AZITHROMYCIN injectable

Therapeutic action

• Macrolide antibacterial

Indications

• Macrolide-sensitive severe infections, when oral administration is not possible (e.g. sepsis, diphtheria)

Forms and strengths, route of administration

• Powder for injection, in 500 mg vial, to be dissolved in 4.8 ml of water for injection, for IV infusion in 0.9% sodium chloride or 5% glucose
• DO NOT ADMINISTER BY IV or IM INJECTION.

Dosage 

Sepsis

• Child: 10 to 20 mg/kg (max. 500 mg) once daily
• Adult: 500 mg to 1 g once daily

Diphtheria 

• Child: 10 to 12 mg/kg (max. 500 mg) once daily
• Adult: 500 mg once daily

Dilute each dose in 0.9% sodium chloride or 5% glucose to obtain a final concentration of 2 mg/ml and administer over 60 minutes.

Examples:

• for a child weighing 15 kg, 150 mg (10 mg x 15 kg) in 75 ml of 0.9% sodium chloride or 5% glucose
• for an adult, 500 mg in 250 ml (or 1 g in 500 ml) of 0.9% sodium chloride or 5% glucose

Duration

• Change to oral treatment as soon as possible.

Contra-indications, adverse effects, precautions

• Do not administer to patients with allergy to azithromycin or another macrolide, nor to patients with severe hepatic impairment.
• Administer with caution to children under 6 weeks of age (risk of hypertrophic pyloric stenosis) and patients with risk factors for QT prolongation (e.g. electrolyte disturbances, pre-existing cardiac and renal disorders, older patients).
• May cause:
  • gastrointestinal disturbances, reversible hearing disorders, electrolyte disturbances, QT prolongation;
  • rarely: hypersensitivity reactions (including severe cutaneous reactions such as Stevens-Johnson, Lyell and DRESS syndromes) and life-threatening hepatotoxicity. In these cases, stop treatment. Signs and symptoms of hypersensitivity reaction (e.g. fever, rash, mouth ulcers, bleeding) and hepatic disorders (e.g. anorexia, nausea, general malaise, dark urine, pale stools, hepatomegaly, jaundice) require immediate medical attention.
• Avoid combination with drugs that prolong the QT interval (amiodarone, chloroquine, co-artemether, fluconazole, haloperidol, mefloquine, moxifloxacin, ondansetron, pentamidine, quinine, etc.).
• Administer with caution and monitor use in patients taking digoxin (increased digoxin toxicity). 
• Pregnancy and breast-feeding: no contra-indication

Remarks

• Do not mix with other drugs in the same infusion.

Storage