Zithromax Powder for oral suspension 1200 mg/30 ml
Pfizer
Pfizer
Composition
Each 1 ml of reconstituted suspension contains
Azithromycin 40 mg (200 mg per 5 ml).
Composition per 100 g of powder
Azithromycin dihydrate 5.008 g (equivalent to 4.778 g azithromycin).
Excipients (including known effects)
Sucrose, sodium phosphate tribasic anhydrous, hydroxypropyl cellulose, xanthan gum, artificial cherry flavour, crème de vanilla, banana flavour.
Description
Azithromycin is a macrolide antibiotic with broad antibacterial activity.
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.
Therapeutic Indications
- Upper respiratory tract infections (sinusitis, tonsillitis, pharyngitis)
- Lower respiratory tract infections (bronchitis, pneumonia)
- Acute otitis media - Odontostomatological infections
- Skin and soft tissue infections.
Dosage and Administration
Once-daily dosing.
May be taken with or without food.
Reconstitution
Add 15 ml water, shake well.
Adults and ≥45 kg: 500 mg once daily for 3 days.
Paediatric population: 10 mg/kg/day for 3 days.
Max total dose: 1500 mg.
Weight-based dosing
- <15 kg: 10 mg/kg/day for 3 days
- 15-25 kg: 200 mg (5 ml)/day for 3 days
- 26-35 kg: 300 mg (7.5 ml)/day for 3 days
- 36-45 kg: 400 mg (10 ml)/day for 3 days
- 45 kg: adult dose.
Streptococcal pharyngitis: 10 mg/kg or 20 mg/kg; do not exceed 500 mg/day.
Penicillin remains drug of choice.
Renal impairment
GFR 10-80 ml/min: no adjustment.
GFR <10 ml/min: caution.
Hepatic impairment
Use with caution; discontinue if dysfunction occurs.
Contraindications
- Hypersensitivity to azithromycin, erythromycin, macrolides, ketolides
- Previous cholestatic jaundice/hepatic dysfunction with Zithromax
- Severe hepatic impairment.
Precautions
- Severe hypersensitivity reactions (anaphylaxis, AGEP, SJS, TEN, DRESS)
- Hepatic injury, hepatic failure
- QT prolongation, ventricular arrhythmias
- C. difficile-associated diarrhoea
- Infantile hypertrophic pyloric stenosis
- Exacerbation of myasthenia gravis
- Diabetes (contains 3.87 g sucrose per 5 ml).
Side Effects
Very common
Diarrhoea.
Common
Nausea, vomiting, abdominal pain, headache, blood count changes.
Uncommon
Candidiasis, tinnitus, palpitations, hepatitis, rash, urticaria.
Rare: Photosensitivity, cholestatic jaundice, AGEP, DRESS.
Not known
Anaphylaxis, pancreatitis, hepatic failure, TEN, torsade de pointes, acute renal insufficiency.
Pregnancy and Lactation
Use only if benefit outweighs risk.
Excreted in breast milk.
Storage Conditions
Store below 25°C in a dry place.
Use reconstituted suspension within 5 days at ≤25°C.
Protect from freezing.
Keep out of reach of children.
Packaging
A carton box containing a bottle with powder, plastic syringe, leaflet.
Reconstituted volume: 30 ml (200 mg/5 ml).