Azithromycin-BP

azithromycin

Each capsule contains azithromycin 500 mg as azithromycin dihydrate. Size 00 capsules, opaque white cap/body, cylindrical with hemispherical ends, containing a white to pale yellow powder or compacted mass.

Each capsule contains azithromycin 250 mg as azithromycin dihydrate. Size 1 capsules, opaque blue cap/opaque white body, cylindrical with hemispherical ends, containing a white to pale yellow powder or compacted mass.

Indication: Indicated for the treatment of infections caused by susceptible micro-organisms: upper respiratory tract infections (bacterial pharyngitis/tonsillitis, sinusitis, otitis media), lower respiratory tract infections (acute bronchitis, community-acquired pneumonia), skin and soft-tissue infections (erythema chronicum migrans, erysipelas, impetigo, secondary pyoderma), and uncomplicated genitourinary infections due to Chlamydia trachomatis.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications Azithromycin-BP is contraindicated in patients with hypersensitivity to azithromycin, erythromycin, other macrolide or ketolide antibiotics, or to any of the excipients listed in section 6.1.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Hypersensitivity As with erythromycin and other macrolides, rare serious allergic reactions have been reported, including angioedema and anaphylaxis (rarely fatal), skin reactions including acute generalised exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (rarely fatal), and drug reactions with eosinophilia and systemic symptoms (DRESS). Some of these reactions associated with azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment. If an allergic reaction occurs, the medicinal product should be discontinued and appropriate treatment instituted. Physicians should be aware that allergic symptoms may reappear when symptomatic treatment is discontinued. […]