Active Ingredient: Azithromycin (as azithromycin monohydrate hemiethanolate)
Strength: 250 mg tablets
Manufacturer: Teva Canada Limited
Indications and Clinical Use
Indications:
Pharyngitis and Tonsillitis: Caused by Streptococcus pyogenes in individuals who cannot use first-line therapy.
Acute Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): Caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Community-Acquired Pneumonia: Caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Chlamydia pneumoniae.
Uncomplicated Skin and Skin Structure Infections: Caused by Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae.
Genitourinary Tract Infections: Urethritis and cervicitis due to Neisseria gonorrhoeae or Chlamydia trachomatis, and genital ulcer disease due to Haemophilus ducreyi.
Contraindications
History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibacterial agent, or any ingredient in the formulation.
Warnings and Precautions
Serious Allergic Reactions: Including angioedema, anaphylaxis, and dermatological reactions (e.g., Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis).
Cardiovascular: Risk of QT interval prolongation and torsade de pointes; caution in patients with a history of QT prolongation or who are on medications that prolong the QT interval.
Hepatotoxicity: Cases of hepatic necrosis and hepatic failure resulting in death have been reported.
Gastrointestinal: Risk of Clostridium difficile-associated disease (CDAD).
Myasthenia Gravis: Exacerbations reported; not recommended for use in these patients.
Adverse Reactions
Common: Gastrointestinal issues such as nausea, vomiting, diarrhea, abdominal pain.
Clinical Trials: Mild and transient nature of most side effects; discontinuation due to side effects is rare.
Drug Interactions
Significant Interactions:
Antacids: Reduced peak serum levels of azithromycin.
Ergot Derivatives: Increased risk of ergot toxicity.
Warfarin: May potentiate effects; monitor prothrombin times.
Cyclosporine: Significant elevation in cyclosporine levels; monitor levels.
Nelfinavir: Increased azithromycin levels; monitor for side effects.
Digoxin and Colchicine: Potential for elevated serum levels; clinical monitoring recommended.
Dosage and Administration
Adults:
Respiratory and Skin Infections: 500 mg on day 1, followed by 250 mg once daily on days 2-5.
Genitourinary Infections: Single 1 gram dose for chlamydial infections; single 2 gram dose for gonococcal infections.
Overdosage
Management: General supportive measures, activated charcoal to aid removal of unabsorbed drug. Ototoxicity and gastrointestinal adverse events may occur.
