Zithromax Powder for oral suspension 600 mg/15 ml
Pfizer
Pfizer
Composition
Active ingredient
Azithromycin dihydrate - 5.008 g.
Equivalent to azithromycin base - 4.778 g.
Excipients (including excipients with known effects)
Sucrose, sodium phosphate tribasic anhydrous, hydroxypropyl cellulose, xanthan gum, artificial cherry flavour, crème de vanilla, banana flavour.
After reconstitution: 1 ml contains 40 mg azithromycin.
5 ml contains 200 mg azithromycin.
Description
Intended for the treatment of infections caused by azithromycin-susceptible microorganisms, including upper and lower respiratory tract infections, acute otitis media, skin and soft tissue infections, and certain dental infections.
Indications for Use
- Upper respiratory tract infections (sinusitis, tonsillitis, pharyngitis)
- Lower respiratory tract infections (bronchitis, pneumonia)
- Acute otitis media
- Odontostomatological infections
- Skin and soft tissue infections
- Infections caused by azithromycin-susceptible bacteria.
Dosage and Method of Administration
Adults: 500 mg once daily for 3 days.
Elderly: Same dosing regimen as adults.
Use caution due to increased risk of cardiac arrhythmia and torsade de pointes.
Paediatric population: 10 mg/kg once daily for 3 days.
For children ≥45 kg - adult dose (500 mg/day × 3 days).
Weight-based dosing
- <15 kg: 10 mg/kg/day × 3 days
- 15-25 kg: 200 mg (5 ml)/day × 3 days
- 26-35 kg: 300 mg (7.5 ml)/day × 3 days
- 36-45 kg: 400 mg (10 ml)/day × 3 days
- 45 kg: 500 mg/day × 3 days
- Acute otitis media in children: 10 mg/kg/day × 3 days.
- Streptococcal pharyngitis: 10-20 mg/kg/day; maximum 500 mg/day.
Administration
Taken once daily.
May be taken with or without food; eating may reduce GI side effects.
Shake well before use.
Reconstitution
Add 9 ml water to obtain 15 ml suspension.
Contraindications
- Hypersensitivity to azithromycin, erythromycin, macrolides, ketolides, or excipients
- History of cholestatic jaundice or hepatic dysfunction from prior azithromycin use.
Precautions
- Risk of severe allergic reactions (anaphylaxis, angioedema, SJS, TEN, DRESS)
- Hepatotoxicity; discontinue if signs of liver dysfunction appear
- Infantile hypertrophic pyloric stenosis in infants up to 42 days
- Do not combine with ergot derivatives
- CDAD (Clostridium difficile-associated diarrhoea)
- QT prolongation; risk of torsade de pointes
- Myasthenia gravis exacerbation
- Contains 3.87 g sucrose per 5 ml - caution in diabetes
- Contains <1 mmol (23 mg) sodium per 5 ml - essentially sodium-free.
Side Effects
Very common
Diarrhoea.
Common
Vomiting, nausea, abdominal pain; blood count changes; headache.
Uncommon
Palpitations, dyspnoea, gastritis, dermatitis, pruritus, myalgia, oedema, fatigue, abnormal liver tests.
Rare
Cholestatic jaundice, photosensitivity, acute generalised exanthematous pustulosis.
Very rare/Not known
Hearing impairment, pancreatitis, hepatic failure, ventricular tachycardia, QT prolongation, SJS, TEN, erythema multiforme, acute renal failure, interstitial nephritis.
Pregnancy and Breastfeeding
Pregnancy
Use only if benefit outweighs risk.
Animal studies show placental transfer; no human data.
Breastfeeding
Azithromycin passes into breast milk (0.1-0.7 mg/kg/day).
Decide whether to discontinue breastfeeding or therapy.
Storage Conditions
Store below 25°C in a dry place.
After reconstitution: use within 5 days.
Protect from freezing.
Keep out of reach of children.
Packaging
A carton box containing a plastic bottle with powder, oral dosing syringe, leaflet.