Zithromax Powder for oral suspension 600 mg/15 ml

Zithromax Powder for oral suspension 600 mg/15 ml 

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.