JOURNAL TRANSCRIPT
CORE SAFETY PROFILE (CSP)
Active Substance: Azithromycin Brand Names: ZITHROMAX, ZITROMAX, ZITROTEK, ZITROCIN, AZITROCIN, AZITROMAX, AZENIL, AZITROMICINA, VICON, AZADOSE, AZIMAX, ULTREON, XISHUMEI, ZITHROMAC, AZITHROMAX ZITHROMAX GRANULAT, ZITROMAX UNO, ZMAX
Pharmaceutical form(s)/strength: 250 mg and 500 mg film-coated tablets 40 mg/ml powder for oral suspension 500 mg powder for solution for infusion 2 g granules, prolonged release, for oral suspension 4.3
Contraindications
The use of this product is contraindicated in patients with hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any excipient listed in Section 6.1 (List of excipients).
4.4
Special warnings and precautions for use
As with erythromycin and other macrolides, rare serious allergic reactions, including angioedema and anaphylaxis (rarely fatal), have been reported. Some of these reactions with azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment. Since liver is the principal route of elimination for azithromycin, the use of azithromycin should be undertaken with caution in patients with significant hepatic disease. Cases of fulminant
hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin (see Section 4.8) Liver function tests/investigations should be performed in cases where signs and symptoms of liver dysfunction occur such as rapid developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy. In patients receiving ergot derivatives, ergotism has been precipitated by coadministration of some macrolide antibiotics. There are no data concerning the possibility of an interaction between ergot and azithromycin. However, because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be coadministered.
1 PFIZER INTERNAL USE
As with any antibiotic preparation, observation for signs of superinfection with non-susceptible organisms, including fungi is recommended. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including azithromycin, 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. In patients with severe renal impairment (GFR