphilis should be treated w/ an appropriate penicillin regimen). Patients should have a serologic test for syphilis before receiving erythromycin as treatment for gonorrhea & a follow-up serologic test for syphilis after 3 mth. Unsafe in porphyric patients. Infantile hypertrophic pyloric stenosis occurring in infants after erythromycin treatment. Long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi. Falsely elevate conc of urinary catecholamines, 17-hydroxycorticosteroids & 17-ketosteroids. May interfere w/ colorimetric assays resulting in falsely elevated AST & ALT conc. May decrease serum folate assay results if a microbiologic method is used. May interfere w/ etiologic diagnosis of mycoplasma pneumonia by masking a rise in the titer of tetrazolium reduction inhibition neutralizing Ab to Mycoplasma pneumoniae. Hepatic impairment or impaired biliary excretion or in those concomitantly receiving potentially hepatotoxic agents. Pregnancy & lactation. Childn.
Adverse Reactions
Upper abdominal pain/discomfort, abdominal cramping, heartburn, nausea, vomiting, diarrhea, pancreatitis, stomatitis, anorexia, infantile hypertrophic pyloric stenosis, melena, pruritus ani, pseudomembranous colitis, hairy tongue (long-term treatment); chest pain, fever, malaise, hypothermia (in childn); allergic reactions ranging from urticaria & mild skin eruptions to anaphylaxis, rash/maculopapular rashes, pruritus, exanthema, angioedema, SJS, TEN, erythema multiforme; prolongation of QT interval & development of ventricular arrhythmias, including atypical ventricular tachycardia (torsades de pointes), palpitations, hypotension; cholestatic/hepatocellular hepatitis, jaundice, hepatic dysfunction/failure, hepatomegaly, increased liver enzyme values/abnormal LFT results; raised serum bilirubin; interstitial nephritis; agranulocytosis, eosinophilia; aggravation of muscular weakness in myasthenia gravis; superinfection w/ resistant organisms.
Drug Interactions
Concomitant use w/ drugs that are potent inhibitors of CYP3A (eg, fluconazole, ketoconazole, itraconazole, diltiazem, verapamil) should be avoided; increased incidence of sudden death from cardiac causes. Sub-therapeutic levels of erythromycin & decreased effect w/ inducers of CYP3A4 (eg, rifampicin, phenytoin, carbamazepine, phenobarb, St. John's Wort). Elevations in serum conc of the following drugs eg, acenocoumarol, alfentanil, astemizole, bromocriptine, carbamazepine, cilostazol, ciclosporin, digoxin, dihydroergotamine, disopyramide, ergotamine, hexobarbital, methylprednisolone, midazolam, omeprazole, quinidine, rifabutin, sildenafil, tacrolimus, terfenadine, theophylline, tolvaptan, triazolam, valproate, vinblastine. Erythromycin alters metabolism of these non-sedating antihistamines eg, astemizole & terfenadine. Cimetidine may inhibit metabolism of erythromycin. Elevated cisapride levels. Precipitate tonic-clonic seizure w/ clozapine. Life-threatening or fatal colchicine toxicity. Increase conc of HMG CoA reductase inhibitors (eg, simvastatin & lovastatin). Initiation of erythromycin treatment in some patients stabilized on warfarin has resulted in prolongation of prothrombin time & bleeding. Decrease effect of OCs. Inhibition of erythromycin's metabolism w/ PIs. Erythromycin increased peak plasma conc, area under the conc time curve, & terminal elimination t1/2 of quetiapine. Hypotension, bradyarrhythmias & lactic acidosis w/ verapamil. Decrease clearance of zopiclone which may result in increased pharmacodynamic effects of this drug. In vitro antagonism exists between erythromycin & bactericidal β-lactam antibiotics (eg, penicillin, cephalosporin). Erythromycin antagonizes action of clindamycin, lincomycin, chloramphenicol, streptomycin, tetracyclines & colistin. Antibacterial activity of erythromycin is increased by acetazolamide, Na bicarbonate or other drugs which alkalinize urine.
MIMS Class
Macrolides
ATC Classification
J01FA01 - erythromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
RiteMED Erythromycin FC tab 500 mg
Packing/Price
100's (P1,850/box, P18.5/film-coated tab)
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