Zithromax Powder for oral suspension 1200 mg/30 ml

Zithromax Powder for oral suspension 1200 mg/30 ml 

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).